

[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
------------------------------------------------------------------------
               Data source name                      Organizations
------------------------------------------------------------------------
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]

BILLING CODE 6560-50-P
