[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Proposed Rules]
[Pages 71520-71523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30467]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[FRL-7415-5]
Notice of Data Availability; National Primary and Secondary
Drinking Water Regulations: Approval of Analytical Methods for Chemical
and Microbiological Contaminants; Additional Information on the
ColitagTM Method
AGENCY: Environmental Protection Agency.
ACTION: Proposed rule; notice of data availability--supplemental
information.
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SUMMARY: On March 7, 2002, the Environmental Protection Agency (EPA)
published ``Unregulated Contaminant Monitoring Regulation: Approval of
Analytical Method for Aeromonas; National Primary and Secondary
Drinking Water Regulations: Approval of Analytical Methods for Chemical
and Microbiological Contaminants; Proposed Rule.'' In this proposed
rule, EPA sought comments on the proposed promulgation of multiple
industry-developed methods, one of which was the ColitagTM
method, a ``Test for Detection and Identification of Coliforms and E.
coli Bacteria in Drinking Water and Source Water as Required in
National Primary Drinking Water Regulations.'' This method was proposed
for the analysis of total coliforms and E. coli in finished drinking
water samples. After the close of the public comment period on the
March 7 proposed rule, EPA received additional information from CPI
International, developers of ColitagTM, relevant to the
performance of the method. Such information (herein after collectively
referred to as ``additional information'') includes supplemental data
as well as a re-evaluation of previously reported data included in the
public record that supported the proposed approval of
ColitagTM. EPA is using today's action to invite comments on
this additional information.
DATES: EPA must receive public comment, in writing, by January 2, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Send comments to: Water Docket,
Environmental Protection Agency, Mail Code 4101T, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460, Attention Docket ID No. OW-2002-
0031. Follow the detailed instructions as provided in section I of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Herb Brass, Technical Support Center,
Standards and Risk Management Division, Office of Ground Water and
Drinking Water, Environmental Protection Agency, Mail Stop 140, 26 W.
Martin Luther King Drive, Cincinnati, OH, PH: (513) 569-7926. E-mail:
[email protected]. For general information and copies of this
document, contact the Safe Drinking Water Hotline at (800) 426-4791.
The hotline is open Monday through Friday, excluding Federal holidays,
from 8:30 a.m. to 4:30 p.m. eastern standard time.
SUPPLEMENTARY INFORMATION:
I. General Information
A. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under Docket ID No. OW-2002-0031. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room
B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., eastern
standard time, 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 materials, please call (202) 566-1744 to schedule an
appointment.
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/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
[[Page 71521]]
then key in the appropriate docket identification number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the docket
facility identified in section I.A.1.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
B. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket identification number in the subject line on the
first page of your comment. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments. The Agency would prefer that
commenters cite, where possible, the paragraph(s) or sections in the
documents to which each comment refers. Commenters should use a
separate paragraph for each issue discussed.
1. Electronically. If you submit an electronic comment as
prescribed below, EPA recommends that you include your name, mailing
address, and an e-mail address or other contact information in the body
of your comment. Also include this contact information on the outside
of any disk or CD ROM you submit, and in any cover letter accompanying
the disk or CD ROM. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. EPA's policy is that EPA
will not edit your comment, and any identifying or contact information
provided in the body of a comment will be included as part of the
comment that is placed in the official public docket, and made
available in EPA's electronic public docket. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
copies must be submitted in WP5.1 or higher, or ASCII file format file,
avoiding the use of special characters and forms of encryption.
Electronic comments must be identified by the docket number OW-2002-
0031. Comments will also be accepted on disks in WP 5.1 or higher, or
ASCII file format. Electronic comments on this notice may be filed
online at many Federal Depository Libraries.
a. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Do not send duplicate electronic and paper
comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and
follow the online instructions for submitting comments. Once in the
system, select ``search,'' and then key in Docket ID No. OW-2002-0031.
The system is an ``anonymous access'' system, which means EPA will not
know your identity, e-mail address, or other contact information unless
you provide it in the body of your comment.
b. E-mail. Comments may be sent by electronic mail (e-mail) to [email protected], Attention Docket ID No. OW-2002-0031. In contrast to
EPA's electronic public docket, EPA's e-mail system is not an
``anonymous access'' system. If you send an e-mail comment directly to
the Docket without going through EPA's electronic public docket, EPA's
e-mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
c. Disk or CD ROM. You may submit comments on a disk or CD ROM that
you mail to the mailing address identified in section I.A.1. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By Mail. Send three copies (including attachments) plus the
original of your comments to: Water Docket, Environmental Protection
Agency, Mail Code 4101T, 1200 Pennsylvania Avenue, NW., Washington, DC
20460, Attention Docket ID No. OW-2002-0031.
3. By Hand Delivery or Courier. Deliver your comments to: Water
Docket, Environmental Protection Agency, Room B102, 1301 Constitution
Ave., NW., Washington, DC, Attention Docket ID No. OW-2002-0031. Such
deliveries are only accepted during the Docket's normal hours of
operation, as identified in 1.A.1.
C. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
identification number in the subject line on the first page of your
response. It would also be helpful if you provided the name, date, and
Federal Register citation related to your comments.
II. Colitag\TM\ Combination Method for Detection of Total Coliform
Bacteria and E. Coli in Drinking Water
The Safe Drinking Water Act (SDWA), as amended in 1996, requires
USEPA to
[[Page 71522]]
promulgate national primary drinking water regulations (NPDWRs) which
specify maximum contaminant levels (MCLs) or treatment techniques for
drinking water contaminants (SDWA section 1412; (42 U.S.C. 300g-1)).
NPDWRs apply to public water systems pursuant to SDWA section
1401(1)(A); (42 U.S.C. 300f(1)(A)). According to SDWA section 1401
(1)(D), NPDWRs include ``criteria and procedures to assure a supply of
drinking water which dependably complies with such maximum contaminant
levels; including accepted methods for quality control and testing
procedures.'' In addition, SDWA section 1445(a) authorizes the
Administrator to establish regulations for monitoring to assist in
determining whether persons are acting in compliance with the
requirements of the SDWA. USEPA's promulgation of analytical methods is
authorized under these sections as well as the general rulemaking
authority in SDWA section 1450(a); (42 U.S.C. 300j-9(a)).
On March 7, 2002, EPA published ``Unregulated Contaminant
Monitoring Regulation: Approval of Analytical Method for Aeromonas;
National Primary and Secondary Drinking Water Regulations: Approval of
Analytical Methods for Chemical and Microbiological Contaminants;
Proposed Rule.'' (67 FR 10532, March 7, 2002). In this proposed rule,
EPA sought comments on the proposed promulgation of multiple industry-
developed methods, one of which was the ColitagTM method, a
``Test for Detection and Identification of Coliforms and E. coli
Bacteria in Drinking Water and Source Water as Required in National
Primary Drinking Water Regulations.'' This method was proposed for the
analysis of finished drinking water samples.
After the close of the public comment period on the March 7
proposed rule, EPA received additional information from CPI
International, developers of ColitagTM, relevant to the
performance of the method. This information included data from two
additional studies and a re-evaluation of data in the original record
associated with the March 7 proposal. Because this additional
information serves to supplement the data included in the public record
that supported the proposed rule (Docket No. W-01-13), and because the
data are relevant to a decision on whether to promulgate
ColitagTM, EPA is using today's action to invite comments on
this additional information.
The additional information concerns the results of comparability
studies that evaluated the equivalence of ColitagTM to
approved reference methods. A key aspect of the studies included the
comparison between the proposed and reference methods for measurement
of chlorine-stressed total coliforms and E. coli. Detection of chlorine
stressed bacteria in chlorinated distribution system water is
important, and selective media are tested to determine that their
selectivity does not inhibit recovery of stressed organisms. The degree
of chlorine stress is represented as ``log reduction'' (comparing
organism counts before and after exposure to chlorine).
Data originally included in Docket No. W-01-13 (in support of the
March 7, 2002 proposed rule) for the ColitagTM method
reported log reductions ranging from 0.7 to 4.5 for total coliforms,
and 1 to 2.0 for E. coli. On July 29, 2002, CPI provided information to
EPA showing that a re-evaluation of the raw data significantly changed
the values for the log reduction for the ColitagTM
comparability study. Such re-evaluation was based on a measurement
(using membrane filter analysis) of bacteria density in the source/
effluent water used in the studies; a dilution factor, accounting for
the addition of drinking water to the source/effluent water; and a
measurement (again using membrane filter analysis) of bacterial density
following chlorine stressing of the diluted source/effluent water:
Log reduction = log10 [(Msource/DF)/
(Mchlorinated x CF)], where:
Msource = original measurement of bacteria density in the
source/effluent water;
DF = dilution factor associated with the addition of tap water to the
source water;
Mchlorinated = measurement of bacteria density following
chlorine stressing
CF = adjustment factor accounting for dilution by the chlorine solution
The original and re-evaluated data for total coliforms and E. coli
using this approach are given in Tables 1 and 2, respectively. They
show that for total coliforms, the corrected log reduction ranged from
1.9 to 3.4. For E. coli, the log reduction ranged from 1.6 to 3.4.
The figures originally reported by CPI (and originally included in
Docket No. W-01-13) were not based on the calculation above but were
instead based on a membrane filter analysis of the diluted source
water. EPA experts in microbiological analytical methods have reviewed
the two approaches to determining bacterial density in the diluted
source water (i.e., measurement by membrane filter analysis of the
diluted source water, versus calculation based on the dilution factor
and a measurement of the source water prior to dilution) and have
concluded that the latter approach is sound and provides consistency
with previous method evaluations by EPA.
CPI has also provided supplemental technical information, from two
additional studies, for the Agency's consideration. This supplemental
information, provided to EPA on July 29, 2002, may be found in Docket
No. OW-2002-0031. The first of the two supplemental studies conducted
by CPI was performed with Richmond Field Station primary wastewater
influent. In three of three dilutions with a 4.3 log reduction of
bacteria, ColitagTM performed as well as or better than the
reference method for detecting E. coli at 44.5[deg] C. In the second
supplemental study conducted by CPI, using the same primary wastewater
influent, and with a 3.4 log reduction from chlorine stress,
ColitagTM again performed as well as or better than the
reference method at 44.5[deg] C.
EPA is requesting public comment on the additional information
presented in this notice, relative to the Agency's March 2002 proposed
promulgation of the ColitagTM method. Comments should be
submitted only on the additional information presented in this notice
and in Docket No. OW-2002-0031. EPA is not reconsidering any other
drinking water issue in this notice nor will EPA respond to any
comments on other issues. Comments should be limited to the additional
information (described herein and found in Docket No. OW-2002-0031) and
its applicability to the Agency's consideration of the
ColitagTM method.
[[Page 71523]]
Table 1.--Chlorine Stress Reduction, Original and Corrected Data for Total Coliforms
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Source water Post-chlorine Chlorine
CFU Dilution CFU dilution Corrected Original
Sample ID Sample source measurement/ factor measurement/ adjustment log log
100 mL (DF) 100 mL factor reduction reduction
(Msource) (Mchlorinated) (CF)
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982084A Millbrae, CA........... 1,400,000 1000 6 2 2.1 1.8-2.1
982305A Millbrae, CA........... 30,000,000 1000 6 2 3.4 4.5
990025A Jacksonville, FL....... 11,000,000 500 7 2 3.2 3.3
990052A Schaumberg, IL......... 1,000,000 1250 2 2 2.3 2
990095A Watertown, WI.......... 16,000,000 7000 2 2 2.8 3.3
990217A Mission, KS............ 5,000,000 600 7 2 2.8 1.2
990273A Salem, OR.............. 2,000,000 800 7 2 2.3 2.1
990438A Ames, IA............... 2,000,000 13,000 1 2 1.9 1
990442A Mission, KS............ 14,000,000 9000 2 2 2.6 1.4
990443A Liberty, MO............ 9,000,000 8000 2 2 2.4 0.7
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Table 2.--Chlorine Stress Reduction, Original and Corrected Data for E. Coli
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Source water Post-chlorine Chlorine
CFU Dilution CFU dilution Corrected Original
Sample ID Sample source measurement/ factor measurement/ adjustment log log
100 mL (DF) 100 mL factor reduction reduction
(Msource) (Mchlorinated) (CF)
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982084A Millbrae, CA........... 230,000 1000 3 2 1.6 1.6
982305A Millbrae, CA........... 11,000,000 1000 2 2 3.4 NA
990025A Jacksonville, FL....... 700,000 500 1 2 2.8 NA
990052A Schaumberg, IL......... 1,000,000 1250 1 2 2.6 2
990095A Watertown, WI.......... NA 3000 7 2 NA 1.7
990217A Mission, KS............ 4,000,000 800 4 2 2.8 1.4
990273A Salem, OR.............. 1,000,000 80 5 2 3.1 1.9
990438A Ames, IA............... 1,000,000 1000 1 2 2.7 1
990442A Mission, KS............ 3,000,000 1000 1 2 3.2 1
990443A Liberty, MO............ 2,000,000 1000 1 2 3.0 1
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Dated: November 25, 2002.
G. Tracy Mehan, III,
Assistant Administrator, Office of Water.
[FR Doc. 02-30467 Filed 11-29-02; 8:45 am]
BILLING CODE 6560-50-P