[Federal Register: July 21, 2003 (Volume 68, Number 139)]
[Rules and Regulations]
[Page 43271-43283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy03-27]
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Part III
Environmental Protection Agency
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40 CFR Part 136
Guidelines Establishing Test Procedures for the Analysis of Pollutants;
Analytical Methods for Biological Pollutants in Ambient Water; Final
Rule
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 136
[FRL-7529-7]
RIN 2040-AD71
Guidelines Establishing Test Procedures for the Analysis of
Pollutants; Analytical Methods for Biological Pollutants in Ambient
Water
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: By today's action, EPA approves test methods for the analysis
of Escherichia coli (E. coli), enterococci, Cryptosporidium and Giardia
in fresh ambient water matrices. In addition, EPA approves test methods
for the analysis of enterococci in marine ambient water matrices. The
test methods approved in today's rule have been published by the
following organizations: EPA, American Public Health Association,
American Water Works Association, Water Environment Federation,
Association of Official Analytical Chemists International, and American
Society for Testing and Materials, or commercial vendors. EPA's
approval of these methods will help States, Tribes, communities, and
environmental laboratories better assess public health risks from
microbiological pollutants.
DATES: This regulation is effective August 20, 2003. The incorporation
by reference of these methods is approved by the Director of the
Federal Register on August 20, 2003. For judicial review purposes, this
final rule is promulgated as of 1 p.m. (Eastern time) on August 4, 2003
as provided at 40 CFR 23.2.
FOR FURTHER INFORMATION CONTACT: Robin K. Oshiro, Engineering and
Analysis Division (4303T), Office of Science and Technology, Office of
Water, U.S. Environmental Protection Agency, Ariel Rios Building, 1200
Pennsylvania Avenue, NW., Washington, DC 20460, or call (202) 566-1075
or E-mail at oshiro.robin@epa.gov.
SUPPLEMENTARY INFORMATION:
A. Potentially Regulated Entities
EPA Regions, as well as States, Tribes, and Territories authorized
to implement the National Pollutant Discharge Elimination System
(NPDES) program, issue permits to implement the technology-based and
water quality-based requirements of the Clean Water Act (CWA). Forty
five States and one Territory are currently authorized to issue NPDES
permits. EPA retains permit issuance authority in non-authorized
jurisdictions. NPDES permitting authorities make a number of
discretionary choices associated with permit writing, including the
selection of pollutants to be measured and, in many cases, limited in
permits. If EPA has ``approved'' (i.e., promulgated through rulemaking)
standardized testing procedures for a given pollutant, the NPDES
permitting authority must specify one of the approved testing
procedures or an approved alternate test procedure for the measurements
required under the permit. Although EPA is including test methods for
four biological pollutants in 40 CFR 136.3, it recommends their use for
ambient water quality monitoring only. EPA is not approving these test
methods for effluent matrices. Therefore, EPA expects entities
operating under an NPDES permit would be affected by the promulgation
of these ambient methods only where their permit specifies ambient
monitoring requirements for the specified parameters.
EPA developed and recommended ambient recreational water quality
criteria for E. coli and enterococci bacteria and is considering
criteria for Cryptosporidium and Giardia. The States, Territories, and
Tribes may adopt these criteria into their water quality standards and
may issue water quality-based permits that require monitoring for these
pollutants in ambient waters. If the NPDES permitting authority
requires ambient water monitoring in the permit for the specified
parameters, dischargers could be affected by the standardization of
testing procedures in this rulemaking. Generally, the permitting
authority requires the use of methods approved at 40 CFR part 136 for
compliance with such monitoring requirements. If no approved methods
are available at 40 CFR part 136, then the permitting authority has
discretion to specify the use of suitable methods.
In addition, when a State, Territory, or authorized Tribe provides
certification of Federal licenses under the CWA section 401, approved
testing procedures generally must be used where applicable. Categories
and entities that may be regulated include:
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Examples of potentially regulated
Category entities
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State, Territorial and Indian States, Territories, and Tribes
Tribal Governments. authorized to administer the NPDES
permitting program.
Municipalities.................... Publicly-owned treatment works with
ambient monitoring requirements for
the specified parameters in their
NPDES permits.
Industry.......................... Industrial facilities with ambient
monitoring requirements for the
specified parameters in their NPDES
permits.
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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 or organization is regulated by this action, you should
carefully examine the applicability criteria in parts 122 and 136 of
title 40 of the Code of Federal Regulations. 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.
B. 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-2002-0010. 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 West, Room B102, 1301
Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m. Eastern Time, Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is
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202-566-1744, and the telephone number for the Water Docket is 202-566-
2426.
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 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. 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 B.1.
3. Copies of Consensus Standards. Copies of the consensus standards
may be obtained from the Docket (see section B.1.). Copies of the
consensus standards may also be obtained from the following sources,
depending on the standard. Copies of final methods published by
American Society for Testing and Materials (ASTM) are available for a
nominal cost through ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. Copies of ``Standard Methods'' are
available for a nominal cost from the American Public Health
Association, 1015 Fifteenth Street, NW., Washington, DC 20005. Copies
of Association of Official Analytical Chemists International (AOAC)
methods are available for a nominal cost from the Association of
Official Analytical Chemists International, 481 N. Frederick Ave.,
Suite 500, Gaithersburg, MD 28077.
I. Statutory Authority
Today's rule is promulgated pursuant to the authority of sections
303(c), 304(a), 304(h), and 501(a) of the Clean Water Act (CWA or ``the
Act''), 33 U.S.C. 1314(a), 1314(h), 1361(a). Section 303(c) of the Act
establishes the basis for the current water quality standards program.
This section requires EPA to review and approve or disapprove State-
adopted water quality standards. Section 304(a) of the Act requires the
EPA Administrator to develop and publish water quality criteria
associated with specific ambient water uses. When these criteria are
adopted as State water quality standards under section 303(c), they
become the enforceable maximum acceptable levels of pollutants in
ambient waters. Section 304(h) of the Act requires the EPA
Administrator to ``promulgate guidelines establishing test procedures
for the analysis of pollutants that shall include the factors which
must be provided in any certification pursuant to section 401 of this
Act or permit applications pursuant to section 402 of this Act.''
Section 501(a) of the Act authorizes the Administrator to ``prescribe
such regulations as are necessary to carry out his functions under this
Act.'' EPA publishes CWA analytical method regulations at 40 CFR part
136.
II. Background
A. The Role of Methods for Biological Pollutants
To fulfill the CWA's mandate to maintain ``fishable and swimmable''
waters, EPA develops ambient water quality criteria based on a
scientific assessment of the relationship between pollutant
concentrations and environmental and human health effects. Ambient
water refers to any fresh, marine, or estuarine surface water used for
recreation, propagation of fish, shellfish, or wildlife, agriculture,
industry, navigation, or as source water for drinking water facilities.
Ambient water quality criteria become enforceable water quality
standards when adopted by State, Territorial, Tribal, and local
governments and approved by EPA.
For bacterial pollution in ambient water designated for
recreational use, EPA has developed water quality criteria for E. coli
in freshwater and for enterococci in both freshwater and marine waters
(51 FR 8012, March 7, 1986). There are a number of zoonotic diseases of
concern to humans (diseases transferred from animals to humans) if
ambient waters are contaminated with fecal material from non-human
animal species. E. coli species are a subset of the coliform bacteria
group that is part of the normal intestinal flora of humans and animals
and are direct indicators of fecal contamination from these sources in
water. Enterococci, which include Enterococcus faecalis and
Enterococcus faecium, are enteric bacteria used to indicate fecal
contamination and the possible presence of pathogens in water. Based on
previous EPA guidance, total and fecal coliform bacteria are included
in many water quality standards as indicators of bacterial
contamination (EPA, 1976). More recent epidemiological studies (Cabelli
1983, Dufour 1984) described in Ambient Water Quality Criteria for
Bacteria--1986 (EPA, 1986a), indicate that E. coli and enterococci show
a direct correlation with swimming-associated gastrointestinal illness
rates, while fecal coliforms do not. As the concentration of E. coli
and/or enterococci increase(s), the illness rates also increase. Thus,
using these indicators as part of the bacterial water quality standards
will enhance the protection of human health and the environment.
In addition to bacterial pollution, EPA is concerned about
waterborne parasites and developed test methods for Cryptosporidium and
Giardia in freshwater. These waterborne parasites have been found to be
the causative agent of human gastroenteritis in some contaminated
waters and are responsible for cases of severe and widespread human
illness when present in drinking water supplies as a result of
contamination of source waters. Because one of the designated uses of
some ambient waters may be use of the water body as a drinking water
source, EPA may develop ambient water quality criteria for
Cryptosporidium and Giardia in the future. EPA would expect to use the
test methods discussed in this action to support these future criteria.
By doing so, EPA desires to promote consistency in the methods used for
these future criteria to ensure that the data collected are of good
quality and are comparable for all freshwater. EPA also wishes to make
these methods available for use by the States for general risk
assessments.
By today's action, EPA is promulgating test methods for E. coli,
enterococci, Cryptosporidium, and Giardia for use in freshwaters, and
enterococci for use in marine waters. Promulgation of the bacterial
methods supports the use of E. coli and enterococci as indicators of
fecal contamination in addition to fecal coliform indicators in State,
Territorial, Tribal, and local water quality-based monitoring. States
may use the test methods for Cryptosporidium and Giardia for different
monitoring purposes, such as evaluating surface water occurrence of
these organisms and the associated watershed vulnerability for
waterbodies designated as potential drinking water sources.
This rule provides uniform methodology to assist State,
Territorial, Tribal, and local implementation of water quality
standards, ambient water monitoring programs, and public notification
programs to reduce public health risks posed by biological pollutants
in ambient water. Today's rule supports several EPA initiatives: The
Beaches Environmental Assessment Closure and Health (BEACH) Program,
the Beach Action Plan (EPA-600-R-98-079), the Beach Watch Program, the
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Beaches Environmental Monitoring for Public Access and Community
Tracking (EMPACT) Program (EPA 905-R-98-002), and the Water Quality
Criteria and Standards Plan (EPA-822-R-98-003). Additionally, this rule
is expected to satisfy requests from governments, regulated entities,
and environmental laboratories that EPA publish analytical test
procedures that were evaluated through interlaboratory validation for
enumerating E. coli, enterococci, Cryptosporidium, and Giardia in
ambient waters.
As previously noted, EPA developed water quality criteria for
enterococci in both freshwater and in marine waters. Today's action
approves methods for measuring enterococci in both freshwater and
marine waters. EPA has not developed marine criteria for E. coli,
Cryptosporidium, and Giardia because these pollutants do not generally
survive in marine conditions. Thus, EPA has not identified any
programmatic need to promulgate methods for these pollutants in marine
waters.
EPA is aware of the importance of having methods for measuring
these pollutants in wastewater effluent. The Agency does not currently
have validated methods for use in this matrix and thus was unable to
propose any such methods with the methods for ambient waters. The
Agency is currently in the process of trying to validate E. coli and
enterococci methods for use with wastewater effluent and plans to
propose them by the end of 2004.
B. Summary of Proposed Rule
EPA published a proposed rule in the Federal Register on August 30,
2001 (66 FR 45811) to amend 40 CFR part 136, ``Guidelines Establishing
Test Procedures for the Analysis of Pollutants,'' by approving several
analytical test procedures for enumerating the bacteria Escherichia
coli (E. coli) and enterococci and the protozoans Cryptosporidium and
Giardia in ambient water. The proposal described a suite of Most
Probable Number (MPN) (i.e., multiple-tube, multiple-well) and membrane
filter (MF) methods for enumerating E. coli and enterococci bacteria in
ambient water, and improved filtration/immunomagnetic separation/
fluorescent antibody methods for Cryptosporidium and Giardia
protozoans. These test methods were proposed for use by States,
Territories, and Tribes, for use in water quality monitoring programs.
A summary of the major comments to the proposal is presented in
Section V.
III. Summary of Final Rule
EPA is approving the use of test methods for E. coli, enterococci,
Cryptosporidium, and Giardia for ambient fresh water quality
monitoring. In addition, EPA is approving the use of test methods for
enterococci for ambient marine water quality monitoring. Although EPA
believes that these methods are appropriate for ambient water quality
monitoring, the Agency has not determined that these methods are
acceptable for application to matrices other than ambient waters.
Today's action promulgates the test methods described in the
proposed rule (66 FR 45811, August 30, 2001) for the analysis of E.
coli, enterococci, Cryptosporidium, and Giardia in ambient water. For
E. coli, approved methods include most probable number methods
(LTB[rarr]EC-MUG, ONPG-MUG) and membrane filtration methods
(mENDO>2S2O35.
6 Fecal streptococci........... PP, G................. Cool, <10[deg] 0.008% 6
Na2S2O35.
7 Enterocci.................... PP, G................. Cool, <10[deg] 0.008% 6
Na2S2O35.
Table IA--Protozoa Tests:
8 Cryptosporidium.............. LDPE.................. 0-8[deg]C.................. 96 \17\
9 Giardia...................... LDPE.................. 0-8[deg]C.................. 96 \17\
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\1\ Polyethylene (P) or glass (G). For bacteria, plastic sample containers must be made of sterilizable
materials (polypropylene [PP] or other autoclavable plastic). For protozoa, plastic sample containers must be
made of low-density polyethylene (LDPE).
\2\ Sample preservation should be performed immediately upon sample collection. For composite chemical samples,
each aliquot should be preserved at the time of collection. When use of an automated sampler makes it
impossible to preserve each aliquot, then chemical samples may be preserved by maintaining at 4[deg]C until
compositing and sample splitting is completed.
\3\ When any sample is to be shipped by common carrier or sent through the United States Mails, it must comply
with the Department of Transportation Hazardous Materials Regulations (49 CFR part 172). The person offering
such material for transportation is responsible for ensuring such compliance. For the preservation
requirements of Table II, the Office of Hazardous Materials, Transportation Bureau, Department of
Transportation, has determined that the Hazardous Materials Regulations do not apply to the following
materials: Hydrochloric acid (HCl) in water solutions at concentrations of 0.04% by weight or less (pH about
1.96 or greater); Nitric acid (HNO3) in water solutions of 0.15% by weight or less (pH about 1.62 or greater);
Sulfuric acid (H2SO4) in water solutions of concentrations of 0.35% by weight or less (pH about 1.15 or
greater); and Sodium hydroxide (NaOH) in water solutions at concentrations of 0.080% by weight or less (pH
about 12.30 or less).
\4\ Samples should be analyzed as soon as possible after collection. The times listed are the maximum times that
samples may be held before analyses and still be considered valid. Samples may be held for longer periods only
if the permittee, or monitoring laboratory, has data on file to show that for the specific types of samples
under study, the analytes are stable for the longer time, and has received a variance from the Regional
Administrator under Sec. 136.3(e). Some samples may not be stable for the maximum time period given in the
table. A permittee or monitoring laboratory is obligated to hold the samples for a shorter time if knowledge
exists to show that this is necessary to maintain sample stability. See Sec. 136.3(e) for details. The term
``analyze immediately'' usually means within 15 minutes or less of sample collection.
\5\ Should only be used in the presence of residual chlorine.
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\16\ Sufficient ice should be placed with the samples in the shipping container to ensure that ice is still
present when samples arrive at the laboratory. However, even if ice is present when the samples arrive, it is
necessary to immediately measure the temperature of the samples and confirm that the 4[deg]C temperature
maximum has not been exceeded. In the isolated cases where it can be documented that this holding temperature
can not be met, the permittee can be given the option of on-site testing or can request a variance. The
request for a variance should include supportive data which show that the toxicity of the effluent samples is
not reduced because of the increased holding temperature.
\17\ Holding time is calculated from time of sample collection to elution for samples shipped to the laboratory
in bulk and calculated from the time of sample filtration to elution for samples filtered in the field.
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[FR Doc. 03-18155 Filed 7-18-03; 8:45 am]
BILLING CODE 6560-50-P