[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