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

AGENCY:

Environmental Protection Agency.

ACTION:

Proposed rule; notice of data availability—supplemental information.

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 Colitag^TM 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 Colitag^TM, 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 Colitag^TM. 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: brass.herb@epa.gov. 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,” 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 OW-Docket@epa.gov, 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 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 Colitag^TM 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 Colitag^TM, 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 Colitag^TM, 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 Colitag^TM 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 Colitag^TM 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 Colitag^TM 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 [(M_source/DF)/(M_chlorinated × CF)], where:

M_source = original measurement of bacteria density in the source/effluent water;

DF = dilution factor associated with the addition of tap water to the source water;

M_chlorinated = 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, Colitag^TM performed as well as or better than the reference method for detecting E. coli at 44.5° 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, Colitag^TM again performed as well as or better than the reference method at 44.5° 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 Colitag^TM 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 Colitag^TM method.