Request for Nominations of Drinking Water Contaminants for the
Contaminant Candidate List
[Federal Register: October 16, 2006 (Volume 71, Number 199)]
[Notices]
[Page 60704-60708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc06-35]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2005-0039; FRL-8231-3]
Request for Nominations of Drinking Water Contaminants for the
Contaminant Candidate List
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is requesting
nominations
[[Page 60705]]
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.
Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to visit the Public Reading Room to
view documents. Consult EPA's Federal Register notice at 71 FR 54815
(September 19, 2006) or the EPA Web site at http://www.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://www.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)(1)). 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
[[Page 60706]]
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 to
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
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Data source name Organizations
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ATSDR CERCLA Priority List................... Agency for Toxic
Substances and Disease
Registry.
ATSDR Minimal Risk Levels (MRLs)............. Agency for Toxic
Substances and Disease
Registry.
Chemical Toxicity Database--Ministry of Ministry of Health and
Health and Welfare, Japan. Welfare, Japan.
Chemical Update System/Inventory Update Rule EPA.
(CUS/IUR).
Cumulative Estimated Daily Intake/Acceptable U.S. Food and Drug
Daily Intake (CEDI/ADI) Database. Administration (FDA).
Database of Sources of Environmental Releases EPA.
of Dioxin-Like Compounds in the United
States.
Distributed Structure Searchable Toxicity EPA.
Public Database Network (DSSTox).
Everything Added to Food in the United States FDA.
(EAFUS) Database.
Federal Insecticide, Fungicide, and EPA.
Rodenticide Act (FIFRA) List.
Generally Regarded As Safe (GRAS) Substance FDA.
List.
Guidelines for Canadian Drinking Water Health Canada.
Quality (CADW): Summary of Guidelines.
World Health Organization (WHO) Guidelines WHO.
for Drinking Water Quality: Summary Tables.
Health Advisories (HA) Summary Tables........ EPA.
High Production Volume (HPV) Chemical List... EPA.
Hazardous Substances Data Bank (HSDB)........ National Library of
Medicine.
Indirect Additives Database.................. FDA.
International Agency for Research on Cancer International Agency for
(IARC) Monographs. Research on Cancer.
International Toxicity Estimates for Risk Toxicology Excellence for
(ITER) Database. Risk Assessment (TERA).
Integrated Risk Information System (IRIS).... EPA.
Joint Meeting On Pesticide Residues (JMPR)-- World Health
2001. Inventory of Pesticide Evaluations. Organization, Food and
Agriculture Organization
National Drinking Water Contaminant EPA.
Occurrence Database (NCOD)--Round 1 & 2.
National Drinking Water Contaminant EPA.
Occurrence Database (NCOD)--Unregulated
Contaminant Monitoring Rule (UCMR).
[[Page 60707]]
National Inorganics and Radionuclides Survey EPA.
(NIRS).
National Pesticide Use Database.............. National Center for Food
and Agricultural Policy.
National Reconnaissance of Emerging U.S. Geological Survey
Contaminants (NREC)--USGS Toxic Substances (USGS).
Hydrology Program.
National Toxicology Program (NTP) Studies.... National Cancer
Institute.
National Water Quality Assessment (NAWQA).... USGS.
OSHA 1988 Permissible Exposure Limits (PELs). National Institute for
Occupational Safety and
Health (NIOSH).
Pesticide Data Program....................... USDA.
Pesticides Pilot Monitoring Program.......... USGS/EPA.
Risk Assessment Information System (RAIS)-- U.S. Department of
Department of Energy--Chemical Factors. Energy.
Risk Assessment Information System (RAIS)-- Department of Energy.
Health Effects Data.
State of California EPA Chemicals Known to State of California.
the State to Cause Cancer or Reproductive
Toxicity.
Storage and Retrieval (STORET)............... EPA.
Substance Registry System (SRS).............. EPA.
Syracuse Research Corporation (SRC)--BIODEG.. Syracuse Research
Corporation.
The Toxics Release Inventory (TRI)........... EPA.
Toxic Substances Control Act (TSCA) List..... EPA.
Toxicity Criteria Database--California Office California Office of
of Environmental Health Hazard Assessment Environmental Health
(OEHHA). Hazard Assessment.
University of Maryland--Partial List of Acute University of Maryland.
Toxins/Partial List of Teratogens.
------------------------------------------------------------------------
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 et 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 NDWAC 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.
[[Page 60708]]
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/safewater/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
NDWAC 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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