Protection
Aaency
x°/EPA
                Data Sources for the
                Contaminant
                Candidate List 4

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Office of Water (4607M)
EPA 815-R-15-004
January 2015

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                                    Contents
1.0 Introduction	1
2.0 Summary of the Process for Evaluating Chemical Data Sources	3
3.0 Chemical Data Sources Evaluated for CCL 4	4
4.0 Microbial Data Sources Evaluated for CCL 4	5
5.0 References	6
6.0 Appendices	Al
   Appendix 1 CCL 4 Data Source Descriptions	Al
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                        Acronyms and Abbreviations

 |i             microgram, one
 Hg/L          micrograms per liter
 ATSDR       Agency for Toxic Substances and Disease Registry
 AWWA       American Water Works Association
 CASRN       Chemical Abstract Services Registry Number
 CDC          Centers for Disease Control and Prevention
 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
 CSTE         Council of State and Territorial Epidemiologists
 CUS/IUR      Chemical Update System/Inventory Update Rule
 CWSs         Community Water Systems
 DRI           Dietary Reference Intake
 EPA          United States Environmental Protection Agency
 FDA          United States Food and Drug Administration
 FR            Federal Register
 g             gram
 HHBPs        Human Health Benchmark for Pesticides
 GAMA        California State Water Resources Control Board's Groundwater Ambient
               Monitoring Assessment
 IARC         International Agency for Research on Cancer
 IOM          Institute of Medicine
 IRIS          Integrated Risk Information System
 kg            kilogram
 L             liter
 LOAEL       Lowest Observed Adverse Effect Level
 MCL         Maximum Contaminant Level
 MCLG        Maximum Contaminant Level Goal
 MCM         Manual of Clinical Microbiology
 mg/kg         milligrams per kilogram body weight
 mg/kg/day     milligrams per kilogram body weight per day
 mg/L         milligrams per liter
 MMWR       Morbidity and Mortality Weekly Report
 MRL         Minimum Risk Level
 NAWQA      National Water Quality Assessment
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 NCOD        National Contaminant Occurrence Database
 NDWAC      National Drinking Water Advisory Council
 NOAEL       No Observed Adverse Effect Level
 NREC         National Reconnaissance of Emerging Contaminants
 NTP          National Toxicology Program
 OEHHA       Office of Environmental Health Hazard Assessment
 OPP          Office of Pesticide Programs
 OSRTI        Office of Superfund Remediation and Technology Innovation
 PCCL         Preliminary Candidate Contaminant List
 PDF          Pesticide Data Program
 PPCPs         Pharmaceuticals and Personal Care Products
 PPRTVs       Provisional Peer Reviewed Toxicity Values
 PWS          Public Water System
 RDAs         Recommended Dietary Allowances
 RED          Reregi strati on Eligibility Document
 RfC           reference concentration
 RfD           reference dose
 RoC          Report on Carcinogens
 SDWA        Safe Drinking Water Act
 STORET      EPAs Storage and Retrieval System
 SWRCB       State Water Resources Control  Board
 TRI           Toxics Release Inventory
 ULs           Upper Intake Levels
 US            United States of America
 USDA         United States Department of Agriculture
 USGS         United States Geological Survey
 WBDO        Waterborne Disease Outbreak
 WHO         World Health Organization
 yr             Year
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1.0   Introduction

Section 1412(b)(l) of the Safe Drinking Water Act (SOWA), as amended in 1996, requires EPA
to publish the Contaminant Candidate List (CCL) every five years. The SDWA specifies that the
list must include contaminants that are not subject to any proposed or promulgated National
Primary Drinking Water Regulations (NPDWRs),  are known or anticipated to occur in public
water systems (PWSs) and may require regulation under the SDWA. EPA uses this list  of
unregulated contaminants to help the agency identify priority contaminants for regulatory
decision making and to prioritize research and data collection efforts. SDWA also requires the
agency to consult with the scientific community, including the Science Advisory Board  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 contaminants that present the greatest public  health
concern related to exposure from drinking water.

EPA published the third CCL (CCL 3), which listed 116 contaminants on October 8, 2009 (74
FR 51850 (USEPA, 2009a)). In developing the CCL 3, EPA implemented a multi-step process  to
select contaminants, which included the following key steps:

   (1) The identification of a broad universe of potential drinking water contaminants (CCL 3
       Universe);
   (2) Screening the CCL 3 Universe to a Preliminary CCL (PCCL) using screening criteria
       based on the potential to occur in PWSs and the potential for public health concern; and
   (3) Evaluation of the PCCL contaminants based on a more detailed review of the occurrence
       and health effects data using a scoring and  classification system to identify a final list of
       116 CCL 3 contaminants; and
   (4) Incorporating public input and expert review in the CCL 3 process.

Steps 1, 2 and 3 in the process are described in detail in the CCL 3 support documents:

   •   Final CCL 3 Chemicals: Identifying the Universe (USEPA, 2009b);
   •   Final CCL 3 Chemicals: Screening to a PCCL (USEPA, 2009c);
   •   Final Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL
       (USEPA, 2009d);
   •   Final CCL 3 Microbes: Identifying the Universe (USEPA, 2009e);
   •   Final CCL 3 Microbes: Screening to the PCCL (USEPA, 2009f); and
   •   Final CCL 3 Microbes: PCCL to CCL Process (USEPA, 2009g).

These documents can be found on the EPA web site at: http://www2.epa.gov/ccl/contaminant-
candidate-list-3-ccl-3 or at http://www.regulations.gov (docket ID: EPA-HQ-OW-2007-1189).

After a Final CCL is published, SDWA  section 1412(b)(l)(B)(ii) as amended in 1996, requires
EPA at five year intervals to make determinations  of whether to regulate or not to regulate no
fewer than five contaminants from the CCL in a process called regulatory determinations.  This
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is a separate process from the listing of contaminants on the CCL. The 1996 SDWA
Amendments specify three criteria to determine whether a contaminant may require regulation:
    •   the contaminant may have an adverse effect on the health of persons;
    •   the contaminant is known to occur or there is a substantial likelihood that the contaminant
       will occur in PWSs with a frequency and at levels of public health concern; and
    •   in the sole judgment of the Administrator, regulation of such contaminant presents a
       meaningful opportunity for health risk reduction for persons served by PWSs.

If EPA determines that these three statutory criteria are met and makes a final determination to
regulate a contaminant, the agency has 24 months to publish a proposed Maximum Contaminant
Level Goal1 (MCLG) and NPDWR2. After the proposal, the agency has 18 months to publish
and promulgate a final MCLG and NPDWR (SDWA section  1412(b)(l)(E))3.

On February 11, 2011, as a separate action, the agency issued a positive regulatory determination
for perchlorate, a chemical listed in CCL 1, CCL 2 and CCL 3 (76 FR 7762 (USEPA, 2011)).
Recently, EPA has published preliminary regulatory determinations for five unregulated
contaminants on the CCL 3 (79 FR 62716 (USEPA, 2014)). The five contaminants include:
dimethoate;  1,3-dinitrobenzene; strontium; terbufos and terbufos sulfone. The agency is making
preliminary determinations to regulate one contaminant (strontium) and to not regulate four
contaminants (dimethoate; 1,3-dinitrobenzene; terbufos; and terbufos sulfone). Therefore, the
agency is removing perchlorate and these five contaminants from the Draft Fourth CCL (CCL 4),
pending the result of the final regulatory determinations for CCL 3.

EPA conducted an abbreviated evaluation and selection process for the CCL 4. This abbreviated
CCL 4 process includes a three pronged approach: (1) carrying forward CCL 3 contaminants
(minus those with regulatory determinations), (2) seeking and evaluating nominations from the
public for additional contaminants to consider and (3) evaluating any new data for those
contaminants with previous negative regulatory determinations from CCL 1 or CCL 2 for
potential inclusion on the CCL 4.

As part of the process to develop the CCL 4, EPA published a Federal Register notice (77 FR
27057 (USEPA, 2012)) requesting that the public submit nominations for chemical and
microbial contaminants to be considered for inclusion in the CCL 4. EPA also requested
supporting information that has been made available since the development of the CCL 3 or
existing information that was not considered in the development of the CCL 3, which shows that
the nominated contaminant may have an adverse health effect on people and occurs or is likely to
occur in public water systems. EPA reviewed the nominations and supporting information
provided by nominators to determine if any new data were provided that had not been previously
1 The MCLG is the "maximum level of a contaminant in drinking water at which no known or anticipated adverse
effect on the health of persons would occur, and which allows an adequate margin of safety. Maximum contaminant
level goals are non-enforceable health goals." (40 C.F.R. 141.2; 42 U.S.C. 300g-l)
2 An NPDWR is a legally enforceable standard that applies to public water systems. An NPDWR sets a legal limit
(called a maximum contaminant level or MCL) or specifies a certain treatment technique (TT) for public water
systems for a specific contaminant or group of contaminants. The MCL is the highest level of a contaminant that is
allowed in drinking water and is set as close to the MCLG as feasible using the best available treatment technology
and analytical methods and taking cost into consideration.
3  The statute authorizes a nine month extension of this promulgation date.
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evaluated for CCL 3. The agency also collected additional data for the nominated contaminants,
when it was available, from both CCL 3 data sources that had been updated and from new data
sources that were not available at the time of CCL 3. A complete list of references provided by
nominators can be found in the support document Summary of Nominations for the Fourth CCL
(USEPA, 2015).

The purpose of this document is to provide a description of the data sources that EPA collected
updated or new information for CCL 4 and to briefly summarize the process, which was
developed under CCL 3, used to evaluate the new data sources.


2.0    Summary of the Process for  Evaluating Chemical Data Sources

As previously described, EPA collected additional data for the nominated contaminants and
contaminants with previous negative regulatory determinations (from Regulatory Determinations
1 & 2), when it was available, from both CCL 3 data sources that had been updated and from
new data sources that were not available at the time of CCL 3. EPA used the same process
developed under CCL 3 for evaluating new data sources for potential inclusion in the CCL 4
process. The process is summarized in this section, and a more detailed description of this
process can be found in the CCL 3 supporting document: Final CCL 3 Chemicals: Identifying
the Universe (USEPA, 2009b).

EPA used four assessment factors (relevance, completeness, redundancy and retrievability) to
evaluate and identify data sources that would be used to make up the CCL 3 Chemical Universe.
These assessment factors ensure that the data sources are: relevant to the CCL process, complete
in basic documentation, not redundant with other data sources and are formatted for automated
retrieval. These factors were based upon the National Drinking Water Advisory Council's
(NDWAC)  recommendation that data sources should:

   1.  Have data and information about actual or potential occurrence of contaminants in
       drinking water or source water and/or about health effects;
   2.  Focus on readily available data (e.g., those that could be automatically retrieved); and
   3.  Meet EPA's minimum guidelines for documentation and quality.

The relevance assessment factor addresses the NDWAC and National Research Council
principles for the CCL 3 Universe and evaluates whether a data source contains information on
demonstrated or potential occurrence of contaminants in the environment and/or demonstrated or
potential human health effects. The completeness assessment evaluates whether the data source
provides complete, minimum documentation and quality requirements. NDWAC recommended
that each source should include: 1) the name of a person to contact about the data source (or
contact information); 2) a description of the data elements; 3) information on how the data were
obtained; and 4) meaningfulness and relevance of the data. The "meaningfulness and relevance"
NDWAC recommendation is addressed by the relevance assessment factor, so it is not included
in the completeness assessment. Also, data sources that provide documentation of peer review
are considered to satisfy the completeness criteria. The redundancy assessment factor evaluates
whether data sources contain information that is identical to (i.e., duplicate information) other,
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more comprehensive data sources. An example of a redundant source would be data contained in
a state or regional data source that were copied from a more comprehensive or representative
national data source. Therefore, to be considered redundant, a data source must contain data
identical with respect to the identity of the original data gatherer, time, place, method, outcome
and data manipulation or modification. The retrievability assessment factor is an evaluation of
whether the data in a source are formatted for automated retrieval. For example, if data are stored
in a tabular format, they may be extracted and formatted using software tools and imported
directly into a database for further use.

Each data source was accessed online (or as provided by the source proprietor) and reviewed.
Basic information about the data source, its purpose and the data elements it contained was
compiled and documented. Every source was evaluated using all four assessment factors. For a
complete list and description of the 40 primary data sources and 64 supplemental data sources
used for CCL 3, please refer to Final CCL 3 Chemicals: Identifying the Universe (USEPA,
2009b).
3.0    Chemical Data Sources Evaluated for CCL 4

This section lists both the chemical data sources that were used for CCL 3 and were updated for
CCL 4 and the new data sources evaluated for CCL 4 that were not available at the time of CCL
3. EPA evaluated each of the new data sources for CCL 4 according to the four assessment
factors that are described in Section 2. A more detailed description of each of these data sources
including an explanation of whether the new data sources met each of the four assessment factors
can be found in Appendix 1.

Occurrence data was collected from updated CCL 3 data sources including:

   •   2006 production data collected in the Chemical Update System (CUS) under the
       Inventory Update Rule (IUR),
   •   2010 data from the Toxics Release Inventory (TRI),
   •   2003-2009 data from the U.S. Department of Agriculture's (USDA) Pesticide Data
       Program (PDF), and
   •   EPA's Storage and Retrieval (STORET) data as of January 2013.

Additional occurrence data for the nominated contaminants were collected from data sources that
are new since the CCL 3 including:

   •   USGS studies that focused on contaminant occurrence in source waters for public water
       systems (Hopple et al., 2009, and Kingsbury et al., 2008) and water quality in public-
       supply wells (Toccalino et al., 2010);
   •   Individual State public water supply data provided to EPA during the second Six-Year
       Review of regulated contaminants (for the time period covering 1998-2005) from States
       including: CA, FL, IL, NC,  OH, Region 9 Tribes, SD, TX and WI;
   •   Data from the California State Water Resources Control Board's Groundwater Ambient
       Monitoring Assessment (GAMA) program; and
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   •   New data from a literature review of published studies on pharmaceuticals, personal care
       products and other contaminants.

In addition to health effects data provided by the nominators, EPA searched for health effects
data for the nominated contaminants from data sources used in CCL 3 that may have been
updated including:

   •   EPA's Integrated Risk Information System (IRIS) program,
   •   EPA's Office of Pesticide Programs (OPP),
   •   Agency for Toxic Substances and Disease Registry (ATSDR),
   •   California EPA (Office of Environmental Health Hazard Assessment),
   •   Institute of Medicine (IOM),
   •   National Toxicology Program (NTP), and
   •   World Health Organization (WHO).

EPA also considered new or updated health effects information contained in the agency's Office
of Superfund Remediation and Technology Innovation (OSRTI) Provisional Peer Reviewed
Toxicity Values (PPRTVs).
4.0    Microbial Data Sources Evaluated for CCL 4

This section outlines the data sources and approaches used to develop the microbial CCL from
the Universe through the final CCL. Because of the inherent differences between microbes and
chemicals and differences in the availability of tabulated data containing the data elements
required for screening evaluations, it was necessary to rely upon text-based resources for
processing microbes.

The Microbial CCL 3 Universe was defined as all known human pathogens and the compilation
of Taylor et al. (2001) served as a practical starting point. This list includes 1,415 bacteria,
viruses, protozoa, helminths and fungi known to be pathogenic for humans based upon literature
review. This list was supplemented by adding six fungi isolated from drinking water distribution
systems that did not appear on the Taylor list and with 2 nominations from the scientific
community (from CCL 3). Since the publication of CCL 3, there have been no updates to Taylor
et al. (2001), so the CCL 3 Universe is being carried forward to the Draft CCL 4.

During CCL 3, text-based resource materials, such as The Manual of Clinical Microbiology
(MCM), 9th Edition, were used to inform the screening and scoring process. The MCM 10th
edition was published in 2011 (MCM, 2011). The MCM is a two-volume peer reviewed
reference that is written by an international team of subject experts. EPA reviewed the latest
edition of the MCM for changes that would affect the outcome of the nominated microbes in
CCL 4. No  new data were found that would result in a different outcome for any of the
nominated microbes.

For CCL 3, web searches were also conducted to identify authoritative online databases which
could be used to document screening decisions (e.g., Universe to PCCL). While it is possible that
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these sources may contain updated information regarding nomenclature or classification, new
data detailing a fundamental change in characteristics were not found for use in CCL 4. Thus, the
criteria used for exclusion of microbes during CCL 3 remain valid. For more information on the
screening criteria developed under CCL 3 and used for CCL 4, please see Final Contaminant
Candidate List 3 Microbes: Screening to the PCCL (USEPA,  2009f).

The MCM (2011) was one of the main sources of information used to inform the scoring of the
PCCL microbes (both for CCL3 and CCL4). EPA also conducted a literature search covering the
time period between CCL 3 and CCL 4 (2007-2012). The literature search focused on health
effects and occurrence of the nominated microbial contaminants in water. No new data were
found as a result of the literature search that would support a change to the CCL 3 scores, thus
the scores remain the same for CCL 4. For more information on the scoring protocols developed
under CCL 3 and used for CCL 4, please see Final Contaminant Candidate List 3 Microbes:
PCCL to CCL Process (USEPA, 2009g).

For Waterborne Disease Outbreaks (WBDOs), the primary source for scoring data was the
Center for Disease Control (CDC) Morbidity and Mortality Weekly Reports (MMWR). CDC,
EPA and the Council of State and Territorial Epidemiologists (CSTE) maintain a collaborative
surveillance system for collecting and periodically reporting data related to occurrences and
causes of WBDOs. These reports from the CDC are published periodically in the MMWR. For
the CCL 3, EPA used CDC's MMWR summaries from 1998-2004 as the source for the WBDO
scoring protocol. The same process was used for CCL 4, however the data were updated through
2008 (CDC, 2008; CDC, 2011).


5.0   References

CDC. 2008. Surveillance for Waterborne Disease and Outbreaks Associated with Drinking
Water and Water not Intended for Drinking — United States,  2005-2006. MMWR 57 (SS-9); 1-
72 (Table 4, p. 45; Table 5 p. 46).

CDC. 2011. Surveillance for Waterborne Disease and Outbreaks Associated with Drinking
Water - United States, 2007-2008. MMWR 60 (SS-12); 1-80 (Table 4, p. 45; Table 5 p. 46).

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; pp. 3129.

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

USEPA. 2009a. Drinking Water Contaminant Candidate List  3—Final Notice. Federal Register.
Vol. 74. No 194. p.51850, October 18, 2009.

USEPA, 2009b. Final Contaminant Candidate List 3 Chemicals: Identifying the Universe. EPA.
815-R-09-006.  August 2009.
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USEPA, 2009c. Final Contaminant Candidate List 3 Chemicals: Screening to a PCCL. EPA 815-
R-09-007. August 2009.

USEPA, 2009d. Final Contaminant Candidate List 3 Chemicals: Classification of PCCL to the
CCL. EPA 815-R-09-008. August 2009.

USEPA, 2009e. Final Contaminant Candidate List 3 Microbes: Identifying the Universe. EPA
815-R-09-008. August 2009.

USEPA, 2009f. Final Contaminant Candidate List 3 Microbes: Screening to the PCCL. EPA
815-R-09-008. August 2009.

USEPA, 2009g. Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA
815-R-09-009. August 2009.

USEPA, 2012. Request for Nominations of Drinking Water Contaminants for the Fourth
Contaminant Candidate List. Federal Register Vol. 77. No 89. p. 27057, May 8, 2012.

USEPA. 2014. Announcement of Preliminary Regulatory Determination for Contaminants on
the Third Drinking Water Contaminant Candidate List. Federal Register. Vol. 79, No. 202, p.
62716, October 20, 2014.

USEPA, 2015. Summary of Nominations for the Fourth Contaminant Candidate List. EPA
815 R-15-001. January, 2015.
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6.0   Appendices

                Appendix 1. CCL 4 Data Source Descriptions
Appendix 1 lists the data sources evaluated for CCL 4 including both CCL 3 data sources that
had been updated and new data sources that were not available at the time of CCL 3. This
appendix provides a brief description of each dasta source, gives the proprietor information,
contact information, type of data elements contained in the data source, provides an explanation
of whether each data source meets the four assessment factors and provides a source URL, if
applicable.
Data Sources for Chemical Contaminants
Data Source Name
Data Source Description
Proprietor

Contact Information
Type of Data Elements
12th Report on Carcinogens - NTP
The Report on Carcinogens (RoC) is a congressionally-mandated
document that is prepared by the National Toxicology Program (NTP) for
the Secretary of the U.S. Department of Health and Human Services.
The RoC is updated periodically, and the 12th RoC (released in 2011)
contains profiles for 240 substances, including 54 substances that are
known to be human carcinogens and 186 substances that are
reasonably anticipated to be human carcinogens. The substance profiles
contain data regarding carcinogenicity, genotoxicity, mechanisms of
action in people and/or in animals, the potential for human exposure to
these substances, federal regulations to limit exposures,
physical/chemical properties, use and production. (Description adapted
from website.)
National Toxicology Program, National Institute of Environmental Health
Sciences
Dr. Ruth M. Lunn
Director, Report on Carcinogens Center
National Toxicology Program
Mailing Address: MD K2-14, P.O. Box 12233
Research Triangle Park, NC 27709
Courier Address: 530 Davis Drive, Room 2006
Morrisville, NC 27560 T
Phone:(919)316-4637
Fax:(919)541-0144
Email: lunn@niehs.nih.gov


Name, CASRN, International Agency for Research on Cancer (IARC)
cancer class, toxicological study data, molecular weight, specific gravity,
vapor pressure, vapor density, Melting Point, Boiling Point, log Kow,
dissociation constant, use, production, critical effect, exposure potential,
releases, occupational exposure limits
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Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation

Source URL
This source is considered relevant for the CCL Universe because it
contains data elements from toxicological studies.
It meets considerations because it is peer reviewed.
This source is not redundant.
This source does not meet retrievability criteria because the data are not
formatted for automated retrieval.
http://ntp.niehs.nih.gov/?objectid=03C9AF75-E1BF-FF40-
DBA9EC0928DF8B15
Data Source Name
Data Source Description
Agency for Toxics Substances and Disease Registry Minimal
Risk Levels (MRLs)
The ATSDR Minimal Risk Levels (MRLs) were developed as an initial
response to Congressional mandate. Following discussions with
scientists within the Department of Health and Human Services (HHS)
and the EPA, ATSDR chose to adopt a practice similar to that of the
EPA's Reference Dose (RfD) and Reference Concentration (RfC) used
for deriving substance-specific health guidance levels for non-neoplastic
endpoints. An MRL is an  estimate of the daily human exposure to a
hazardous substance that is likely to be without appreciable risk of
adverse noncancer health effects over a specified duration of exposure.
These substance-specific estimates, which are intended to serve as
screening levels,  are used by ATSDR health assessors and other
responders to identify contaminants and potential health effects that may
be of concern at hazardous waste sites. It is  important to note that MRLs
are not intended to define clean-up or action levels for ATSDR or other
Agencies.
During the development of toxicological profiles, MRLs are derived when
ATSDR determines that reliable and sufficient data exist to identify the
target organ(s) effected or the most sensitive health effect(s) for a
specific duration for a given route of exposure to the substance. MRLs
are based on noncancer health effects only and are not based on a
consideration of cancer effects. Inhalation MRLs are exposure
concentrations expressed in units of parts per million (ppm) for gases
and volatiles or milligrams per cubic meter (mg/m3) for particles. Oral
MRLs are expressed as daily human doses in units of milligrams per
kilogram per day  (mg/kg/day). Radiation MRLs are expressed as
external exposures in units of millisieverts.
ATSDR uses the  no-observed-adverse-effect-level/uncertainty factor
(NOAEL/UF) approach to derive MRLs for hazardous substances. They
are set below levels that, based on current information, might cause
adverse health effects in the people most sensitive to such substance-
induced  effects. MRLs are derived for acute (1-14 days), intermediate
(>14-364 days), and chronic (365 days and longer) exposure durations,
and for the oral and inhalation routes of exposure. Currently MRLs for
the dermal route of exposure are not derived because ATSDR has not
yet identified a method suitable for this route of exposure. MRLs are
generally based on the most sensitive substance-induced end point
considered to be  of relevance to humans. ATSDR does not use serious
health effects (such as irreparable damage to the liver or kidneys, or birth
defects) as a basis for establishing MRLs. Exposure to a level above the
MRL does not mean that adverse health effects will occur.
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Proprietor
Contact Information
Type of Data Elements
Relevance Explanation

Completeness Explanation
Redundancy Explanation

Retrievability Explanation
Source URL
Proposed MRLs undergo a rigorous review process. They are reviewed
by the Health Effects/MRL Workgroup within the Division of Toxicology;
an expert panel of external peer reviewers; the agency wide MRL
Workgroup, with participation from other federal agencies, including
EPA; and are submitted for public comment through the toxicological
profile public comment period. Each MRL is subject to change as new
information becomes available concurrently with updating the
toxicological profile of the substance. MRLs in the most recent
toxicological profiles supersede previously published levels. As of the
date last accessed for CCL update, 120 inhalation MRLs, 189 oral MRLs
and 6 external radiation MRLs have been derived. (Description adapted
from website.)
Agency for Toxic Substances and Disease Registry
Dr. Selene Chou
Division of Toxicology
Agency for Toxic Substances and Disease Registry
1600 Clifton Road, Mailstop E29
Atlanta, Georgia 30333Telephone: 404-498-0705
E-Mail: cjc3@cdc.gov
Name,  CASRN, MRL  (chronic, intermediate, acute)
This source is considered relevant for the CCL Universe because it
contains data elements (MRL) derived from toxicological studies.
It meets considerations because it is peer reviewed.
These data are also represented in the ATSDR Toxicological Profiles;
however, these data are tabular while the Profiles are monographic.
This source meets retrievability criteria because it is in tabular format.
http://www.atsdr.cdc.gov/mrls/index.html
Data Source Name
Data Source Description
Background document for development of WHO Guidelines
for Drinking-water Quality
The fourth edition of the World Health Organization's Guidelines for
Drinking-water Quality are intended to support the development and
implementation of risk management strategies that will ensure the safety
of drinking-water supplies through the control of hazardous constituents
of water. WHO has  been issuing drinking water guidelines for over 50
years.

WHO informs the public through the establishment of health-based
targets, catchment-to-consumer water safety plans and independent
surveillance. The first WHO document dealing specifically with public
drinking-water quality was published in 1958 as International Standards
for Drinking-water and was revised in 1963 and in 1971. In 1984-1985,
the first edition of the WHO Guidelines for Drinking-water Quality
(GDWQ) was published in three volumes. Second editions of these
volumes were published in 1993, 1996 and 1997. Addenda to Volumes 1
and 2 of the second edition were published in 1998 addressing selected
chemicals. An addendum on  microbiological aspects reviewing selected
microorganisms was published in 2002. The third edition of the GDWQ
was published in 2004, the first addendum to the third edition was
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                             published in 2006 and the second addendum to the third edition was
                             published in 2008. The fourth edition was published in 2011.
Proprietor
Contact Information
Type of Data Elements

Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation

Source URL
The GDWQ are subject to a rolling revision process. Through this
process, microbial, chemical and radiological aspects of drinking-water
are subject to periodic review and documentation related to aspects of
protection and control of public drinking water quality is accordingly
prepared and updated. (Description adapted from website and document
introduction.)
World Health Organization
World Health Organization
Avenue Appia 20
1211 Geneva 27
Switzerland
Telephone:+41 22791 21 11
Facsimile (fax): + 41 22 791 31 11
Name, CASRN, chemical properties, concentration data, guideline value,
Tolerable Daily Intake, NOAEL
This source is considered relevant for the CCL Universe because it
contains data elements from toxicological studies.
It meets considerations because it is peer reviewed.
This source is not redundant.
This source does not meet retrievability criteria because the data are not
formatted for automated retrieval.
http://www.who.int/water  sanitation  health/dwq/guidelines/en/
Data Source Name
Data Source Description
California EPA Office of Environmental Health Hazard
Assessment (OEHHA)
The Toxicity Criteria Database from California EPA OEHHA contains
information on over 260 chemicals. The database reports information
that includes the following: cancer potency information (oral/inhalation
slope factors), chronic and acute Reference Exposure Levels (RELs),
California Public Health Goals (CPHG), California Proposition 65 No
Significant Risk Levels (NSRLs) and Maximum Allowable Daily Levels
(MADLs).The "Technical Support Document for Describing Available
Cancer Potency Factors (TSD)" contains cancer unit risks and potency
factors for 121 of the 201 carcinogenic substances or groups of
substances for which emissions must be quantified in the Air Toxics Hot
Spots program. The purpose of this document is to provide a summary of
the data supporting the carcinogenic potential of the substance or group
of substances and to provide the calculation procedure used to derive
the estimated unit  risk and cancer potency factors. For the complete
document, go to: http://www.oehha.ca.gov/air/cancer_guide/TSD2.html
to download. No new data was identified for use in CCL 4. (Description
adapted from website.)
Proprietor
Contact Information
California Office of Environmental Health Hazard Assessment
Office of Environmental Health Hazard Assessment
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Type of Data Elements

Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation
Source URL
California Environmental Protection Agency
1515 Clay Street, 16th Floor
Oakland, California 94612
(510)622-3200


Critical effect, CAMCL, CAPHG, cancer risk, cancer groups, MADL,
NSRL, REL, slope factor, unit risk
This source is considered relevant for the CCL Universe because it
contains data elements derived from toxicological studies.
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.oehha.ca.gov/risk/ChemicalDB/index.asp
Data Source Name
Data Source Description
Proprietor
Contact Information
Type of Data Elements
Relevance Explanation


Completeness Explanation

Redundancy Explanation
Chemical Update System (CUS)/lnventory Update Reporting
(IUR) rule
The Chemical Update System (CUS) database contains confidential data
reported by industry (approximately 1,200 companies) as a partial
update of the Toxic Substances Control Act (TSCA) Inventory. Data
reported under the Inventory Update Reporting (IUR) rule were stored in
the CUS database. Under the IUR, manufacturers and importers were
required to report company information (e.g., plant site name, address
and Data Universal Numbering System (DUNS) number) and chemical
information (e.g., CAS registry number, Premanufactures Number
(PMN)/Bonafide/Test Marketing Exemption Application (TMEA) or
Confidential Chemicals Identification (CCID) System Assession Number
and production volume) for chemicals they manufactured or imported in
excess of 25,000 pounds (up from 10,000 pounds in 2002) in the
previous fiscal year. U.S. Environmental Protection Agency (EPA)
released the 2006 IUR rule (currently called the Chemical Data
Reporting (CDR) rule) information on more than 6,200 chemicals in
commerce. EPA had previously compiled the 1998 and 2002 IUR data
for CCL 3. EPA downloaded the 2006 IUR data in August, 2010 for use
in CCL 4. The CUS database contains comprehensive use and exposure
information on the most widely used  chemicals in the United States.
(Description adapted from website.)
EPA
E-mail: TSCA Hotline (tsca-hotline@epamail.epa.gov)
TSCA Hotline Phone: 202-554-1404
IUR/CDR Helpline Phone: 202-564-3012
Production Volume
This source is considered relevant for the CCL Universe because it
contains information on production volume, which may indicate potential
occurrence.
It meets considerations because it meets all NDWAC minimum data
requirements.
This source is not redundant.
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Retrievability Explanation
Source URL
This source meets retrievability criteria because it is in tabular format.
http://www.epa.gov/cdr/
Data Source Name
Data Source Description
Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic,
Boron, Chromium, Copper, Iodine, Iron, Manganese,
Molybdenum, Nickel, Silicon, Vanadium, and Zinc - Institute
of Medicine
This volume is from a series issued by the National Academy of
Sciences on dietary reference intakes (DRIs). This series provides
recommended intakes, such as Recommended Dietary Allowances
(RDAs) and Tolerable Upper Intake Levels (ULs), for maintaining
nutritionally adeguate diets for individuals in the United States and
Canada based on factors such as age and gender. In addition, the ULs
will help a consumer know how much is "too much" of a nutrient.
Proprietor
Contact Information
Type of Data Elements
Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation

Source URL
Recommendations have been made for the following: vitamins A and K,
iron, iodine, chromium, copper, manganese, molybdenum, zinc and other
potentially beneficial trace elements such as boron to determine the
roles, if any, they play in health. (Description adapted from website.)
National Academy of Sciences - Institute of Medicine
Geraldine Kennedo
Administrative Assistant, Food and Nutrition Board
Phone:202-334-1732
Fax:202-334-2316
E-mail:gkennedo@nas.edu
Keck Center
W700
500 Fifth St. NW
Washington, DC 20001
Name, DRIs, RDAs, ULs.
This source is considered  relevant for the CCL Universe because it
contains data elements  from toxicological studies.
It meets considerations  because it is peer reviewed.
This source is not redundant.
This source does not meet retrievability criteria because the data are not
formatted for automated retrieval. However, this source was only used
for the UL for manganese, thus retrievability was not an issue.
http://www.iom.edu/Reports/2001/Dietary-Reference-lntakes-for-Vitamin-
A-Vitamin-K-Arsenic-Boron-Chromium-Copper-lodine-lron-Manganese-
Molybdenum-Nickel-Silicon-Vanadium-and-Zinc.aspx
Data Source Name
Data Source Description
EPA Office of Water Literature Search for Supplemental Water
Occurrence Data for Pharmaceuticals, Personal Care
Products and Other Contaminants
As part of its ongoing assessment of Pharmaceuticals in the
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Contact Information
Type of Data Elements


Relevance Explanation


Completeness Explanation
Redundancy Explanation



Retrievability Explanation

Source URL
environment, and particularly in water, the USEPA Office of Water's,
Office of Science and Technology has been conducting a search and
review of peer-reviewed, published journal literature for studies dealing
with the occurrence of Pharmaceuticals and personal care products
(PPCPs)  in the environment. The literature  review included 171  papers
that were published between 2001 through  2010. For CCL 4, EPA
reviewed  the literature found in the search to identify papers that present
supplemental occurrence data for ambient water or drinking water that
were not  previously considered under CCL 3. Many of the studies were
highly localized in scope, so were only evaluated as supplemental data if
other more comprehensive studies were not available.  Many of the
studies involved waste waters and media other than water and these
were not  used for CCL 4. The Office of Ground Water and Drinking
Water, to supplement the journal literature,  reviewed 14 studies
published by the USGS since CCL 3 (since late 2008) on PPCPs  and
other contaminants for possible additional supplemental data
(http://toxics.usgs.gov/).
U.S. EPA
Octavia Conerly
USEPA - Office of Science and Technology
Email: conerly.octavia@epa.gov
Meredith  Russell
USEPA- Office of Ground Water and  Drinking Water
Email: russell.meredith@epa.gov
Measured contaminant concentrations from water samples, number  of
samples and/or sites with samples, number of detections, type of sites
and samples, etc.
This source is considered relevant for the CCL Universe because it
contains data elements for supplemental contaminant occurrence in
water, which may indicate potential occurrence in drinking 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. This source may also overlap with
prior published USGS reports and the NAWQA and NREC data,
collected  for CCL 3.
Data not retrievable. This source contains tabulated occurrence  data that
can be copied and formatted.
Not applicable
Data Source Name
Data Source Description
Groundwater Ambient Monitoring and Assessment (GAMA)
Program
The GAMA Program is California's comprehensive groundwater quality
monitoring program conducted cooperatively with  USGS. The GAMA
data used in this analysis are from water samples from public drinking
water supply wells (i.e., untreated "source water"). Major groundwater
supply basins are a specific focus of the GAMA program. The main goals
of the program are to improve statewide groundwater monitoring and to
increase the availability of groundwater quality information to the public.
GAMA collects data by testing the untreated or raw water in different
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Proprietor

Contact Information
Type of Data Elements
Relevance Explanation


Completeness Explanation

Redundancy Explanation
Retrievability Explanation
types of wells for naturally-occurring and man-made chemicals. In 2000
the State Water Resources Control Board (SWRCB) created the ambient
monitoring program to better understand California's groundwater quality
issues. The GAMA Program was later expanded, resulting in a plan to
monitor and assess groundwater quality in basins that account for over
95% of the state's groundwater use. GAMA Program projects have
analyzed thousands of water samples for hundreds of chemicals - many
of the chemicals at ultra-low detection limits requiring state-of-the-art
facilities and methods. GAMA compiles these test results with existing
groundwater quality data from several agencies into a publicly-accessible
internet database, GeoTracker GAMA. There are four active GAMA
projects: Priority Basin Project, Domestic Well Project, Special Studies
Project, and GeoTracker GAMA.
California State Water Resources Control Board (SWRCB)/U.S.
Geological Survey (USGS)
John Borkovich
jborkovich@waterboards.ca.gov
GAMA Program Manager
916-341-5779
Drinking water (source water) occurrence concentrations
This source is considered relevant for the CCL Universe because it
contains measurements of contaminants in water, demonstrating
occurrence.
This source meets completeness considerations because it meets all
NDWAC minimum data requirements.
This source is not redundant.
This source contains tabulated occurrence data that can be downloaded
and analyzed.
Source URL
http://www.waterboards.ca.qov/qama/
Data Source Name
Data Source Description
Hopple, et al., 2009. Anthropogenic Organic Compounds in
Source Water of Selected Community Water Systems that
Use Groundwater, 2002-05 - USGS
As part of the NAWQA program,  Hopple et al. (2009) conducted studies
to analyze 258 anthropogenic organic compounds in groundwater used
as source waters for community water systems (CWSs). Most of the 258
compounds analyzed are unregulated in drinking water. In Phase 1 of
the sampling, source water samples were collected between October
2002 and July 2005 from 221 wells that withdraw from 12 aquifers across
the U.S. In Phase 2 of the sampling, USGS collected source and finished
water samples from 94 wells at selected CWSs between June 2004 and
September 2005. These samples were analyzed for a smaller subset of
compounds, which occurred most frequently, or were found  at relatively
high concentrations in Phase 1 of the sampling.
                            Reference: Hopple, J.A., Delzer, G.C., and Kingsbury, J.A., 2009,
                            Anthropogenic organic compounds in source water of selected
                            community water systems that use groundwater, 2002-05: U.S.
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Proprietor
Contact Information
Type of Data Elements

Relevance Explanation


Completeness Explanation
Redundancy Explanation


Retrievability Explanation

Source URL
Geological Survey Scientific Investigations Report 2009-5200, 74 p.
United States Geological Survey (USGS)
Director, USGS South Dakota Water Science Center
1608 Mt. View Rd.
Rapid City, SD 57702
Phone: (605) 394-3200
Web: http://sd.water.usgs.gov
Email: dc sd@usgs.gov
Measured contaminant concentrations from water samples, number of
samples/sites with samples, number of detections, etc.
This source is considered relevant for the CCL Universe because it
contains data elements for contaminant occurrence in source water
obtained from ground water resources.
It meets all considerations because it is peer reviewed.
This source is not redundant though some, but not all, data may overlap
with Toccalino et a/, and with the NAWQA database analyzed separately
for CCL 3.
This source contains tabulated occurrence data that can be copied and
formatted.
http://pubs.usgs.gov/sir/2009/5200/
Data Source Name
Data Source Description
Integrated Risk Information System (IRIS)
EPA's IRIS Program is a human health assessment program that
evaluates guantitative and gualitative risk information on effects that may
result from exposure to chemical substances found in the environment.
Through the IRIS Program, EPA provides the highest guality science-
based human health assessments to support the agency's regulatory
activities. The IRIS database contains information for more than 550
chemical substances that can be used to support the first two steps
(hazard identification and dose-response evaluation) of the risk
assessment process. When supported by available data, IRIS provides
toxicity values and gualitative information for chronic cancer and
noncancer health effects, including:
•   Noncancer effects: Oral reference doses and inhalation reference
    concentrations (RfDs and RfCs,  respectively) for effects known or
    assumed to be produced through a nonlinear (possibly threshold)
    mode of action. In most instances, RfDs and RfCs are developed for
    the noncarcinogenic effects of substances.


•   Cancer effects: Descriptors that characterize the weight of evidence
    for human carcinogenicity, oral slope factors, and oral and inhalation
    unit risks for carcinogenic effects. Where a nonlinear mode of action
    is established, RfD and RfC values may be used.

Government and private entities use IRIS by combining IRIS toxicity
values with specific exposure information to help characterize public
health risks of chemical substances and thereby support risk
management decisions designed to protect public health.
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Proprietor

Contact Information


Type of Data Elements


Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation
Source URL
EPA Office of Research and Development; ORD, National Center for
Environmental Assessment
U.S. EPA Risk Information Hotline at telephone 1-301-345-2870, or fax
to 1-301-345-2876, or
by email to Hotline.IRIS@epamail.epa.gov
Name, Synonyms, CASRN, RfC, RfD, SF(i,o), UR(i,o), NO(A)EL,
LO(A)EL, Benchmark Concentration/ Dose (BMC/D), Benchmark Dose
Limit (BMDL), Critical effect
This source is considered relevant for the CCL Universe because  it
contains data elements from toxicological studies.
It meets all considerations because it is peer reviewed.
For CCL 4, IRIS is available electronically and retrievable. During CCL 3,
the toxicological data for IRIS were available in tabular format from ITER
(data source #110) and RAIS-Health Effects (data source #178) (see
USEPA, 2009b. Final Contaminant Candidate List 3 Chemicals:
Identifying the Universe.) Hence, there is some overlap and redundancy
but each also provides additional information not available elsewhere.)
For CCL 4, IRIS is available electronically and retrievable. During CCL 3
this source contained monographs that were not formatted for automated
retrieval. However, the toxicological data from this source have been
compiled for electronic retrieval in ITER and were obtained from there for
CCL 3. IRIS monographs were used to confirm the IRIS/ITER data.
http://www.epa.gov/iris/index.html
Data Source Name
Data Source Description
Kingsbury, et al., 2008. Anthropogenic Organic Compounds
in Source Water of Nine Community Water Systems that
Withdraw from Streams, 2002-05 - USGS
As part of the NAWQA program, Kingsbury et al. (2008) conducted
studies to analyze 258 anthropogenic organic compounds in surface
waters used as source waters for nine CWSs. In Phase 1 of the studies,
source water samples were collected between 2002 and 2004 from nine
CWSs served by streams across the U.S. In  Phase 2 of the studies,
USGS collected source and finished water samples at eight of the nine
CWSs between 2004 and 2005.
Proprietor
Contact Information
Type of Data Elements
Reference: Kingsbury, J.A., Delzer, G.C., and Hopple, J.A., 2008,
Anthropogenic organic compounds in source water of nine community
water systems that withdraw from streams, 2002-05: U.S. Geological
Survey Scientific Investigations Report 2008-5208, 66 p.
United States Geological Survey (USGS)
Director, USGS South Dakota Water Science Center
1608 Mt. View Rd.
Rapid City, SD 57702
Phone: (605) 394-3200
Web: http://sd.water.usgs.gov Email: dc sd@usgs.gov
Water occurrence data elements, measured concentrations, number of
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Relevance Explanation


Completeness Explanation
Redundancy Explanation

Retrievability Explanation

Source URL
sites, number of detections, etc.
This source is considered relevant for the CCL Universe because it
contains data elements for contaminant occurrence in source water
obtained from surface water resources.
It meets all considerations because it is peer reviewed.
This source is not redundant (though some, but not all, data may overlap
with the NAWQA database analyzed separately for CCL 3).
This source contains tabulated occurrence data that can be copied and
formatted.
http://pubs.usgs.gov/sir/2008/5208/
Data Source Name
Data Source Description
Proprietor
Contact Information
Type of Data Elements
Office of Pesticide Programs (OPP) Health Effects Data
EPA's Office of Pesticide Programs publishes health effects data in a
variety of sources, including Reregistration Eligibility Decision (RED)
Documents and  Health Assessments. "When EPA completes the review
and risk management decision for a pesticide that is subject to
reregistration (i.e., one initially registered before November 1984),  EPA
generally issues a RED document. The RED summarizes the risk
assessment conclusions and outlines any risk reduction measures
necessary for the pesticide to continue to be registered in the U.S."
There are REDs for over 176 pesticides currently. Two other types of
documents - the Interim RED and Tolerance RED may also be issued.
The IRED is issued when a pesticide is undergoing  reregistration,
requires a reregistration eligibility decision, and also needs a cumulative
assessment. A TRED may be issued if no changes  in the tolerances for a
pesticide are required as a result of EPA's review.
EPA has also developed human health benchmarks (HHBPs) for
approximately 363 pesticides to  enable states, tribes, water systems, the
public and other stakeholders to better determine whether the detection
of a pesticide in  drinking water or source waters for  drinking water may
indicate a potential health risk. The HHBP table includes pesticide  active
ingredients for which Health Advisories or enforceable National Primary
Drinking Water Regulations (e.g., maximum contaminant levels) have not
been developed. For pesticides with HHBPs, EPA checked the source
document used to develop the HHBP to determine if there were any new
or updated health effects data for CCL 4. These source documents can
be found by clicking on the pesticide name at the  following
link: http://www.epa.gov/pesticides/hhbp
(Description adapted from website.)
EPA Office of Pesticide Programs
US Environmental Protection Agency
Office of Pesticide Programs
Washington, DC 20460
Telephone 703-308-8000
Name, Synonyms, Drinking Water Level of Concern (DWLOC),
Population Adjusted Dose (PAD), Reference Dose (RfD), Safety Factors,
Lethal Concentration (LCx), Lethal Dose (LDx), Lowest Observed
Adverse Effect Level LO(A)EL, Margin of Exposure  (MOE), No  Observed
Adverse Effect Level (NO(A)EL), highest dose tested (HOT)
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Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation

Source URL
This source is considered relevant for the CCL Universe because it
contains data elements from toxicological studies
It meets considerations because it is peer reviewed.
This source is not redundant.
This source does not meet retrievability criteria because the data are not
formatted for automated retrieval.
http://iaspub.epa.qov/apex/pesticides/f?p=chemicalsearch:1
Data Source Name
Data Source Description
Office of Solid Waste and Emergency Response (OSWER)
Provisional Peer-Reviewed Toxicity Values for Superfund
(PPRTV)
The Provisional Peer-Reviewed Toxicity Values (PPRTVs) currently
represent the second tier of human health toxicity values for the EPA
Superfund and Resource Conservation and Recovery Act (RCRA)
hazardous waste programs. A PPRTV is a toxicity value derived for use
in the Superfund Program when such value is not available in EPA's
Integrated Risk Information System (IRIS). PPRTVs are derived after a
review of the relevant scientific literature using the methods, sources of
data and guidance for value derivation used by the EPA IRIS Program.
All provisional peer-reviewed toxicity values receive internal review by
EPA scientists and external peer review by independent scientific
experts. PPRTVs differ from IRIS values in that PPRTVs do not undergo
a multi-program  internal agency review, inter-agency review, or public
comment. Additionally,  IRIS values are generally intended to be used in
all EPA programs, while PPRTVs are developed specifically for the
Superfund Program.
Proprietor
The development of PPRTVs enables OSWER to make informed clean-
up decisions regarding the screening of chemicals of concern, conduct
human health risk assessments and evaluate alternative clean-up
actions at federal and state Superfund sites, which can lead to
improvements in human and ecological health in the vicinity of Superfund
sites, as well as improved economic conditions and quality of life for
nearby communities. PPRTVs are also used by EPA's regions when
making site specific clean-up decisions.
PPRTVs are prepared on an ongoing basis for those substances found
at clean-up sites and for which no IRIS value is available. The purpose of
PPRTV documents are to provide hazard and dose-response
assessments pertaining to chronic and subchronic exposures to
substances of concern, present the major conclusions reached in the
hazard identification and derivation of the PPRTVs and characterize the
overall confidence in  these conclusions and toxicity values. PPRTV
assessments are updated approximately on a 5-year cycle for new data
or methodologies that might impact the toxicity values or characterization
of potential for adverse human health effects and are revised as
appropriate. (Description adapted from website.)
U.S. EPA Office of Solid Waste and Emergency Response (OSWER) /
Office of Superfund Remediation and Technology Innovation  (OSRTI) &
U.S. EPA Office of Research and Development (ORD)/ National Center
for Environmental Assessment (NCEA)
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Type of Data Elements

Relevance Explanation

Completeness Explanation

Redundancy Explanation
Retrievability Explanation

Source URL
Annette Gatchett
ORD/ NCEA
Gatchett.Annette@epa.gov

Michele Burgess
OSWER/ OSRTI
Burgess.Michele@epa.gov
Name, Synonyms, CASRN, RfC, RfD, LOAEL, Critical effect, Cancer
classification
This source is considered relevant for the CCL Universe because it
contains data elements from toxicological studies.
This source meets all completeness considerations because it is peer
reviewed.
This source is not redundant.
Data are retrievable by EPA but require special processing and analysis
for CCL use.
http://hhpprtv.ornl.gov/index.html
Data Source Name
Data Source Description
Proprietor
Pesticide Data Program
The USDA Pesticide Data Program (POP) has developed a national
pesticide residue database. POP was initiated in 1991 to collect data on
pesticide residues in food with sampling conducted on a statistically
defensible representation of pesticide residuals in the United States food
supply. Sampling and testing are conducted on fruits and vegetables,
select grains, milk and (as of 2001) drinking water. The  POP drinking
water sampling program was initiated at community water systems
(CWSs) in New York and California in 2001. Since then, the drinking
water sampling program has expanded, though the States where
sampling occurs may differ from year to year. At one time or another,
CWSs in 27 states and Washington, D.C. contributed raw and/or finished
water data to the program. The sampling frame is designed to provide
coverage in regions of interest for at least two years, to  reflect the
seasonal and climatic variability during growing seasons. POP works
with EPA and the American Waterworks Association (AWWA) to identify
specific water treatment facilities to be monitored. EPA  reviews the POP
data on the occurrence of select contaminants in untreated and treated
water. The CWSs selected for sampling tend to be small- and medium-
sized systems (primarily CWSs serving less than 50,000 persons),
systems served by surface water, and systems located  in  regions of
heavy agriculture. The number of sites and samples has varied during
different sampling periods. Sampling of untreated water in addition to
treated water began in 2004. EPA  had previously compiled the 2001 and
2002 POP data for CCL 3. EPA compiled the 2003 through 2009 POP
data used in CCL 4 in December, 2011. (Description adapted from
website.)
USDA
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Contact Information
POP Staff:
Agricultural Marketing Service
Science & Technology, Monitoring Programs Office
8609 Sudley Road, Suite 206
Manassas, VA20110
Director: Martha Lamont
Phone: (703) 330-2300 ext. 17
Fax: (703) 369-0678
Type of Data Elements
Relevance Explanation
Completeness Explanation
Redundancy Explanation
Retrievability Explanation
Source URL
Deputy Director: Diana Haynes
Phone: (703) 330-2300 ext. 34
Fax: (703) 369-0678
E-mail: amsmpo.data@ams.usda.gov
Total Samples Analyzed, Samples with Residues Detected, Percent of
Samples with Detections, Pesticides Detected, Residues Detected, Total
Residue Detections, % of Samples with Detects, Minimum Value
Detected (ppm), Maximum Value Detected (ppm), Number of Detections
of Pesticides in Drinking Water, Pesticides Detected Above Limit of
Quantification in Drinking Water
This source is considered relevant for the CCL Universe because it
contains measurements of pesticide residues in water, demonstrating
occurrence.
It meets considerations because it meets all NDWAC minimum data
requirements (i.e., contact information for an administrator of the data
source, a list of data elements in the data source, and an explanation of
how the data were generated).
This source is not redundant.
This source meets retrievability criteria because it is in tabular format.
http://www.ams.usda.gov/science/pdp/index.htm
Data Source Name
Data Source Description
State Drinking Water Data Sets
For EPA's Second Six-Year Review of drinking water regulations, EPA
requested (through an ICR) that primacy agencies submit drinking water
compliance occurrence data to EPA that was collected during 1998-
2005. Eight states (CA, FL, IL, NC, OH, SD, TX,  and Wl) and the Region
9 tribes also submitted PWS occurrence data for unregulated
contaminants in addition to the data for regulated contaminants. EPA
was able to supplement these data on unregulated contaminants by
downloading additional publicly available monitoring data from State
Web sites (specifically, from Florida and Wisconsin). The result was a
collection of unregulated contaminant monitoring data from nine states
(eight states and one tribal entity; this support document uses the term
"state" for SDWA primacy entities for convenience) The nine data sets
vary in the range of monitoring dates (in some cases extending beyond
the 1998-2005  period of interest for Six-Year Review), the number of
contaminants monitored, the number of systems reporting monitoring,
and the number of samples taken. The data sets vary widely in the
number of PWSs sampled in each State relative  to the total number of
PWSs in that State. Hence, these data are used  only to augment and
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EPA-OGWDW
         Data Sources for the
     Contaminant Candidate List 4
EPA 815-R-15-004
Proprietor
Contact Information
Type of Data Elements

Relevance Explanation



Completeness Explanation

Redundancy Explanation


Retrievability Explanation
complement any national drinking water data and to assess any unique
occurrence that may suggest a need for further review.
EPA OGWDW; The Cadmus Group, Inc.
Erin Mateo
The Cadmus Group
100 5th Ave Suite 100
Waltham, MA 02451
Phone:617-673-7000
Drinking water occurrence concentrations, number of PWSs with
samples, etc.
This source is considered relevant for the CCL Universe because it
contains measurements of contaminants in water, demonstrating
occurrence. Most data are available for regulated contaminants. Some
data are available for unregulated contaminants.
It meets considerations because it meets all NDWAC minimum data
requirements.
This source is partially redundant, since data for contaminants that are
regulated in drinking water are available  as part of the National
Contaminant Occurrence Database (NCOD) - Six Year.
Data are retrievable by EPA but require special processing and analysis
for CCL use.
Source URL
Internet source not available
Data Source Name
Data Source Description
Proprietor
Contact Information
Type of Data Elements

Relevance Explanation
STORET - STORage and RETrieval
STORET is a water quality, biological, and physical property data
warehouse, containing information collected from over 60 organizations
including States, tribes, watershed groups, other Federal Agencies,
volunteer groups and universities. The extent of national coverage and
data completeness varies from parameter to parameter. Many (though
not all) sample results are accompanied by information on sample
location  (e.g.,  latitude, longitude, state, county, Hydrologic Unit Code and
a brief site identification), sample date, the medium sampled (e.g., water,
sediment, fish tissue) and the name of the organization that sponsored
the monitoring. In addition, there can  be information on why the data
were gathered; sampling and analytical methods used; the laboratory
used to analyze the samples; the quality control checks used when
sampling, handling the samples, and  analyzing the data; and the
personnel responsible for the data. All data supplied to EPA since
January 1, 1999 have been placed in the STORET Data Warehouse.
Data supplied to EPA before 1999 are stored in the Legacy STORET
Data Center. EPA downloaded STORET data for use in CCL 4 in
January, 2013. (Description  adapted from website.)
EPA
STORET User Assistance: 1-800-424-9067 orSTORET@epa.gov
Water occurrence data elements, measured concentrations, number of
sites, number of detections,  etc.
This source is considered relevant for the CCL Universe because it
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EPA 815-R-15-004
Redundancy Explanation
Retrievability Explanation

Source URL
contains measurements of contaminants in water, demonstrating
occurrence.
This source is not redundant.
Data are retrievable by EPA but require special processing and analysis
for CCL use.
http://www.epa.gov/storet/
Data Source Name
Data Source Description
Proprietor
Contact Information
Type of Data Elements

Relevance Explanation


Completeness Explanation
Redundancy Explanation


Retrievability Explanation

Source URL
Toccalino, et al., 2010. Quality of Source Water from Public-
Supply Wells in the United States, 1993-2007 - USGS
As part of USGS's National Water Quality Assessment (NAWQA)
program, water samples were collected from source (untreated) ground
water from 932 public water system wells located in parts of 40 NAWQA
Study Units in 41 states. Each well was sampled once between  1993
and 2007. Water samples were analyzed for up to 215 regulated and
unregulated contaminants and several water-quality properties (e.g.,
hardness). The public wells sampled in this study represented 629
unique  PWSs, representing 0.5% of the approximately 140,000 ground
water-supplied PWSs, but nearly 25% of the population served by
ground water supplied PWSs in the United States.

Reference: Toccalino, P.L., Norman, J.E., and Hitt, K.J., 2010, Quality of
source  water from  public-supply wells in the United States, 1993-2007:
U.S. Geological Survey Scientific Investigations Report 2010-5024, 206
P-
United  States Geological Survey (USGS)
Chief, National Water-Quality Assessment Program
U.S. Geological Survey
413 National Center
12201 Sunrise Valley Drive
Reston, Virginia 20192
http://water.usgs.gov/nawqa/studies/public_wells/
Measured contaminant concentrations from  water samples, number of
samples/sites/PWSs with samples, number  of detections, etc.
This source is considered relevant for the CCL Universe because it
contains data elements for contaminant occurrence in source water
obtained from public-supply wells.
It meets all considerations because it is peer reviewed.
This source is not redundant though some, but not all,  data may overlap
with Hopple et al. and with the NAWQA database analyzed separately
for CCL 3.
This source contains tabulated occurrence data that can be copied and
formatted.
http://pubs.usgs.gov/sir/2010/5024/
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         Data Sources for the
     Contaminant Candidate List 4
EPA 815-R-15-004
Data Source Name
Data Source Description
Proprietor
Contact Information
Type of Data Elements
Relevance Explanation


Completeness Explanation
Redundancy Explanation
Retrievability Explanation
Source URL
The Toxics Release Inventory (TRI)
TRI contains information from almost 20,000 U.S. companies and
government facilities that report their air, land and water releases of
industrial chemicals and other waste management activities. TRI also
contains some information about source reduction efforts. This
database's information on releases to water is a valuable source of
potential occurrence data for screening drinking water contaminants for
the CCL. It includes many categories of air, land, and water release data
for the years 1988 through 2010. As of 2010, the TRI toxic chemical list
contains 498 individually listed chemicals. EPA downloaded the 2010
TRI data (used in CCL 4) in March 2012. Facilities may also revise or
withdraw submittals that they have made under TRI. This may explain
why data for a given chemical and year (i.e., pounds released and
number of states where a chemical was released) were sometimes
observed during the compilation of CCL 3 to change overtime after initial
release of the data to the public (Description adapted from website.)
EPA
(800) 424-9346 - select option 3
(703) 412-9810 - Wash.  DC metro area
(800) 553-7672 - TDD
Email: tri.us@epa.gov
Pounds per year of chemical releases to air, land and water
This  source is considered relevant for the CCL Universe because it
contains information on chemical releases, which may indicate potential
occurrence.
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.epa.gov/triexplorer/
Data Sources for Microbial Contaminants
Data Source Name
Data Source Description
Center for Disease Control and Prevention's Morbidity and
Mortality Weekly Reports (MMWR)
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 3 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 (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
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EPA 815-R-15-004
                            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
Type of Data Elements
Relevance Explanation

Completeness Explanation
Redundancy Explanation
Retrievability Explanation
Source URL
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

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
Type of Data Elements
Relevance Explanation

Completeness Explanation
Redundancy Explanation

Retrievability Explanation

Source URL
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 2007 through 2012. EPA reviewed all relevant research reports
found to identify papers that might present data for the nominated
microbes that might help inform CCL 4. EPA also reviewed studies
submitted and referenced by nominators.
U.S. EPA
Cesar Cordero
Email: cordero.cesar@epa.gov

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
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         Data Sources for the
      Contaminant Candidate List 4
EPA 815-R-15-004
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), 10th Edition
The 10th 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.
http://mcm10.asmpress.org/
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