Drinking Water Contaminant Candidate List 2; Final Notice, 9071-9077 [05-3527]
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
EPA West, U.S. EPA, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: Mr.
M. Ahmar Siddiqui, Document Control
Officer, at (202) 566–1044, or via e-mail
at siddiqui.ahmar@epa.gov.
SUPPLEMENTARY INFORMATION: EPA has
previously transferred to its contractor,
ERG (located in Chantilly, Virginia and
Lexington, Massachusetts), information,
including CBI, that was collected under
the authority of section 308 of the CWA.
Notice of the transfer was provided to
the affected industries (see, for example,
59 FR 58840, November 15, 1994). EPA
determined that this transfer was
necessary to enable the contractors and
subcontractors to perform their work in
supporting EPA in planning,
developing, and reviewing effluent
guidelines and standards for certain
industries.
Today, EPA is giving notice that it has
entered into additional contracts,
numbers 68–C–02–095 and 68–C–01–
073, with ERG. The reason for these
contracts is to secure additional
contractor support in engineering
analysis, survey and database
development, economic analyses, and
ecological analyses. To obtain assistance
in responding to these contracts, ERG
has entered into contracts with their
subcontractors. In particular, ERG has
obtained the services of the following
subcontractors: Abt Associates (located
in Cambridge, Massachusetts); AH
Environmental Consultants, Inc.
(located in Newport News and
Springfield, Virginia); AmDyne
Corporation (located in Glen Burnie,
Maryland); Amendola Engineering, Inc.
(located in Westlake, Ohio); Analytica
Alaska, Inc. (located in Juneau, Alaska);
Applied Geographics, Inc. (located in
Boston, Massachusetts); Avanti
Corporation (located in Annandale,
Virginia); CK Environmental (located in
Atlanta, Georgia); DRPA, Inc. (located in
Rosslyn, Virginia); GeoLogics
Corporation (located in Alexandria,
Virginia); Hydraulic and Water
Resources Engineers, Inc. (located in
Waltham, Massachusetts); N. McCubbin
Consultants, Inc. (located in Foster,
Quebec, Canada); Stratus Consulting,
Inc. (located in Boulder, Colorado);
Tetra Tech, Inc. (located in Fairfax,
Virginia); Versar, Inc. (located in
Springfield, Virginia); and independent
consultant Danforth Bodien.
All EPA contractor, subcontractor,
and consultant personnel are bound by
the requirements and sanctions
contained in their contracts with EPA
and in EPA’s confidentiality regulations
found at 40 CFR Part 2, Subpart B. ERG
and its subcontractors adhere to EPA-
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approved security plans which describe
procedures to protect CBI. The
procedures in these plans are applied to
CBI previously gathered by EPA for the
industries identified below and to CBI
that may be gathered in the future for
these industries. The security plans
specify that contractor and
subcontractor personnel are required to
sign non-disclosure agreements and are
briefed on appropriate security
procedures before they are permitted
access to CBI. No person is
automatically granted access to CBI; a
need to know must exist.
The information that will be
transferred to ERG and its
subcontractors consists primarily of
information previously collected by
EPA to support the development and
review of effluent limitations guidelines
and standards under the CWA and the
development of discharge standards
under Title XIV. In particular,
information, including CBI, collected for
the planning, development, and review
of effluent limitations guidelines and
standards for the following industries
may be transferred: Airport deicing;
aquaculture; concentrated animal
feeding operations; centralized waste
treatment; coal mining; drinking water;
industrial laundries; waste combustors;
iron and steel manufacturing; landfills;
meat and poultry products; metal
finishing; metal products and
manufacturing; nonferrous metals
manufacturing; oil and gas extraction
(including coalbed methane); ore
mining and dressing; organic chemicals,
plastics, and synthetic fibers; pesticide
chemicals; pharmaceutical
manufacturing; petroleum refining;
pulp, paper, and paperboard
manufacturing; steam electric power
generation; textile mills; timber
products processing; tobacco; and
transportation equipment cleaning. In
addition, for the development of
standards under Title XIV, EPA may
transfer information, including CBI,
about large cruise ships that operate in
the waters around Alaska.
EPA also intends to transfer to ERG
and its subcontractors all information
listed in this notice, of the type
described above (including CBI) that
may be collected in the future under the
authority of section 308 of the CWA or
voluntarily submitted (e.g., in comments
in response to a Federal Register
notice), as is necessary to enable ERG
and its subcontractors to carry out the
work required by their contracts to
support EPA’s effluent guidelines
planning process; development of
effluent limitations guidelines and
standards; and discharge standards from
cruise ships.
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9071
Dated: February 15, 2005.
Geoffrey H. Grubbs,
Director, Office of Science and Technology.
[FR Doc. 05–3528 Filed 2–23–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[OW–2003–0028; FRL–7876–9]
RIN 2060–AD86
Drinking Water Contaminant Candidate
List 2; Final Notice
Environmental Protection
Agency.
ACTION: Notice.
AGENCY:
SUMMARY: The Safe Drinking Water Act
(SDWA), as amended in 1996, requires
the Environmental Protection Agency
(EPA) to publish a list of contaminants
that, at the time of publication, are not
subject to any proposed or promulgated
national primary drinking water
regulations, that are known or
anticipated to occur in public water
systems, and that may require
regulations under SDWA (section 1412
(b)(1)). SDWA, as amended, specifies
that EPA must publish the first list of
drinking water contaminants no later
than 18 months after the date of
enactment, i.e., by February 1998, and
every five years thereafter.
The EPA published the first
Candidate Contaminant List (CCL) in
March of 1998 (63 FR 10273). The
second draft CCL (CCL 2) was published
on April 2, 2004 (69 FR 17406) and
announced EPA’s preliminary decision
to carry forward the remaining 51
contaminants on the 1998 CCL as the
draft CCL 2, provided information on
EPA’s efforts to expand and strengthen
the underlying CCL listing process to be
used for future CCL listings, and sought
comment on the draft list as well as
EPA’s efforts to improve the
contaminant selection process for future
CCLs. Today’s final CCL 2 carries
forward the remaining 51 contaminants
proposed on April 2, 2004.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. OW–2003–0028. All documents in
the docket are listed in the EDOCKET
index at https://www.epa.gov/edocket.
Although listed in the index, some
information is not publically available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publically
available only in hard copy form.
Publically available docket materials are
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
available either electronically in
EDOCKET or in hard copy at the Water
Docket, EPA/DC, EPA West, Room
B102, 1301 Constitution Avenue, NW.,
Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the Water Docket is (202) 566–2426. For
access to docket material, please call
(202) 566–2426 to schedule an
appointment.
For
questions about this notice contact Dan
Olson, Standards and Risk Management
Division, Office of Ground Water and
Drinking Water (MC–4607M),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: 202–564–
5239; fax number: 202–564–3752; e-mail
address: olson.daniel@epa.gov. For
general information contact the EPA
Safe Drinking Water Hotline at (800)
426–4791 or e-mail: hotlinesdwa@epa.gov. The Safe Drinking Water
Hotline is open Monday through Friday,
excluding legal holidays, from 9 a.m. to
5 p.m.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. General Information
A. Does This Action Impose Any
Requirements on My Public Water
System?
Today’s action does not impose any
requirements on anyone. Instead, it
notifies interested parties of EPA’s final
CCL 2 as well as EPA’s efforts to
improve the contaminant selection
process for future CCLs. Contaminants
on the list will be considered under the
regulatory determination provision of
SDWA (see section 1412(b)(1)(B)(ii)),
which directs EPA to select at least five
contaminants from the CCL every five
years to determine if regulating the
contaminants through National Primary
Drinking Water Regulations would
present a meaningful opportunity to
reduce health risk.
II. Background and Summary of
Today’s Action
A. What Is the Purpose of Today’s
Action?
The CCL is the primary source of
priority contaminants for evaluation by
EPA’s drinking water program.
Contaminants on the CCL are currently
not subject to any proposed or
promulgated national primary drinking
water regulation, but are known or
anticipated to occur in public water
systems, and may require regulation
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under SDWA. The EPA conducts
research on health effects, analytical
methods, contaminant occurrence,
treatment technologies, and treatment
effectiveness for priority drinking water
contaminants on the CCL. The Agency
also develops drinking water guidance
and health advisories, and makes
regulatory determinations for priority
contaminants on the CCL.
Today’s action informs interested
parties of EPA’s final CCL 2 as well as
EPA’s efforts to improve the
contaminant selection process for future
CCLs.
B. The Background of the CCL
The SDWA is the core statute
protecting drinking water at the Federal
level. Under SDWA, EPA sets public
health goals and enforceable standards
for drinking water quality. In 1996,
Congress amended SDWA to emphasize
sound science and risk-based prioritysetting. Congress also changed the way
drinking water regulatory priorities are
set by establishing the CCL
requirements. The 1996 SDWA
amendments require EPA to (1) publish
every five years a list of currently
unregulated contaminants in drinking
water that may pose risks (the CCL), and
(2) make determinations on whether or
not to regulate at least five of these
contaminants on a five year cycle, or
three and a half years after each CCL is
published (SDWA section (b)(1)).
Today’s action is being published
pursuant to the requirements in section
1412(b)(1). The contaminants included
are not subject to any proposed or
promulgated national primary drinking
water regulation, are known or
anticipated to occur in public water
systems, and may require regulation
under the SDWA. A draft CCL 2 was
published in the April 2, 2004 edition
of the Federal Register (69 FR 17406) to
announce EPA’s preliminary decision to
carry forward the remaining 51
contaminants on the 1998 CCL as the
CCL 2, to provide information on EPA’s
efforts to expand and strengthen the
underlying CCL listing process to be
used for future CCL listings, and to seek
comment on the draft list as well as
EPA’s efforts to improve the
contaminant selection process for future
CCLs.
Today’s action establishes the final
CCL 2 which includes 42 chemicals or
chemical groups and nine
microbiological contaminants. This list
continues to be an important tool under
the SDWA to help prioritize research
and serves as the central focus of the
regulatory determination process noted
previously. It is important to note,
however, that under the SDWA, the EPA
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may also make regulatory
determinations for any unregulated
contaminant not on today’s CCL (see
SDWA section 1412(b)(1)(B)(ii)(III)).
Thus, the Agency has the authority to
act as necessary to protect public health
as new information becomes available.
III. Drinking Water Contaminant
Candidate List 2
Table III–1 lists the contaminants on
the final CCL 2. These contaminants are
identified by name and, where
available, the Chemical Abstracts
Service Registry Number (CASRN). The
final CCL 2 consists of nine
microbiological contaminants and 42
chemical contaminants or contaminant
groups.
TABLE III–1.—FINAL DRINKING WATER
CONTAMINANT CANDIDATE LIST 2
Microbiological contaminant candidates
Adenoviruses Aeromonas hydrophila
Caliciviruses
Coxsackieviruses
Cyanobacteria (blue-green algae), other
freshwater algae, and their toxins
Echoviruses
Helicobacter pylori
Microsporidia (Enterocytozoon and Septata)
Mycobacterium avium intracellulare (MAC)
Chemical contaminant candidates
CASRN
1,1,2,2tetrachloroethane.
1,2,4trimethylbenzene.
1,1-dichloroethane ....
1,1-dichloropropene ..
1,2-diphenylhydrazine
1,3-dichloropropane ..
1,3-dichloropropene ..
2,4,6-trichlorophenol
2,2-dichloropropane ..
2,4-dichlorophenol .....
2,4-dinitrophenol .......
2,4-dinitrotoluene ......
2,6-dinitrotoluene ......
2-methyl-Phenol (ocresol).
Acetochlor .................
Alachlor ESA & other
acetanilide pesticide degradation
products.
Aluminum ..................
Boron .........................
Bromobenzene ..........
DCPA mono-acid
degradate.
DCPA di-acid
degradate.
DDE ...........................
Diazinon ....................
Disulfoton ..................
Diuron ........................
EPTC (s-ethyldipropylthiocarbamate).
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79–34–5
95–63–6
75–34–3
563–58–6
122–66–7
142–28–9
542–75–6
88–06–2
594–20–7
120–83–2
51–28–5
121–14–2
606–20–2
95–48–7
34256–82–1
N/A
7429–90–5
7440–42–8
108–86–1
887–54–7
2136–79–0
72–55–9
333–41–5
298–04–4
330–54–1
759–94–4
Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
Fonofos .....................
p-Isopropyltoluene (pcymene).
Linuron ......................
Methyl bromide .........
Methyl-t-butyl ether
(MTBE).
Metolachlor ................
Molinate .....................
Nitrobenzene .............
Organotins .................
Perchlorate ................
Prometon ...................
RDX ...........................
Terbacil .....................
Terbufos ....................
Triazines and degradation products of
triazines.
Vanadium ..................
944–22–9
99–87–6
51218–45–2
2212–67–1
98–95–3
N/A
14797–73–0
1610–18–0
121–82–4
5902–51–2
13071–79–9
including, but not limited to Cyanazine
21725–46–2 and
atrazine-desethyl
6190–65–4
7440–62–2
IV. Summary of Comments
The comment period on the April 2,
2004, Federal Register notice, ‘‘Drinking
Water Contaminant Candidate List 2;
Notice’’ (69 FR 17406) ended on June 1,
2004. EPA received a total of seven
comments that focused on EPA’s draft
CCL 2 and EPA’s efforts to improve the
contaminant selection process for future
CCLs. EPA received two comments from
associations representing water utilities,
one comment from a State-related
association, one comment from a water
utility, one comment from a State
agency, one comment from an
individual, and one anonymous
comment. A summary of these
comments and EPA’s response to these
comments follow. A complete copy of
the public comments and the Agency’s
responses are included in the Docket for
today’s action and can be obtained at
https://www.epa.gov/edocket/.
The majority of comments were
supportive of the CCL process. The
comments on development of the draft
CCL 2 focused on two key topic areas:
(1) Reassembling the CCL taking new
available information into account;
suggestions on information that should
be considered, and contaminants that
should be included or deleted from the
CCL; and (2) requests for information on
the status of CCL-related research.
Comments on the development of future
CCLs focused on four key topic areas:
(1) Expert judgement and transparency,
(2) the role of data quality, (3) a
simplified approach with adaptive
management for future CCLs, and (4) the
role of virulence factor activity
relationships (VFARs). The remainder of
this section discusses these key areas in
turn.
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of the revised and expanded CCL 3
review process. The Agency believes
1. Suggestions on new information
that this will be a more appropriate and
and contaminants that should be
effective approach for evaluating this
included or deleted from the CCL.
bacteria in comparison to a wide range
Comment Summary: Two
of other microbes that will be
commenters believe that EPA should
considered under the broader analytical
create a new CCL taking new available
approach recommended by the NRC and
information into account. One
NDWAC.
commenter recommended that EPA not
2. Provide the status of CCL-related
carry forward five chemicals (1,1,2,2research, data collection, and pending
tetrachloroethane, 1,1-dichloropropene,
initiatives that have been undertaken
1,3-dichloropropane, 1,3since CCL 1.
dichloropropene, and 2,2,
Comment Summary: Commenters
dichloropropane) currently on CCL 1 to
identified several CCL-related research
CCL 2, two commenters recommended
activities that have been undertaken
that N-nitrosodimethylamine (NDMA)
since CCL 1 and requested that EPA
should be added to the CCL, and one
provide the status of CCL-related
commenter recommended that
research, data collection, and pending
enterotoxigenic Escherichia coli (E. coli) initiatives that have been undertaken
be included on the final CCL 2.
since CCL 1.
Agency Response: In response to
Two commenters also requested
commenters who recommended that
information about the Agency’s progress
EPA create a new CCL to take new
to date and the intended future path for
available information into account, and
integrating the 35 deferred pesticides
the suggestion that EPA remove five
and 21 contaminants (suspected of
chemicals (1,1,2,2-tetrachloroethane,
having adverse effects on endocrine
1,1-dichloropropene, 1,3function) into the CCL process.
dichloropropane, 1,3-dichloropropene,
Agency Response: EPA agrees that the
and 2,2, dichloropropane) from the CCL, status of CCL-related research should be
EPA does not believe that it is
publically available. The Agency has
appropriate to create a new CCL, or
taken a number of steps to provide this
remove any contaminants from the CCL, information through its Web sites and in
at this time. Where there is adequate
documents it has published.
information about a particular
EPA Web sites addressing CCL-related
contaminant, EPA plans to make a
research information include the
regulatory determination which will
following:
either remove that contaminant from the
• EPA’s Office of Ground Water and
CCL or start a national rule making
Drinking Water Drinking Water
process to set a national primary
Research Information Network (DRINK),
drinking water regulation. With regard
found at https://www.epa.gov/safewater/
to future CCLs, EPA is developing an
drink/intro.html, is a publicly
expanded comprehensive system for
accessible, Web based system that tracks
evaluating a wider range of existing
over 1,000 ongoing research projects
information, identifying new data, and
conducted by EPA and other research
applying revised screening criteria to
partners from national, regional, and
generate the CCL 3 in response to
international research agencies and
extensive recommendations from the
organizations. The DRINK system stores,
National Academy of Sciences National manages, and delivers descriptive
Research Council (NRC) and National
summary data on drinking water-related
Drinking Water Advisory Council
projects, including abstracts, status of
(NDWAC).
projects, uniform resource locators to
With specific regard to NDMA, there
datasets and reports, and contact
is already a substantive body of health
information on projects.
effects research that the Agency has
• EPA’s Office of Ground Water and
relied upon to classify it as a ‘‘probable
Drinking Water Web site at https://
human carcinogen’’ (USEPA, 1993). The www.epa.gov/safewater/ccl/cclfs.html
key information gap for this
has information on the NDWAC (e.g.,
contaminant relates to occurrence in
reports, meeting announcements, and
public water system distribution
meeting summaries which includes
systems. Some initial research has been
meetings of the NDWAC CCL Work
conducted in this area and the Agency
Group), monitoring of unregulated
plans to collect more comprehensive
contaminants from public water
occurrence information as part of the
systems, the National Contaminant
upcoming national survey of key
Occurrence Database, analytical
unregulated contaminants under section methods for compliance monitoring,
1445(a)(2).
and treatment technologies.
• EPA’s Office of Research and
Regarding enterotoxigenic E. coli, EPA
Development (ORD) environmental
will be considering this microbe as part
A. Developing the draft CCL 2
330–55–2
74–83–9
1634–04–4
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information management system Web
site at https://www.epa.gov/eims/
maintains information on EPA research
projects, including project title, abstract,
start and end dates, principal
investigator, funding, results and
publications, and related technical
documents.
• EPA’s Office of Science and
Technology Web site at https://
www.epa.gov/waterscience/
humanhealth/ has information on EPA’s
drinking water standards, health and
consumer advisories, criteria
documents, and related technical
documents.
A key document addressing CCLrelated research and information is
EPA’s Draft Multi-Year Plan (MYP) for
the drinking water research program.
The Draft MYP describes the Agency’s
drinking water research program
activities and plans for fiscal years
2003—2010 (see https://www.epa.gov/
osp/myp/dw.pdf). As a tool for planning
and communication, the MYP provides:
(1) A context for annual planning
decisions and a basis for describing the
impacts of these decisions; (2) a
framework for integrating research on
common issues across the EPA’s ORD
laboratories and centers, as well as
across the various Agency Goals
established under the Government
Performance and Results Act; and (3) a
resource for communicating research
plans and products within ORD and
with EPA programs, the regions and
interested parties outside of EPA. MYPs
are updated on a biennial basis to
provide opportunities for making the
necessary adjustments to the research
program.
As discussed in the draft CCL 2 notice
(69 FR 17406), EPA plans to consider
the deferred pesticides in the context of
an improved approach for selecting
contaminants for future CCLs (CCL 3).
This will enable the Agency to consider
these contaminants in a consistent,
reproducible manner with a wide range
of other contaminants. In this regard, it
is important to note that EPA may
conduct research, and make regulatory
determinations for any unregulated
contaminant not on today’s CCL (see
SDWA section 1412(b)(1)(B)(ii)(III)).
Thus, the Agency has the authority to
act as necessary to protect public health
as new information becomes available.
As with pesticides, EPA believes that
suspected endocrine disruptors should
be considered when the next CCL is
developed. This enables the Agency to
use a more refined and improved
approach in evaluating these
contaminants. As previously stated,
EPA is not restricted to the
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contaminants on this CCL for making
regulatory determinations.
B. Developing a Process for Future CCLs
There were four key issues identified
by commenters on developing a process
for future CCLs. They are:
1. Expert judgement and transparency
2. The Role of Data Quality.
3. Simplified approach with adaptive
management applied for future CCLs.
4. The role of virulence factor activity
relationships.
Each of these issues is discussed in
turn below.
1. Expert Judgement and Transparency
Comment Summary: Two
commenters stated that there is a need
for the CCL process to be a transparent
process. The commenters stated that
they view the transparency of the CCL
process as being critical to its success so
that both the regulated community and
the public can understand it. One
commenter also recommended that the
Agency combine expert judgement and
classification algorithms (a formula or
set of steps for solving a particular
problem) in developing the CCL.
Classification algorithms or automated
processes should serve as mechanisms
for screening down the number of
contaminants that the experts must then
evaluate in greater depth.
Both commenters believe that the use
of expert judgement can be transparent
and is an essential component to any
future CCL process. They urged EPA to
clearly define the role of expert
judgement including the specific parts
of the listing process where it would be
used.
One commenter also suggested that
the CCL process should be an ongoing
process within the Office of Water and
that the Agency should actively monitor
appropriate peer-reviewed literature for
new contaminants, new methods, and
new health effects data. In addition, the
Agency should also increase its
involvement in ongoing symposia,
professional meetings, and workshops
on topics relevant to the CCL.
Agency’s Response: The Agency
agrees with the commenters that
transparency and use of expert
judgement should be important
components of the CCL process. These
recommendations were included in both
the NRC report (NRC, 2001) and in the
NDWAC Report on the CCL
Classification Process to the U.S.
Environmental Protection Agency
(NDWAC, 2004). The Agency received
the NDWAC report in May of 2004 and
is currently evaluating the
recommendations.
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The NRC and NDWAC reports
recommend that the EPA conduct the
CCL process so that interested
stakeholders have an opportunity to
participate at key steps in developing
the CCL. Additionally the reports
recommend greater use of expert
judgment and critical review of the CCL
classification process. While the reports
did not provide specific advice on how
to accomplish these recommendations
they did identify key milestones, such
as selecting sources of data and
developing criteria to select
contaminants. Structuring the process
around such milestones should enhance
transparency and facilitate expert
review.
The Agency continues to evaluate the
NDWAC recommendation on how to
include expert judgment and conduct
the CCL process in a transparent manner
and will consider these comments as
future CCLs are developed.
2. The Role of Data Quality
Comment Summary: Two
commenters stressed the importance of
data quality in the CCL process. Both
commenters support the use of high
quality data and sound science in the
CCL process.
The commenters expressed some
concern about the current quality of
data used for the CCL process. The
commenters suggested that EPA should
focus on using high quality data that are
appropriate to support valid
characterization of a contaminant and
that EPA maintains a focus on data
quality at each stage of the CCL process.
One commenter expressed an interest
in participating in the ongoing
development and application of a viable
data quality assurance system that
would support the data objectives for
each step in the CCL process.
Agency’s Response: The NDWAC
recommendations also discussed the
nature and type of data and information
used in the CCL process. In discussing
information quality considerations, the
Council noted that data and information
on contaminants considered in the CCL
process will consist of different types of
data and that some contaminants will
not be robustly characterized. The
report also recommends that while the
Agency should be explicit about how it
selects data for the CCL process, the
process must have some flexibility to
adequately consider emerging
contaminants. As the Agency develops
the CCL process and evaluates the
NDWAC recommendations, it will
consider the commenters’
recommendations as well as the SDWA
data quality requirements.
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
3. Simplified Approach
Comment Summary: One commenter
expressed concern over the NAS and
NDWAC recommendations,
characterizing them as ‘‘a theoretical
and esoteric process and not a pragmatic
process.’’ The commenter believes that
there is a need for the Agency to
develop a simpler, more streamlined
approach that uses only the attributes of
occurrence and health effects and that
potentially eliminates some of the major
complications associated with the NRC
three-step, five-attribute CCL process,
thereby making the process more
effective in the near term. The NRC
approach can serve as a useful guide for
the Agency’s long-term CCL
development effort; however, the details
and logistics of the approach require
additional work.
One commenter was concerned about
the resources and time needed to
develop the CCL using a new approach.
The commenter suggested that
convening a series of workshops with
external experts would be an efficient
way of addressing issues related to data
quality, contaminant attributes, training
sets, process performance, and protocols
for classification algorithms.
Agency’s Response: The NDWAC
report provides a series of
recommendations for the Agency to
consider as it develops the CCL process.
The NDWAC report also noted that the
NRC three-step approach using five
attributes has merit, but identified
practical limitations or difficulties the
Agency would need to address. For
example, the NDWAC report
recommends that the Agency should
consider classification approaches but
‘‘should use another approach for
selecting contaminants for the near term
(i.e., for CCL 3) if there are difficulties
that cannot be overcome.’’ The NDWAC
report also identifies issues that the
Agency should consider in the NRC’s
recommendation on classification
approaches and emphasizes that the
Agency should consider practical
constraints. The NDWAC report
specifically recommended that the
screening step be as simple as possible,
which would require fewer resources
and less time while adequately
identifying those contaminants of
greatest significance. The report further
encouraged the Agency to consider
whether fewer than the five attributes
used in the NRC example of a
classification approach are adequate for
a new CCL process. The NDWAC report
recognizes that the Agency will learn
more about the CCL process in each
iterative step and recommended an
adaptive management approach to
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develop the CCL process. As the Agency
evaluates the NDWAC
recommendations, it will consider the
need for a pragmatic approach using
available resources for development of
the next CCL and the most efficient
ways to incorporate expert involvement
in the CCL process.
4. The Role of Virulence Factor Activity
Relationship.
Comment Summary: A variety of
comments were received on the
proposed role of genomic data and the
VFAR concept for the CCL process.
Most of the commenters acknowledged
that VFAR appears to be a powerful and
useful tool that shows great promise for
future CCL development, but felt that
the Agency had not made clear how it
proposes to use VFAR technology.
The commenters suggested that the
Agency is placing too much emphasis
on VFAR. One commenter stated that
the Agency appears to be relying too
heavily on an advanced genomic
technology. The commenter expressed
concerns that the technology’s
applications to environmental samples
are unproven and recommended that it
not be used in the next CCL process.
One commenter suggested that there
are many unknown variables associated
with the VFAR concept and it should
therefore be treated with extreme
caution. Two commenters are concerned
that VFAR may not offer practical
solutions to immediate concerns
regarding waterborne disease and would
require a multi-year commitment and
collaboration by EPA and other
participating organizations before it
would be useful.
Agency Response: The NRC (NRC,
2001) recommendations provided a
detailed discussion of the potential and
proposed role of VFARs in the CCL
process. The VFAR principle can be
described as comparing the gene
structure of newly identified waterborne
pathogens to pathogens with known
genetic structures that have been
associated with human disease.
Virulence factors are defined broadly
by the NRC as the ability of a pathogen
to persist in the environment, gain entry
into a host (e.g., humans), reproduce,
and cause disease or other health
problems either because of its
architecture or because of its
biochemical compounds. A number of
virulence factors are known, including
the ability of a microbe to move within
a host under its own power, the ability
of mechanisms to protect the microbe
against the body’s defenses (e.g., antiphagocytosis mechanisms), the ability of
a microbe to adhere or attach to the
surface of a host cell, and the ability of
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9075
microbes to produce toxins that injure
host cells. The NDWAC was specifically
charged to provide an evaluation of the
VFAR approach and to identify studies
that explore the feasibility of the
approach. While the Agency recognizes
VFAR as a potential tool for future
CCLs, EPA is not planning to solely rely
on the approach in the near term for
CCLs. In its deliberation, the NDWAC
conducted several explorations and
literature reviews on the nature and
type of genomic data available to
characterize genes that may be
associated with virulence factors and an
organism’s potential to cause harm. The
reviews and analyses showed that the
technology, although powerful, still has
serious limitations for near term CCLs.
The NDWAC provided a series of
pragmatic recommendations for
considering pathogens for near term
CCLs and several recommendations for
improving this process as genomic
technology and reporting improve. As
the Agency develops the CCL process
for microbes it will take these comments
under consideration.
V. Developing Future CCLs—NDWAC
Recommendations and Next Steps
A. NDWAC Recommendations
In the Federal Register notice of April
2, 2004 (69 FR 17406), EPA discussed
the activities of the NRC and the
NDWAC related to the CCL. The EPA
sought the advice of the NRC in
response to comments received during
the development of the 1998 CCL,
which advocated a broader, more
comprehensive approach for selecting
contaminants.
The Agency asked the NRC to address
three key topics related to drinking
water contaminant selection and
prioritization:
1. What approach should be used to
develop future CCLs?
2. How best should EPA assess
emerging drinking water contaminants
and related databases to support future
CCL efforts?
3. What approach should EPA use to
set priorities for contaminants on the
CCL?
The NRC’s findings and
recommendations on these topics were
published in three reports: Setting
Priorities for Drinking Water
Contaminants (NRC, 1999a), Identifying
Future Drinking Water Contaminants
(NRC, 1999b), and Classifying Drinking
Water Contaminants for Regulatory
Consideration (NRC, 2001).
The NRC recommendations provided
a framework for evaluating a larger
number of contaminants and making
decisions about contaminants for which
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
data are limited through the use of
innovative technologies and expert
advice. The EPA requested the
assistance of NDWAC to evaluate and
provide advice on implementing the
NRC’s recommended classification
process.
The NDWAC formed the CCL
Classification Process Work Group (the
Work Group) and charged it with
reviewing the NRC 2001 report. The
Work Group was asked to advise the
NDWAC on development and
application of the classification
approach suggested by the NRC,
including evaluating proposed and
alternative methodologies. The Work
Group met 10 times from September of
2002 to March of 2004. All Work Group
meetings were open to the public and
announced in the Federal Register. In
conducting its review, the Work Group
considered the large and growing
number of agents that might become
candidates for scrutiny in the CCL
process, and the rapid expansion of
information on these agents. Based on
this review, the Work Group provided
the following recommendations:
1. There is merit in the three-step
selection process proposed by NRC for
classifying chemical and microbial
contaminants. The NDWAC believes the
three-step process should involve
identification of the CCL universe,
screening the universe to a preliminary
CCL, and selecting the CCL from the
Preliminary CCL.
2. The NDWAC recommends that the
Agency should move forward with the
NRC recommendation to develop and
evaluate some form of prototype
classification approach. (A prototype
classification uses computer-based
computational tools to weigh selected
contaminant characteristics against the
characteristics of various classes of
drinking water contaminants whose
occurrence and health effects are
relatively well understood.)
3. The NDWAC believes that expert
judgment plays an important role
throughout the three-step selection
process, particularly in reviewing the
prototype model and the output of the
new classification approach.
4. The NDWAC recommended
enhancing the surveillance for emerging
chemical and microbial contaminants
and also soliciting information from the
public via a nomination process to
assure a full consideration of potential
contaminants.
The NDWAC also identified a number
of practical limitations or difficulties in
developing and applying the
recommended approach and provided
advice on how these might be
addressed.
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The NDWAC presented the final
report to the Administrator on May 19,
2004. The report, entitled National
Drinking Water Advisory Council
Report on the CCL Classification Process
to the U.S. Environmental Protection
Agency provides a detailed summary of
the questions considered by the
NDWAC, the analyses conducted to
explore the questions, key points
discussed, and the NDWAC’s
recommendations and rationale for the
recommendations. The report is
available at https://www.epa.gov/
safewater/ndwac/council.html.
B. Next Steps
The Agency is working to evaluate the
NDWAC recommendations and to meet
the statutory deadline to issue the next
CCL. The NDWAC recommendations
encourage the Agency to consider the
practical limitations identified in their
report and to use an adaptive
management approach to develop CCLs.
This adaptive management approach
will enable the Agency to identify
which recommendations can be
implemented for the next CCL while
learning from and improving upon each
successive listing process and at the
same time protecting public health. In
its development of a new CCL process,
the Agency will focus on several areas
in the near future and continue to seek
input and advice from experts and
interested stakeholders. Some of the key
areas to be explored in developing the
new CCL process are discussed below.
The NDWAC recommended that
microbial and chemical contaminants be
evaluated by parallel processes that
meet in the formation of a single CCL.
The Agency is developing parallel
processes for microbial and chemical
contaminants that take into account the
systematic differences in how these
contaminants are characterized and take
the best advantage of the information
available for microbial and chemical
contaminants.
The Agency is also considering
approaches and opportunities to seek
out and incorporate input from experts
and interested stakeholders as the CCL
process is developed. EPA held a public
meeting on September 15, 2004, to
provide an update on its efforts to
improve upon the CCL process. The
Agency is also consulting with
interested stakeholders on how to
increase expert involvement in the
process and on opportunities to gather
information on new and emerging
contaminants through professional
conferences, focused workshops, and
coordination with other Federal and
State agencies. The Agency will provide
additional opportunities for the
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exchange of information with the public
before the next CCL is proposed in the
Federal Register.
The Agency is evaluating data sources
that characterize a contaminant’s
potential to occur in drinking water and
produce adverse health effect. The
evaluation will consider the NRC and
NDWAC recommendations as well as
SDWA requirements in selecting
information and data to consider for the
next CCL. This evaluation will identify
the best available data that for use in the
CCL process and result in a process to
compile information for a significantly
larger group of chemical and microbial
contaminants than initially considered
for CCL 1.
The Agency anticipates conducting
analyses to identify specific criteria
related to occurrence and health effects
associated with contaminants that could
be used to select contaminants for the
CCL. The Agency is evaluating the
NDWAC recommendation to develop a
series of screening criteria that would
identify contaminants for additional
scrutiny and prioritization. The
NDWAC recommendations provide
insight on the occurrence and health
effects data that the Agency could use
to identify a smaller set of contaminants
for additional evaluation but does not
recommend specific levels or criteria to
implement the screening process.
The NDWAC also recommended that
the Agency explore the use of
classification approaches to identify
contaminants for consideration for the
CCL. The Agency is evaluating the
requirements for a classification
approach for the next CCL and
anticipates seeking additional advice
from experts and stakeholders. EPA will
need to evaluate various classification
approaches, consider the range of
potential performance indicators,
conduct calibration and validation
analyses, and engage experts in the
evaluation of the selected approach(es)
and associated validation results.
As a new CCL process is developed
and implemented for the next list, the
Agency will provide updates and
information on the process. The CCL
process is a critical input to shaping the
future direction of the drinking water
program. The Agency anticipates that
improvements to the process will result
in a more comprehensive approach to
developing the CCL.
VI. References
Federal Register, Vol. 63, No. 40.
Announcement of the Drinking Water
Contaminant Candidate List; Notice.
March 2, 1998. 10273. (63 FR 10273).
Federal Register, Vol. 69, No. 64. Drinking
Water Contaminant Candidate List 2;
E:\FR\FM\24FEN1.SGM
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Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
Notice. April 2, 2004. 17406. (69 FR
17406).
National Drinking Water Advisory Council
(NDWAC). 2004. National Drinking
Water Advisory Council Report on the
CCL Classification Process to the U.S.
Environmental Protection Agency.
Available at https://www.epa.gov/
safewater/ndwac/council.html.
National Research Council (NRC). 1999a.
Setting Priorities for Drinking Water
Contaminants. National Academy Press,
Washington, DC https://www.nap.edu/
catalog/6294.html.
National Research Council (NRC). 1999b.
Identifying Future Drinking Water
Contaminants. National Academy Press,
Washington, DC https://www.nap.edu/
catalog/9595.html.
NRC. 2001. Classifying Drinking Water
Contaminants for Regulatory
Considerations. National Academy Press,
Washington, DC https://books.nap.edu/
books/0309074088/html/.
USEPA. 1993. N-nitrosodimethylamine;
CASRN 62–75–9, Integrated Risk
Information Service (IRIS).
Carcinogenicity assessment last updated
July 1, 1993.
Dated: February 17, 2005.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. 05–3527 Filed 2–23–05; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collection(s) Being Reviewed by the
Federal Communications Commission
February 15, 2005.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
Act (PRA) of 1995, Public Law 104–13.
An agency may not conduct or sponsor
a collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a valid control number.
Comments are requested concerning (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
the quality, utility, and clarity of the
information collected; and (d) ways to
VerDate jul<14>2003
18:49 Feb 23, 2005
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minimize the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology.
DATES: Written Paperwork Reduction
Act (PRA) comments should be
submitted on or before March 28, 2005.
If you anticipate that you will be
submitting PRA comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all Paperwork
Reduction Act (PRA) comments to
Judith B. Herman, Federal
Communications Commission, Room 1–
C804, 445 12th Street, SW., Washington,
DC 20554 or via the Internet to JudithB.Herman@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information or copies of the
information collection(s), contact Judith
B. Herman at 202–418–0214 or via the
Internet at Judith-B.Herman@fcc.gov.
SUPPLEMENTARY INFORMATION:
OMB Control No.: 3060–0823.
Title: Pay Telephone Reclassification,
Memorandum Opinion and Order, CC
Docket No. 96–128.
Form No.: N/A.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit.
Number of Respondents: 400.
Estimated Time Per Response: 2–35
hours.
Frequency of Response:
Recordkeeping requirement, third party
disclosure requirement, and on
occasion, monthly, and quarterly
reporting requirements.
Total Annual Burden: 44,700 hours.
Total Annual Cost: $480,000.
Privacy Act Impact Assessment: No.
Needs and Uses: The Commission is
seeking extension (no change in
requirements) for this information
collection. The Commission is
submitting this information collection to
the OMB in order to obtain the full
three-year clearance from them. For
background, the Commission adopted
and released a Memorandum Opinion
and Order in March 1998, which
clarified the requirements established in
the Payphones Orders for the provision
of payphone-specific coding digits and
for tariffs that local exchange carriers
(LECs) must file pursuant to the
Payphone Orders. The Commission also
granted a waiver of Part 69 of the
Commission’s rules so that LECs can
establish rate elements to recover the
costs of implementing FLEX–ANI (a
type of switch software) to provide
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9077
payphone specific coding digits for percall compensation. The Commission is
required in the Payphone Orders to
implement section 276 of the Act.
OMB Control No.: 3060–0986.
Title: Competitive Carrier Line Count
Report.
Form No.: FCC Form 525.
Type of Review: Revision of a
currently approved collection.
Respondents: Business or other forprofit.
Number of Respondents: 1,300
respondents; 4,753 responses.
Estimated Time Per Response: .5–6
hours.
Frequency of Response: On occasion,
quarterly and annual reporting
requirements and third party disclosure
requirement.
Total Annual Burden: 3,707 hours.
Total Annual Cost: N/A.
Privacy Act Impact Assessment: N/A.
Needs and Uses: The Commission has
revised this information collection. The
information collection has been revised
as a result of: (1) Certain collections
associated with the election of a
disaggregation path were one-time in
nature and have been eliminated and
removed from this burden estimate; and
(2) the Commission has created a new
FCC Form 525 to collect line count data
required by Competitive Eligible
Telecommunications Carriers (CETCs)
pursuant to this and other OMB control
numbers, as well as line count data
related to lines provided by CETCs
using unbundled network elements
(UNEs). The UNE data are necessary for
Universal Service Administrative
Company (USAC) to implement section
54.307 of the Commission’s rules. It is
anticipated that the implementation of
FCC Form 525 will reduce burdens in
several collections by standardizing the
information submission format. As
collections 3060–0972, 3060–0774 and
3060–0942 are renewed, the information
provided in FCC Form 525 will be
eliminated from the burden estimates
for these collections. The Commission
will use the information requirements to
determine whether and to what extent
rural telecommunications carriers
providing the data are eligible to receive
universal service support.
OMB Control No.: 3060–0298.
Title: Competitive Carrier Line Count
Report.
Form No.: FCC Form 525.
Type of Review: Revision of a
currently approved collection.
Respondents: Business or other forprofit.
Number of Respondents: 1,300
respondents; 4,753 responses.
Estimated Time Per Response: 57
hours.
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Notices]
[Pages 9071-9077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3527]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OW-2003-0028; FRL-7876-9]
RIN 2060-AD86
Drinking Water Contaminant Candidate List 2; Final Notice
AGENCY: Environmental Protection Agency.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Safe Drinking Water Act (SDWA), as amended in 1996,
requires the Environmental Protection Agency (EPA) to publish a list of
contaminants that, at the time of publication, are not subject to any
proposed or promulgated national primary drinking water regulations,
that are known or anticipated to occur in public water systems, and
that may require regulations under SDWA (section 1412 (b)(1)). SDWA, as
amended, specifies that EPA must publish the first list of drinking
water contaminants no later than 18 months after the date of enactment,
i.e., by February 1998, and every five years thereafter.
The EPA published the first Candidate Contaminant List (CCL) in
March of 1998 (63 FR 10273). The second draft CCL (CCL 2) was published
on April 2, 2004 (69 FR 17406) and announced EPA's preliminary decision
to carry forward the remaining 51 contaminants on the 1998 CCL as the
draft CCL 2, provided information on EPA's efforts to expand and
strengthen the underlying CCL listing process to be used for future CCL
listings, and sought comment on the draft list as well as EPA's efforts
to improve the contaminant selection process for future CCLs. Today's
final CCL 2 carries forward the remaining 51 contaminants proposed on
April 2, 2004.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. OW-2003-0028. All documents in the docket are listed in the EDOCKET
index at https://www.epa.gov/edocket. Although listed in the index, some
information is not publically available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publically available only in hard copy form. Publically available
docket materials are
[[Page 9072]]
available either electronically in EDOCKET or in hard copy at the Water
Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Avenue, NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the Water Docket is (202) 566-2426. For access to docket
material, please call (202) 566-2426 to schedule an appointment.
FOR FURTHER INFORMATION CONTACT: For questions about this notice
contact Dan Olson, Standards and Risk Management Division, Office of
Ground Water and Drinking Water (MC-4607M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: 202-564-5239; fax number: 202-564-3752; e-mail address:
olson.daniel@epa.gov. For general information contact the EPA Safe
Drinking Water Hotline at (800) 426-4791 or e-mail: hotline-
sdwa@epa.gov. The Safe Drinking Water Hotline is open Monday through
Friday, excluding legal holidays, from 9 a.m. to 5 p.m.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Impose Any Requirements on My Public Water System?
Today's action does not impose any requirements on anyone. Instead,
it notifies interested parties of EPA's final CCL 2 as well as EPA's
efforts to improve the contaminant selection process for future CCLs.
Contaminants on the list will be considered under the regulatory
determination provision of SDWA (see section 1412(b)(1)(B)(ii)), which
directs EPA to select at least five contaminants from the CCL every
five years to determine if regulating the contaminants through National
Primary Drinking Water Regulations would present a meaningful
opportunity to reduce health risk.
II. Background and Summary of Today's Action
A. What Is the Purpose of Today's Action?
The CCL is the primary source of priority contaminants for
evaluation by EPA's drinking water program. Contaminants on the CCL are
currently not subject to any proposed or promulgated national primary
drinking water regulation, but are known or anticipated to occur in
public water systems, and may require regulation under SDWA. The EPA
conducts research on health effects, analytical methods, contaminant
occurrence, treatment technologies, and treatment effectiveness for
priority drinking water contaminants on the CCL. The Agency also
develops drinking water guidance and health advisories, and makes
regulatory determinations for priority contaminants on the CCL.
Today's action informs interested parties of EPA's final CCL 2 as
well as EPA's efforts to improve the contaminant selection process for
future CCLs.
B. The Background of the CCL
The SDWA is the core statute protecting drinking water at the
Federal level. Under SDWA, EPA sets public health goals and enforceable
standards for drinking water quality. In 1996, Congress amended SDWA to
emphasize sound science and risk-based priority-setting. Congress also
changed the way drinking water regulatory priorities are set by
establishing the CCL requirements. The 1996 SDWA amendments require EPA
to (1) publish every five years a list of currently unregulated
contaminants in drinking water that may pose risks (the CCL), and (2)
make determinations on whether or not to regulate at least five of
these contaminants on a five year cycle, or three and a half years
after each CCL is published (SDWA section (b)(1)).
Today's action is being published pursuant to the requirements in
section 1412(b)(1). The contaminants included are not subject to any
proposed or promulgated national primary drinking water regulation, are
known or anticipated to occur in public water systems, and may require
regulation under the SDWA. A draft CCL 2 was published in the April 2,
2004 edition of the Federal Register (69 FR 17406) to announce EPA's
preliminary decision to carry forward the remaining 51 contaminants on
the 1998 CCL as the CCL 2, to provide information on EPA's efforts to
expand and strengthen the underlying CCL listing process to be used for
future CCL listings, and to seek comment on the draft list as well as
EPA's efforts to improve the contaminant selection process for future
CCLs.
Today's action establishes the final CCL 2 which includes 42
chemicals or chemical groups and nine microbiological contaminants.
This list continues to be an important tool under the SDWA to help
prioritize research and serves as the central focus of the regulatory
determination process noted previously. It is important to note,
however, that under the SDWA, the EPA may also make regulatory
determinations for any unregulated contaminant not on today's CCL (see
SDWA section 1412(b)(1)(B)(ii)(III)). Thus, the Agency has the
authority to act as necessary to protect public health as new
information becomes available.
III. Drinking Water Contaminant Candidate List 2
Table III-1 lists the contaminants on the final CCL 2. These
contaminants are identified by name and, where available, the Chemical
Abstracts Service Registry Number (CASRN). The final CCL 2 consists of
nine microbiological contaminants and 42 chemical contaminants or
contaminant groups.
Table III-1.--Final Drinking Water Contaminant Candidate List 2
------------------------------------------------------------------------
-------------------------------------------------------------------------
Microbiological contaminant candidates
------------------------------------------------------------------------
Adenoviruses Aeromonas hydrophila
Caliciviruses
Coxsackieviruses
Cyanobacteria (blue-green algae), other freshwater algae, and their
toxins
Echoviruses
Helicobacter pylori
Microsporidia (Enterocytozoon and Septata)
Mycobacterium avium intracellulare (MAC)
------------------------------------------------------------------------
------------------------------------------------------------------------
Chemical contaminant candidates
------------------------------------------------------------------------
CASRN
1,1,2,2-tetrachloroethane................. 79-34-5
1,2,4-trimethylbenzene.................... 95-63-6
1,1-dichloroethane........................ 75-34-3
1,1-dichloropropene....................... 563-58-6
1,2-diphenylhydrazine..................... 122-66-7
1,3-dichloropropane....................... 142-28-9
1,3-dichloropropene....................... 542-75-6
2,4,6-trichlorophenol..................... 88-06-2
2,2-dichloropropane....................... 594-20-7
2,4-dichlorophenol........................ 120-83-2
2,4-dinitrophenol......................... 51-28-5
2,4-dinitrotoluene........................ 121-14-2
2,6-dinitrotoluene........................ 606-20-2
2-methyl-Phenol (o-cresol)................ 95-48-7
Acetochlor................................ 34256-82-1
Alachlor ESA & other acetanilide pesticide N/A
degradation products.
Aluminum.................................. 7429-90-5
Boron..................................... 7440-42-8
Bromobenzene.............................. 108-86-1
DCPA mono-acid degradate.................. 887-54-7
DCPA di-acid degradate.................... 2136-79-0
DDE....................................... 72-55-9
Diazinon.................................. 333-41-5
Disulfoton................................ 298-04-4
Diuron.................................... 330-54-1
EPTC (s-ethyl-dipropylthiocarbamate)...... 759-94-4
[[Page 9073]]
Fonofos................................... 944-22-9
p-Isopropyltoluene (p-cymene)............. 99-87-6
Linuron................................... 330-55-2
Methyl bromide............................ 74-83-9
Methyl-t-butyl ether (MTBE)............... 1634-04-4
Metolachlor............................... 51218-45-2
Molinate.................................. 2212-67-1
Nitrobenzene.............................. 98-95-3
Organotins................................ N/A
Perchlorate............................... 14797-73-0
Prometon.................................. 1610-18-0
RDX....................................... 121-82-4
Terbacil.................................. 5902-51-2
Terbufos.................................. 13071-79-9
Triazines and degradation products of including, but not limited
triazines. to Cyanazine 21725-46-2 and
atrazine-desethyl 6190-65-4
Vanadium.................................. 7440-62-2
------------------------------------------------------------------------
IV. Summary of Comments
The comment period on the April 2, 2004, Federal Register notice,
``Drinking Water Contaminant Candidate List 2; Notice'' (69 FR 17406)
ended on June 1, 2004. EPA received a total of seven comments that
focused on EPA's draft CCL 2 and EPA's efforts to improve the
contaminant selection process for future CCLs. EPA received two
comments from associations representing water utilities, one comment
from a State-related association, one comment from a water utility, one
comment from a State agency, one comment from an individual, and one
anonymous comment. A summary of these comments and EPA's response to
these comments follow. A complete copy of the public comments and the
Agency's responses are included in the Docket for today's action and
can be obtained at https://www.epa.gov/edocket/.
The majority of comments were supportive of the CCL process. The
comments on development of the draft CCL 2 focused on two key topic
areas: (1) Reassembling the CCL taking new available information into
account; suggestions on information that should be considered, and
contaminants that should be included or deleted from the CCL; and (2)
requests for information on the status of CCL-related research.
Comments on the development of future CCLs focused on four key topic
areas: (1) Expert judgement and transparency, (2) the role of data
quality, (3) a simplified approach with adaptive management for future
CCLs, and (4) the role of virulence factor activity relationships
(VFARs). The remainder of this section discusses these key areas in
turn.
A. Developing the draft CCL 2
1. Suggestions on new information and contaminants that should be
included or deleted from the CCL.
Comment Summary: Two commenters believe that EPA should create a
new CCL taking new available information into account. One commenter
recommended that EPA not carry forward five chemicals (1,1,2,2-
tetrachloroethane, 1,1-dichloropropene, 1,3-dichloropropane, 1,3-
dichloropropene, and 2,2, dichloropropane) currently on CCL 1 to CCL 2,
two commenters recommended that N-nitrosodimethylamine (NDMA) should be
added to the CCL, and one commenter recommended that enterotoxigenic
Escherichia coli (E. coli) be included on the final CCL 2.
Agency Response: In response to commenters who recommended that EPA
create a new CCL to take new available information into account, and
the suggestion that EPA remove five chemicals (1,1,2,2-
tetrachloroethane, 1,1-dichloropropene, 1,3-dichloropropane, 1,3-
dichloropropene, and 2,2, dichloropropane) from the CCL, EPA does not
believe that it is appropriate to create a new CCL, or remove any
contaminants from the CCL, at this time. Where there is adequate
information about a particular contaminant, EPA plans to make a
regulatory determination which will either remove that contaminant from
the CCL or start a national rule making process to set a national
primary drinking water regulation. With regard to future CCLs, EPA is
developing an expanded comprehensive system for evaluating a wider
range of existing information, identifying new data, and applying
revised screening criteria to generate the CCL 3 in response to
extensive recommendations from the National Academy of Sciences
National Research Council (NRC) and National Drinking Water Advisory
Council (NDWAC).
With specific regard to NDMA, there is already a substantive body
of health effects research that the Agency has relied upon to classify
it as a ``probable human carcinogen'' (USEPA, 1993). The key
information gap for this contaminant relates to occurrence in public
water system distribution systems. Some initial research has been
conducted in this area and the Agency plans to collect more
comprehensive occurrence information as part of the upcoming national
survey of key unregulated contaminants under section 1445(a)(2).
Regarding enterotoxigenic E. coli, EPA will be considering this
microbe as part of the revised and expanded CCL 3 review process. The
Agency believes that this will be a more appropriate and effective
approach for evaluating this bacteria in comparison to a wide range of
other microbes that will be considered under the broader analytical
approach recommended by the NRC and NDWAC.
2. Provide the status of CCL-related research, data collection, and
pending initiatives that have been undertaken since CCL 1.
Comment Summary: Commenters identified several CCL-related research
activities that have been undertaken since CCL 1 and requested that EPA
provide the status of CCL-related research, data collection, and
pending initiatives that have been undertaken since CCL 1.
Two commenters also requested information about the Agency's
progress to date and the intended future path for integrating the 35
deferred pesticides and 21 contaminants (suspected of having adverse
effects on endocrine function) into the CCL process.
Agency Response: EPA agrees that the status of CCL-related research
should be publically available. The Agency has taken a number of steps
to provide this information through its Web sites and in documents it
has published.
EPA Web sites addressing CCL-related research information include
the following:
EPA's Office of Ground Water and Drinking Water Drinking
Water Research Information Network (DRINK), found at https://
www.epa.gov/safewater/drink/intro.html, is a publicly accessible, Web
based system that tracks over 1,000 ongoing research projects conducted
by EPA and other research partners from national, regional, and
international research agencies and organizations. The DRINK system
stores, manages, and delivers descriptive summary data on drinking
water-related projects, including abstracts, status of projects,
uniform resource locators to datasets and reports, and contact
information on projects.
EPA's Office of Ground Water and Drinking Water Web site
at https://www.epa.gov/safewater/ccl/cclfs.html has information on the
NDWAC (e.g., reports, meeting announcements, and meeting summaries
which includes meetings of the NDWAC CCL Work Group), monitoring of
unregulated contaminants from public water systems, the National
Contaminant Occurrence Database, analytical methods for compliance
monitoring, and treatment technologies.
EPA's Office of Research and Development (ORD)
environmental
[[Page 9074]]
information management system Web site at https://www.epa.gov/eims/ maintains information on EPA research projects, including project
title, abstract, start and end dates, principal investigator, funding,
results and publications, and related technical documents.
EPA's Office of Science and Technology Web site at https://
www.epa.gov/waterscience/humanhealth/ has information on EPA's drinking
water standards, health and consumer advisories, criteria documents,
and related technical documents.
A key document addressing CCL-related research and information is
EPA's Draft Multi-Year Plan (MYP) for the drinking water research
program. The Draft MYP describes the Agency's drinking water research
program activities and plans for fiscal years 2003--2010 (see https://
www.epa.gov/osp/myp/dw.pdf). As a tool for planning and communication,
the MYP provides: (1) A context for annual planning decisions and a
basis for describing the impacts of these decisions; (2) a framework
for integrating research on common issues across the EPA's ORD
laboratories and centers, as well as across the various Agency Goals
established under the Government Performance and Results Act; and (3) a
resource for communicating research plans and products within ORD and
with EPA programs, the regions and interested parties outside of EPA.
MYPs are updated on a biennial basis to provide opportunities for
making the necessary adjustments to the research program.
As discussed in the draft CCL 2 notice (69 FR 17406), EPA plans to
consider the deferred pesticides in the context of an improved approach
for selecting contaminants for future CCLs (CCL 3). This will enable
the Agency to consider these contaminants in a consistent, reproducible
manner with a wide range of other contaminants. In this regard, it is
important to note that EPA may conduct research, and make regulatory
determinations for any unregulated contaminant not on today's CCL (see
SDWA section 1412(b)(1)(B)(ii)(III)). Thus, the Agency has the
authority to act as necessary to protect public health as new
information becomes available.
As with pesticides, EPA believes that suspected endocrine
disruptors should be considered when the next CCL is developed. This
enables the Agency to use a more refined and improved approach in
evaluating these contaminants. As previously stated, EPA is not
restricted to the contaminants on this CCL for making regulatory
determinations.
B. Developing a Process for Future CCLs
There were four key issues identified by commenters on developing a
process for future CCLs. They are:
1. Expert judgement and transparency
2. The Role of Data Quality.
3. Simplified approach with adaptive management applied for future
CCLs.
4. The role of virulence factor activity relationships.
Each of these issues is discussed in turn below.
1. Expert Judgement and Transparency
Comment Summary: Two commenters stated that there is a need for the
CCL process to be a transparent process. The commenters stated that
they view the transparency of the CCL process as being critical to its
success so that both the regulated community and the public can
understand it. One commenter also recommended that the Agency combine
expert judgement and classification algorithms (a formula or set of
steps for solving a particular problem) in developing the CCL.
Classification algorithms or automated processes should serve as
mechanisms for screening down the number of contaminants that the
experts must then evaluate in greater depth.
Both commenters believe that the use of expert judgement can be
transparent and is an essential component to any future CCL process.
They urged EPA to clearly define the role of expert judgement including
the specific parts of the listing process where it would be used.
One commenter also suggested that the CCL process should be an
ongoing process within the Office of Water and that the Agency should
actively monitor appropriate peer-reviewed literature for new
contaminants, new methods, and new health effects data. In addition,
the Agency should also increase its involvement in ongoing symposia,
professional meetings, and workshops on topics relevant to the CCL.
Agency's Response: The Agency agrees with the commenters that
transparency and use of expert judgement should be important components
of the CCL process. These recommendations were included in both the NRC
report (NRC, 2001) and in the NDWAC Report on the CCL Classification
Process to the U.S. Environmental Protection Agency (NDWAC, 2004). The
Agency received the NDWAC report in May of 2004 and is currently
evaluating the recommendations.
The NRC and NDWAC reports recommend that the EPA conduct the CCL
process so that interested stakeholders have an opportunity to
participate at key steps in developing the CCL. Additionally the
reports recommend greater use of expert judgment and critical review of
the CCL classification process. While the reports did not provide
specific advice on how to accomplish these recommendations they did
identify key milestones, such as selecting sources of data and
developing criteria to select contaminants. Structuring the process
around such milestones should enhance transparency and facilitate
expert review.
The Agency continues to evaluate the NDWAC recommendation on how to
include expert judgment and conduct the CCL process in a transparent
manner and will consider these comments as future CCLs are developed.
2. The Role of Data Quality
Comment Summary: Two commenters stressed the importance of data
quality in the CCL process. Both commenters support the use of high
quality data and sound science in the CCL process.
The commenters expressed some concern about the current quality of
data used for the CCL process. The commenters suggested that EPA should
focus on using high quality data that are appropriate to support valid
characterization of a contaminant and that EPA maintains a focus on
data quality at each stage of the CCL process.
One commenter expressed an interest in participating in the ongoing
development and application of a viable data quality assurance system
that would support the data objectives for each step in the CCL
process.
Agency's Response: The NDWAC recommendations also discussed the
nature and type of data and information used in the CCL process. In
discussing information quality considerations, the Council noted that
data and information on contaminants considered in the CCL process will
consist of different types of data and that some contaminants will not
be robustly characterized. The report also recommends that while the
Agency should be explicit about how it selects data for the CCL
process, the process must have some flexibility to adequately consider
emerging contaminants. As the Agency develops the CCL process and
evaluates the NDWAC recommendations, it will consider the commenters'
recommendations as well as the SDWA data quality requirements.
[[Page 9075]]
3. Simplified Approach
Comment Summary: One commenter expressed concern over the NAS and
NDWAC recommendations, characterizing them as ``a theoretical and
esoteric process and not a pragmatic process.'' The commenter believes
that there is a need for the Agency to develop a simpler, more
streamlined approach that uses only the attributes of occurrence and
health effects and that potentially eliminates some of the major
complications associated with the NRC three-step, five-attribute CCL
process, thereby making the process more effective in the near term.
The NRC approach can serve as a useful guide for the Agency's long-term
CCL development effort; however, the details and logistics of the
approach require additional work.
One commenter was concerned about the resources and time needed to
develop the CCL using a new approach. The commenter suggested that
convening a series of workshops with external experts would be an
efficient way of addressing issues related to data quality, contaminant
attributes, training sets, process performance, and protocols for
classification algorithms.
Agency's Response: The NDWAC report provides a series of
recommendations for the Agency to consider as it develops the CCL
process. The NDWAC report also noted that the NRC three-step approach
using five attributes has merit, but identified practical limitations
or difficulties the Agency would need to address. For example, the
NDWAC report recommends that the Agency should consider classification
approaches but ``should use another approach for selecting contaminants
for the near term (i.e., for CCL 3) if there are difficulties that
cannot be overcome.'' The NDWAC report also identifies issues that the
Agency should consider in the NRC's recommendation on classification
approaches and emphasizes that the Agency should consider practical
constraints. The NDWAC report specifically recommended that the
screening step be as simple as possible, which would require fewer
resources and less time while adequately identifying those contaminants
of greatest significance. The report further encouraged the Agency to
consider whether fewer than the five attributes used in the NRC example
of a classification approach are adequate for a new CCL process. The
NDWAC report recognizes that the Agency will learn more about the CCL
process in each iterative step and recommended an adaptive management
approach to develop the CCL process. As the Agency evaluates the NDWAC
recommendations, it will consider the need for a pragmatic approach
using available resources for development of the next CCL and the most
efficient ways to incorporate expert involvement in the CCL process.
4. The Role of Virulence Factor Activity Relationship.
Comment Summary: A variety of comments were received on the
proposed role of genomic data and the VFAR concept for the CCL process.
Most of the commenters acknowledged that VFAR appears to be a powerful
and useful tool that shows great promise for future CCL development,
but felt that the Agency had not made clear how it proposes to use VFAR
technology.
The commenters suggested that the Agency is placing too much
emphasis on VFAR. One commenter stated that the Agency appears to be
relying too heavily on an advanced genomic technology. The commenter
expressed concerns that the technology's applications to environmental
samples are unproven and recommended that it not be used in the next
CCL process.
One commenter suggested that there are many unknown variables
associated with the VFAR concept and it should therefore be treated
with extreme caution. Two commenters are concerned that VFAR may not
offer practical solutions to immediate concerns regarding waterborne
disease and would require a multi-year commitment and collaboration by
EPA and other participating organizations before it would be useful.
Agency Response: The NRC (NRC, 2001) recommendations provided a
detailed discussion of the potential and proposed role of VFARs in the
CCL process. The VFAR principle can be described as comparing the gene
structure of newly identified waterborne pathogens to pathogens with
known genetic structures that have been associated with human disease.
Virulence factors are defined broadly by the NRC as the ability of
a pathogen to persist in the environment, gain entry into a host (e.g.,
humans), reproduce, and cause disease or other health problems either
because of its architecture or because of its biochemical compounds. A
number of virulence factors are known, including the ability of a
microbe to move within a host under its own power, the ability of
mechanisms to protect the microbe against the body's defenses (e.g.,
anti-phagocytosis mechanisms), the ability of a microbe to adhere or
attach to the surface of a host cell, and the ability of microbes to
produce toxins that injure host cells. The NDWAC was specifically
charged to provide an evaluation of the VFAR approach and to identify
studies that explore the feasibility of the approach. While the Agency
recognizes VFAR as a potential tool for future CCLs, EPA is not
planning to solely rely on the approach in the near term for CCLs. In
its deliberation, the NDWAC conducted several explorations and
literature reviews on the nature and type of genomic data available to
characterize genes that may be associated with virulence factors and an
organism's potential to cause harm. The reviews and analyses showed
that the technology, although powerful, still has serious limitations
for near term CCLs. The NDWAC provided a series of pragmatic
recommendations for considering pathogens for near term CCLs and
several recommendations for improving this process as genomic
technology and reporting improve. As the Agency develops the CCL
process for microbes it will take these comments under consideration.
V. Developing Future CCLs--NDWAC Recommendations and Next Steps
A. NDWAC Recommendations
In the Federal Register notice of April 2, 2004 (69 FR 17406), EPA
discussed the activities of the NRC and the NDWAC related to the CCL.
The EPA sought the advice of the NRC in response to comments received
during the development of the 1998 CCL, which advocated a broader, more
comprehensive approach for selecting contaminants.
The Agency asked the NRC to address three key topics related to
drinking water contaminant selection and prioritization:
1. What approach should be used to develop future CCLs?
2. How best should EPA assess emerging drinking water contaminants
and related databases to support future CCL efforts?
3. What approach should EPA use to set priorities for contaminants
on the CCL?
The NRC's findings and recommendations on these topics were
published in three reports: Setting Priorities for Drinking Water
Contaminants (NRC, 1999a), Identifying Future Drinking Water
Contaminants (NRC, 1999b), and Classifying Drinking Water Contaminants
for Regulatory Consideration (NRC, 2001).
The NRC recommendations provided a framework for evaluating a
larger number of contaminants and making decisions about contaminants
for which
[[Page 9076]]
data are limited through the use of innovative technologies and expert
advice. The EPA requested the assistance of NDWAC to evaluate and
provide advice on implementing the NRC's recommended classification
process.
The NDWAC formed the CCL Classification Process Work Group (the
Work Group) and charged it with reviewing the NRC 2001 report. The Work
Group was asked to advise the NDWAC on development and application of
the classification approach suggested by the NRC, including evaluating
proposed and alternative methodologies. The Work Group met 10 times
from September of 2002 to March of 2004. All Work Group meetings were
open to the public and announced in the Federal Register. In conducting
its review, the Work Group considered the large and growing number of
agents that might become candidates for scrutiny in the CCL process,
and the rapid expansion of information on these agents. Based on this
review, the Work Group provided the following recommendations:
1. There is merit in the three-step selection process proposed by
NRC for classifying chemical and microbial contaminants. The NDWAC
believes the three-step process should involve identification of the
CCL universe, screening the universe to a preliminary CCL, and
selecting the CCL from the Preliminary CCL.
2. The NDWAC recommends that the Agency should move forward with
the NRC recommendation to develop and evaluate some form of prototype
classification approach. (A prototype classification uses computer-
based computational tools to weigh selected contaminant characteristics
against the characteristics of various classes of drinking water
contaminants whose occurrence and health effects are relatively well
understood.)
3. The NDWAC believes that expert judgment plays an important role
throughout the three-step selection process, particularly in reviewing
the prototype model and the output of the new classification approach.
4. The NDWAC recommended enhancing the surveillance for emerging
chemical and microbial contaminants and also soliciting information
from the public via a nomination process to assure a full consideration
of potential contaminants.
The NDWAC also identified a number of practical limitations or
difficulties in developing and applying the recommended approach and
provided advice on how these might be addressed.
The NDWAC presented the final report to the Administrator on May
19, 2004. The report, entitled National Drinking Water Advisory Council
Report on the CCL Classification Process to the U.S. Environmental
Protection Agency provides a detailed summary of the questions
considered by the NDWAC, the analyses conducted to explore the
questions, key points discussed, and the NDWAC's recommendations and
rationale for the recommendations. The report is available at https://
www.epa.gov/safewater/ndwac/council.html.
B. Next Steps
The Agency is working to evaluate the NDWAC recommendations and to
meet the statutory deadline to issue the next CCL. The NDWAC
recommendations encourage the Agency to consider the practical
limitations identified in their report and to use an adaptive
management approach to develop CCLs. This adaptive management approach
will enable the Agency to identify which recommendations can be
implemented for the next CCL while learning from and improving upon
each successive listing process and at the same time protecting public
health. In its development of a new CCL process, the Agency will focus
on several areas in the near future and continue to seek input and
advice from experts and interested stakeholders. Some of the key areas
to be explored in developing the new CCL process are discussed below.
The NDWAC recommended that microbial and chemical contaminants be
evaluated by parallel processes that meet in the formation of a single
CCL. The Agency is developing parallel processes for microbial and
chemical contaminants that take into account the systematic differences
in how these contaminants are characterized and take the best advantage
of the information available for microbial and chemical contaminants.
The Agency is also considering approaches and opportunities to seek
out and incorporate input from experts and interested stakeholders as
the CCL process is developed. EPA held a public meeting on September
15, 2004, to provide an update on its efforts to improve upon the CCL
process. The Agency is also consulting with interested stakeholders on
how to increase expert involvement in the process and on opportunities
to gather information on new and emerging contaminants through
professional conferences, focused workshops, and coordination with
other Federal and State agencies. The Agency will provide additional
opportunities for the exchange of information with the public before
the next CCL is proposed in the Federal Register.
The Agency is evaluating data sources that characterize a
contaminant's potential to occur in drinking water and produce adverse
health effect. The evaluation will consider the NRC and NDWAC
recommendations as well as SDWA requirements in selecting information
and data to consider for the next CCL. This evaluation will identify
the best available data that for use in the CCL process and result in a
process to compile information for a significantly larger group of
chemical and microbial contaminants than initially considered for CCL
1.
The Agency anticipates conducting analyses to identify specific
criteria related to occurrence and health effects associated with
contaminants that could be used to select contaminants for the CCL. The
Agency is evaluating the NDWAC recommendation to develop a series of
screening criteria that would identify contaminants for additional
scrutiny and prioritization. The NDWAC recommendations provide insight
on the occurrence and health effects data that the Agency could use to
identify a smaller set of contaminants for additional evaluation but
does not recommend specific levels or criteria to implement the
screening process.
The NDWAC also recommended that the Agency explore the use of
classification approaches to identify contaminants for consideration
for the CCL. The Agency is evaluating the requirements for a
classification approach for the next CCL and anticipates seeking
additional advice from experts and stakeholders. EPA will need to
evaluate various classification approaches, consider the range of
potential performance indicators, conduct calibration and validation
analyses, and engage experts in the evaluation of the selected
approach(es) and associated validation results.
As a new CCL process is developed and implemented for the next
list, the Agency will provide updates and information on the process.
The CCL process is a critical input to shaping the future direction of
the drinking water program. The Agency anticipates that improvements to
the process will result in a more comprehensive approach to developing
the CCL.
VI. References
Federal Register, Vol. 63, No. 40. Announcement of the Drinking
Water Contaminant Candidate List; Notice. March 2, 1998. 10273. (63
FR 10273).
Federal Register, Vol. 69, No. 64. Drinking Water Contaminant
Candidate List 2;
[[Page 9077]]
Notice. April 2, 2004. 17406. (69 FR 17406).
National Drinking Water Advisory Council (NDWAC). 2004. National
Drinking Water Advisory Council Report on the CCL Classification
Process to the U.S. Environmental Protection Agency. Available at
https://www.epa.gov/safewater/ndwac/council.html.
National Research Council (NRC). 1999a. Setting Priorities for
Drinking Water Contaminants. National Academy Press, Washington, DC
https://www.nap.edu/catalog/6294.html.
National Research Council (NRC). 1999b. Identifying Future Drinking
Water Contaminants. National Academy Press, Washington, DC https://
www.nap.edu/catalog/9595.html.
NRC. 2001. Classifying Drinking Water Contaminants for Regulatory
Considerations. National Academy Press, Washington, DC https://
books.nap.edu/books/0309074088/html/.
USEPA. 1993. N-nitrosodimethylamine; CASRN 62-75-9, Integrated Risk
Information Service (IRIS). Carcinogenicity assessment last updated
July 1, 1993.
Dated: February 17, 2005.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. 05-3527 Filed 2-23-05; 8:45 am]
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