[Federal Register Volume 68, Number 139 (Monday, July 21, 2003)]
[Rules and Regulations]
[Pages 43272-43283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18155]



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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

  Federal Register / Vol. 68, No. 139 / Monday, July 21, 2003 / Rules 
and Regulations  

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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 [email protected].

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.
------------------------------------------------------------------------

    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