Request for Nominations of Drinking Water
Contaminants for the Contaminant Candidate
List
October 16, 2006
Office of Water (4607M) EPA 815-Z-06-004 October 2006 www.epa.gov/safewater
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Federal Register/Vol. 71, No. 199/Monday, October 16, 2006/Notices
60705
ENVIRONMENTAL PROTECTION
AGENCY
[EPA-HQ-OW-200S-0039; FRL-8231-3]
Request for Nominations of Drinking
Water Contaminants for the
Contaminant Candidate List
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: The Environmental Protection
Agency (EPA) is requesting nominations
of chemical and microbial contaminants
for possible inclusion in the third
drinking water Contaminant Candidate
List (CCL 3). EPA is also requesting
information that shows the nominated
contaminant may have an adverse
health effect on people and the
contaminant occurs or is likely to occur
in public water systems.
DATES: Nominations must be received
on or before December 15, 2006.
ADDRESSES: Submit your nominations to
the CCL3 Nominations Web site http://
www.epa.gov/safewater/ccl/ccl3.html by
following the on-line instructions for
submitting nominations or mail to CCL
Nominations, Environmental Protection
Agency, Mail Code: 4607M, 1200
Pennsylvania Ave., NW., Washington,
DC 20460.
FOR FURTHER INFORMATION CONTACT: For
general information contact the EPA
Safe Drinking Water Hotline at (800)
426-4791 or e-mail: hotline-
sdwa@epa.gov. For technical questions
about this notice contact Clifton
Townsend, Standards and Risk
Management Division, Office of Ground
Water and Drinking Water,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: (202)
564-1576; e-mail address:
townsend.clifton@epa.gov. For technical
inquiries regarding EPA's CCL 3
Nominations Web site, please contact
Zeno Bain at (202) 564-5970 or e-mail:
bain.zeno@epa.gov.
SUPPLEMENTARY INFORMATION
I. General Information
A. Does This Action Apply to Me
This action requests drinking water
contaminant candidate nominations and
provides information on how the public
can submit nominations to the Agency.
B. How Can I Get Copies of This
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under Docket ID
No. EPA-HQ-OW-2005-0039. Publicly
available docket materials are available
either electronically through http://
www.regulations.gov or in hard copy at
the Water Docket in the EPA Docket
Center.
or the EPA Web site at http://wvfw.epa.gov/
epahome/dockets.htm for current
information on docket status, locations and
telephone numbers.
2. Electronic Access. You may access
this Federal Register document
electronically through the EPA Internet
under the Federal Register listings at
http://ivwiv.epa.gov/fedrgstr/.
II. Background
A. What Is the CCL?
There are thousands of naturally
occurring and man-made contaminants
that have the potential to enter sources
of drinking water (e.g., pesticides,
Pharmaceuticals, personal care
products, industrial chemicals). Some of
these contaminants may pose no risk to
human health, but others may cause
cancer or have endocrine disrupting.
reproductive, or developmental effects.
Naturally occurring microbial
contaminants may also cause acute
illness. To ensure that public health is
protected, EPA must assess the universe
of unregulated drinking water
contaminants to determine if they may
require regulation under the'Safe
Drinking Water Act (SDWA). '•
The CCL is the primary vehicle used
by EPA to target and prioritize
unregulated contaminants in'drinking
water for research and analysis to
determine which new contaminants
should be regulated. SDWA requires
that EPA publish, every five years, a list
of unregulated chemical and microbial
contaminants that are known or
anticipated to occur in public water
systems and which may require
regulation under the Safe Drinking
Water Act (SWDA Section 1412(b)(l)).
EPA is also required to consult with the
scientific community and provide
notice and opportunity for public
comment prior to publication of the
CCL.
SDWA also requires EPA to determine
whether to regulate at least five
contaminants from the CCL every five
years. In making regulatory
determinations, the Agency must
consider the following three statutory
criteria:
1. Is the contaminant likely to cause
an adverse effect on the health of
persons?
2. Is the contaminant known or likely
to occur in public water systems at a
frequency and level of concern?
3. Does regulation of the contaminant
present a meaningful opportunity for
health risk reduction for persons served
by public water systems?
B. How Did EPA Develop Previous
Contaminant Candidate Lists?
The first CCL (CCL 1) was published
on March 2, 1998 (63 FR 10273). The
contaminants were categorized based on
four priority areas in drinking water
research: occurrence, health effects,
treatment, and analytical methods. CCL
1 was developed based on a review by
technical experts of readily available
information and contained 50 chemicals
and 10 microbial contaminants. EPA
consulted with the scientific community
and the National Drinking Water
Advisory Council (NDWAC) on a
process for developing the first CCL.
Based on the NDWAC
recommendations, the Agency
developed and used screening and
evaluation criteria to develop a list of
chemical contaminants for CCL 1. For
microbiological contaminants, the
Agency followed NDWAC
recommendations and sought external
expertise to identify and select potential
waterborne pathogens. The Agency
convened a workshop of microbiologists
and public health experts who
developed criteria for screening and
evaluation and subsequently developed
an initial list of potential
microbiological contaminants.
On July 18, 2003 (68 FR 42897), EPA
announced its final regulatory
determination for nine contaminants
from CCL 1, which concluded that
sufficient data and information was
available to make the determination not
to regulate nine contaminants (eight
chemicals and one microbial).
The second CCL (CCL2) was
published on February 24, 2005 (70 FR
9071) and carried forward the remaining
51 chemical and microbial
contaminants listed on CCL 1.
Currently, the Agency is evaluating data
and research on these chemicals and
microbes to make regulatory
determinations as it continues work to
develop the CCL 3.
C. How Is EPA Developing Future CCLs?
After publication of CCL 1, the
Agency recognized the need for a more
robust and transparent process for
identifying and narrowing the list of
potential contaminants for future CCLs
and sought advice from the National
Academies of Science (NAS) on how to
improve the CCL process. The 2001
NAS report, Classifying Drinking Water
Contaminants for Regulatory
Consideration (NAS 2001), proposed a
broader, more comprehensive screening
process to assist EPA in identifying
those contaminants for the CCL. The
NAS recommended that EPA develop
and use a process for creating future
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CCLs whereby a broadly defined
"universe" of potential drinking water
contaminants is identified, assessed,
and reduced to a preliminary CCL
(PCCL) using simple screening criteria
that indicate public health risk and the
likelihood of occurrence in drinking
water. All of the contaminants on the
PCCL would then be assessed in more
detail using a classification approach
and tools along with expert judgment to
evaluate the likelihood that specific
contaminants could occur in drinking
water at levels and at frequencies that
pose a public health risk. The outcome
of the detailed classification approach
results in the draft CCL.
The contaminants initially considered
for the CCL (i.e. CCL Universe) include
naturally occurring substances,
emerging waterborne pathogens,
chemical agents, byproducts and
degradants of chemical agents, and
biological toxins. The PCCL will include
contaminants that occur, or have the
potential to occur, in drinking water and
cause, or may cause adverse health
effects.
In 2002, EPA consulted with NDWAC
and received advice for implementing
the 2001 NAS recommendations.
NDWAC recommended that EPA move
forward with the NAS recommendations
using an adaptive management
approach. This approach provides a
framework to implement
recommendations in phases and refine
and adjust the CCL process as more
information and experience are attained.
NDWAC provided specific
recommendations on eliciting public
participation and suggested that EPA
seek contaminant nominations from the
public for inclusion on the CCL.
Implementing the nominations process
provides a mechanism for early public
participation in the CCL process and
allows the Agency Jo obtain suggestions
for contaminants that should be on the
CCL (NDWAC 2004).
D. How Will EPA Use Data Sources To
Identify Contaminants for the CCL
Universe?
Based upon recommendations from
NAS and NDWAC, the Agency is using
the following guiding principles to
construct the CCL Universe: (1) The
universe should include those
contaminants that have demonstrated or
have potential occurrence in drinking
water, and (2) the universe should
include those contaminants that have
demonstrated or have potential adverse
health effects. These inclusionary
principles apply to the selection of CCL
contaminants for initial consideration in
the CCL Universe.
EPA has evaluated over 280 resources
(referred to as "data sources") to
determine whether they are appropriate
for use in identifying potential drinking
water contaminants for the CCL. The
data sources vary widely in their
development and use (e.g., research,
surveys, and compliance monitoring);
type of data (e.g., concentrations, health
effects, microbiological occurrence, and
environmental fate); data format;
availability; and possible applicability
to the universe of contaminants for
consideration.
The Agency recognizes that there are
significant differences in the methods
and information used to characterize
chemical and microbiological
contaminants. Chemical contaminants
tend to be characterized by toxicological
and occurrence data that can be
modeled or estimated if measurement is
not possible. These discrete
characteristics are often captured in data
sources.
To identify chemical contaminants,
consistent with recommendations for
developing the Universe, the Agency
recognizes that the most appropriate
data sources for use in the CCL
classification process will provide
information in a number of areas
including concentrations, health effects,
occurrence, and environmental fate.
EPA has identified four factors that
should be met for data sources to be
considered useable. Sources are
screened for relevance, completeness,
redundancy (those sources with the
most comprehensive sources are
selected, while less comprehensive
sources with the same information are
rejected), and retrievability to determine
use in the CCL classification process.
Table 1 provides a list of the data
sources that EPA will use in compiling
the Chemical CCL Universe.
TABLE 1— INITIAL CLASSIFICATION OF CHEMICAL DATA SOURCES
Data source name
Organizations
ATSDR CERCLA Priority List
ATSDR Minimal Risk Levels (MRLs)
Chemical Toxicity Database—Ministry of Health and Welfare, Japan
Chemical Update System/Inventory Update Rule (CUS/IUR)
Cumulative Estimated Daily Intake/Acceptable Daily Intake (CEDI/ADI) Database
Database of Sources of Environmental Releases of Dioxin-Uke Compounds in the United
States.
Distributed Structure Searchable Toxicity Public Database Network (DSSTox)
Everything Added to Food in the United States (EAFUS) Database
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) List
Generally Regarded As Safe (GRAS) Substance List
Guidelines for Canadian Drinking Water Quality (CADW). Summary of Guidelines
World Health Organization (WHO) Guidelines for Drinking Water Quality: Summary Tables
Health Advisories (HA) Summary Tables
High Production Volume (HPV) Chemical List
Hazardous Substances Data Bank (HSDB)
Indirect Additives Database
International Agency for Research on Cancer (IARC) Monographs
international Toxicity Estimates for Risk (ITER) Database
Integrated Risk Information System (IRIS)
Joint Meeting On Pesticide Residues (JMPR)—2001. Inventory of Pesticide Evaluations
National Drinking Water Contaminant Occurrence Database (NCOD)—Round 1 & 2
National Drinking Water Contaminant Occurrence Database (NCOD)—Unregulated Contami-
nant Monitoring Rule (UCMR).
Agency for Toxic Substances and Disease
Registry.
Agency for Toxic Substances and Disease
Registry.
Ministry of Health and Welfare, Japan.
EPA.
U.S. Food and Drug Administration (FDA).
EPA.
EPA.
FDA.
EPA.
FDA.
Health Canada.
WHO.
EPA.
EPA.
National Library of Medicine.
FDA.
International Agency for Research on Cancer.
Toxicology Excellence for Risk Assessment
(TERA).
EPA.
World Health Organization, Food and Agri-
culture Organization
EPA.
EPA.
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60707
TABLE 1 .—INITIAL CLASSIFICATION OF CHEMICAL DATA SOURCES—Continued
Data source name
Organizations
National Inorganics and Radionuclides Survey (NIRS)
National Pesticide Use Database
National Reconnaissance of Emerging Contaminants (NREC)—USGS Toxic Substances Hy-
drology Program.
National Toxicology Program (NTP) Studies
National Water Quality Assessment (NAWQA)
OSHA 1988 Permissible Exposure Limits (PELs)
Pesticide Data Program
Pesticides Pilot Monitoring Program
Risk Assessment Information System (RAIS)—Department of Energy—Chemical Factors
Risk Assessment Information System (RAIS)—Health Effects Data
State of California EPA Chemicals Known to the State to Cause Cancer or Reproductive Tox-
icity.
Storage and Retrieval (STORET)
Substance Registry System (SRS)
Syracuse Research Corporation (SRC)—BIODEG
The Toxics Release Inventory (TRI)
Toxic Substances Control Act (TSCA) List
Toxicity Criteria Database—California Office of Environmental Health Hazard Assessment
(OEHHA).
University of Maryland—Partial List of Acute Toxins/Partial List of Teratogens
EPA.
National Center for Food and Agricultural Pol-
icy.
U.S. Geological Survey (USGS).
National Cancer Institute.
USGS.
National Institute for Occupational Safety and
Health (NIOSH).
USDA.
USGS/EPA.
U.S. Department of Energy.
Department of Energy.
State of California.
EPA.
EPA.
Syracuse Research Corporation.
EPA.
EPA.
California Office of Environmental Health Haz-
ard Assessment.
University of Maryland.
For microbes, the adverse health
effects from exposure are characterized
by clinical or epidemiological data and
there are few analytical methods to
estimate or model the occurrence of
microbes. Limited sources of tabular
data for microbes may require
evaluation of primary literature,
technical reports, monographs and
reference, books to identify the universe
of microbes for consideration. The
Agency is using human pathogens as the
starting point for identifying
microorganisms considered for
inclusion in the CCL Universe. The
primary source of information on
human pathogens is Risk Factors for
Human Disease Emergence (Taylor ef al.
2001), which provides a list of 1,415
human pathogens. In addition to the
Taylor et al study, the Agency will use
the nominations process to ensure that
the CCL universe captures emerging
pathogens.
E. Why Is EPA Soliciting Contaminant
Nominations?
EPA is requesting contaminant
nominations from the public to ensure
that contaminants that may not be
identified for consideration as part of
the recommended CCL process are
considered. The Agency is making
significant progress in developing a
contaminant classification approach and
continues to implement the NAS and
NDVVAC recommendations.
While NAS and NDWAC
recommended a data driven step-wise
approach to classifying contaminants,
these experts also recognized the
importance of providing an additional
pathway for the public to identify new
and emerging contaminants that may
not be identified in an evaluation of the
data sources. A public nominations
process allows the Agency to consider
new and emerging contaminants that
might not otherwise be considered
because new information has not-been
widely reported or recorded.
Following the recommendations of
NAS and NDWAC, the Agency has
compiled a universe of contaminants
and will add nominated contaminants
from the public to the CCL Universe.
The nominees will be considered as
EPA evaluates NAS and NDWAC
recommendations to screen the CCL
universe and develops criteria to
classify contaminants for the draft CCL.
III. EPA CCL Nominations Process
This contaminant nominations
process is the first opportunity to make
nominations to the new CCL (CCL 3).
The Agency will also accept
nominations during the notice and
comment period following EPA's
publication of the draft CCL 3.
A. How can Stakeholders, Agencies,
Industry, and the Public Nominate
Contaminants for the CCL?
EPA's preferred method for
submission of contaminant nominations
is through the EPA CCL 3 Nomination
Web site. Interested parties can
nominate chemicals, microbes, or other
materials for consideration on the new
CCL by sending information
electronically, or in hard copy to EPA.
Do not submit confidential business
information (CBI) through e-mail. If you
wish to submit CBI, first contact EPA
(see ADDRESSES section) for instructions
on how to submit CBI. When submitting
a nomination, it is preferred that the
nominators include a name, affiliation,
phone number, mailing address, and e-
mail address; however, this information
is not required and nominations can be
submitted anonymously. The nominator
should also address the following
questions for each contaminant
nominated to the CCL:
1. What is the contaminant's name,
CAS number, and/or common synonym
(if applicable)?
2. 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;
released to air, land, and/or water;
contaminants manufactured in large
quantities with a potential to occur in
source waters)?
3. 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? Please
provide complete citations, including
author(s), title, journal and date, Contact
information for the primary investigator
would also be helpful.
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B. How Do I Submit Nominations
Through EPA's Nominations Web Site?
The Web site is designed to provide
key information to the Agency, as
described in Section III. A of this notice,
for each contaminant nominated to the
CCL process.
The Web address to nominate a
contaminant can be found at http://
www. epa .gov/safe wa ter/ccl/ccl3 .html.
C. How do I Submit Nominations in
Hard Copy?
You may submit nominations by mail.
To allow full Agency consideration of
your nomination, please ensure that
your nominations are received or
postmarked by midnight December 15,
2006. The addresses for submittal of
nominations by mail are listed in the
ADDRESSES section of this document
D. What Will Happen to My
Nominations After I Submit Them?
The Agency will include nominated
contaminants into the CCL Universe
EPA will evaluate the information
available for the nominated
contaminants to determine the
appropriateness of inclusion on the
PCCL and finally the CCL. While EPA
does not intend to respond to the
nominations directly or individually,
the Agency will fully explain nominated
contaminants for the CCL3.
IV. References
Copies of these documents are found
at http://www.regulations.gov, Docket ID
No. EPA-OW-2005-0039.
NAS 2001. National Academy of Sciences,
National Research Council. 2001. Classifying
Drinking Water Contaminants for Regulatory
Consideration. National Academy Press.
Washington, DC. Available at http://
books.nap.edu/books/0309074088/html/
index.html NOW AC 2004. National Drinking
Water Advisory Council. National Drinking
Water Advisory Council Report on the CCL
Classification Process to the U.S.
Environmental Protection Agency, May 18,
2004. Available at http://www.epa.gov/
safewater/ndwac/pdfs/report_ccl_ndwac_07-
06-04 pdf.
Taylor, Latham, and Woolhouse. 2001.
Risk factors for human disease emergence
(Appendix A). Philosophical Transactions of
the Royal Society of London Biology:
256:983-98.
Dated: October 6, 2006.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. E6-17099 Filed 10-13-06; 8:45 am]
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