[Federal Register Volume 69, Number 30 (Friday, February 13, 2004)]
[Rules and Regulations]
[Pages 7156-7161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3226]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 141

[FRL-7622-8]
RIN 2040-AD90


National Primary and Secondary Drinking Water Regulations: 
Approval of Additional Method for the Detection of Coliforms and E. 
Coli in Drinking Water

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: In today's final rule, the Environmental Protection Agency 
(EPA) approves the ColitagTM method to support previously 
established requirements for National Primary Drinking Water Regulation 
(NPDWR) compliance monitoring for total coliforms and E. coli in 
finished drinking water. This method was proposed on March 7, 2002, and 
a Notice of Data Availability was published on December 2, 2002, which 
provided additional information on the ColitagTM method. 
This action provides water utilities and certified laboratories an 
additional analytical method option to test for total coliforms and E. 
coli.

DATES: This regulation is effective March 15, 2004. The incorporation 
by reference of the method listed in the rule is approved by the 
Director of the Federal Register as of March 15, 2004. For purposes of 
judicial review, this final rule is promulgated as of 1 p.m. eastern 
time February 27, 2004, as provided in 40 CFR 23.7.

ADDRESSES: The official public docket for this rule is located at EPA 
West Building, Room B102, 1301 Constitution Avenue, NW., Washington, 
DC, 20004.

FOR FURTHER INFORMATION CONTACT: For information regarding the actions 
included in this final rule contact Gregory J. Carroll, EPA, 26 West 
Martin Luther King Dr. (MLK 140), Cincinnati, Ohio, 45268, (513) 569-
7948, or e-mail at [email protected]. General information may 
also be obtained from the EPA Safe Drinking Water Hotline. Callers 
within the United States may reach the Hotline at (800) 426-4791. The 
Hotline is open Monday through Friday, excluding legal holidays, from 9 
a.m. to 4:30 p.m., Eastern Time.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Potentially Regulated Entities

    Use of the ColitagTM method approved in this action is 
voluntary. If, however, it is used to support compliance monitoring, 
then compliance with the procedures specified in the method is 
required.

----------------------------------------------------------------------------------------------------------------
                                                                     Examples of potentially regulated
                              Category                                            entities                NAICS
----------------------------------------------------------------------------------------------------------------
State, Local, & Tribal Governments.................................  States, local and Tribal             924110
                                                                      governments that analyze water
                                                                      samples on behalf of public
                                                                      water systems required to
                                                                      conduct such analysis; States,
                                                                      local and Tribal governments
                                                                      that themselves operate
                                                                      community and non-transient non-
                                                                      community water systems required
                                                                      to monitor.
Industry...........................................................  Private operators of community       221310
                                                                      and non-transient non-community
                                                                      water systems required to
                                                                      monitor.
Municipalities.....................................................  Municipal operators of community    924110
                                                                      and non-transient non-community
                                                                      water systems required to
                                                                      monitor.
----------------------------------------------------------------------------------------------------------------
\1\ North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be regulated by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be regulated by this action. Other types of entities 
not listed in the table could also be regulated. To determine whether 
your facility is regulated by this action, you should carefully examine 
the applicability criteria in Sec. 141.21 of title 40 the Code of 
Federal Regulations (CFR). If you have questions regarding the 
applicability of this action to a particular entity, consult the person 
listed in the preceding FOR FURTHER INFORMATION CONTACT section.

[[Page 7157]]

B. How Can I Get Copies of Related Information?

    1. 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., 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. If you would like to schedule an 
appointment for access to docket materials, please call (202) 566-2426.
    2. 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 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. Although not all docket materials may be available 
electronically, you may still access any of the publically available 
docket materials through the docket facility identified in section 
I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket identification number.

II. Statutory Authority and Background

    The Safe Drinking Water Act (SDWA), as amended in 1996, requires 
EPA 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 (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. EPA's promulgation of analytical methods is 
authorized under these sections of the SDWA, as well as the general 
rulemaking authority in SDWA section 1450(a), (42 U.S.C. 300j-9(a)).

III. Explanation of Today's Action

    In this final rule, EPA is approving the Colitag TM 
method for compliance monitoring of total coliforms and E. coli in 
drinking water. The action taken in this final rule was first proposed 
in the Federal Register published on March 7, 2002 (67 FR 10532). In 
October 2002, EPA decided to evaluate additional clarifying information 
from the developer of the Colitag TM method, CPI 
International, and indicated such in the Federal Register notice on 
October 29, 2002 (67 FR 65888, 65891). EPA did not take final action on 
this method at that time and stated that all comments relating to the 
Colitag TM method would be responded to in a future action.
    EPA published a Federal Register Notice of Data Availability (NODA) 
on December 2, 2002 (67 FR 71520) to provide additional information 
concerning the results of studies that evaluated the comparability 
between Colitag TM and the approved reference methods. The 
additional information in the NODA described the performance of the 
method, including additional analysis by EPA of the data in the 
original record associated with the March 2002 proposal, and included 
data from two additional studies.
    Based on the evaluation of the comparability data generated for the 
Colitag TM method, and taking into consideration the public 
comments received, EPA has concluded that the Colitag TM 
method is acceptable as an alternative to the approved reference 
methods because the information available to EPA indicates that the 
performance of the Colitag method compares favorably to the approved 
reference methods. The Colitag TM method was compared to 
Standard Method 9222B for total coliforms and to Standard Method 9222D 
for E. Coli (reference 1 in the table at Sec. 141.21). EPA assessed the 
quality and quantity of the data provided by CPI International (i.e., 
data provided to support EPA's original evaluation of the Colitag 
TM method and the additional clarifying information cited in 
the December 2, 2002, NODA) and conducted a thorough statistical 
analysis of relevant data, all of which was included in the public 
record.
    As part of this assessment, EPA performed an extensive review of 
the information from each of the ten sets of method comparability 
studies, including the data sheets available from the independent 
laboratory that performed the total coliforms and E. coli analyses for 
the studies. EPA also addressed the following key issues as part of 
this process: adherence to the protocol used in the Agency's Alternate 
Test Procedure (ATP) program; adequacy of the stress applied to the 
target microorganisms prior to testing using the Colitag TM 
method; and the time that elapsed between chlorine stressing and 
comparability test completion. As discussed later in ``Summary of 
Comments,'' each was addressed to EPA's satisfaction.
    The full title of the Colitag TM method approved in this 
action and how to obtain a copy of the method are being added to the 
table at Sec. 141.21(f)(3), at footnote 15. The full title was included 
in the discussion of the method detailed in the proposal to this 
regulation, published in the Federal Register on March 7, 2002 (67 FR 
10532).

IV. Summary of Comments

    EPA received five sets of comments related to the Colitag 
TM method in response to the March 2002 proposal and 
received eight sets of comments in response to the December 2002 NODA. 
Four of the eight sets of NODA comments were from those who had also 
commented on the proposal; thus, in total, EPA received comments from 
nine commenters. Based on EPA's review of the comments, the Agency 
believes that today's action is warranted. Detailed responses to 
comments are contained in ``Public Comment and Responses for the 
National Primary and Secondary Drinking Water Regulations: Approval of 
Colitag TM for Compliance Monitoring of total coliforms and 
E. coli in Finished Drinking Water'' which is available in Docket ID 
No. OW-2002-0031. See section I.B.1 (How Can I Get Copies Of Related 
Information?) for information on contacting the official public docket.
    All comments are addressed in the aforementioned document. Three 
specific comment subjects are discussed as follows: (1) Adherence to 
the protocol used in the Agency's Alternate Test Procedures (ATP) 
program; (2) the adequacy of the stress applied to the target 
microorganisms prior to testing

[[Page 7158]]

the Colitag TM method; and (3) the time elapsed between 
chlorine stressing and the comparability study (i.e., ``hold time'').
    The ATP protocol that guided the Colitag TM method 
comparability testing is titled ``Protocol for Alternate Test 
Procedures for Coliform Bacteria in Compliance With Drinking Water 
Regulations,'' published in 1995. The protocol is not a rule and is not 
mandatory in nature. Rather, EPA established the guidelines in the 
protocol to encourage the collection of adequate information for the 
Agency's evaluation of a new method (i.e., to allow the Agency to 
determine the comparability between the new method and the reference 
method). Keeping that objective in mind, EPA notes that it has 
exercised a degree of flexibility in the application of the guidance. 
While EPA believes that those who follow the protocol guidelines 
increase the likelihood that the Agency will have sufficient 
information on which to base an approval decision, EPA notes that 
following the guidelines precisely does not guarantee method approval. 
Similarly, deviation from the guidelines does not preclude EPA from 
considering a method for approval. EPA considers all information 
submitted and, when there is a question or concern (e.g., when there is 
a suggestion that some information was not collected precisely in 
accordance with the guidance), EPA generally considers the underlying 
issue that the protocol was designed to address. Where the Agency has 
concluded that adequate information is available to judge a particular 
issue, it has proceeded with the evaluation of the method; this 
approach has been reflected in EPA's past evaluation of numerous 
methods, including currently approved methods for the measurement of 
total coliforms and E. coli.
    With respect to the comparability study tests to determine if 
Colitag TM could adequately recover damaged total coliforms 
and E. coli, EPA experts evaluated the chlorine stress that was applied 
to the test bacteria and concluded that such bacteria had been 
adequately stressed. Consistent with the approach described above, 
EPA's microbiologists considered the underlying issue (i.e., ``Can the 
Colitag TM method adequately recover and detect chlorine-
stressed bacteria?''). Acknowledging that the protocol, on which the 
tests were based recommended 3-4 logs of stress, EPA concluded that a 
lesser degree of chlorine stress applied in a number of the Colitag 
TM samples still provided an adequate challenge to the 
method performance. Moreover, EPA's microbiologists, upon more closely 
examining the mechanisms by which bacteria become stressed and are 
subsequently recovered, concluded that a wider range (2-4 log 
reduction) for the chlorine-stress goal is reasonable for judging 
method comparability. As a result, the Colitag TM test data 
support EPA's conclusion that the method is comparable to the reference 
methods in its ability to recover chlorine-stressed bacteria. Again, 
EPA notes that it has previously approved coliform methods that were 
tested with less than 3-4 logs of chlorine stressing; the Colitag 
TM evaluation is not unique in this respect.
    With respect to comments concerning ``hold time,'' EPA notes that 
it has not established guidelines for such in its ATP protocol. The 
Agency has not asked that hold time be documented, nor has it applied a 
standard for such in previous method evaluations. EPA's presumption 
with respect to this issue is that the certified drinking water 
laboratories performing the comparability studies will employ a 
reasonable hold time. To address this issue, however, EPA conducted a 
thorough review of the hold times for the ten samples collected in 
evaluating the Colitag TM method. In doing so, EPA 
considered dates identified for sample collection; sample receipt at 
the laboratory; original density determination; and comparability study 
completion, as reflected in the worksheets, comparability study data 
sheets, and chain of custody documentation in the record. EPA further 
considered the chronology and duration of the steps associated with the 
various tests performed. Based on all of this information, EPA 
concluded that a reasonable hold time could be documented for the 
majority of the tests, but that clear hold times could not be 
conclusively determined for four of the tests (samples 990025A, 
990052A, 990217A, and 990273A). EPA notes, however, that it was unable 
to determine that unreasonable hold times were employed for these four 
tests. Therefore, EPA has evaluated the results of all ten samples for 
the comparison analysis.
    As a conservative measure, however, EPA repeated its statistical 
analysis of the Colitag TM data set, excluding the results 
of the four aforementioned tests. The conclusion (i.e., that the 
comparability study did not identify a statistically significant 
difference in performance between the reference method and Colitag 
TM'') did not change, nor was the strength of the conclusion 
substantially different using the more limited (6-test) data set. 
Hence, even if the four tests were excluded, EPA's decision to approve 
Colitag TM would not change.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866, [58 FR 51735 (October 4, 1993)] the 
Agency must determine whether a regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities;
    (2) create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that this rule is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to Executive Order 12866.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under 
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. 
This rule merely provides drinking water utilities an additional 
analytical method to use to meet existing monitoring requirements. 
Burden means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, or disclose or provide 
information to or for a Federal agency. This includes the time needed 
to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise

[[Page 7159]]

disclose the information. An agency may not conduct or sponsor, and a 
person is not required to respond to a collection of information unless 
it displays a currently valid OMB control number. The OMB control 
numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    The RFA provides default definitions for each type of small entity. 
It also authorizes an agency to use alternative definitions for each 
category of small entity, ``which are appropriate to the activities of 
the agency'' after proposing the alternative definition(s) in the 
Federal Register and taking comment. 5 U.S.C. 601(3)-(5). In addition 
to the above, to establish an alternative small business definition, 
agencies must consult with the Small Business Administration's (SBA) 
Chief Counsel for Advocacy.
    For purposes of assessing the impacts of today's rule on small 
entities, EPA considered small entities to be public water systems 
serving 10,000 persons or fewer. This is the cut-off level specified by 
Congress in the 1996 Amendments to the SDWA for small system 
flexibility provisions. In accordance with the RFA requirements, EPA 
proposed using this alternative definition in the Federal Register, (63 
FR 7620, February 13, 1998) requested comment, consulted with SBA, and 
expressed its intention to use the alternative definition for all 
future drinking water regulations in the Consumer Confidence Reports 
regulation (63 FR 44511, August 19, 1998). As stated in that final 
rule, the alternative definition would be applied to this regulation as 
well.
    After considering the economic impacts of today's final rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The use of 
the ColitagTM method is optional. Additionally, the cost of 
using the ColitagTM is similar to the cost of using other 
previously approved methods for the measurement of total coliforms and 
E. coli. Thus, we have determined that this rule will not impact small 
entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and Tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and Tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective, or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective, or least burdensome alternative, if the 
Administrator publishes with the final rule an explanation of why that 
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may 
significantly or uniquely affect small governments, including Tribal 
governments, it must have developed under UMRA section 203 of the UMRA 
a small government agency plan. The plan must provide for notifying 
potentially affected small governments, enabling officials of affected 
small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    Today's rule contains no Federal mandates (under the regulatory 
provision of Title II of the UMRA) for State, local, or Tribal 
governments or the private sector. The rule imposes no enforceable duty 
on any State, local, or Tribal governments or the private sector. It 
merely provides drinking water utilities an additional analytical 
method to use to meet existing monitoring requirements. Thus, today's 
rule is not subject to the requirement of sections 202 and 205 of the 
UMRA.
    EPA has determined that this final rule contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. The adoption and use of the ColitagTM method is 
voluntary because drinking water systems can continue to use the 
existing approved methods. Thus, today's rule is not subject to the 
requirements of section 203 of UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. This final rule approves 
ColitagTM as an additional analytical method option, thereby 
allowing public water systems an additional choice to conduct analyses 
previously required. There is no added cost to State and local 
governments, and the rule does not preempt State law. Thus, Executive 
Order 13132 does not apply to this rule. In the spirit of Executive 
Order 13132, and consistent with EPA policy to promote communications 
between EPA and State and local governments, EPA specifically solicited 
comment on the proposed rule from State and local officials. No 
comments were received that concerned issues covered by Executive Order 
13132.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on

[[Page 7160]]

one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.''
    This final rule does not have Tribal implications. It will not have 
substantial direct effects on Tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
This final rule is to specify ColitagTM as an approved 
analytical method option, thereby allowing public water systems the 
choice to use it to conduct analyses previously required. Thus, 
Executive Order 13175 does not apply to this rule. Moreover, in the 
spirit of Executive Order 13175, and consistent with EPA policy to 
promote communications between EPA and Tribal governments, EPA 
specifically solicited comment on the proposed rule from Tribal 
officials. No comments concerning Tribal issues were received.

G. Executive Order 13045: Protection of Children From Environmental 
Health & Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies 
to any rule that: (1) Is determined to be ``economically significant'' 
as defined under Executive Order 12866, and (2) concerns an 
environmental health or safety risk that EPA has reason to believe may 
have a disproportionate effect on children. If the regulatory action 
meets both criteria, the Agency must evaluate the environmental health 
or safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    This final rule is not subject to Executive Order 13045 because it 
is not economically significant as defined under Executive Order 12866. 
Further, it does not concern an environmental health or safety risk 
that EPA has reason to believe may have a disproportionate effect on 
children. This rule merely provides an additional analytical method to 
use for monitoring. It does not require any public water systems to use 
this method.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Effect Energy Supply, 
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    As noted in the proposed rule, Section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (``NTTAA''), Public Law 
104-113, Section 12(d) (15 U.S.C. 272 note) directs EPA to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. The NTTAA directs EPA to provide to Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.
    This rulemaking involves a technical standard. Therefore, the NTTAA 
requires that the Agency identify and consider potentially applicable 
voluntary consensus standards. In response to those requirements, EPA 
notes that it has recently approved updated versions of previously 
approved voluntary consensus methods for total coliforms and E. coli 
and published them in the Federal Register on October 23, 2002 (67 FR 
65220). EPA has decided to approve the ColitagTM method in 
this regulation as an additional analytical method, submitted to EPA by 
industry, for use in drinking water compliance monitoring. This 
industry-developed method will supplement existing approved methods.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective on March 15, 2004.

List of Subjects in 40 CFR Part 141

    Environmental protection, Chemicals, Incorporation by reference, 
Indians-lands, Intergovernmental relations, Radiation protection, 
Reporting and recordkeeping requirements, Water supply.

    Dated: February 9, 2004.
Michael O. Leavitt,
Administrator.

0
For the reasons set out in the preamble, title 40, chapter I of the 
Code of Federal Regulations is amended as follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

0
1. The authority citation for part 141 continues to read as follows:

    Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.


0
2. Section 141.21 is amended by revising the table including the 
footnotes in paragraph (f)(3) and by adding paragraph (f)(6)(x) to read 
as follows.


Sec. 141.21  Coliform sampling.

* * * * *
    (f) * * *
    (3) * * *

------------------------------------------------------------------------
           Organism                Methodology\12\        Citation\1\
------------------------------------------------------------------------
Total Coliforms \2\...........  Total Coliform         9221A, B.
                                 Fermentation
                                 Technique 3, 4, 5.
                                Total Coliform         9222A, B, C.
                                 Membrane Filter
                                 Technique \6\.
                                Presence-Absence (P-   9221D.
                                 A) Coliform Test 5,
                                 7.
                                ONPG-MUG Test \8\....  9223.
                                Colisure Test \9\.     .................
                                E*Colite [reg] Test    .................
                                 \10\.
                                m-ColiBlue24 [reg]     .................
                                 Test \11\.
                                Readycult [reg]        .................
                                 Coliforms 100
                                 Presence/Absence
                                 Test \13\.

[[Page 7161]]

 
                                Membrane Filter        .................
                                 Technique using
                                 Chromocult [reg]
                                 Coliform Agar\14\.
                                Colitag [reg] Test     .................
                                 \15\.
------------------------------------------------------------------------
The procedures shall be done in accordance with the documents listed
  below. The incorporation by reference of the following documents
  listed in footnotes 1, 6, 8, 9, 10 , 11, 13, 14 and 15 was approved by
  the Director of the Federal Register in accordance with 5 U.S.C.
  552(a) and 1 CFR Part 51. Copies of the documents may be obtained from
  the sources listed below. Information regarding obtaining these
  documents can be obtained from the Safe Drinking Water Hotline at 800-
  426-4791. Documents may be inspected at EPA's Drinking Water Docket,
  EPA West, 1301 Constitution Avenue, NW., EPA West, Room B102,
  Washington DC 20460 (Telephone: 202-566-2426); or at the Office of
  Federal Register, 800 North Capitol Street, NW., Suite 700,
  Washington, DC 20408.
\1\ Standard Methods for the Examination of Water and Wastewater, 18th
  edition (1992), 19th edition (1995), or 20th edition (1998). American
  Public Health Association, 1015 Fifteenth Street, NW., Washington, DC
  20005. The cited methods published in any of these three editions may
  be used.
\2\ The time from sample collection to initiation of analysis may not
  exceed 30 hours. Systems are encouraged but not required to hold
  samples below 10 deg. C during transit.
\3\ Lactose broth, as commercially available, may be used in lieu of
  lauryl tryptose broth, if the system conducts at least 25 parallel
  tests between this medium and lauryl tryptose broth using the water
  normally tested, and this comparison demonstrates that the false-
  positive rate and false-negative rate for total coliform, using
  lactose broth, is less than 10 percent.
\4\ If inverted tubes are used to detect gas production, the media
  should cover these tubes at least one-half to two-thirds after the
  sample is added.
\5\ No requirement exists to run the completed phase on 10 percent of
  all total coliform-positive confirmed tubes.
\6\ MI agar also may be used. Preparation and use of MI agar is set
  forth in the article, ``New medium for the simultaneous detection of
  total coliform and Escherichia coli in water'' by Brenner, K.P., et.
  al., 1993, Appl. Environ. Microbiol. 59:3534-3544. Also available from
  the Office of Water Resource Center (RC-4100T), 1200 Pennsylvania
  Avenue, NW., Washington, DC 20460, EPA/600/J-99/225. Verification of
  colonies is not required.
\7\ Six-times formulation strength may be used if the medium is filter-
  sterilized rather than autoclaved.
\8\ The ONPG-MUG Test is also known as the Autoanalysis Collect System.
\9\ A description of the Colisure Test, Feb 28, 1994, may be obtained
  from IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine
  04092. The Colisure Test may be read after an incubation time of 24
  hours.
\10\ A description of the E*Colite [reg] Test, ``Presence/Absence for
  Coliforms and E. Coli in Water,'' Dec 21, 1997, is available from
  Charm Sciences, Inc., 36 Franklin Street, Malden, MA 02148-4120.
\11\ A description of the m-ColiBlue24 [reg] Test, Aug 17, 1999, is
  available from the Hach Company, 100 Dayton Avenue, Ames, IA 50010.
\12\ EPA strongly recommends that laboratories evaluate the false-
  positive and negative rates for the method(s) they use for monitoring
  total coliforms. EPA also encourages laboratories to establish false-
  positive and false-negative rates within their own laboratory and
  sample matrix (drinking water or source water) with the intent that if
  the method they choose has an unacceptable false-positive or negative
  rate, another method can be used. The Agency suggests that
  laboratories perform these studies on a minimum of 5% of all total
  coliform-positive samples, except for those methods where verification/
  confirmation is already required, e.g., the M-Endo and LES Endo
  Membrane Filter Tests, Standard Total Coliform Fermentation Technique,
  and Presence-Absence Coliform Test. Methods for establishing false-
  positive and negative-rates may be based on lactose fermentation, the
  rapid test for [beta]-galactosidase and cytochrome oxidase, multi-test
  identification systems, or equivalent confirmation tests. False-
  positive and false-negative information is often available in
  published studies and/or from the manufacturer(s).
\13\ The Readycult [reg] Coliforms 100 Presence/Absence Test is
  described in the document, ``Readycult [reg] Coliforms 100 Presence/
  Absence Test for Detection and Identification of Coliform Bacteria and
  Escherichla coli in Finished Waters'', November 2000, Version 1.0,
  available from EM Science (an affiliate of Merck KGgA, Darmstadt
  Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. Telephone
  number is (800) 222-0342, e-mail address is: [email protected].
\14\ Membrane Filter Technique using Chromocult [reg] Coliform Agar is
  described in the document, ``Chromocult [reg] Coliform Agar Presence/
  Absence Membrane Filter Test Method for Detection and Identification
  of Coliform Bacteria and Escherichla coli in Finished Waters'',
  November 2000, Version 1.0, available from EM Science (an affiliate of
  Merck KGgA, Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ
  08027-1297. Telephone number is (800) 222-0342, e-mail address is:
  [email protected].
\15\ Colitag [reg] product for the determination of the presence/absence
  of total coliforms and E. coli is described in ``Colitag [reg] Product
  as 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,'' August 2001, available from CPI
  International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 95403,
  telephone (800) 878-7654, Fax (707) 545-7901, Internet address http://www.cpiinternational.com.

* * * * *
    (6) * * *
    (x) Colitag [reg], a description of which is cited in footnote 15 
to the table at paragraph (f)(3) of this section.
* * * * *
[FR Doc. 04-3226 Filed 2-12-04; 8:45 am]
BILLING CODE 6560-50-P