[Federal Register Volume 69, Number 220 (Tuesday, November 16, 2004)]
[Rules and Regulations]
[Pages 67218-67243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25303]



[[Page 67217]]

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Part II





Environmental Protection Agency





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40 CFR Part 131



Water Quality Standards for Coastal and Great Lakes Recreation Waters; 
Final Rule

  Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / 
Rules and Regulations  

[[Page 67218]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[OW-2004-0010; FRL-7837-5]
RIN 2040-AE63


Water Quality Standards for Coastal and Great Lakes Recreation 
Waters

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is promulgating 
water quality criteria for bacteria for coastal recreation waters in 
specific States and Territories. The States and Territories covered by 
this promulgation do not have water quality standards for bacteria that 
comply with the requirements of section 303(i)(1)(A) of the Clean Water 
Act. Under these circumstances, the Act requires EPA to promptly 
propose such standards and to promulgate such standards not later than 
90 days after proposal. The criteria promulgated today apply to coastal 
and Great Lakes waters that specific States and Territories have 
designated for swimming, bathing, surfing, or similar water contact 
activities and for which the State or Territory does not have in place 
EPA-approved bacteria criteria that are as protective of human health 
as EPA's 1986 recommended bacteria criteria. Through this promulgation, 
the Federally designated water quality criteria will be added to the 
States' and Territories' water quality criteria applicable to coastal 
recreation waters.

DATES: This final rule is effective December 16, 2004.

ADDRESSES: EPA has established a docket for this action under DOCKET ID 
No. OW-2004-0010. All documents in the docket are listed in the EDOCKET 
index at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, i.e., Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Certain other material, such as copyrighted material, is 
not placed on the Internet and will be publicly available only in hard 
copy form. Publicly available docket materials are available either 
electronically in EDOCKET or in hard copy at the Water Quality 
Standards for Coastal and Great Lakes Recreation Waters Docket, EPA/DC, 
EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC 20460. 
The 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 Quality Standards for Coastal and Great Lakes Recreation Water 
Docket is (202) 566-2422.

FOR FURTHER INFORMATION CONTACT: For information concerning today's 
rulemaking, contact Lars Wilcut, Standards and Health Protection 
Division, Office of Science and Technology (4305 T), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 566-0447; fax number: (202) 566-0409; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. Does This Action Apply to Me?
    B. How Can I Get Copies of This Document and Other Related 
Information?
II. Background
    A. Statutory and Regulatory Background
    1. Clean Water Act
    2. BEACH Act of 2000
    B. 1986 Ambient Water Quality Criteria for Bacteria
III. EPA's Proposed Rule and Solicitation of Comment
    A. July 2004 Proposed Rule
    B. Public Comments
IV. Criteria That EPA Is Promulgating Today
    A. Scope of the Rule
    B. Criteria for Pathogen Indicators
    1. Selection of Pathogen Indicator
    2. Bacteria Criteria Values
    3. Use of the Single Sample Maximum
    4. Intensity of Use Categories of Coastal Recreation Waters
    5. Intrastate vs. Interstate Determinations of Use Intensity
    6. State Calculation of Site-Specific Single Sample Maximums
    7. Addressing Non-Human Sources of Bacteria
    C. Applicability of Today's Rule
    1. Applies in Addition to Any State/Territorial Criteria
    2. Role of State/Territorial General Rules of Applicability
    D. Compliance Schedules
V. EPA Review of State and Territorial Standards
    A. How Did EPA Decide Which States and Territories To Include In 
Today's Rule?
    B. Which States and Territories Are Included in Today's Rule?
    C. Under What Conditions Will States and Territories Be Removed 
From Today's Rule?
VI. Response to Additional Significant Public Comments
    A. 1986 Bacteria Criteria
    B. Economics
    C. Analytical Methods
    D. Effective Date
VII. Alternative Regulatory Approaches and Implementation Mechanisms
VIII. Economic Analysis
    A. Identifying Affected Facilities
    B. Method for Estimating Potential Compliance Costs
    C. Results
IX. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Congressional Review Act

I. General Information

A. Does This Action Apply to Me?

    State and Territorial agencies responsible for adopting and 
implementing water quality standards in the States and Territories 
identified in 40 CFR 131.41 are the entities most directly affected by 
today's rule. People concerned with water quality in coastal and Great 
Lakes States may be interested in this rulemaking. Facilities 
discharging pollutants to certain waters of the United States in 
coastal and Great Lakes States could be affected by this rulemaking 
because water quality standards are used in determining water quality-
based National Pollutant Discharge Elimination System permit limits. In 
addition, beach managers and businesses in beach areas could also be 
indirectly affected by this rulemaking because water quality standards 
are used in making decisions regarding beach advisories and closures. 
Categories and entities that may be affected include:

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                                             Examples of potentially
                Category                        affected entities
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Industry...............................  Industries discharging
                                          pollutants to the waters of
                                          the States and Territories
                                          identified in 40 CFR 131.41.
Municipalities.........................  Publicly-owned treatment works
                                          or municipal wet weather
                                          discharges (such as combined
                                          sewer overflows) that
                                          discharge pollutants to the
                                          waters of the States and
                                          Territories identified in 40
                                          CFR 131.41.
Other..................................  Beach owners and managers,
                                          beach goers. States identified
                                          in 40 CFR 131.41.
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    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be affected by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be affected by this action. Other types of entities 
not listed in the table could also be affected. To determine whether 
your facility may be affected by this action, you should carefully 
examine the language in 40 CFR 131.41 of today's final rule. 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-2004-0010. 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 
the disclosure of which is restricted by statute. The official public 
docket is the collection of materials that is available for public 
viewing at the Water Quality Standards for Coastal and Great Lakes 
Recreation Waters Docket, EPA/DC, EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC. The 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 Quality Standards for 
Coastal and Great Lakes Recreation Waters Docket is (202) 566-2422. 
Docket copying costs are as follows: the first 266 pages are free, 
additional copying incurs a $25 administrative fee, and each additional 
page is $0.15.
    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, EDOCKET. You may use 
EDOCKET 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 publicly available 
docket materials through the docket facility identified in Section I.B. 
Once in the system, select ``search,'' then key in the appropriate 
docket identification number.

II. Background

A. Statutory and Regulatory Background

1. Clean Water Act
    Section 303 (33 U.S.C. 1313) of the Clean Water Act directs States, 
Territories, and authorized Tribes, with oversight by EPA, to adopt 
water quality standards to protect the public health and welfare, 
enhance the quality of water and serve the purposes of the Clean Water 
Act. Under section 303, States, Territories, and authorized Tribes are 
to develop water quality standards for navigable waters of the United 
States within the State, Territory, or authorized Tribe. Section 303(c) 
provides that water quality standards shall include the designated use 
or uses for the waters and water quality criteria necessary to protect 
those uses. Section 303(c)(2)(A) of the Clean Water Act specifies the 
uses that States, Territories, and authorized Tribes should consider in 
establishing new or revised water quality standards. These uses are 
public water supplies, propagation of fish and wildlife, recreational 
purposes, agricultural, industrial, and other purposes, and navigation. 
States, Territories, and authorized Tribes must review their water 
quality standards at least once every three years and, if appropriate, 
revise or adopt new standards. States, Territories, and authorized 
Tribes must submit the results of this triennial review to EPA, and EPA 
must approve or disapprove any new or revised standards.
    Section 303(c) of the Clean Water Act authorizes the EPA 
Administrator to promulgate water quality standards to supersede State, 
Territorial, or authorized Tribal standards that have been disapproved 
or in any case where the Administrator determines that a new or revised 
standard is needed to meet the Clean Water Act's requirements. EPA 
regulations implementing Clean Water Act section 303(c) are published 
at 40 CFR Part 131. Under these rules, the minimum elements that 
States, Territories, or authorized Tribes must incorporate in their 
water quality standards include: use designations for all water bodies 
in the State, Territory, or authorized Tribe, water quality criteria 
sufficient to protect those use designations, and an antidegradation 
policy (see 40 CFR 131.6). Section 303(c)(4) requires the EPA 
Administrator to promulgate any new or revised water quality standard 
not later than 90 days after publishing a proposed Federal standard 
unless prior to this deadline, the State, Territory or authorized Tribe 
has adopted a water quality standard that the Administrator determines 
to be in accordance with the Clean Water Act.
2. The BEACH Act of 2000
    The Beaches Environmental Assessment and Coastal Health (BEACH) Act 
of 2000 amended the Clean Water Act in part by adding section 303(i). 
Section 303(i)(1)(A) requires that not later than April 10, 2004, 
``each State having coastal recreation waters shall adopt and submit to 
the Administrator water quality criteria and standards for the coastal 
recreation waters of the State for those pathogens and pathogen 
indicators for which the Administrator has published criteria under 
section 304(a).'' EPA's Ambient Water Quality Criteria for Bacteria--
1986 (EPA 440/5-84-002, January 1986) (the 1986 bacteria criteria 
document) is the relevant criteria document published by the 
Administrator under Clean Water Act section 304(a).
    Section 303(i)(2)(A) requires that, ``[i]f a State fails to adopt 
water quality

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criteria and standards in accordance with [section 303(i)(1)(A)] that 
are as protective of human health as the criteria for pathogens and 
pathogen indicators for coastal recreation waters published by the 
Administrator, the Administrator shall promptly propose regulations for 
the State setting forth revised or new water quality standards for 
pathogens and pathogen indicators described in [section 303(i)(1)(A)] 
for coastal recreation waters of the State.''
    The BEACH Act also added section 502(21)(A) to the Clean Water Act, 
which defines ``coastal recreation waters'' as ``(i) the Great Lakes; 
and (ii) marine coastal waters (including coastal estuaries) that are 
designated under section 303(c) by a State for use for swimming, 
bathing, surfing, or similar water contact activities.'' Section 
502(21)(B) explicitly excludes from the definition of coastal 
recreation waters ``inland waters; or * * * waters upstream of the 
mouth of a river or stream having an unimpaired natural connection with 
the open sea.''

B. 1986 Ambient Water Quality Criteria for Bacteria

    In 1986, EPA published Ambient Water Quality Criteria for 
Bacteria--1986. This document contains EPA's current recommended water 
quality criteria for bacteria to protect people from gastrointestinal 
illness in recreational waters, i.e., waters designated for primary 
contact recreation or similar full body contact uses. States and 
Territories typically define primary contact recreation to encompass 
recreational activities that could be expected to result in the 
ingestion of, or immersion in, water, such as swimming, water skiing, 
surfing, kayaking, or any other recreational activity where ingestion 
of, or immersion in, the water is likely. The main route of exposure to 
illness-causing organisms during recreation in water is through 
accidental ingestion of fecally contaminated water while engaging in 
these activities.
    EPA based its 1986 water quality criteria for bacteria on levels of 
indicator bacteria, namely Escherichia coli (E. coli) and enterococci, 
which demonstrate the presence of pathogens in fecal pollution that can 
cause acute gastrointestinal illness. Public health agencies have long 
used indicator organisms such as these to protect people from illnesses 
that they may contract from engaging in recreational activities in 
surface waters contaminated by fecal pollution. These organisms 
generally do not cause illness directly, but have demonstrated 
characteristics that make them good indicators of fecal contamination 
and thus the potential presence of pathogens capable of causing human 
illnesses such as gastroenteritis. Gastroenteritis describes a variety 
of diseases that affect the gastrointestinal tract and are rarely life-
threatening. Symptoms of the illness include nausea, vomiting, 
stomachache, diarrhea, headache, and fever. Prior to its publication of 
the 1986 bacteria criteria document, EPA recommended the use of fecal 
coliforms as an indicator organism to protect people from 
gastrointestinal illness in recreational waters. The previously 
recommended numeric criteria for fecal coliform were a geometric mean 
of 200/100 ml, with no more than 10% of the total samples taken during 
any 30-day period exceeding 400/100 ml. However, EPA conducted 
epidemiological studies and evaluated the use of several organisms as 
indicators, including fecal coliforms, E. coli, and enterococci. EPA 
subsequently recommended the use of E. coli or enterococci for fresh 
recreational waters and enterococci for marine recreational waters 
because levels of these organisms more accurately predict acute 
gastrointestinal illness than levels of fecal coliforms. On page 5, 
EPA's 1986 bacteria criteria document states: ``[E]nterococci showed 
the strongest relationship to gastroenteritis. E. coli was a very poor 
second and all of the other indicators, including total coliforms and 
fecal coliforms showed very weak correlations to gastroenteritis.''
    In EPA's epidemiological studies, E. coli and enterococci exhibited 
the strongest correlation to swimming-associated gastroenteritis, the 
former in freshwaters only and the latter in both fresh and marine 
waters (1986 bacteria criteria document; Health Effects Criteria for 
Fresh Recreational Waters, EPA 600/1-84-004, August 1984; Health 
Effects Criteria for Marine Recreational Waters, EPA 600/1-80-031, 
August 1983). In marine waters, the stronger correlation may be due to 
enterococci's ability to survive longer than coliforms, similar to the 
pathogens of concern. In addition, fecal coliforms are sometimes 
detected where fecal contamination is absent, possibly resulting in 
inaccurate assessments of recreational safety. For example, Klebsiella 
spp., a bacterial organism that is part of the fecal coliform group but 
which is generally not harmful to humans and does not occur with fecal 
contamination, is often present in pulp and paper and textile mill 
effluents (Archibald, F., Water Qual. Res. J. Canada 35(1):1-22, 2000; 
Dufour, Journal WPCF, 48:872-879, 1976).
    Table 1 contains the water quality criteria values for the 
protection of primary contact recreation that EPA recommended in the 
1986 bacteria criteria document. EPA developed these values based on 
the concentrations of E. coli and enterococci from EPA-sponsored 
epidemiological studies that roughly correlated to the estimated 
illness rate associated with EPA's previously recommended fecal 
coliform criteria. EPA estimated this illness rate to be approximately 
0.8% of swimmers exposed in freshwater and 1.9% of swimmers exposed in 
marine waters. EPA's 1986 bacteria criteria document indicates the 
illness rates are ``only approximate'' and that the Agency based the 
1986 values that appear in Table 1 on these approximations. The 1986 
bacteria criteria document provides geometric mean densities as well as 
four different single sample maximum values (representing values below 
which an increasing percentage of single values are expected to fall if 
the mean (average) of all samples equals the geometric mean criterion). 
The higher the single sample maximum, the lower the probability that a 
single sample exceeding that value would occur as part of the normal 
random variability of samples around the geometric mean. Single sample 
maximums are water quality assessment tools that provide a sense of 
when a single value that comes from a waterbody may be part of a 
bacterial density with a geometric mean concentration higher than that 
specified by the water quality criteria. For instance, if the geometric 
mean concentration in the water at a marine beach is 35/100 ml, then 
there is an 18% probability that the concentration of enterococci in a 
single sample would be over 158/100 ml. One could thus consider a 
single sample with this value to be indicative of bacterial densities 
with a geometric mean above 35/100 ml, but there would be a non-trivial 
chance of being wrong in this determination. Statisticians say this 
conclusion can be drawn ``with 82% confidence.''
    The 1986 bacteria criteria document includes, for each geometric 
mean, a table of four single sample maximum values that are appropriate 
for different levels of beach usage. In general, where a given area has 
a greater potential for more people to be exposed, that area may 
warrant a higher degree of protectiveness (i.e., a lower single sample 
maximum). The 1986 bacteria criteria document categorizes the levels of 
beach usage corresponding to the four single sample maximums as 
follows: ``designated bathing beach'' for the 75%

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(most protective) confidence level, ``moderate use for bathing'' for 
the 82% confidence level, ``light use for bathing'' for the 90% 
confidence level, and ``infrequent use for bathing'' for the 95% 
confidence level. Note that the lowest confidence level corresponds to 
the highest level of protection because it leads to a more 
precautionary judgment to treat the waterbody as exceeding the mean 
criterion, even though there is less statistical confidence that this 
is the case. EPA assigned the lowest single sample maximum to 
designated bathing beach areas because a high degree of caution should 
be used to evaluate the status of such areas, giving greater weight to 
a measured single value above the geometric mean, even though the 
statistical significance of this single measurement may be weak. EPA 
believes this is appropriate because more people are likely to become 
ill at heavily used areas if they exceed the criteria. The 1986 
bacteria criteria document described bathing beach areas as those areas 
that are ``frequently lifeguard protected, provide parking and other 
public access and are heavily used by the public.'' The document does 
not specifically describe in greater detail the potential use frequency 
differences of ``moderate,'' ``lightly used,'' and ``infrequently 
used'' full body contact recreation waters.

                                          Table 1.--1986 Criteria for Indicators for Bacteriological Densities
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                                        Acceptable                                          Single sample maximum allowable density \4\ \5\
                                         swimming                            ---------------------------------------------------------------------------
                                        associated          Steady state                           Moderate full    Lightly used full  Infrequently used
                                     gastroenteritis       geometric mean      Designated beach     body contact       body contact    full body contact
                                      rate  per 1000     indicator  density    area (upper 75%   recreation (upper  recreation (upper  recreation (upper
                                         swimmers                                   C.L.)            82% C.L.)          90% C.L.)          95% C.L.)
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Freshwater
    Enterococci...................                  8  33/100 ml \1\........                 61                 78                107                151
    E. coli.......................                  8  126/100 ml \2\.......                235                298                409                575
Marine Water
    Enterococci...................                 19  35/100 ml \3\........                104                158                276               501
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Notes:
\1\ Calculated to nearest whole number using equation: (mean enterococci density) = antilog10 ((illness rate/1000 people + 6.28)/9.40).
\2\ Calculated to nearest whole number using equation: (mean E. coli density) = antilog10 ((illness rate/1000 people + 11.74)/9.40).
\3\ Calculated to nearest whole number using equation: (mean enterococci density) = antilog10 ((illness rate/1000 people -0.20)/12.17).
\4\ Single sample limit = antilog10 (log10 indicator geometric mean density/100 ml + (factor determined from areas under the normal probability curve
  for the assumed level of probability * log10 standard deviation)).
The appropriate factors for the indicated one sided confidence levels are:
 
75% C.L.-.675
82% C.L.-.935
90% C.L.-1.28
95% C.L.-1.65.
\5\ Based on the observed log standard deviations during the EPA studies: 0.4 for freshwater E. coli and enterococci; and 0.7 for marine water
  enterococci. Each jurisdiction may establish its own standard deviation for its conditions which would then vary the single sample limit.

III. EPA's Proposed Rule and Solicitation of Comment

A. July 2004 Proposed Rule

    On July 9, 2004, EPA published a proposal entitled ``Water Quality 
Standards for Coastal and Great Lakes Recreation Waters'' (see 69 FR 
41720). At that time, EPA proposed to promulgate E. coli and 
enterococci standards for coastal recreation waters in States that had 
not adopted water quality standards for those waters that are as 
protective of human health as EPA's 1986 bacteria criteria.
    EPA proposed a geometric mean of 126/100 ml for E. coli in fresh 
coastal recreation waters and a geometric mean of 35/100 ml for 
enterococci in marine coastal recreation waters. EPA also proposed four 
different single sample maximums in both fresh and marine coastal 
recreation waters. Each single sample maximum was assigned to a 
category of coastal recreation water based on intensity of use. EPA 
proposed to interpret the single sample maximums as maximum values that 
would not be allowed to be exceeded, but requested comment on various 
other interpretations. EPA did not propose particular waters to which a 
specific single sample maximum would apply; rather, EPA proposed that 
States and Territories would determine which single sample maximum 
would apply to each of its coastal recreation waters. The criteria 
values for fresh and marine coastal recreation waters are the same 
values that are found in the 1986 bacteria criteria document.
    EPA did not include coastal or Great Lakes States and Territories 
in the proposed rule if their current standards met each of five 
criteria: the standards are based on EPA's 1986 recommended pathogen 
indicators; the standards are derived from a scientifically-defensible 
methodology linked quantitatively to an acceptable risk level under 
Clean Water Act section 303(i); the standards include appropriate 
single sample maximums; the standards do not address fecal 
contamination from non-human sources in a way inconsistent with the 
1986 bacteria criteria; and EPA approved the standards. If a State or 
Territory met all five criteria, EPA proposed to not include that State 
or Territory in the rule.\1\
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    \1\ In the case of Washington State, EPA has determined that a 
fecal coliform standard of 14/100 ml for marine waters is ``as 
protective as'' EPA's 1986 bacteria criteria. (See section V.A.1 of 
this preamble.)
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B. Public Comments

    The comment period for this rule closed on August 9, 2004. EPA 
received 55 comments on the proposed rule from a variety of sources, 
including academic associations, environmental groups, municipal 
wastewater associations, industry, State agencies, local governments, 
and private citizens. Most of the comments focused on the following 
issues: choice of pathogen indicator, promulgation of a geometric mean 
and four single sample maximums for the indicators, use of the single 
sample maximum, intensity of use categories of coastal recreation 
waters, intrastate vs. interstate determinations of use intensity, 
State calculation of site-specific single sample maximums, and 
addressing non-human sources of bacteria. This preamble includes a 
general summary of public comments in

[[Page 67222]]

the discussions of the various issues addressed here. EPA has prepared 
a ``Comment Response Document'' that includes responses to comments 
submitted on the proposed rule, which is in the docket for today's 
rule.

IV. Criteria That EPA Is Promulgating Today

A. Scope of the Rule

    EPA is promulgating the rule to apply, as proposed, to Great Lakes 
and marine coastal recreation waters (including coastal estuaries) 
designated by a State or Territory under Clean Water Act 303(c) for 
swimming, bathing, surfing, or similar water contact activities. As 
explained in the preamble to the proposed rule (69 FR 41723), the 
requirements of the BEACH Act are limited to ``coastal recreation 
waters,'' which are defined in Clean Water Act section 502(21) as the 
Great Lakes and marine coastal recreation waters (including coastal 
estuaries) that are designated under Clean Water Act section 303(c) by 
a State for use for swimming, bathing, surfing, or similar water 
contact activities. The definition explicitly excludes ``inland waters 
or waters upstream of the mouth of a river or stream having an 
unimpaired natural connection with the open sea.'' EPA interprets Clean 
Water Act section 502(21) to apply only to those Great Lakes waters 
that are designated for swimming, bathing, surfing, or similar water 
contact activities, consistent with the purpose of the BEACH Act to 
protect the public from the health risks associated with swimming in 
polluted water.
    The BEACH Act clearly envisioned and intended that States, 
Territories, and authorized Tribes with coastal recreation waters adopt 
into their water quality standards bacteria criteria as protective of 
human health as EPA's 1986 bacteria criteria. Under EPA's water quality 
standards regulations at 40 CFR Part 131, States, Territories, and 
authorized Tribes have broad discretion to designate specific uses to 
specific waters. They are not required to designate all waters for 
swimming, bathing, surfing, or similar water contact activities (i.e., 
primary contact recreation), as long as they have complied with the 
requirements of the Clean Water Act and EPA's implementing regulations 
for designating uses. Today's rule applies only to those waters 
designated by a State or Territory for swimming, bathing, surfing, or 
similar water contact activities, not to waters designated for uses 
that only involve incidental contact. However, States, Territories, and 
authorized Tribes are to continue to work towards the goal of achieving 
full attainment of Clean Water Act section 101(a) uses (``fishable/
swimmable'') in waters that do not currently attain such uses. Further, 
any waters with designated uses that do not include the uses specified 
in Clean Water Act section 101(a)(2) must be re-examined every three 
years to determine if any new information has become available (40 CFR 
131.20(a)). If such new information indicates that the uses specified 
in Clean Water Act section 101(a)(2) are attainable, the State, 
Territory, or authorized Tribe is required to revise its water quality 
standards accordingly. EPA expects States, Territories, and authorized 
Tribes to continue this process and revise their water quality 
standards where appropriate. States, Territories, and authorized Tribes 
may remove a designated use that is not an existing use if it conducts 
a use attainability analysis to demonstrate that the designated use is 
not attainable (40 CFR 131.10(g)).
    EPA received few comments on the scope of the rule. One commenter 
suggested that the rule should not apply to State waters outside of the 
areas where swimming normally occurs, citing as an example Hawaii's 
water quality standards, which are consistent with EPA's 1986 bacteria 
criteria but apply only to those swimming waters within 300 meters of 
shore. This commenter also suggested that the criteria should only have 
to apply at depths of less than 150 feet. EPA does not find these 
comments persuasive in light of the clear language of Clean Water Act 
sections 303(i) and 502(21), which together require the adoption of 
criteria for all of the coastal or Great Lakes waters designated by the 
State for use for swimming, bathing, surfing, or similar water contact 
activities even if, as a factual matter, the waters designated for 
swimming are not frequently or typically used for swimming.
    One commenter expressed concern that the rule could establish a 
binding precedent for EPA's review of pathogen criteria for inland 
waters that do not fall within the definition of a coastal recreation 
water. As discussed above, section 303(i) of the Clean Water Act does 
not apply to inland waters other than the Great Lakes because such 
waters are explicitly excluded from the definition of ``coastal 
recreation waters'' in section 502(21) of the Clean Water Act. For all 
other waters (i.e., waters that are not coastal recreation waters), 
section 303(c) of the Clean Water Act and EPA's implementing 
regulations at 40 CFR part 131 require States, Territories, and 
authorized Tribes to adopt criteria that are scientifically defensible 
and sufficient to protect the designated uses of those waters. When EPA 
reviews a State's, Territory's or authorized Tribe's new or revised 
water quality standards, EPA applies its regulations at 40 CFR 131.5 
and 131.6. EPA's decision on future State or Territorial submissions 
will be based on the information supporting those submissions. EPA's 
decisions in today's rule should not be considered as binding on States 
and Territories adopting bacteria criteria for inland waters other than 
the Great Lakes.

B. Criteria for Pathogen Indicators

1. Selection of Pathogen Indicator
    For States and Territories covered by today's rule, EPA is 
promulgating water quality criteria using the pathogen indicators of 
enterococci for marine waters and both enterococci and E. coli for 
freshwaters. EPA interprets Clean Water Act section 303(i)(1)(A) to 
require States and Territories to adopt and submit water quality 
criteria for enterococci in marine waters and either enterococci or E. 
coli in fresh waters because it requires States and Territories to 
submit criteria ``for the pathogens and pathogen indicators for which 
the Administrator has published criteria under section 304(a).'' EPA's 
1986 bacteria criteria document is the relevant Clean Water Act section 
304(a) criteria referred to in Clean Water Act section 303(i)(1)(A). It 
recommends the use of enterococci in marine waters and E coli or 
enterococci in fresh waters for the protection of primary contact 
recreation. Clean Water Act section 303(i)(2)(A) requires EPA to 
promptly propose regulations for the State setting forth revised or new 
water quality standards for pathogens and pathogen indicators described 
in Clean Water Act section 303(i)(1)(A) for coastal recreation waters 
of the State for those States that fail to adopt criteria that are as 
protective of human health as the criteria referenced in section 
303(i)(1)(A).
    In the proposal (69 FR 41727), EPA proposed to adopt only E. coli 
for freshwaters because most of the States and Territories that had 
adopted or were in the process of adopting the 1986 bacteria criteria 
had chosen to use E. coli instead of enterococci. However, EPA also 
solicited comment on whether to promulgate criteria based on both 
indicators for freshwater and to allow States and Territories to choose 
which indicator to apply to its coastal recreation waters at the time 
of

[[Page 67223]]

implementation. EPA received comments from the New York Department of 
Environmental Conservation (DEC) and the Pennsylvania Department of 
Environmental Protection (DEP) requesting EPA to do so. Both of these 
State agencies have responsibility for promulgating State water quality 
standards. New York DEC explained that the New York Department of 
Health had recently adopted regulations adding both E. coli and 
enterococci as the criteria for its freshwater bathing beaches, and 
that the New York DEC was in the process of deciding which of the two 
indicators it would adopt for its water quality standards in the Great 
Lakes. Consequently, New York DEC requested that EPA's final rule 
include values for both indicators and allow the State to select either 
at the time of implementation. Pennsylvania DEP explained that the 
Pennsylvania Department of Health had adopted E. coli criteria for 
public bathing beaches, but also requested that EPA promulgate a final 
rule allowing Great Lakes States to choose either E. coli or 
enterococci criteria at the time of implementation. Pennsylvania DEP 
offered no reason for its request. None of the other States included in 
the proposal with fresh coastal recreation waters commented on this 
aspect of the proposal.
    As requested by these States, EPA is promulgating criteria for both 
indicators and allowing New York and Pennsylvania determine which 
indicator to apply for each waterbody. EPA also determined that it is 
reasonable to extend this flexibility to all of the Great Lakes States 
covered by this rule. Accordingly, EPA has added the freshwater 
criteria values for enterococci to the table in 40 CFR 131.41(c)(1) as 
well as a footnote to the table explicitly recognizing that the State 
may decide which indicator, E. coli or enterococci, will be the 
applicable criterion for its freshwater coastal recreation water (i.e., 
which criteria apply to the Great Lakes waters within the State's 
jurisdiction). Until a State makes that determination, E. coli will be 
the applicable indicator.
    EPA is providing this flexibility to all Great Lakes States in the 
rule because the Great Lakes States have a history of cooperating to 
protect the Great Lakes resource, and may find a need to agree on a 
consistent pathogen indicator for the Great Lakes. Because both the E. 
coli and enterococci freshwater criteria in the 1986 bacteria criteria 
have the same illness rate they provide equal protection against acute 
gastrointestinal illness. In light of these considerations, EPA does 
not want to create a barrier to this cooperation by promulgating only 
one of the two freshwater criteria in some Great Lakes States and both 
indicators in other Great Lakes States.
2. Bacteria Criteria Values
    EPA is promulgating a geometric mean of 35/100 ml for enterococci 
in marine coastal recreation waters and four different single sample 
maximums, which vary for marine coastal recreation waters based on 
intensity of use as shown in Table 2. These are the same values as in 
the 1986 bacteria criteria document and in the proposed rule.

                                              Table 2.--Ambient Marine Water Quality Criteria for Bacteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              C  Single sample maximum  (per 100 ml)
                                                                         -------------------------------------------------------------------------------
                                                                            C1  Designated     C2  Moderate use      C3  Light use    C4  Infrequent use
               A  Indicator                       B  Geometric mean          bathing beach    coastal recreation  coastal recreation  coastal recreation
                                                                            (75% confidence      waters  (82%        waters  (90%        waters  (95%
                                                                                level)         confidence level)   confidence level)   confidence level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enterococci...............................  35/100 ml a.................              104 b               158 b               276 b              501 b
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(2):
a This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
b Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
  confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.7.

    For fresh coastal recreation waters, EPA is also promulgating a 
geometric mean of 126/100 ml for E. coli and a geometric mean of 33/100 
ml for enterococci with four different single sample maximums, which 
vary based on intensity of use. As described above, only the criteria 
for one of these indicators will apply in freshwaters at the choice of 
the State. These values are shown in Table 3, and are the same values 
as in the 1986 bacteria criteria document. For E. coli, these values 
are the same as those that EPA proposed. EPA is also promulgating 
criteria for enterococci in freshwater based on the request of two 
Great Lakes States and used the values from the 1986 bacteria criteria 
document for these enterococci criteria.

                                               Table 3.--Ambient Freshwater Quality Criteria for Bacteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                C  Single sample maximum  (per 100 ml)
                                                                             ---------------------------------------------------------------------------
                                                                                                  C2  Moderate use    C3  Light use      C4  Infrequent
               A  Indicator d                        B  Geometric mean          C1  Designated        coastal            coastal          use coastal
                                                                                bathing beach    recreation waters  recreation waters  recreation waters
                                                                               (75% confidence     (82% confidence    (90% confidence    (95% confidence
                                                                                    level)             level)             level)             level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli.....................................  126/100 ml a..................              b 235              b 298              b 409              b 575
Enterococci.................................  33/100 ml c...................               b 61               b 78              b 107             b 151
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(1):

[[Page 67224]]

 
a This value is for use with analytical methods 1103.1, 1603, or 1604 or any equivalent method that measures viable bacteria.
b Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
  confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.4.
c This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
d The State may determine which of these indicators applies to its fresh coastal recreation waters. Until a State makes that determination, E. coli will
  be the applicable indicator.

    In proposed 40 CFR 131.41(c), EPA included footnotes to the 
geometric mean values for E. coli and enterococci stating that ``[t]his 
value is for use with [specified] analytical methods * * * or any 
equivalent viable method.'' The specified methods are based on 
measurement of viable bacteria. New analytical methods that rely on 
genetic material for measurement may yield different results that are 
not appropriately calibrated to the numeric criteria in today's rule. 
To address this concern, EPA is identifying, as in the proposal, the 
specific methods that must be used to apply the bacteria criteria.
    In today's rule, EPA is also making two minor changes to this 
aspect of the proposal. First, EPA had incorrectly identified the 
analytical methods for enterococci as being for E. coli and the 
analytical methods for E. coli as being for enterococci, and is 
correcting this technical error in the footnotes in the final rule. 
Second, EPA has revised the footnotes to explain more clearly what the 
methods are. The footnotes state: ``This value is for use with 
[specific methods] or any equivalent method that measures viable 
bacteria.''
    EPA notes that today's rule does not specify the duration over 
which the geometric mean is calculated. The criteria in the tables at 
40 CFR 131.41(c) are identical to those in table 4 of the 1986 bacteria 
criteria document, which does not specify the duration for computing 
the geometric mean. The 1986 bacteria criteria document discusses the 
duration over which the mean is calculated in two places. The first is 
in the discussion of the basis for the criteria (page six). Here, EPA 
calculated the geometric mean bacteria density over a summer swimming 
season (recreation season). The second place is in the summary of the 
criteria (page 16) where EPA stated that ``[b]ased on a statistically 
sufficient number of samples (generally not less than 5 samples equally 
spaced over a 30-day period), the geometric mean.* * *'' EPA considers 
this statement in the 1986 bacteria criteria document to provide 
guidance on how a regulatory agency could compute the geometric mean, 
and not as a definition of the specific period over which the mean must 
be computed. For the geometric mean to be only computed over a 30-day 
period would mean that regulatory agencies would need to sample more 
than once a month, which is contrary to the guidance on monitoring 
provided in the 1986 bacteria criteria document. EPA expects from 
current practice by States and Territories that they will compute the 
geometric mean on either a monthly or recreation season basis.
    EPA is not specifying in the final rule how the averaging period 
for the geometric must be applied. EPA recommends that the averaging 
period be applied as a ``rolling'' or ``running'' average. EPA expects 
that most States will in fact apply the averaging period as a rolling 
average; however, EPA also recognizes that it would be technically 
appropriate to apply the averaging period on a set basis such as 
monthly or recreation season. EPA therefore has concluded that it is 
appropriate to allow the States to exercise discretion in deciding how 
to apply the averaging period for the geometric mean.
3. Use of the Single Sample Maximum
    EPA is promulgating the single sample maximum values that it 
proposed without change, but is clarifying its expectations with regard 
to how these values could be used in the context of beach notification 
and closure decisions, and in the context of the implementation of 
other Clean Water Act programs. EPA expects that the single sample 
maximum values would be used for making beach notification and closure 
decisions. EPA recognizes, however, that States and Territories also 
use criteria in their water quality standards for other purposes under 
the Clean Water Act in order to protect and improve water quality. 
Other than in the beach notification and closure decision context, the 
geometric mean is the more relevant value for ensuring that appropriate 
actions are taken to protect and improve water quality because it is a 
more reliable measure, being less subject to random variation, and more 
directly linked to the underlying studies on which the 1986 bacteria 
criteria were based. Nevertheless, the single sample maximum can play a 
role in identifying potential pollution episodes, especially in waters 
that are prone to short-term spikes in bacteria concentrations, e.g., 
waters that may be affected by a combined sewer overflow outfall. 
Having identified that a water is prone to short-term spikes in 
bacteria concentrations due to pollution episodes, States and 
Territories have significant flexibility in how they address those 
episodes consistent with the Clean Water Act and implementing 
regulations. (Note that additional guidance on making water quality 
standard attainment status determinations may be found in EPA's 
guidance to States on integrated reporting of water quality for 
sections 303(d) and 305(b) purposes.)
    EPA received considerable comment on this topic. Some comments 
addressed the issue of whether the single sample maximum should be part 
of the criteria that applies in all applications, including beach 
closure, waterbody assessment, Total Maximum Daily Load establishment, 
and National Pollutant Discharge Elimination System permitting 
decisions, or instead was only designed for beach notification and 
closure decisions. Most commenters expressed their interpretation of 
the 1986 bacteria criteria document as discussing the single sample 
maximum only in the context of making beach decisions based on limited 
data. Several of these commenters argue that the geometric mean 
criterion was included in the 1986 bacteria criteria document for 
protection against acute gastrointestinal illness in other contexts, 
and that the single sample maximum was included as a tool to implement 
the criteria in beach monitoring situations, and therefore, was not 
necessary to provide protection in other contexts. Other commenters 
asserted that the single sample maximum should be used for all Clean 
Water Act purposes.
    EPA notes that the 1986 bacteria criteria document clearly 
identifies the single sample maximum values as part of the criteria, in 
addition to the geometric mean values. Therefore, consistent with 
section 303(i)(2)(A) of the Clean Water Act, EPA is promulgating them 
today. EPA recognizes that the single sample maximum discussion in the 
1986 bacteria criteria document refers only to beach monitoring, and 
does not discuss how or whether the single sample maximum should be 
implemented for other Clean Water Act applications, such as 
establishing Total Maximum Daily Loads or National Pollutant Discharge 
Elimination System permit limitations. EPA agrees that the single 
sample maximum values in the criteria

[[Page 67225]]

are best used for making beach notification and closure decisions. 
However, as noted above, they may, but need not, also play a role in 
implementing other Clean Water Act programs. Except in the beach 
notification and closure context, EPA expects that States will 
determine how to use the single sample maximum criteria in the context 
of their broader programs implementing the Clean Water Act.
    For beach monitoring and beach notification and closure decisions, 
beach managers frequently need to make beach decisions based on one or 
very few data points. Thus, having a trigger level for a single sample 
value enables beach managers to make an immediate decision for the 
protection of public health at beaches. The beach manager will 
frequently not be able to obtain sufficient samples to compute a 
geometric mean for the purposes of making a decision to close a beach 
or issue a beach advisory. Of the 2,823 beaches reporting information 
to EPA in 2002, 65% reported that pathogen levels were monitored at 
least once per week (EPA's Beach Watch Program: 2002 Swimming Season, 
EPA 823-F-03-007, May 2003, http://www.epa.gov/waterscience/beaches/beachwatch2003-newformat.pdf). This means that at 35% of the beaches, 
the beach managers had fewer than four samples each month for making 
decisions to open or close the beach and in many cases only had one 
sample in any week. Furthermore, beach management programs need to be 
able to respond rapidly to short-term changes in water quality. Because 
a geometric mean provides information pertaining to water quality that 
looks backwards in time, it is not necessarily useful in determining 
whether a beach is safe for swimming on a particular day.
    EPA's National Beach Guidance and Required Performance Criteria for 
Grants (EPA-823-B-02-004, June 2002) requires States and Territories 
receiving Clean Water Act section 406 implementation grants to either 
immediately issue a public notification or, if there are reasons to 
doubt the accuracy of the first sample, resample when any sample 
surpasses a water quality standard at beaches. Although this 
requirement pertains only to the States and Territories receiving these 
grants, given that the States and Territories covered by this rule 
receive Clean Water Act section 406 implementation grants, it reflects 
the actions that States and Territories will be expected to take when a 
sample shows an exceedance of the applicable single sample maximum in 
today's rule. (EPA notes that all 35 eligible coastal States and 
Territories received grants in 2003, and most have received these 
grants in 2004.) In other words, States and Territories will use a 
single sample maximum to trigger a notification or closure action at 
beaches; whether the action taken is an advisory or a closure depends 
on the decision rules established by the State, Territory or local 
beach management authority, although the National Beach Guidance and 
Required Performance Criteria for Grants requires the State or 
Territory to provide a notification of the exceedance. Using a single 
sample maximum is especially important for beaches that are 
infrequently monitored or prone to short-term spikes in bacteria 
concentrations, e.g., waters that may be affected by combined sewer 
overflow outfalls. Thus, consistent with the 1986 bacteria criteria 
document, EPA expects that States and Territories would apply the 
single sample maximums for making beach notification decisions as 
values that if exceeded would trigger a notification or closure action 
at the beach.
    Numerous commenters said that application of the single sample 
maximum values in the criteria as never-to-be-surpassed limitations in 
other contexts could lead to consequences which were not contemplated 
in the 1986 bacteria criteria document, including, for example, Total 
Maximum Daily Loads and National Pollutant Discharge Elimination System 
permit limitations which might be technologically and economically 
unattainable at a particular location. EPA agrees that the 1986 
bacteria criteria document did not discuss using the single sample 
maximum as a never-to-be-surpassed value for all implementation 
applications under the Clean Water Act.
    In developing the 1986 bacteria criteria document, EPA derived 
single sample maximums as upper percentiles of the frequency 
distributions around the geometric mean. The 1986 bacteria criteria 
document recognizes that there will be instances where the 
concentration of bacteria in one or more individual samples will be 
higher than the acceptable geometric mean concentration. This is to be 
expected when dealing with water quality criteria expressed as average 
concentrations over a period of time. For example, in a waterbody with 
a 30-day average concentration exactly at the water quality criterion, 
it can be expected that approximately half of the samples collected 
will have a concentration above the criterion concentration (e.g., 126/
100 ml for E. coli), while the other half of the samples will have 
lower concentrations. Thus, that the value of one sample is greater 
than the numerical value of the geometric mean criterion, or even the 
numerical value of the single sample maximum, does not necessarily 
indicate that the geometric mean criterion has actually been exceeded. 
Furthermore, the single sample maximum values in the 1986 bacteria 
criteria document were not developed as acute criteria; rather, they 
were developed as a statistical construction to allow decision makers 
to make informed decisions to open or close beaches based on small data 
sets. This does not mean single sample maximums serve no purpose 
outside of beach notification decisions. For example, they may give 
States and Territories the ability to make waterbody assessments where 
they have limited data for a waterbody. However, the single sample 
maximums were not designed to provide a further reduction in the design 
illness level provided for by the geometric mean criterion.
    Based on the derivation of the single sample maximums as 
percentiles of a distribution around the geometric mean, using the 
single sample maximums as values not to be surpassed for all Clean 
Water Act applications, even when the data set is large, could impart a 
level of protection much more stringent than intended by the 1986 
bacteria criteria document. For example, in marine waters the geometric 
mean criterion for enterococci is 35/100 ml, and the single sample 
maximum is 104/100 ml at designated bathing beach waters based on the 
75th percentile of the distribution of individual values around the 
mean. If that single sample maximum were used as a value-not-to-be-
surpassed, it would become a maximum value and all other values in the 
statistical distribution of individual measurements would have to be 
less than the maximum. EPA typically uses the 99th percentile of a 
distribution to derive regulatory maximums. Assuming a waterbody had 
the same standard deviation in concentrations of bacteria employed in 
deriving the single sample maximums (e.g., 0.7 for marine waters), the 
waterbody geometric mean needed to keep the waterbody concentration 
below 104/100 ml 99% of the time would be 2/100 ml. This would be far 
more stringent than the level of protection provided by the actual 
geometric mean criterion for enterococci of 35/100 ml. Therefore, EPA 
intends that States and Territories should retain the discretion to use 
single sample maximum values as they deem appropriate in the context of 
Clean Water Act implementation programs other than beach notification 
and

[[Page 67226]]

closure, consistent with the Clean Water Act and its implementing 
regulations.
    The final rule does not constrain States and Territories 
flexibility in how they use the single sample maximum values in the 
context of Clean Water Act implementation programs such as Total 
Maximum Daily Loads and National Pollutant Discharge Elimination System 
permit requirements, as long as the geometric mean criteria for E. coli 
and enterococci are met. The flexibility afforded to States and 
Territories in applying the single sample maximum values in the 
National Pollutant Discharge Elimination System permitting program does 
not mean that maximum daily or seven-day average permit limits for 
bacteria are inappropriate for National Pollutant Discharge Elimination 
System permits. EPA notes that maximum daily and 7-day average effluent 
limits can be calculated based on 30-day average conditions and an 
understanding of effluent variability. See Section 5.4.4 of EPA's 
Technical Support Document for Water Quality-based Toxics Control (EPA-
505-2-90-001, March 1991). (These procedures are based on statistical 
methodologies similar to those employed in deriving the single sample 
maximums in the 1986 water quality criteria for bacteria.) EPA's 
recommendation that the single sample maximum values in the 1986 
bacteria criteria document should be used primarily for making beach 
notification and closure decisions does not constrain States' use of 
maximum daily permit limits in accordance with current State permitting 
procedures.
    EPA received a few comments about the specific use of single sample 
maximums in making waterbody assessment decisions, for example, in the 
development of Clean Water Act section 305(b) reports or developing 
section 303(d) lists. One commenter stated that the single sample 
maximum should not be used solely as the means for deciding if a 
waterbody was impaired. Another commenter stated that one sample should 
not be used to characterize a waterbody. Yet another commenter 
suggested that the single sample maximum only be used when there were 
insufficient data to compute a geometric mean.
    In general, EPA agrees with these comments. As discussed above, EPA 
recognizes the utility of single sample maximums where there are 
insufficient data (generally fewer than five samples over a given 
period) to compute a geometric mean for the purposes of assessing 
waterbodies, and expects that States and Territories will use single 
sample maximums in these instances. While it is far preferable for 
States and Territories to obtain more robust data for making decisions 
about waterbody impairments (the 1986 bacteria criteria document 
recommends determining the geometric mean using generally not less than 
5 samples equally spaced over a 30-day period), EPA recognizes that in 
some instances States and Territories will have limited data and may 
decide to use the single sample maximums or other similarly derived 
statistical constructs for making waterbody impairment decisions.
4. Intensity of Use Categories of Coastal Recreation Waters
    EPA is promulgating the same intensity of use categories of coastal 
recreation waters as in the proposal, specifically, the four categories 
of waters with a corresponding single sample maximum as described in 
the 1986 bacteria criteria document. Only one single sample maximum 
applies to each category of coastal recreation water: designated 
bathing beach waters, moderate use coastal recreation waters, light use 
coastal recreation waters, and infrequent use coastal recreation 
waters. EPA is also promulgating the definitions of the categories as 
proposed. By providing definitions for the four categories, EPA 
provides clear guidance to States and Territories and information for 
the public to identify the category in which each coastal recreation 
water belongs based on its intensity of use for primary contact 
recreation.
    EPA does not have sufficient information regarding frequency of use 
of each specific coastal recreation water covered by this rule to list 
all those waters in the rule according to the four categories defined 
in 40 CFR 131.41(b). Therefore, EPA does not list individual coastal 
recreation waters by intensity of use category. EPA recommends that 
States and Territories evaluate existing use information and identify 
which individual coastal recreation waters belong to each category and 
make this information publicly available (e.g., on a State's or 
Territory's website). As explained in the preamble to the proposed rule 
(69 FR 41726), States and Territories could use their existing beach 
tiering process for BEACH Act implementation grants as a source of 
information for determining frequency in categorizing a coastal 
recreation water for purposes of determining the applicable single 
sample maximum.
    Today's rule does not require that States and Territories apply the 
definitions at 40 CFR 131.41(b) such that the State or Territory finds 
at least one water for each of the four categories of waters. A State 
or Territory could, at its discretion, apply the single sample maximum 
for designated bathing beaches (the lowest single sample maximum) to 
all its coastal recreation waters because this approach would be more 
protective of human health than the structure for single sample 
maximums in 40 CFR 131.41(b) and (c). Thus, a State or Territory that 
had commented that it preferred that EPA promulgate only one category 
of waters could exercise its discretion and apply the single sample 
maximum for designated bathing beaches to all of its waters. 
Alternatively, a State or Territory may choose to place their coastal 
recreation waters in only two of the four single sample maximum 
categories, such as the 75% confidence level single sample maximum for 
designated bathing beaches and the 95% confidence level single sample 
maximum for all other coastal recreation waters, if the recreational 
usage of the waters matches the definitions at 40 CFR 131.41(b). This 
approach would be appropriate if the State or Territory determined that 
the ``infrequent use'' definition was the most appropriate 
categorization for its coastal recreation waters that were not 
identified as designated bathing beaches. Although the rule does not 
specify which State waters belong in which use category, the 
definitions in the rule must be used to determine which single sample 
maximum would apply to a particular coastal recreation water.
    A number of comments requested that EPA promulgate only the 75% 
confidence level criterion for all coastal recreation waters because 
having only one single sample maximum would provide for consistency in 
all coastal recreation waters, and provide the same level (and highest 
level) of protection to all users of coastal recreation waters, no 
matter what the use intensity of that particular water might be.
    EPA declines to take this approach in today's rule. EPA 
acknowledges the reasons expressed in the comments. However, EPA 
believes this would be more restrictive than necessary to ensure that 
the promulgated water quality criteria are as protective of human 
health as the 1986 bacteria criteria document, which provides single 
sample maximums for four categories of waters. Thus, such an approach 
would unnecessarily restrict the flexibility of States and Territories 
to determine when to impose standards more protective than EPA's 1986 
bacteria criteria. EPA normally defers to a State's or Territory's 
decision on what criteria apply to protect a designated use subject to 
the State or Territory

[[Page 67227]]

providing information to show that the water quality criteria are 
sufficient to protect the designated uses, and for coastal recreation 
waters, that the water quality criteria are as protective of human 
health as the criteria for the pathogen or pathogen indicators that EPA 
has published. EPA does not consider the benefits of identical 
standards in the States and Territories covered by this rule to 
outweigh the negative effects of unnecessarily constraining the 
flexibility that the Clean Water Act and EPA's rules give States and 
Territories in establishing water quality standards, particularly 
because there is already variation in the single sample maximums in use 
among States and Territories that are not covered by today's rule.
5. Intrastate vs. Interstate Determinations of Use Intensity
    In today's final rule, as in the proposal, single sample maximums 
apply to categories of waters based on intensity of use. These 
categories are based on intrastate comparisons of frequency of use 
(i.e., relative to the other waters within that State or Territory). 
Using this approach, a State or Territory will identify its designated 
bathing beach waters first and then evaluate all other waters in 
comparison to those waters. However, today's rule does not require that 
a State or Territory use all four categories of intensity of use. 
Rather, EPA expects that States and Territories will first identify 
portions of waters as designated bathing beaches based on the factors 
listed in 40 CFR 131.41(b)(2) and then categorize the remaining waters 
based on their intensity of use relative to those beaches. In 
interpreting the phrase ``heavily used,'' EPA expects States will make 
reasonable judgments about the level of use at a given beach. EPA does 
not intend that States should exclude heavily used waters from the 
designated bathing beach category merely because they can identify 
other beaches, either within the State or in other States, that are 
more heavily used.
    While several commenters supported intrastate comparison of 
intensity of use, others suggested using an interstate comparison of 
intensity of use because beach use varies significantly across States 
and Territories. While EPA recognizes that beach use intensity varies 
significantly across the nation, EPA does not agree that interstate 
comparisons are the best approach for categorizing use intensity. An 
interstate approach could result in some States or Territories 
comparing their beaches only to the most heavily used beaches in the 
nation and determining that they have no beaches warranting protection 
at the 75% confidence level. Rather, States and Territories will need 
to evaluate the intensity of use of their own beaches, independent of 
beaches in the rest of the nation, and assign the beaches to categories 
based on the definitions provided in 40 CFR 131.41(b). This does not 
mean that there is any minimum number or percentage of beaches that 
must be placed in the designated bathing beach category. Rather, States 
should identify those beaches, if any, in the State which satisfy the 
criteria for this category and then assign the remaining waters to one 
or more of the lower intensity of use categories as appropriate. 
Intrastate comparison of use will allow States and Territories the 
flexibility to provide the level of protection that is appropriate to 
visitors to beaches with different intensities of use.
    In today's rule, EPA is also making a minor change to this aspect 
of the proposed rule. The Agency added text to the definition of 
``designated bathing beach'' in 40 CFR 131.41(b)(2) to provide 
expressly that the determination of ``heavy use'' is based on an 
evaluation of use within the State, which is consistent with the above 
discussion.
6. State Calculation of Site-Specific Single Sample Maximums
    EPA is promulgating, as proposed, default single sample maximums 
based on the 75, 82, 90, and 95% confidence levels, along with the 
equation to calculate site-specific single sample maximums. EPA 
calculated the values for the single sample maximums in tables 2 and 3 
using the standard deviations observed during the EPA epidemiological 
studies. The Agency recognizes that standard deviations observed in 
EPA's epidemiological studies may not coincide with that for a 
particular waterbody. States and Territories may decide to collect data 
to calculate site-specific standard deviations. To compute the site-
specific log standard deviation in a statistically meaningful way as 
explained in the preamble to the proposed rule (69 FR 41727), today's 
rule requires that the States and Territories collect at least 30 
samples in a single recreation season (see 40 CFR 131.41(c)(3)). If 
this requirement is met, the State or Territory may use the resulting 
site-specific standard deviation to calculate a corresponding single 
sample maximum.
    EPA considers that the calculation of site-specific single sample 
maximums as specified in 40 CFR 131.41(c)(3) provides enough detail on 
the calculation that States and Territories can implement the provision 
of the rule without needing to adopt it as a site-specific water 
quality criterion. As a result, States and Territories do not need EPA 
review and approval under 40 CFR Part 131 in their application of 40 
CFR 131.41(c)(3).
    All commenters that addressed this issue supported EPA's proposal 
to require 30 samples to derive a site-specific standard deviation; 
however, one commenter stated that States and Territories should be 
allowed to collect the samples over two recreation seasons if there 
were not significant differences in bacteria concentrations over the 
two-year period. The commenter explained that States and Territories 
may find it difficult to collect 30 samples in one recreation season. 
EPA recognizes the difficulty in collecting the required number of 
samples over a single recreation season, but the Agency has nonetheless 
concluded that collecting this data during a single season is necessary 
in order to capture the variability inherent in bacteria concentrations 
at a site over the period of a single season without introducing 
additional variability from extreme weather conditions such as drought 
or El Nino conditions. Using 30 samples over more than one recreation 
season could affect the outcome of the single sample maximum such that 
it may not be as protective of human health as EPA's 1986 bacteria 
criteria.
7. Addressing Non-Human Sources of Bacteria
    EPA is adopting the approach preferred in the proposal for 
addressing non-human sources of bacteria. In today's rule, EPA added 
footnote ``e'' to 40 CFR 131.41(c)(1) and footnote ``c'' to 40 CFR 
131.41(c)(2) to describe this approach for addressing non-human sources 
of bacteria. The footnotes state: ``These values apply to [E. coli or 
enterococci] regardless of origin unless a sanitary survey shows that 
sources of the indicator bacteria are non-human and an epidemiological 
study shows that the indicator densities are not indicative of a human 
health risk.'' Specifically, States and Territories must apply the E. 
coli and enterococci criteria to all coastal recreation waters. If, 
however, sanitary surveys and epidemiological studies show the sources 
of the indicator bacteria to be non-human and the indicator densities 
do not indicate a human health risk, then it is reasonable for the 
State or Territory to not consider those sources of fecal contamination 
in determining whether the standard is being attained. This is the 
approach taken in the 1986

[[Page 67228]]

bacteria criteria document. It would be reasonable for a State or 
Territory to use existing epidemiological studies rather than conduct 
new or independent epidemiological studies for every waterbody if it is 
scientifically appropriate to do so.
    EPA also anticipates that a State or Territory that has conducted a 
sanitary survey and an epidemiological study to show that the sources 
of the indicator bacteria in a waterbody are non-human and that the 
indicator densities do not indicate a health risk to those swimming in 
the waters, will apply the criteria in today's rule where a change in 
circumstances affecting the waterbody makes it appropriate to do so. 
For example, the criteria would apply to a waterbody in which there is 
a subsequent sewer line break or other later occurrence that results in 
the introduction in the waterbody of bacteria that is a human health 
risk to those using the waters for primary contact recreation.
    EPA is promulgating this approach because Clean Water Act section 
303(i)(2)(A) requires EPA to propose criteria which are ``as protective 
of human health as'' EPA's 1986 bacteria criteria in cases where a 
State or Territory has failed to do so. While EPA's scientific 
understanding of pathogens and pathogen indicators has evolved since 
1986, data characterizing the public health risk associated with non-
human sources is still too limited for the Agency to promulgate another 
approach.
    Almost half of the commenters addressed some or all of the 
approaches to exempting non-human sources of fecal contamination 
described in the proposed rule (69 FR 41729-41731). Several commenters 
expressed support for EPA's preferred approach. EPA agrees that the 
criteria should apply unless sanitary surveys and epidemiological 
studies show the sources of the indicator bacteria to be non-human and 
that the indicator densities are not indicative of a human health risk. 
This is the approach taken in the 1986 bacteria criteria document.
    Some commenters expressed a preference for not allowing any 
exclusion of non-human sources from the criteria. They emphasized the 
significance of the human health risk associated with any type of fecal 
contamination and asserted that this approach would be most protective 
of human health. EPA does not agree that this approach is necessary for 
States to adopt if an epidemiological study demonstrates that non-human 
sources do not pose a risk to human health at a given waterbody.
    Several commenters supported a non-human source exclusion based on 
sanitary surveys only. In general, these commenters expressed concern 
about the cost of epidemiological studies, especially in areas where 
evidence of human fecal contamination was absent. EPA has found the 
scientific understanding of the human health risks associated with non-
human sources of fecal contamination is still too incomplete to 
promulgate this option. In the proposed rule (69 FR 41730-41731), EPA 
cited several instances where studies have attributed disease outbreaks 
to non-human sources of fecal contamination. Given the potential human 
health risk from non-human sources of fecal contamination, EPA 
concludes that this option would not be as protective of human health 
as the 1986 bacteria criteria.
    Some commenters supported exclusion of bacteria from wildlife 
sources from the criteria because wildlife sources may pose less of a 
risk to human health than human sources or domestic animal and 
livestock sources. Other commenters raised issues with the reliability 
of current bacteria source tracking methods that may be needed to 
support this exclusion. EPA finds the scientific understanding of the 
human health risks associated with wildlife sources of fecal 
contamination still too incomplete to support promulgation of this 
option. Once again, EPA concludes that this option is not as protective 
as the 1986 bacteria criteria.
    Many commenters expressed the need for more research on non-human 
sources. Commenters emphasized two major areas of needed research: 
research on bacterial source tracking methods to better distinguish 
between different types of bacteria contamination and research on the 
health risks associated with different types of non-human fecal 
contamination. EPA expects to conduct research in these areas as time 
and resources allow. EPA also encourages others to continue to conduct 
research in these areas.

C. Applicability of Today's Rule

1. Applies in Addition to Any State/Territorial Criteria
    EPA is promulgating the rule as proposed with respect to the 
interaction of today's criteria with existing State and Territorial 
water quality criteria. Under today's rule, the promulgated criteria do 
not replace existing bacteria criteria for coastal recreation waters 
already adopted by States and Territories (and for those adopted after 
May 30, 2000, approved by EPA). Rather, today's promulgated criteria 
apply for Clean Water Act purposes in addition to any existing State or 
Territorial criteria already applicable to those waters. This will 
ensure that, where commercial shellfishing and primary contact 
recreation occur in the same coastal recreation waters, both uses will 
be adequately protected by existing State and Territorial standards 
(which generally still use fecal coliform) and the new standards for 
either E. coli or enterococci. States and Territories may also continue 
to use existing criteria for fecal coliform to supplement the new 
indicators for the purposes of waterbody assessment and other purposes 
where ambient data are needed. The dual sets of bacteria criteria also 
will enable regulatory decisions and actions to continue while 
collecting data for the newly adopted E. coli or enterococci criteria. 
For States and Territories included in today's rule, EPA expects that 
States and Territories will be actively collecting data on E. coli and/
or enterococci and working to incorporate E. coli and/or enterococci 
water quality criteria into their water quality programs, e.g., 
National Pollutant Discharge Elimination System, Clean Water Act 
section 305(b), and Clean Water Act section 303(d) programs. As they 
accomplish this, States and Territories may phase out their use of 
fecal coliform as a supplemental indicator to protect primary contact 
recreation. While EPA cannot remove or revise existing State or 
Territorial standards, EPA believes that it would not be an efficient 
use of resources for States and Territories to base Clean Water Act 
actions related to protection of primary contact recreation on both 
fecal coliform and the new, preferred indicators. However, if States 
believe their existing standards are as protective as the criteria in 
today's rule, they may submit data to EPA to support this 
determination, and if EPA then determines that the State standards are 
at least as protective as the criteria in today's rule, EPA will 
withdraw the Federal criteria for that State. (See section V.C.) States 
and Territories are encouraged to expeditiously revise their water 
quality standards to remove fecal coliform criteria as an indicator for 
primary contact recreation where it has been replaced by the new 
indicators in their implementation of the Clean Water Act. Today's rule 
also provides in 40 CFR 131.41(d)(1) that new EPA-approved bacteria 
criteria in State or Territorial water quality standards become the 
effective Clean Water Act criteria upon their approval, replacing the 
criteria in today's rule.

[[Page 67229]]

    EPA received very few comments on this topic. All commenters 
addressing this topic supported EPA's proposal that once EPA approves a 
State's or Territory's standards as being as protective of human health 
as EPA's 1986 bacteria criteria, the EPA-approved bacteria criteria in 
State or Territorial water quality standards would become effective for 
Clean Water Act purposes and EPA's promulgated criteria would no longer 
apply. EPA will still remove the State or Territory from 40 CFR 131.41, 
but any delay in that process would not delay the approved State 
criteria from becoming the sole applicable criteria for Clean Water Act 
purposes.
2. Role of State/Territorial General Rules of Applicability
    Today's rule, like the proposal, makes today's criteria subject to 
States' and Territories' general rules of applicability in the same way 
and to the same extent as are other Federally-adopted or State-adopted 
numeric criteria. EPA received a few comments on this topic and these 
generally pertained to mixing zones. One commenter suggested that the 
final rule prohibit the use of mixing zones to comply with today's 
criteria. The commenter said that the use of mixing zones would not be 
as protective of human health as the 1986 bacteria criteria. Another 
commenter supported allowing States to apply their existing mixing zone 
provisions.
    EPA appreciates the concerns of commenters regarding human health 
risks of exposure to fecal contamination within mixing zones. However, 
EPA has determined that the Agency's existing guidance provides 
sufficient direction to permitting authorities as they implement State 
or Territorial mixing zone policies. EPA's Water Quality Standards 
Handbook: Second Edition (EPA-823-B-94-005a, August 1994) as well as 
EPA's Technical Support Document for Water Quality Based Toxics Control 
(EPA-505-2-90-001, March 1991) advise against the use of mixing zones 
where the location may pose a significant health risk. These documents 
stress the importance of determining the appropriate placement and size 
of mixing zones depending on the potential effects to human health and 
the environment. As a result, EPA is not prohibiting the application of 
mixing zones in the final rule in cases where they would be allowed 
under existing State and Territorial programs.

D. Compliance Schedules

    Where a State or Territory does not have a regulation that is in 
effect for Clean Water Act purposes authorizing compliance schedules 
for water quality-based effluent limits, EPA proposed to authorize, but 
not require, the permit issuing authority to include compliance 
schedules in permits under appropriate circumstances. EPA also proposed 
that if a State or Territory has a regulation in effect authorizing 
compliance schedules for Clean Water Act purposes then that compliance 
schedule regulation could be used in implementing the water quality 
standards in this rule; it would not be affected by the final rule. 
Because EPA recognizes that a State or Territory without a regulation 
authorizing compliance schedules may not want such a regulation, in the 
preamble to the proposed rule, EPA asked such States to notify EPA 
prior to promulgation. No State or Territory notified EPA that it does 
not want the ability to use the compliance schedule provision in 
today's rule. Therefore, EPA is not including in today's final rule any 
regulatory text identifying States or Territories that do not want a 
compliance schedule provision for their standards.
    EPA received several comments in support of the allowance for 
compliance schedules. One commenter requested that EPA remove the 
requirement that a permittee request a compliance schedule; this 
commenter believed that the permitting authority could determine 
whether the permittee needed time to comply with the new effluent 
limitation based on the criterion. EPA disagrees that it needs to make 
this change because the rule does not impose a requirement for a 
request. The rule at 40 CFR 131.41(f)(3) provides permittees with the 
opportunity to request a compliance schedule where the permittee 
reasonably believes it will be infeasible to immediately achieve the 
new limitation, but it does not require them to do so. The permitting 
authority also has the discretion to suggest the need for compliance 
schedules as part of the permit even if the permittee does not initiate 
a request for one.
    One commenter supported the definition of a new pathogen 
discharger. Another commenter requested clarification that the 
definition does not apply to relocated combined sewer overflow 
outfalls. EPA agrees that the definition does not apply to relocated 
combined sewer overflow outfalls. The rule at 40 CFR 131.41(f)(2) does 
not authorize compliance schedules for new pathogen dischargers because 
EPA recognizes that a new discharger could design and build a new 
treatment system, which will meet the new water quality-based 
requirements more efficiently (69 FR 41736). However, a relocated 
combined sewer overflow outfall is not a new discharge, rather it is an 
existing discharge being released at an alternate location. The 
relocating of the outfall does not necessarily provide an opportunity 
for the discharger to apply additional controls or reduce pathogen 
loads to the extent anticipated for a new pathogen discharger. EPA's 
Combined Sewer Overflow Control Policy, published on April 11, 1994, 
recommends that Long Term Control Plans consider relocating overflow 
away from sensitive areas wherever physically possible and economically 
achievable (59 FR 18688, 18692). In today's final rule, EPA has added 
text to the definition of a ``new pathogen discharger'' in 40 CFR 
131.41(b)(6) to provide expressly that ``[i]t does not include 
relocation of existing combined sewer overflow outfalls.''
    Many commenters addressed the length of the compliance schedule. 
Some commenters supported capping the length of the compliance schedule 
at five years, while one commenter suggested that three years should be 
sufficient. Other commenters suggested that compliance schedules longer 
than five years may be necessary, or that the rule should not specify 
the length of a compliance schedule, but rather allow the permitting 
authority to exercise discretion in determining how much time is 
necessary for each discharger. Finally, several commenters noted that 
combined sewer overflow systems may need compliance schedules longer 
than five years, and that the compliance schedule provision of the rule 
should be consistent with EPA's Combined Sewer Overflow Control Policy 
and the requirements of Clean Water Act section 402(q).
    EPA has determined that five years is a reasonable limit on the 
length of a compliance schedule within a National Pollutant Discharge 
Elimination System permit. EPA expects that most continuous dischargers 
will look to optimize their existing disinfection treatment, and that 
five years is sufficient time to do so. As discussed in section VIII, 
EPA believes that experiences from facilities with bacteria effluent 
limits that are currently meeting the E. coli and enterococci criteria, 
as well as the current fecal coliform criteria, suggest that 
disinfection processes can be upgraded or adjusted to produce the 
levels of bacteria necessary for compliance with the rule. EPA has used 
five years for compliance schedules where permittees were expected to 
design, construct, and operate new treatment processes, and not just 
optimize their current treatment. (See 40 CFR 131.38(e)(6) and

[[Page 67230]]

40 CFR Part 132, Appendix F, Procedure 9.B.1.)
    EPA does not regard the five-year cap on compliance schedules as 
inconsistent with either EPA's Combined Sewer Overflow Control Policy 
or Clean Water Act section 402(q). Section 402(q) requires that 
National Pollutant Discharge Elimination System permits conform to 
EPA's Combined Sewer Overflow Control Policy published on April 11, 
1994 (59 FR 18688). EPA's Combined Sewer Overflow Control Policy 
recommends that permittees develop a construction and financing 
schedule for implementation of combined sewer overflow controls (59 FR 
18694). The Combined Sewer Overflow Control Policy recommends that 
permitting (and water quality standards setting) authorities include, 
in an appropriate enforceable mechanism, compliance dates, on the 
soonest practicable schedule, for requirements to implement Long Term 
Control Plans (59 FR 18696). In addition, permits need to include water 
quality-based effluent limits requiring compliance by no later than the 
date allowed under the water quality standards that apply. The Combined 
Sewer Overflow Control Policy itself does not require compliance 
schedules in water quality standards (or otherwise constrain the 
authority of water quality standard setting agencies). Finally, the 
Combined Sewer Overflow Control Policy recommends, in cases where water 
quality standards do not allow compliance schedules and the permittee 
cannot, on the effective date of the permit, comply with effluent 
limitations established in the permit, that the compliance schedule be 
placed in a judicial order for major permittees (59 FR 18697). EPA 
recognizes that combined sewer overflow systems often need more than 
five years to meet the requirements of the Clean Water Act. In these 
situations, the permitting authority can provide sufficient time for 
the combined sewer overflow system to comply by using the enforceable 
mechanisms identified in the Combined Sewer Overflow Control Policy.
    Finally, in today's final rule, EPA is making two corrections to 
the proposed rule at 40 CFR 131.41(f)(3)-(4) to refer to paragraph (c) 
as the paragraph containing the water quality criteria for bacteria.

V. EPA Review of State and Territorial Standards

A. How Did EPA Decide Which States and Territories To Include in 
Today's Rule?

    EPA evaluated the water quality standards for bacteria for all 35 
coastal States and Territories with coastal recreation waters to 
determine whether the water quality standards for such waters are as 
protective of human health as the 1986 bacteria criteria document, as 
required by Clean Water Act section 303(i)(1)(A). If a State's or 
Territory's approved water quality standards for bacteria for coastal 
recreation waters are as protective of human health as the 1986 
bacteria criteria as of the signature date of today's rule, EPA is not 
including the State or Territory in the promulgated rule.
    EPA described the five considerations used to evaluate the State 
and Territorial water quality standards in detail in the proposed rule 
(69 FR 41728-41731). Today, EPA uses the same five considerations to 
evaluate State and Territorial water quality standards for inclusion in 
the final rule. The following five sections summarize the 
considerations.
1. Are the standards based on EPA's recommended indicators of E. coli 
and enterococci as pathogen indicators for freshwaters and enterococci 
for marine waters?
    As discussed in section IV.B.1 of the preamble to today's rule, EPA 
is promulgating water quality criteria for E. coli and enterococci for 
use as standards for State and Territorial coastal and Great Lakes 
recreation waters. These are the indicator bacteria for which EPA 
published criteria in the 1986 bacteria criteria document.
    EPA received a number of comments asserting that a fecal coliform 
water quality criterion of 14/100 ml for the protection of a 
shellfishing use should generally be as protective of human health as 
the enterococci criterion of 35/100 ml. Some of these commenters 
referenced the statement in the 1986 bacteria criteria document that 
EPA selected the value of the enterococci criterion to be no more 
protective of human health than the then current fecal coliform 
criterion of 200/100 ml for recreation protection in support of their 
argument that if there is equal protection between the 1986 bacteria 
criteria and a fecal coliform value of 200/100 ml, then a fecal 
coliform value of 14/100 ml should be even more protective of human 
health than an enterococci value of 35/100 ml for marine waters. EPA 
disagrees that this statement in the 1986 bacteria criteria document 
provides a basis for determining that a fecal coliform criterion of 14/
100 ml is ``as protective as'' an enterococci criterion of 35/100 ml. 
EPA explicitly acknowledged in the 1986 bacteria criteria document that 
these illness rates for fecal coliform were only approximations, but 
were the best available estimates. (The fecal coliform criteria were 
developed long before EPA calculated the corresponding estimated 
illness rates.) EPA used these estimated illness rates for one purpose: 
to select illness rates for the enterococci and E. coli criteria in 
marine and fresh waters that would be least likely to cause a change in 
the stringency of the water quality standards for bacteria. However, 
that discussion in the 1986 bacteria criteria document must be 
considered along with the purpose of the 1986 bacteria criteria 
document: to recommend that States replace their fecal coliform 
criteria for recreation with enterococci or E. coli criteria because 
studies showed low correlation between fecal coliform densities and 
illness rates. In EPA's view, it would not be reasonable to rely on the 
equivocal discussion regarding the after-the-fact approximation of an 
illness rate for fecal coliform in light of the unequivocal conclusion 
of the entire document: That the fecal coliform criteria for recreation 
is not a reliable indicator of illness to swimmers.
    One commenter, the Washington Department of Ecology, supplied EPA 
with recently-collected ambient water monitoring data for both fecal 
coliform and enterococci, and stated that the data for enterococci and 
fecal coliform, when compared to each other, show that, in Washington 
State coastal recreation waters, when fecal coliform concentrations 
were at 14/100 ml or less (a level substantially below the 200/100 ml 
level that EPA recommended prior to 1986), the enterococci 
concentrations were almost always at 35/100 ml or less. The State 
currently has a fecal coliform criterion of 14/100 ml as a geometric 
mean and 43/100 ml as a value not to be exceeded more than 10% of the 
time for its Class AA and A waters, which for marine waters are the 
only classes with primary recreation uses. The data submitted to EPA 
are from 37 locations in the King County area of the Puget Sound for 
the years 1995 through 2004, 155 locations in the Kitsap County area of 
the Puget Sound and its embayments for early 1997, and 36 locations 
across the Puget Sound, Strait of Juan de Fuca, and two Pacific Ocean 
embayments from November 2000 through July 2001.

[[Page 67231]]

    EPA reviewed the data provided by the Washington Department of 
Ecology. EPA analyzed the data that were collected from stations 
located close to shore and within the upper two meters of depth, 
because these are the areas where people most frequently swim. EPA also 
excluded data that the State identified as invalid. From these data, 
there are 3535 samples with both fecal coliform and enterococci 
bacterial counts. From these samples, EPA calculated 241 summertime 
geometric means for both fecal coliform and enterococci for the data 
from King County. EPA could not calculate summertime geometric means 
for the other locations because there were insufficient data in these 
data sets to do so.
    These geometric mean calculations show that, for King County, the 
attainment of the State's current fecal coliform geometric mean 
criterion of 14/100 ml always assures attainment of an enterococci 
geometric mean of 35/100 ml. Further, there were 67 of 191 relevant 
occasions (35% of the time) when the State's fecal coliform geometric 
mean criterion was exceeded but the geometric mean enterococci 
criterion was not.
    The data also show that attainment of the State's current fecal 
coliform criterion also ensures attainment of the enterococci 75th 
percentile single sample maximum criterion (04/100 ml) in 99% of the 
samples collected at all locations in Washington. Of 2194 relevant data 
points, the State's upper bound fecal coliform criterion of 43/100 ml 
assures attainment of the Federal enterococci 75th percentile single 
sample maximum criterion on 2166 occasions. Finally, there were 570 of 
2736 relevant occasions (21% of the samples) when use of the State's 
fecal coliform criterion could be used to close a beach or issue an 
advisory but the Federal enterococci criterion (expressed as a single 
sample maximum) would not support closure or an advisory. Based on this 
analysis, EPA agrees that the data provided by the State of Washington 
for the Puget Sound, Strait of Juan de Fuca, and the Pacific Ocean 
embayments shows that use of the State's 14/100 ml fecal coliform 
criterion is as protective of human health as the 1986 bacteria 
criteria for the State of Washington.
    In the proposed rule, EPA solicited comment on its interpretation 
that Clean Water Act section 303(i) requires States and Territories to 
adopt criteria for E. coli or enterococci to comply with the provisions 
of that section. Section 303(i)(1)(A) requires that States and 
Territories submit criteria `` * * * for the pathogens and pathogen 
indicators for which the Administrator has published criteria under 
section 304(a).'' EPA's Ambient Water Quality Criteria for Bacteria--
1986 is considered to be the Clean Water Act section 304(a) criteria 
referred to in Clean Water Act section 303(i)(1)(A). The Ambient Water 
Quality Criteria for Bacteria--1986 strongly recommended the use of E. 
coli and enterococci as pathogen indicators for fresh waters and 
strongly recommended enterococci for marine waters.
    Clean Water Act section 303(i)(2)(A) requires EPA to propose water 
quality standards regulations for a State ``[i]f a State fails to adopt 
water quality criteria and standards * * * that are as protective of 
human health as the criteria for pathogens and pathogen indicators for 
coastal recreation waters published by the Administrator * * * '' 
(emphasis added). EPA solicited comment on whether section 303(i)(2)(A) 
could be read to require that EPA need only promulgate for a State or 
Territory if the State or Territory failed to adopt any criteria (not 
necessarily E. coli or enterococci) that were as protective of human 
health as EPA's 1986 bacteria criteria. In other words, EPA solicited 
comment on whether it was required to promulgate E. coli or enterococci 
under section 303(i)(2)(A) in situations where a State or Territory 
adopted a low fecal coliform criterion for protection of primary 
contact recreation that was demonstrated to provide protection equal to 
the protection provided by EPA's 1986 bacteria criteria. EPA has 
reconsidered its interpretation and believes that there is some 
ambiguity in section 303(i)(2)(A) and that given this ambiguity that it 
should interpret section 303(i)(2)(A) as allowing EPA to approve 
standards based on other indicators provided they are as protective as 
EPA's 1986 bacteria criteria because this approach is most consistent 
with the purposes of the Clean Water Act. Thus, EPA is taking the 
position that EPA is not required to promulgate E. coli or enterococci 
criteria if a State demonstrates that other criteria, based on other 
bacteria indicators, are as protective of human health as EPA's 1986 
bacteria criteria. That is, if a State or Territory adopts criteria, 
even though they are not for E. coli or enterococci, that are 
demonstrated to be as protective of human health as EPA's 1986 bacteria 
criteria, section 303(i)(2)(A) does not require EPA to promulgate 
criteria for E. coli or enterococci. Promulgation of criteria for E. 
coli or enterococci in that situation would not provide any greater 
level of public health protection. Protection of public health was 
Congress's primary intent in enacting the BEACH Act. Therefore, if a 
State or Territory can show that in waters in which the State or 
Territory intends to protect primary contact recreation uses with its 
criteria for fecal coliform, that such uses will be protected at a 
level equal to or greater than the protection provided by EPA's 1986 
bacteria criteria for enterococci and E. coli, EPA does not believe 
Congress intended EPA to promulgate water quality criteria for 
pathogens or pathogen indicators for those waters in that State or 
Territory where this has been demonstrated. The facts presented by the 
Washington Department of Ecology highlight the reasonableness of this 
interpretation.
    In addition, EPA considers it to be an appropriate exercise of 
Federal discretion to take this approach with Washington State. 
Congress intended through Clean Water Act section 303(c) to give States 
the paramount role in weighing any available credible information for 
establishing water quality standards that are protective of the 
designated uses of their waters. Congress maintained this same approach 
in Clean Water Act section 303(i) by giving States the responsibility 
to adopt water quality standards for protecting human health, with 
EPA's role being to promulgate standards for those States that had not 
adopted standards as protective of human health as the 1986 bacteria 
criteria. This interpretation is supported by the legislative history 
of Clean Water Act section 303(i). For example, S. Rep. No. 106-366 
states in the section-by-section analysis of the Act:

    These provisions are consistent with the applicable requirements 
of the Clean Water Act and specifically section 303(c) and the 
regulations implementing that section. States must incorporate into 
their water quality standards, water quality criteria for pathogens 
and pathogen indicators that are at least as protective of human 
health as criteria EPA publishes under section 304(a). The State's 
criteria may be as protective as those of EPA without being 
numerically equivalent. However, if a State adopts criteria 
differing from those published by EPA, the State has a duty to 
defend the criteria from a scientific perspective. EPA's approval or 
disapproval of the criteria is based upon the information provided 
by the State. (S. Rep. No. 106-366, at 4 (2000)).

EPA believes that this language demonstrates Congress's intent that 
section 303(i) be interpreted within the broader context of section 
303, and that section 303(i) not be interpreted to preclude a State's 
adopting alternative criteria from those published by EPA

[[Page 67232]]

under section 304(a), provided that the State demonstrates (and EPA 
agrees) that the alternative criteria are as protective of human health 
as EPA's published criteria.
    H. Rep. No. 106-98 has similar language in its section-by-section 
analysis as follows:

    The Committee intends that the legal standard for determining 
when a State water quality standard is consistent with the 
applicable requirements of the Clean Water Act be governed by the 
existing requirements of section 303(c) of the Clean Water Act, and 
the regulations implementing that section. This standard has been 
interpreted to mean that State water quality criteria must be at 
least as protective of human health as EPA's water quality criteria. 
Thus, a State must incorporate into its water quality standards 
water quality criteria for pathogens and pathogen indicators that 
are at least as protective as criteria that EPA has published under 
section 304(a), including EPA's 1986 criteria for enterococcus and 
Escherichia coli. (H. Rep. No. 106-98, at 8 (1999)).

Here again, EPA believes Congress is clarifying its intent that State 
criteria to be approvable under section 303(i), must be at least as 
protective as EPA's 1986 bacteria criteria, but not necessarily the 
same as the 1986 criteria.
    With respect to the State of Washington, EPA looked at the process 
that the State took in reviewing its fecal coliform standards for 
protecting recreation uses in marine waters. The State did this as part 
of its triennial review of water quality standards. The State undertook 
a multi-year process starting in the summer of 1996 and finishing in 
2003. In this period, the State convened a multi-stakeholder technical 
workgroup to examine the technical merits of the State's bacteria 
criteria, and documented the technical and policy issues evaluated by 
the work-group and its predecessor (see http://www.ecy.wa.gov/pubs/0010072.pdf). The State used this information to focus discussions with 
numerous advisory panels both internal and external to the Washington 
Department of Ecology. The State held a formal 60-day public review and 
comment period on proposed revisions to its water quality standards 
(including adoption of EPA's recommended enterococci criteria for Class 
AA and Class A marine waters), and as part of the public notification 
process, directly mailed out approximately 3320 announcements, 550 
email announcements, and 621 CDs to potential interested citizens, 
regulated businesses, governmental officials, and every city, county, 
and Tribe in the State. The State conducted eight public workshops and 
hearings regarding proposed changes to its standards at locations 
across the State. Finally, the State made all documents available to 
the public at its Web site at http://www.ecy.wa.gov/programs/wq/swqs/supporting_docs/supporting_docs.html.
    Based on the input from the various stakeholders in the State and 
the paired monitoring data for fecal coliform and enterococci, the 
State concluded that its fecal coliform criteria for marine waters is 
protective of the recreation use in these waters, and also is at least 
as protective of human health as EPA's 1986 bacteria criteria. Many 
stakeholders in Washington share this conclusion, as expressed in the 
public comments by many stakeholders on the State's proposed water 
quality standards (see http://www.ecy.wa.gov/programs/wq/swqs/supporting_docs/public_comments.html) and comments by a Puget Sound 
public interest group and a Northern Pacific Ocean shellfish group on 
EPA's proposed rule. Given this conclusion, the State and some 
stakeholders were concerned that the State adoption of the enterococci 
standard and the attendant new monitoring that this would entail would 
limit the State's ability to monitor as comprehensively for fecal 
coliform as it does currently and thus provide the maximum assurance 
that its waters are meeting its protective 14/100 ml fecal coliform 
standard. However, this rule does not require monitoring.
    As discussed previously in this preamble, EPA reviewed the State's 
data and determined that it shows that the State's fecal coliform 
criterion is as protective as the 1986 bacteria criteria. Accordingly, 
EPA considers it appropriate and consistent with Congressional intent 
to exclude Washington from today's Federal promulgation because the 
State has fully met its obligations under the Clean Water Act using a 
full and open public process and is ensuring protection of human health 
in the coastal recreation waters of Washington.
    EPA considers its analysis of the data provided by the State of 
Washington to only be relevant to the State's waters. EPA does not 
agree that the Washington data show that use of a fecal coliform 
criterion of 4/100 ml is as protective of human health as the 1986 
bacteria criteria for any other coastal recreation waters in the United 
States because the conditions of the Washington State waters may differ 
from waters of other States. The relationship between fecal coliform 
and enterococci in the data provided by the Washington Department of 
Ecology is an empirical relationship, and reflects the conditions of 
the water from which the samples were collected. EPA cannot determine 
without water-specific data the extent to which the Washington State 
waters where the samples were collected are representative of other 
waters in other parts of the United States. The Washington data reflect 
the pathogen sources in that area, the local rainfall which has an 
effect on pathogen loadings, the tidal flushing in the waters, and the 
temperature of the waters. Further, as noted above, the legislative 
history indicates that any State wishing to adopt criteria other than 
those in the 1986 bacteria criteria document, `` has a duty to defend 
the criteria from a scientific perspective'' and specifically to 
demonstrate that they are as protective of human health as EPA's 1986 
bacteria criteria.
    No other comments received by EPA included the type and amount of 
information that EPA views as necessary to demonstrate that fecal 
coliform criteria (or any other pathogen indicator) in any other State 
or Territory are as protective of human health as the 1986 bacteria 
criteria. However, if following promulgation of this rule, some other 
State or Territory provides data to EPA sufficient to make this 
demonstration, EPA will approve such other criteria as meeting the 
requirements of section 303(i) and withdraw today's Federal criteria 
from that State's coastal recreation waters. EPA cautions, however, 
that given the focus of the BEACH Act on the specific indicators in 
EPA's 1986 bacteria criteria document, there is a substantial burden of 
proof for States wishing to adopt criteria based on alternative 
indicators. EPA believes that both the process and quantity of 
information and data provided by Washington State in making this 
determination may provide guidance to any other State that wished to 
make a similar showing.
2. Are the Standards for E. coli and Enterococci Derived From a 
Scientifically-Defensible Methodology That Links Them Quantitatively to 
an Acceptable Risk Level Under Clean Water Act Section 303(i)?
    As discussed in section IV.B.2 of the preamble to today's rule, EPA 
is promulgating water quality criteria that correspond to an illness 
rate of 0.8% for swimmers in freshwater and 1.9% for swimmers in marine 
waters. In deciding which States and Territories have already adopted 
water quality criteria as protective of human health as these criteria, 
EPA considered an illness rate of 1.0% of swimmers to be as protective 
as the 1986 bacteria criteria in determining whether to include a State 
or Territory in the rule. EPA explained

[[Page 67233]]

its reasons for this consideration in the proposed rule (69 FR 41724-
41725). EPA would consider State or Territorial bacterial criteria for 
fresh coastal recreation waters to not be as protective of human health 
if the risk level of the criteria was above 1.0%.
    Some commenters addressed this topic. Of these, a majority agreed 
with EPA that a 1.0% illness rate in swimmers in freshwater is as 
protective of human health as the 1986 bacteria criteria for different 
reasons. One commenter said that a 1.0% illness rate would result in 
only a small increase in risk of illness and that would still be below 
the risk of illness in marine waters. Another commenter stated that the 
difference between 0.8% and 1.0% was well within the inherent 
variability in the criteria. One commenter expressed support for the 
1.0% risk level but only if EPA had examined and analyzed all available 
updated epidemiological data in identifying an acceptable risk level. 
As explained in the proposal (69 FR 41724-41725), EPA conducted an 
external peer review of EPA's analysis of the epidemiological data from 
EPA's bacteriological studies on which the 1986 bacteria criteria 
document is based.
    Of the commenters who did not agree that the 1.0% illness rate was 
as protective of human health of the 1986 bacteria criteria, most 
argued that there is no logical reason to allow for different 
acceptable illness rates in marine and freshwater. One commenter said 
that the increase from 0.8% to 1.0% in freshwater would increase the 
incidence of gastrointestinal illness by 25%. Three commenters believed 
that the illness rate for freshwater should be 0.8%, while one 
commenter felt that EPA should promulgate additional geometric mean and 
single sample maximum values relative to other risk levels. EPA 
disagrees that it should only consider an illness rate of 0.8% to be as 
protective of human health as the 1986 bacteria criteria document. As 
explained in the proposal, EPA does not see any a priori reason to 
require a greater level of protection for freshwaters than for marine 
waters, which account for the vast majority of swimming days in coastal 
recreation waters subject to section 303(i) of the Clean Water Act. See 
the proposed rule (69 FR 41724) for further discussion of EPA's 
reasoning.
3. Do the Standards Include Appropriate Single Sample Maximums for All 
Coastal Recreation Waters?
    As discussed in sections IV.B.3 and IV.B.4 of the preamble to 
today's rule, EPA is promulgating water quality criteria that include 
separate single sample maximums for four categories of waters based on 
intensity of use, which allows the State or Territory to assign waters 
to the four use intensity categories. In determining whether existing 
State or Territorial water quality standards for coastal recreation 
waters are as protective of human health as EPA's 1986 bacteria 
criteria, EPA determined whether the water quality standards include a 
single sample maximum for all coastal recreation waters and if 
designated bathing beaches have a single sample maximum based on at 
least the 75% confidence level. EPA considers this approach to be as 
protective as the 1986 bacteria criteria and also consistent with the 
criteria as discussed in section IV.B of the preamble to today's rule. 
EPA included in the rule any State or Territory that does not cover all 
coastal recreation waters with a single sample maximum and that for 
designated bathing beaches does not have a single sample maximum based 
on at least the 75% confidence level. EPA does not expect a State or 
Territory to use all four of the use categories identified in the 
criteria document for its standards to be at least as protective as the 
1986 bacteria criteria. For example, a State that applied the 75% 
confidence based maximum to all waters would clearly be as protective 
as the 1986 bacteria criteria, even though it would only have a single 
use category.
    Most commenters agreed with this approach. Those that disagreed 
with it commented that the single sample maximum should not be a part 
of the water quality criteria but rather available for use as an 
implementation tool for monitoring at beaches. EPA addressed these 
comments in sections IV.B.3 and IV.B.4 of today's preamble.
    EPA notes that all of the 35 coastal and Great Lakes States and 
Territories have identified coastal recreation waters where there are 
beaches or similar points of access (National List of Beaches, EPA-823-
R-04-004, 69 FR 24597, May 4, 2004). Also, all 35 of these States and 
Territories have received Clean Water Act section 406 grants since 2002 
for monitoring and notification of beach advisories or closures at 
beaches adjacent to coastal recreation waters. Today's rule specifies 
that the highest use category with a single sample maximum based on the 
75% confidence level applies to all beaches meeting the definition of 
designated bathing beaches in 40 CFR 131.41(b)(2) (``* * * coastal 
recreation waters that, during the recreation season are heavily-used 
(based on an evaluation of use within the State) and may have: a 
lifeguard, bathhouse facilities, or public parking for beach access'') 
and that the other use categories apply to lower use waters 
accordingly. Based on the applications for Clean Water Act section 406 
grants, EPA expects that many coastal and Great Lakes States will have 
at least some beaches in the higher use categories.
4. Do the Standards Exempt Fecal Contamination From Non-Human Sources?
    For the reasons discussed in section IV.B.7 of the preamble to 
today's rule, EPA is promulgating the exemption for non-human sources 
expressed in the 1986 bacteria criteria document. EPA is including in 
today's rule those States and Territories for which the criteria 
include exemptions for non-human sources that are inconsistent with the 
exemption provision in the criteria document, as promulgated in today's 
final rule. EPA addressed comments on this issue in section IV.B.7 of 
the preamble to this rule.
5. Has EPA Approved the Standards?
    Under section 303(i)(1)(A) of the Clean Water Act, States and 
Territories must adopt water quality standards as protective of human 
health as EPA's 1986 bacteria criteria. Moreover, under 40 CFR 131.21, 
EPA must approve State or Territorial water quality standards adopted 
after May 30, 2000, in order for those standards to be in effect for 
Clean Water Act purposes. Therefore, EPA must have approved State and 
Territorial standards for enterococci or E. coli adopted after May 30, 
2000, as consistent with Clean Water Act section 303(i) in order for 
EPA to exclude the State or Territory from the final rule. State and 
Territorial standards adopted prior to May 30, 2000, that are 
consistent with Clean Water Act section 303(i) are in effect for Clean 
Water Act purposes even without explicit EPA approval.

B. Which States and Territories Are Included in Today's Rule?

    The proposed rule contains a State-by-State summary of the status 
of each State or Territory (69 FR 41731-41735). EPA did not include any 
Tribes in the proposal because although there are Federally-recognized 
Tribes located next to either coastal or Great Lakes waters, none of 
those Tribes have coastal recreation waters as defined in 40 CFR 
131.41(b)(1). (See 69 FR 41735.)
    Today, EPA is promulgating a rule that is identical with respect to 
the water quality criteria values to what EPA proposed. While there 
were some changes in other provisions of the rule,

[[Page 67234]]

none of these affected EPA's determination with regard to specific 
States. Therefore, EPA is not excluding any other States from the final 
rule based on changes in the provisions of the final rule.
    Table 4 contains a summary of the status of each of the 35 States 
and Territories under today's rule. EPA considered three possible 
reasons for a change in a State's or Territory's status from that 
described in the proposal: (1) Since the publication of the proposed 
rule, the State or Territory may have adopted (and EPA approved) water 
quality standards that are as protective of human health as the 1986 
bacteria criteria; (2) the State's or Territory's water quality 
standards may now be viewed as being as protective of human health in 
light of EPA's final decision with respect to the application of the 
single sample maximum in the final rule; and (3) new information 
submitted following publication of the proposal may have caused EPA to 
reassess its previous determination. During the period between 
publication of the proposal and the final rule, four States--Delaware, 
Hawaii, Maryland, and South Carolina--and the Commonwealth of the 
Northern Mariana Islands adopted revised water quality criteria for 
pathogens. In addition, the State of Washington provided information 
that caused EPA to reassess its determination as to whether the State's 
fecal coliform criterion of 14/100 ml is as protective of human health 
as the 1986 bacteria criteria. Below, EPA describes the status of these 
States and Territory and provides an update on the status of several 
other States working to adopt water quality standards, as described in 
the preamble to the proposed rule.

     Table 4.--Categorization of 35 States/Territories With Coastal
                            Recreation Waters
------------------------------------------------------------------------
    Not subject to 40 CFR 131.41           Subject to 40 CFR 131.41
------------------------------------------------------------------------
Alabama                               Alaska
American Samoa                        California
Connecticut                           Florida
Delaware \1\                          Georgia
Guam                                  Hawaii
Indiana                               Illinois
Michigan                              Louisiana
New Hampshire                         Maine
New Jersey                            Maryland
Northern Mariana Islands \1\          Massachusetts
South Carolina \1\                    Minnesota
Texas                                 Mississippi
Virginia                              New York
Washington \1\                        North Carolina
                                      Ohio
                                      Oregon
                                      Pennsylvania
                                      Puerto Rico
                                      Rhode Island
                                      Virgin Islands
                                      Wisconsin
------------------------------------------------------------------------
\1\ These States were removed from 40 CFR 131.41 following publication
  of the proposed rule.

Commonwealth of the Northern Mariana Islands
    The Attorney General for the Commonwealth of the Northern Mariana 
Islands certified the adoption of revisions to their water quality 
standards on September 30, 2004. These revisions add single sample 
maximum standards of 104/100 ml for Class AA waters and 276/100 ml for 
Class A waters in the Commonwealth of the Northern Mariana Islands. 
Along with the bacteria standards that Commonwealth of the Northern 
Mariana Islands adopted and EPA approved in 1997, the revised standards 
will fully satisfy the requirements of the Clean Water Act. On October 
28, 2004, EPA approved the revised standards and the Commonwealth of 
the Northern Mariana Islands is not included in the rule.
Delaware
    On September 17, 2004, Delaware submitted to EPA newly adopted 
criteria for all its coastal recreation waters. The State's criteria 
specify a geometric mean of 35/100 ml and a single sample maximum of 
104/100 ml for enterococci for all primary contact recreation marine 
waters. Delaware's regulations also limit the application of the 
criteria when the bacteria comes from wildlife sources. The State has 
submitted documentation to EPA in support of its source tracking 
methodology for bacteria, together with epidemiological work on illness 
rates from bacteria of wildlife origin. The State uses the source 
information to apply a factor to bacteria from wildlife sources that 
accounts for illness risk from such bacteria. EPA reviewed the 
submitted criteria in accordance with this rule and on November 4, 
2004, approved the specific numeric criteria as meeting the 
requirements of both sections 303(c) and 303(i) of the Clean Water Act. 
EPA is discussing the State's methodology for source tracking with the 
State and is reviewing it to determine whether it meets the 
requirements of the Clean Water Act and this rule. Until EPA approves 
this limitation, for purposes of the Clean Water Act, Delaware's 
bacteria criteria for primary contact recreation apply to enterococci 
bacteria regardless of the source. As a result, Delaware is not 
included in today's rule.
Hawaii
    On September 21, 2004, Hawaii adopted bacteria criteria for its 
coastal estuaries, and a single sample maximum for coastal waters 
within 300 meters (1000 feet) of the shore. The criteria are for 
enterococci and have a geometric mean of 33/100 ml and a single sample 
maximum of 89/100 ml in coastal estuaries. These newly adopted criteria 
also contain a single sample maximum of 100/100 ml in coastal waters 
within 300 meters from shore to complement the existing geometric mean 
for coastal waters. On October 28, 2004, EPA approved these criteria. 
However, Hawaii still has no numeric criteria protecting State waters 
beyond 300 meters from shore, although these waters are designated for 
recreation in the State's water quality standards. Therefore, EPA is 
including Hawaii in this rule but only for the lack of criteria in 
State waters beyond 300 meters from shore.
Maryland
    On July 5, 2004, Maryland adopted new criteria for all its coastal 
recreation waters. These criteria specify a geometric mean of 35/100 ml 
enterococci for all recreation waters and at least a single sample 
maximum of 104/100 ml for those waters that are designated natural 
bathing areas under the State regulations. EPA is reviewing these 
criteria in accordance with this rule and is consulting with the State 
regarding the intent and meaning of the State regulations. EPA and 
Maryland have not concluded discussions of the applicability of the 
State criteria. Because Maryland does not yet have approved criteria, 
EPA is including Maryland in this rule. If EPA determines that 
Maryland's standards comply with Clean Water Act 303(i), they will 
become immediately effective for Clean Water Act purposes, as specified 
in 40 CFR 131.41(d)(1).
South Carolina
    On June 25, 2004, South Carolina adopted criteria for all of its 
coastal recreation waters consistent with EPA's 1986 bacteria criteria. 
The criteria are for enterococci and have a geometric mean of 35/100 
ml, a single sample

[[Page 67235]]

maximum of 104/100 ml for coastal waters designated by South Carolina 
as Classes SFH (Shellfish Harvesting) and SA, and a single sample 
maximum of 501/100ml for coastal waters designated by South Carolina as 
Class SB. However, the South Carolina water quality standard delays the 
applicability of the enterococci criteria for permit effluent limits 
until such time that EPA publishes analytical methods for enterococci 
in effluents. On October 7, 2004, EPA disapproved part of the South 
Carolina standards and approved the remainder of the standards that 
pertain to pathogens and pathogen indicators. EPA considers the 
approved water quality standards to be as protective of human health as 
EPA's 1986 bacteria criteria, and South Carolina is not included in the 
rule.
Washington
    The Washington Department of Ecology submitted data consisting of 
paired samples of fecal coliform and enterococci measurements collected 
in Puget Sound, the Strait of Juan de Fuca, and the Pacific Ocean 
embayments. The Department of Ecology considers this information as 
sufficient to demonstrate that use of the State's fecal coliform 
criterion of 14/100 ml ensures that enterococci concentrations are 
below the 1986 bacteria criteria, and requested that EPA consider the 
State's fecal coliform criterion to be as protective of human health as 
the 1986 bacteria criteria. As discussed in section V.A.1 of the 
preamble, EPA reviewed these data and has determined that the 
Washington fecal coliform criterion of 14/100 ml is as protective of 
human health as the 1986 bacteria criteria. The Washington fecal 
coliform criterion applies to all marine waters with primary contact 
recreation use, and thus applies to all coastal recreation waters. 
Therefore, Washington is not included in the rule.
Maine
    EPA is also making a minor change with respect to including Maine 
in today's final rule. As explained in the preamble to the proposal (69 
FR 41733), EPA intended to exclude Maine's Class SA waters from 
coverage under the rule; however, EPA failed to list Maine's Class SA 
waters as excluded in the regulatory text of 40 CFR 131.41(e)(2). EPA 
has corrected this omission in today's final rule.
Other States
    EPA identified two other States or Territories that, at the time of 
proposal, intended to adopt EPA's 1986 bacteria criteria by September 
30, 2004. These were Illinois and the Virgin Islands. However, neither 
Illinois nor the Virgin Islands adopted the criteria and received EPA 
approval as of the signature of today's rule.

C. Under What Conditions Will States and Territories Be Removed From 
Today's Rule?

    State and Territorial standards for bacteria approved by EPA 
pursuant to Clean Water Act sections 303(c) and 303(i) will be in 
effect for Clean Water Act purposes, and the Federal criteria for 40 
CFR 131.41 will no longer apply. EPA recognizes that once it approves 
the water quality standards of the State or Territory, the Code of 
Federal Regulations will still include a reference to the State in 40 
CFR 131.41 until EPA formally withdraws the State or Territory from the 
Federal rule, and thereby the Code of Federal Regulations. However, the 
State and Territorial standards for bacteria approved by EPA pursuant 
to Clean Water Act sections 303(c) and 303(i) will be in effect for 
Clean Water Act purposes (and not the Federal criteria at 40 CFR 
131.41) between the time EPA approves the State standards and formal 
withdrawal of the State or Territory from the rule.
    A State or Territory may adopt and submit partial water quality 
standards for EPA's review and approval under today's rule. EPA 
envisions two types of partial water quality standards submittals with 
different results. If a State adopts and submits water quality 
standards that meet all the requirements discussed in today's rule but 
the standards apply only to a portion of the State's coastal recreation 
waters, EPA expects to approve the State standards for the coastal 
recreation waters to which they apply, and today's Federal standards 
would continue to apply to all coastal recreation waters that are not 
addressed in the submittal. The combination of the approved State and 
Federal standards serve to meet the requirements of Clean Water Act 
section 303(i). If a State adopts and submits standards for all of its 
coastal recreation waters but the standards do not satisfy all of the 
considerations described in today's rule as necessary for EPA to make a 
determination that the State standards are as protective of human 
health as the 1986 bacteria criteria, EPA expects to disapprove the 
entire submittal and today's Federal standards would continue to apply 
to the State's coastal recreation waters. For example, a State might 
adopt water quality standards that contain only a geometric mean for 
marine waters of 35/100 ml for enterococci and not a single sample 
maximum provision. This would not be sufficient to satisfy section 
303(i). EPA anticipates that it would be administratively unworkable to 
approve State standards in piecemeal fashion and to supplement 
piecemeal State standards with components of today's rule, as in the 
example of a State that adopts a State geometric mean but must still 
retain a Federal single sample maximum for its coastal recreation 
waters.

VI. Response to Additional Significant Public Comments

    EPA has prepared a Comment Response Document, which addresses the 
comments that EPA received and is included in the docket for today's 
rule. Below, EPA provides a summary of its responses to four additional 
categories of significant comments.

A. 1986 Bacteria Criteria

    Some commenters raised concerns about EPA's 1986 bacteria criteria. 
The bulk of the comments questioned the reliability of the studies on 
which EPA based the criteria. Some remarked that the studies evaluated 
in the criteria document did not appropriately select test sites 
because the test sites were all located on the East Coast and therefore 
may not represent conditions on the West Coast; the test sites had only 
one source of pollution (human); and no control sites were used. In 
addition, commenters characterized the data as anecdotal rather than 
clinical in nature (e.g., blood and stool samples) and suggested that 
the studies did not ensure that the reported illnesses were due to 
pathogens relating to bathing in the water. Others questioned EPA's 
chosen risk levels. One commenter suggested other possible indicators. 
Others commented on the lack of EPA follow-up epidemiological studies 
since 1986.
    EPA acknowledges these comments, but notes that Clean Water Act 
section 303(i) requires States and Territories with coastal recreation 
waters to adopt water quality criteria for bacteria as protective of 
human health as the criteria published by EPA under Clean Water Act 
section 304(a). Section 303(i) was added to the Clean Water Act in 2000 
by the BEACH Act. At the time the BEACH Act was enacted, the current 
Clean Water Act section 304(a) criteria were EPA's 1986 bacteria 
criteria because these are EPA's only currently recommended bacteria 
criteria for protection of primary contact recreation waters. The 
legislative history makes it clear that Congress recognized that EPA's 
1986 bacteria criteria have flaws, but also that Congress wanted States 
to adopt standards based on them by April 10, 2004, despite those 
flaws,

[[Page 67236]]

presumably because Congress thought the 1986 bacteria criteria are 
better than what it characterized as ``outdated'' criteria used by some 
States. (See H. Rep. No. 106-98, at 6 (1999); see generally S. Rep. No. 
106-366 (2000) and H. Rep. No. 106-98.)
    EPA had reviewed its original studies supporting its recommended 
1986 water quality criteria for bacteria and the literature on human 
health research conducted since EPA completed the original studies of 
health effects associated with swimming in marine and freshwater, as 
discussed on pages 10-13 of the Implementation Guidance for Ambient 
Water Quality Criteria for Bacteria (EPA-823-B-02-003, May 2002 Draft) 
. Based on these reviews, EPA has confirmed that the 1986 EPA 
recommended water quality criteria for bacteria are protective of human 
health against acute gastrointestinal illness.
    The epidemiological studies used to develop the criteria were 
themselves peer reviewed. The marine studies were peer reviewed in the 
Journal of the American Public Health Association. EPA's Office of 
Research and Development reviewed the freshwater studies. The Harvard 
School of Public Health evaluated the epidemiology test protocol for 
both fresh and marine studies, and the University of Pittsburgh Center 
for Excellence provided an independent review of the results of the 
epidemiology studies. Finally, the 1986 bacteria criteria were reviewed 
by the public when EPA published a Federal Register notice concerning 
the criteria (49 FR 21987, May 24, 1984).
    While Congress directed in Clean Water Act section 303(i) that, by 
April 9, 2004, States and Territories adopt criteria as protective as 
EPA's current criteria, Congress also recognized that ``EPA's 1986 
criteria need to be updated to improve the scientific basis for 
identifying pathogens in coastal waters.'' S. Rep. No. 106-366, at 2. 
To address this concern, Congress amended Clean Water Act section 
304(a) to require EPA to ``publish [within five years of enactment of 
the BEACH Act] new or revised water quality criteria for pathogens and 
pathogen indicators (including a revised list of testing methods, as 
appropriate), based on the results of the studies conducted * * * for 
the purpose of protecting human health in coastal recreation waters.'' 
See Clean Water Act section 304(a)(9). Thus, while Congress recognized 
that the 1986 bacteria criteria need improvement, Congress still 
required States and Territories to adopt water quality standards as 
protective of human health as the 1986 bacteria criteria. EPA is 
currently conducting epidemiological studies on potential health risks 
resulting from exposure to pathogens or pathogen indicators in coastal 
recreation waters, as required under this section of the Clean Water 
Act. Once EPA publishes these new criteria, EPA expects that States and 
Territories will begin to adopt water quality standards as protective 
of human health as the new criteria for coastal and Great Lakes 
recreation waters, as required by Clean Water Act section 303(i)(1)(B).

B. Economics

    Some commenters noted that, if the rule imposes single sample 
maximums as ``not-to-be-exceeded'' values, the geometric mean component 
of the criteria would be significantly different from the geometric 
mean values in most State current fecal coliform bacteria criteria for 
recreation. For fecal coliform criteria to protect recreational uses, 
most State criteria include a geometric mean value and a threshold 
value not to be exceeded in more than 10% of the samples. Some 
commenters state that there will be a substantial cost difference to 
regulated entities if the rule imposes single sample maximums for E. 
coli or enterococci as ``not-to-be exceeded'' values, noting that EPA's 
economic analysis in the proposal does not address the cost of 
controlling discharges from combined sewer overflows, sanitary sewer 
overflows, and municipal separate storm sewer systems to meet such 
single sample maximums, and that EPA's cost estimates for controlling 
these sources in other regulatory and policy actions are not based on a 
single sample maximum as a never-to-be exceeded criterion for Clean 
Water Act purposes.
    Today's rule does not treat single sample maximums as a requirement 
that may never be exceeded in all instances. Single sample maximums are 
values that indicate, with a certain degree of confidence, that a 
waterbody may exceed the geometric mean. The State can collect 
additional data on a receiving water if it believes that the violation 
of the single sample maximum does not indicate violation of the 
geometric mean, as described in the preamble to today's rule.
    For its economic analysis, EPA evaluated the potential controls for 
publicly owned treatment plants and industrial facilities likely to 
discharge bacteria to meet permit limits based on the single sample 
maximums as never-to-be exceeded values to provide a conservatively 
high estimate of cost. In reality, States and Territories have 
flexibility in implementing the criteria in National Pollutant 
Discharge Elimination System permits. EPA also assumed that none of the 
States covered by the rule had adopted E. coli or enterococci as the 
applicable water quality standard whereas several of the States in 
today's rule have water quality standards for E. coli or enterococci 
already in place for some of their coastal recreation waters. This also 
led to a higher estimate of cost than may actually be incurred. EPA 
addresses discharges of bacteria from municipal separate storm sewers, 
combined sewer overflows, sanitary sewer overflows, and nonpoint 
sources (e.g., agriculture) to coastal waters in existing regulations 
and policies, and has tallied potential control costs to comply with 
those regulations and policies as part of analyses for those actions. 
In general, the best management practices or treatment controls for wet 
weather discharges that are designed to meet fecal coliform standards 
in a waterbody are also the best management practices or treatment 
controls used to address E. coli and enterococci. Because of the 
substantial variability in bacterial indicators and the site-specific 
effectiveness of control measures, EPA is not able to determine at this 
time if additional measures will ultimately be necessary to meet 
criteria based on the new indicators. Compliance with pathogen 
standards is best achieved through an adaptive management approach 
based on cost-effective management practices and control measures 
coupled with on-going monitoring and revision of control plans as 
necessary.

C. Analytical Methods

    EPA received a few comments on the topic of analytical methods. One 
commenter expressed concern that EPA has not published EPA-approved 
analytical methods for measuring enterococci and E. coli in effluent. 
EPA recognizes that it has not yet published analytical methods for 
measuring enterococci and E. coli in effluents. EPA published its 
methods for measuring enterococci and E. coli in ambient waters on July 
21, 2003, and is now in the process of proposing methods for measuring 
these pathogen indicators in effluent. EPA has completed its inter-
laboratory study of method 1600 for enterococci and method 1603 for E. 
coli in secondary treated effluents, and has determined that the 
variability found in this study support publication of a proposed 
method for effluents. EPA is moving expeditiously to promulgate these 
methods.
    Three commenters noted that the inter-laboratory study for 
enterococci and E. coli methods discussed above did not address pulp 
and paper effluents,

[[Page 67237]]

and that these effluents are suspected of containing E. coli and 
enterococci independent of fecal matter. As a result, the commenters 
suggest that EPA complete validation studies of enterococci and E. coli 
methods for pulp and paper effluents before requiring States to 
implement the criteria in National Pollutant Discharge Elimination 
System permits for pulp and paper facilities. EPA disagrees that it 
must complete additional validation studies before States use the 
criteria for permits. EPA has completed its inter-laboratory validation 
for EPA Methods 1600 and 1603 for effluents, and is in the process of 
proposing these methods. In addition, EPA is currently completing its 
inter-laboratory validation for EPA Methods 1103.1 and 1106.1 in 
effluents, and intends to propose them after the validation process is 
completed. EPA did not specifically use pulp and paper effluent 
matrices in the study. EPA method validation studies typically include 
several representative matrices and are not intended to include every 
potential effluent matrix to which a method may be applicable. In 
addition, EPA notes that its National Pollutant Discharge Elimination 
System regulations do not require that compliance monitoring for 
National Pollutant Discharge Elimination System permits be based on 
EPA-approved methods. 40 CFR 122.41(j)(4) provides that monitoring 
results must be conducted according to test procedures approved under 
40 CFR Part 136 unless other test procedures have been specified in the 
permit. States implementing the criteria in National Pollutant 
Discharge Elimination System permits may thus specify some other 
analytical method that the permittee is to use for compliance 
monitoring. Of course, any such method must be scientifically 
defensible, which usually means that it has been tested and verified by 
some other recognized standard setting or method development body. 
Permittees who believe that a particular method is not appropriate or 
reliable for their effluent may present documentation of this concern 
to the permitting authority for consideration in determining compliance 
monitoring requirements.

D. Effective Date

    Section 553 of the Administrative Procedure Act provides that a 
substantive rule shall be published not less than 30 days before its 
effective date, except under certain circumstances. EPA is promulgating 
today's rule with an effective date of 30 days after publication in the 
Federal Register in order to make the water quality criteria effective 
as soon as possible and available for use in assessing beach safety and 
for other Clean Water Act purposes. This will serve to protect human 
health at coastal recreation waters.
    EPA received two comments on this issue. One commenter requested 
that EPA delay promulgating the rule until July 2005 and another 
commenter suggested that EPA delay the effective date for 90 days so 
that a State could complete its own promulgation of water quality 
standards based on the 1986 bacteria criteria. EPA disagrees that it 
should allow more than 30 days because this would delay the time at 
which States and Territories will begin using today's water quality 
criteria to govern decisions about opening and closing beaches and for 
other Clean Water Act purposes. EPA understands the interest of the 
commenters in having their State standards serve as the effective 
standards for Clean Water Act purposes. If a State adopts, and EPA 
approves, standards satisfying Clean Water Act section 303(i) shortly 
after the effective date of this rule, the State criteria will 
immediately replace the criteria in today's rule for Clean Water Act 
purposes within the State, consistent with 40 CFR 131.41(d)(i). EPA 
does not expect that a short window during which Federal standards are 
in effect will unduly disrupt on-going State water quality standards 
programs. Therefore, EPA is making the rule effective 30 days after 
publication in the Federal Register.

VII. Alternative Regulatory Approaches and Implementation Mechanisms

    States and Territories have considerable discretion in designating 
uses. A State or Territory may find that changes in use designations 
are warranted. EPA will review any new or revised use designations 
adopted by States or Territories for coastal recreation waters covered 
by this rule to determine if the standards meet the requirements of the 
Clean Water Act and implementing regulations. In adopting recreation 
uses, the States and Territories may wish to consider additional 
categories of recreation uses. If States and Territories change the 
designated use of a waterbody consistent with Clean Water Act section 
303(c) and the regulations at 40 CFR Part 131, such that they are no 
longer designated for swimming, bathing, surfing, or similar water 
contact activities, then the waterbody would not be covered by the 
Clean Water Act definition of ``coastal recreation waters'' or this 
rule.
    EPA reminds the States and Territories that they must conduct use 
attainability analyses as required by 40 CFR 131.10(g) when adopting 
water quality standards that do not include the uses specified in Clean 
Water Act section 101(a)(2) or with subcategories of the designated 
uses specified in Clean Water Act section 101(a)(2) that require less 
stringent criteria (see 40 CFR 131.10(j)), than those currently in 
effect.

VIII. Economic Analysis

    These water quality standards may serve as a basis for development 
of National Pollutant Discharge Elimination System permit limits. Many 
of the affected jurisdictions (i.e., States and Territories) are the 
National Pollutant Discharge Elimination System permitting authorities, 
which retain considerable discretion in implementing standards. EPA 
evaluated the potential costs to National Pollutant Discharge 
Elimination System dischargers in affected jurisdictions associated 
with State and Territorial implementation of today's standards. This 
analysis is documented in ``'Economic Analysis for Final Water Quality 
Standards for Coastal Recreation Waters,''' which can be found in the 
record for this rulemaking.
    Any National Pollutant Discharge Elimination System-permitted 
facility that discharges to waterbodies affected by this rule could 
potentially incur compliance costs. The types of affected facilities 
may include industrial facilities and publicly owned treatment works 
(POTWs) discharging sanitary wastewater to surface waters (i.e., point 
sources). In addition, EPA addresses discharges of bacteria from 
municipal separate storm sewer systems, combined sewer overflows, and 
sanitary sewer overflows to coastal waters in existing regulations and 
policies, and has tallied potential control costs as part of the 
analyses for those actions. EPA expects that States and municipalities 
will continue to use the same types of controls to come into compliance 
with the revised criteria as are currently used for compliance with 
existing regulations and policies. Available evidence suggests that if 
discharges are controlled in such a way that fecal coliform criteria 
are met, it is likely that enterococci and E. coli criteria would also 
be met, and there would not be an increase in impaired waters, 
resulting in additional Total Maximum Daily Loads, though not enough is 
known about the relationship between sources, controls, and the various 
indicators to conclude this with any certainty at this time. EPA did 
not evaluate the costs of this rule to Concentrated Animal Feeding

[[Page 67238]]

Operations because the regulations for Concentrated Animal Feeding 
Operations prohibit discharges except in unusual circumstances (i.e., 
very large storms) and therefore those entities are unlikely to incur 
any additional costs as a result of today's rule. EPA did not evaluate 
the potential for costs to nonpoint sources, such as agricultural 
runoff. Finally, EPA did not attempt to quantify the potential benefits 
of the rule.
    EPA recognizes that a State or Territory may decide to require 
controls for nonpoint sources (e.g., agricultural runoff). However, it 
is difficult to model and evaluate the potential costs impacts of this 
rule to those sources because they are intermittent, highly variable, 
and occur under different hydrologic or climatic conditions than 
continuous discharges from industrial and municipal facilities, which 
EPA evaluates under critical low flow or drought conditions. Also, data 
on instream and discharge levels of bacteria after States have 
implemented controls to meet current water quality standards based on 
fecal coliform are not available. Therefore, trying to determine which 
sources would not achieve standards based on E. coli or enterococci 
after complying with existing regulations and policies may not be 
possible, and would be extremely time and resource intensive. Finally, 
it is likely that controls needed to meet existing criteria (assumed 
for the purpose of costing to be fecal coliform for all States covered 
by the rule) would also address water quality problems indicated by 
criteria for E. coli or enterococci.

A. Identifying Affected Facilities

    EPA identified approximately 734 point source facilities that may 
be affected by the rule. Of these potentially affected facilities, 306 
are classified as major dischargers, and 428 are minor dischargers. EPA 
did not include general permit facilities in its analysis because data 
for such facilities are extremely limited, and flows are usually 
negligible. Furthermore, EPA could not determine if any of these 
facilities with general permits actually discharge to the affected 
water bodies because facility location information is not available in 
EPA's Permit Compliance System database.
    Of the facilities located in jurisdictions included in the rule, 
EPA evaluated that subset of facilities with individual permits that 
discharge within two miles of coastal waters or the Great Lakes. EPA 
identified these facilities by relating facility information to the 
potentially affected waters using Geographic Information System 
software. EPA also assumed that only wastewater treatment plants or 
facilities with similar effluent characteristics (i.e., facilities 
having the potential to discharge bacteria in the form of fecal matter) 
may be affected. For those facilities for which latitude/longitude data 
are not included in the Permit Compliance System, EPA included only 
facilities for which the receiving waterbody name in the Permit 
Compliance System indicates a coastal water (e.g., Pacific Ocean, Lake 
Erie). Table 5 summarizes these potentially affected facilities by type 
and category.

                                  Table 5.--Potentially Affected Facilities \1\
----------------------------------------------------------------------------------------------------------------
                                                               Number of Facilities
                                                 ------------------------------------------------
                    Category                                                   Minor                   Total
                                                     Major \2\   --------------------------------
                                                                     Municipal       Other \3\
----------------------------------------------------------------------------------------------------------------
Coastal.........................................             242             233             100             575
Great Lakes.....................................              64              75              20             159
                                                 -----------------
    Total.......................................             306             308             120            734
----------------------------------------------------------------------------------------------------------------
\1\ Facilities from States and Territories included in the rule that discharge within two miles of coastal
  waters or the Great Lakes.
\2\ No major industrial facilities are affected by the rule. However, 4 other facilities (SIC codes 9711 and
  9999) are included because their names indicate that they are wastewater treatment plants.
\3\ Includes the following standard industrial classifications: eating places (5812), drinking places (5813),
  operators of nonresidential buildings (6512), operators of apartment buildings (6513), operators of dwellings
  other than apartment buildings (6514), operators of residential mobile home sites (6515), hotels and motels
  (7011), recreational vehicle parks and campsites (7033), organization hotels and lodging houses (7041),
  physical fitness facilities (7991), amusement and recreation services (7999), skilled nursing care facilities
  (8051), general medical and surgical hospitals (8062), elementary and secondary schools (8211), colleges,
  universities, and professional schools (8221), civic, social, and fraternal associations (8641), private
  households (8811). Also includes the following SICs if the facility name suggests that they may discharge
  sanitary waste: operative builders (1531), sanitary services, not elsewhere classified (4959), real estate
  agents and managers (6531), business associations (8611), religious organizations (8661), services not
  elsewhere classified (8999), air and water resource and solid waste management (9511), national security
  (9711), and nonclassifiable establishments (9999).

B. Method for Estimating Potential Compliance Costs

    To estimate costs, EPA evaluated the 15 major municipal facilities 
with design flows greater than 120 mgd, thus ensuring that the 
facilities with the potential for the largest costs would be evaluated. 
For the remaining facilities, EPA evaluated a sample of facilities to 
represent discharger type and category.
    The Permit Compliance System does not contain E. coli or 
enterococci effluent data for any of the sample facilities. Therefore, 
to evaluate potential costs associated with the E. coli criteria, EPA 
assumed that 100% of the fecal coliform measured at the sample 
facilities is E. coli because E. coli is a type of fecal coliform. EPA 
assumed that all potentially affected facilities need effluent limits 
that are required to meet both the applicable geometric mean and single 
sample maximum values promulgated in today's rule. Based on the last 3 
years of data, EPA thus estimated that facilities with average monthly 
effluent levels exceeding a geometric mean of 126/100 ml, or maximum 
daily levels exceeding 235/100 ml, would most likely need treatment 
controls to meet potential permit limits based on today's rule.
    Enterococci are fecal bacteria in the fecal streptococcus group, 
and their relationship to fecal coliform bacteria is uncertain. 
Therefore, for coastal facilities, EPA used data and information in the 
literature regarding the ratio of fecal coliform to enterococci in 
untreated sewage, and the inactivation of both of these bacteria at 
minimum disinfection levels, to identify the concentrations of fecal 
coliform (as related to enterococci) that may indicate a need for 
controls. Data in the literature indicate that the ratio of fecal 
coliform to fecal streptococcus in untreated sewage ranges from about 4 
to 28. EPA

[[Page 67239]]

used the most conservative (i.e., erring on the side of overestimating 
costs) ratio of 4 (i.e., fecal coliform levels are 4 times fecal 
streptococcus levels) to estimate the fecal coliform levels at which 
facilities would need treatment to comply with the enterococci 
criteria. A ratio of 4 translates to fecal coliform levels of 140 fecal 
coliform per 100 ml (4 * 35 = 140/100 ml); however, for consistency 
with the Great Lakes analysis, EPA estimated costs based on meeting a 
more stringent value of 126 fecal coliform per 100 ml. In addition, EPA 
assumed that coastal facilities with maximum fecal coliform effluent 
values exceeding 235 colonies per 100 ml would need treatment controls 
(even though 235/4 = 59, which is more stringent than the single sample 
maximum value of 104 in the final rule).
    Experiences from four facilities currently having effluent 
limitations to meet E. coli and enterococci criteria, as well as the 
current fecal coliform criteria, suggest that chlorination processes 
can be upgraded or adjusted to treat the levels of bacteria necessary 
for compliance with effluent limitations based on today's rule. 
Therefore, EPA estimated that optimization of existing disinfection 
processes would enable the sample facilities to comply with the rule. 
Process optimization usually involves process analysis and process 
modifications, and EPA's cost estimates include both capital and 
operating and maintenance costs.

C. Results

    Based on the results for the 15 facilities with flows greater than 
120 mgd, and extrapolating the sample results to the remaining 
potentially affected facilities, EPA estimated a total annual cost of 
approximately $20 million ($13 million for coastal facilities, and $7 
million for Great Lakes facilities). EPA estimates that approximately 
70 major and 20 minor permittees could incur control costs as a result 
of permit modifications to include limits based on the criteria in 
today's rule.

IX. 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 the regulatory action is ``significant'' 
and therefore subject to Office of Management and Budget (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.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that this rule is a ``significant regulatory action.'' As 
such, this action was submitted to OMB for review. Changes made in 
response to OMB suggestions or recommendations are documented in the 
public record.

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.). 
It does not include any information collection, reporting, or record-
keeping 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 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), as amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 
601 et seq., 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.
    For purposes of assessing the impacts of today's rule on small 
entities, small entity is defined as: (1) A small business according to 
RFA default definitions for small business (based on Small Business 
Administration size standards); (2) a small governmental jurisdiction 
that is a government of a city, county, town, school district or 
special district with a population of less than 50,000; and (3) a small 
organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of today's rule on small 
entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. As discussed 
below, these water quality standards do not directly apply to any 
discharger, including small entities.
    Clean Water Act section 303(i)(2)(A) requires that if a State or 
Territory fails to adopt water quality criteria and standards in 
accordance with paragraph (1)(A) that are as protective of human health 
as the criteria for pathogen indicators for coastal recreation waters 
published by the Administrator, the Administrator shall promptly 
propose regulations for the State or Territory setting forth revised or 
new water quality standards for pathogen indicators described in 
paragraph (1)(A) for coastal recreation waters of the State or 
Territory. These State standards (or EPA-promulgated standards) are 
implemented through various water quality control programs including 
the National Pollutant Discharge Elimination System program, which 
limits discharges to navigable waters except in compliance with a 
National Pollutant Discharge Elimination System permit. The Clean Water 
Act requires that all National Pollutant Discharge Elimination System 
permits include any limits on discharges that are necessary to meet 
applicable water quality standards.
    In cases in which a discharger (including a small entity) is 
discharging pathogens into waters subject to these standards, the 
permitting authority will

[[Page 67240]]

need to determine whether the discharge is or may be discharged at a 
level which will cause, contribute to, or have the reasonable potential 
to cause an exceedance of the applicable water quality standard. In 
making that determination, the permitting authority would need to 
consider the factors listed in 40 CFR 122.44(d)(1)(ii). Whether a 
permitting authority will need to require a water quality-based 
effluent limit depends on the analysis of these factors, which will 
vary based on the specific facts of each permit decision. Based on that 
analysis, if the permitting authority finds that the discharger causes, 
contributes to, or has the reasonable potential to cause an exceedance 
of the applicable water quality standard, after the application of any 
required technology-based effluent limits, then the permitting 
authority will need to impose a water quality-based effluent limit to 
meet the applicable water quality standard. (See Clean Water Act 
section 301(b)(1)(C); 40 CFR 122.44(d).) Therefore, as a practical 
matter, today's rule may or may not necessitate a change in the permit, 
depending on the specific circumstances. While the Clean Water Act and 
its implementing regulations may trigger the need for new or revised 
discharge limits based on the water quality standards in today's rule 
to be placed on small entities in some cases, the standards themselves 
do not directly apply to any discharger, including small entities.
    In the ``Economic Analysis for Final Water Quality Standards for 
Coastal Recreation Waters,'' EPA presents an analysis which supports a 
conclusion that today's rule will likely affect only a few small 
entities. (See the docket for today's rule.)

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. The definition of ``State'' for the 
purposes of the Unfunded Mandates Reform Act includes ``a territory or 
possession of the United States.'' Under section 202 of the Unfunded 
Mandates Reform Act, 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 Unfunded 
Mandates Reform Act 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 
section 203 of the Unfunded Mandates Reform Act 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 
provisions of Title II of the Unfunded Mandates Reform Act) that may 
result in expenditures to State, local and Tribal governments, or the 
private sector, in the aggregate of $100 million or more in any one 
year. Therefore, this rule is not subject to the requirements of 
sections 202 and 205 of the Unfunded Mandates Reform Act.
    EPA has determined that this rule contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. Thus, this rule is not subject to the requirements of 
section 203 of the Unfunded Mandates Reform Act.

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. EPA's authority and 
responsibility to promulgate Federal water quality standards when State 
standards do not meet the requirements of the Clean Water Act is well 
established and has been used on various occasions in the past. The 
final rule does not substantially affect the relationship of EPA and 
the States and Territories, or the distribution of power or 
responsibilities between EPA and the various levels of government. The 
final rule does not alter the States' or Territories' considerable 
discretion in implementing these water quality standards. Further, this 
rule does not preclude the States and Territories from adopting water 
quality standards that meet the requirements of the Clean Water Act, 
either before or after promulgation of the final rule, thus eliminating 
the need for Federal standards. Thus, Executive Order 13132 does not 
apply to this rule.
    Although Executive Order 13132 does not apply to this rule, in the 
spirit of Executive Order 13132 and consistent with EPA's policy to 
promote communication between EPA and State and local governments, EPA 
did consult with representatives of the States and Territories subject 
to Clean Water Act section 303(i) in developing this rule. Prior to 
this rulemaking action, EPA had numerous phone calls, meetings and 
exchanges of written correspondence with the States to discuss EPA's 
concerns with the States' bacteria criteria, compliance with the BEACH 
Act, and the Federal rulemaking process. In June 2000, EPA and the 
Association of State and Interstate Water Pollution Control 
Administrators (ASIWPCA) established a State/EPA Work Group on Water 
Quality Standards, composed of selected senior State and EPA managers, 
to provide input to EPA on water quality standards issues. The group 
has met approximately three times per year since then, beginning with a 
meeting in September 2000. At every meeting the group has discussed the 
scientific, programmatic, and policy aspects of bacteria criteria for 
both coastal and non-coastal recreation waters, and has provided useful 
input to EPA on these topics. Members of this group, together with 
other interested State participants, have also served as an ad-hoc work

[[Page 67241]]

group since 2001 to assist EPA in developing draft detailed scientific 
and policy guidance (Implementation Guidance for Ambient Water Quality 
Criteria for Bacteria (EPA-823-B-02-003, May 2002 Draft)) concerning 
adoption and implementation of EPA's recommended criteria for bacteria. 
Today's final rule reflects State and Territorial input, and EPA has 
responded to State and Territorial comment on various topics in the 
preamble to today's rule and in the Comment Response Document, which is 
part of the record for this rule.

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 6, 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.''
    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. 
There are four authorized Indian Tribes with coastal or Great Lakes 
waters; however, they have not yet adopted water quality standards, and 
therefore, have no designated coastal recreation waters within their 
jurisdiction. These Tribes are therefore not subject to today's rule. 
Thus, Executive Order 13175 does not apply to this rule.
    EPA has contacted those Tribes identified as having coastal or 
Great Lakes waters to inform them of the potential future impact this 
could have on Tribal waters.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and 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 rule on children, and explain why the 
regulation is preferable to other potentially effective and reasonably 
feasible alternatives considered by the Agency.
    This rule is not subject to the Executive Order because it is not 
economically significant as defined in Executive Order 12866, and 
because the Agency does not have reason to believe the environmental 
health or safety risks addressed by this action present a 
disproportionate risk to children. As explained in section II.B of the 
preamble to today's rule, EPA developed the water quality criteria 
promulgated in today's rule based on concentrations of E. coli and 
enterococci from EPA-sponsored epidemiological studies reflecting all 
reported illnesses, including those of children. In the marine and 
freshwater studies, the range of the number of children under age 10 
was between 15% and 25% of the total study population. Children in the 
age range 10 to 19 years old made up a slightly higher percentage of 
the study population. During the studies, information on 
gastroenteritis, respiratory symptoms, and other symptoms were 
collected for all participants, including children. EPA designed the 
1986 bacteria criteria to protect all age groups.

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

    This rule is not a ``significant energy action'' as defined in 
Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) because it is not likely to have a significant 
adverse effect on the supply, distribution, or use of energy. EPA 
estimates that compliance with the final rule will create a negligible 
increase in nationwide energy consumption for point source facilities 
discharging to coastal recreation waters in affected States. In section 
VIII, EPA presented its estimated incremental costs to permitted 
facilities as a result of the final rule. Some of these costs include 
energy use associated with increased maintenance of disinfection tanks. 
EPA estimates that the increased energy use from these activities would 
be about 99,000 kilowatt hours. Net production by electric power 
generation facilities in the United States in 2002 was 3,858,452 
million kilowatt hours (Energy Information Administration, Department 
of Energy, http://www.eia.doe.gov/neic/quickfacts/quickelectric.htm). 
EPA estimates that the additional energy requirements of EPA's rule are 
insignificant (i.e., 0.000003% of national energy generation).

I. National Technology Transfer and Advancement Act

    As noted in the proposal, 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 Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.
    While ambient water quality criteria may be considered technical 
standards, EPA is not aware of any voluntary consensus standards 
relating to bacteria criteria to protect human health and none were 
brought to our attention in comments on the proposed rule. Furthermore, 
even if there were such voluntary consensus standards, the BEACH Act 
specifically directs EPA to promulgate Federal standards based on its 
own bacteria criteria, in accordance with Clean Water Act section 
304(a), in cases where States fail to do so. Therefore, EPA is not 
considering the use of any voluntary consensus standards.

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 December 16, 2004.

List of Subjects in 40 CFR Part 131

    Environmental protection, Intergovernmental relations, Reporting

[[Page 67242]]

and recordkeeping requirements, Water pollution control.

    Dated: November 8, 2004.
Michael O. Leavitt,
Administrator.

0
For the reasons set out in the preamble, 40 CFR part 131 is amended as 
follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.

Subpart D--[Amended]

0
2. Section 131.41 is added to Subpart D to read as follows:


Sec.  131.41  Bacteriological criteria for those states not complying 
with Clean Water Act section 303(i)(1)(A).

    (a) Scope. This section is a promulgation of the Clean Water Act 
section 304(a) criteria for bacteria for coastal recreation waters in 
specific States. It is not a general promulgation of the Clean Water 
Act section 304(a) criteria for bacteria. This section also contains a 
compliance schedule provision.
    (b) Definitions. (1) Coastal Recreation Waters are the Great Lakes 
and marine coastal waters (including coastal estuaries) that are 
designated under section 303(c) of the Clean Water Act for use for 
swimming, bathing, surfing, or similar water contact activities. 
Coastal recreation waters do not include inland waters or waters 
upstream from the mouth of a river or stream having an unimpaired 
natural connection with the open sea.
    (2) Designated bathing beach waters are those coastal recreation 
waters that, during the recreation season, are heavily-used (based upon 
an evaluation of use within the State) and may have: a lifeguard, 
bathhouse facilities, or public parking for beach access. States may 
include any other waters in this category even if the waters do not 
meet these criteria.
    (3) Moderate use coastal recreation waters are those coastal 
recreation waters that are not designated bathing beach waters but 
typically, during the recreation season, are used by at least half of 
the number of people as at typical designated bathing beach waters 
within the State. States may also include light use or infrequent use 
coastal recreation waters in this category.
    (4) Light use coastal recreation waters are those coastal 
recreation waters that are not designated bathing beach waters but 
typically, during the recreation season, are used by less than half of 
the number of people as at typical designated bathing beach waters 
within the State, but are more than infrequently used. States may also 
include infrequent use coastal recreation waters in this category.
    (5) Infrequent use coastal recreation waters are those coastal 
recreation waters that are rarely or occasionally used.
    (6) New pathogen discharger for the purposes of this section means 
any building, structure, facility, or installation from which there is 
or may be a discharge of pathogens, the construction of which commenced 
on or after December 16, 2004. It does not include relocation of 
existing combined sewer overflow outfalls.
    (7) Existing pathogen discharger for the purposes of this section 
means any discharger that is not a new pathogen discharger.
    (c) EPA's section 304(a) ambient water quality criteria for 
bacteria.
    (1) Freshwaters:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                C  Single sample maximum  (per 100 ml)
                                                                             ---------------------------------------------------------------------------
                                                                                                                      C3  Light use      C4  Infrequent
               A  Indicator d                        B  Geometric mean          C1  Designated    C2  Moderate use       coastal          use coastal
                                                                                bathing beach    costal recreation  recreation waters  recreation waters
                                                                               (75% confidence      waters  (82%      (90% confidence    (95% confidence
                                                                                    level)       confidence level)        level)             level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli e...................................  126/100 mil a.................              b 235              b 298              b 409              b 575
Enterococci e...............................  33/100 ml c...................               b 61               b 78              b 107             b 151
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(1):
a. This value is for use with analytical methods 1103.1, 1603, or 1604 or any equivalent method that measures viable bacteria.
b. Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
  confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.4.
c. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
d. The State may determine which of these indicators applies to its freshwater coastal recreation waters. Until a State makes that determination, E.
  coli will be the applicable indicator.
e. These values apply to E. coli or enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non-human
  and an epidemiological study shows that the indicator densities are not indicative of a human health risk.

    (2) Marine waters:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              C  Single sample maximum  (per 100 ml)
                                                                         -------------------------------------------------------------------------------
                                                                            C1  Designated     C2  Moderate use      C3  Light use    C4  Infrequent use
               A  Indicator                       B  Geometric mean          bathing beach    coastal recreation  coastal recreation  coastal recreation
                                                                            (75% confidence      waters  (82%        waters  (90%        waters  (95%
                                                                                level)         confidence level)   confidence level)   confidence level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enterococci c.............................  35/100 ml a.................              b 104               b 158               b 276              b 501
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(2):
a. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.

[[Page 67243]]

 
b. Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
  confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.7.
c. These values apply to enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non-human and an
  epidemiological study shows that the indicator densities are not indicative of a human health risk.

    (3) As an alternative to the single sample maximum in paragraph 
(c)(1) or (c)(2) of this section, States may use a site-specific log 
standard deviation to calculate a single sample maximum for individual 
coastal recreation waters, but must use at least 30 samples from a 
single recreation season to do so.
    (d) Applicability. (1) The criteria in paragraph (c) of this 
section apply to the coastal recreation waters of the States identified 
in paragraph (e) of this section and apply concurrently with any 
ambient recreational water criteria adopted by the State, except for 
those coastal recreation waters where State regulations determined by 
EPA to meet the requirements of Clean Water Act section 303(i) apply, 
in which case the State's criteria for those coastal recreation waters 
will apply and not the criteria in paragraph (c) of this section.
    (2) The criteria established in this section are subject to the 
State's general rules of applicability in the same way and to the same 
extent as are other Federally-adopted and State-adopted numeric 
criteria when applied to the same use classifications.
    (e) Applicability to specific jurisdictions. (1) The criteria in 
paragraph (c)(1) of this section apply to fresh coastal recreation 
waters of the following States: Illinois, Minnesota, New York, Ohio, 
Pennsylvania, Wisconsin.
    (2) The criteria in paragraph (c)(2) of this section apply to 
marine coastal recreation waters of the following States: Alaska, 
California (except for coastal recreation waters within the 
jurisdiction of Regional Board 4), Florida, Georgia, Hawaii (except for 
coastal recreation waters within 300 meters of the shoreline), 
Louisiana, Maine (except for SA waters and SB and SC waters with human 
sources of fecal contamination), Maryland, Massachusetts, Mississippi, 
New York, North Carolina, Oregon, Puerto Rico (except for waters 
classified by Puerto Rico as intensely used for primary contact 
recreation and for those waters included in Sec.  131.40), Rhode 
Island, United States Virgin Islands.
    (f) Schedules of compliance. (1) This paragraph (f) applies to any 
State that does not have a regulation in effect for Clean Water Act 
purposes that authorizes compliance schedules for National Pollutant 
Discharge Elimination System permit limitations needed to meet the 
criteria in paragraph (c) of this section. All dischargers shall 
promptly comply with any new or more restrictive water quality-based 
effluent limitations based on the water quality criteria set forth in 
this section.
    (2) When a permit issued on or after December 16, 2004, to a new 
pathogen discharger as defined in paragraph (b) of this section 
contains water quality-based effluent limitations based on water 
quality criteria set forth in paragraph (c) of this section, the 
permittee shall comply with such water quality-based effluent 
limitations upon the commencement of the discharge.
    (3) Where an existing pathogen discharger reasonably believes that 
it will be infeasible to comply immediately with a new or more 
restrictive water quality-based effluent limitations based on the water 
quality criteria set forth in paragraph (c) of this section, the 
discharger may request approval from the permit issuing authority for a 
schedule of compliance.
    (4) A compliance schedule for an existing pathogen discharger shall 
require compliance with water quality-based effluent limitations based 
on water quality criteria set forth in paragraph (c) of this section as 
soon as possible, taking into account the discharger's ability to 
achieve compliance with such water quality-based effluent limitations.
    (5) If the schedule of compliance for an existing pathogen 
discharger exceeds one year from the date of permit issuance, 
reissuance or modification, the schedule shall set forth interim 
requirements and dates for their achievement. The period between dates 
of completion for each requirement may not exceed one year.
    If the time necessary for completion of any requirement is more 
than one year and the requirement is not readily divisible into stages 
for completion, the permit shall require, at a minimum, specified dates 
for annual submission of progress reports on the status of interim 
requirements.
    (6) In no event shall the permit issuing authority approve a 
schedule of compliance for an existing pathogen discharge which exceeds 
five years from the date of permit issuance, reissuance, or 
modification, whichever is sooner.
    (7) If a schedule of compliance exceeds the term of a permit, 
interim permit limits effective during the permit shall be included in 
the permit and addressed in the permit's fact sheet or statement of 
basis. The administrative record for the permit shall reflect final 
permit limits and final compliance dates. Final compliance dates for 
final permit limits, which do not occur during the term of the permit, 
must occur within five years from the date of issuance, reissuance or 
modification of the permit which initiates the compliance schedule.

[FR Doc. 04-25303 Filed 11-15-04; 8:45 am]
BILLING CODE 6560-50-P