National Primary and Secondary Drinking Water Regulations:
Approval of Additional Method for the Detection of Coliforms and E.
Coli in Drinking Water
[Federal Register: February 13, 2004 (Volume 69, Number 30)]
[Rules and Regulations]
[Page 7156-7161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe04-15]
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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.
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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 carroll.gregory@epa.gov. 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.
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Examples of potentially regulated
Category entities NAICS
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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.
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\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'' (59 FR 22951, 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.
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
? 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.
? 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: adellenbusch@emscience.com.
\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:
\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