[Federal Register Volume 69, Number 131 (Friday, July 9, 2004)]
[Proposed Rules]
[Pages 41720-41743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15614]



[[Page 41719]]

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Part V





Environmental Protection Agency





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40 CFR Part 131



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

  Federal Register / Vol. 69, No. 131 / Friday, July 9, 2004 / Proposed 
Rules  

[[Page 41720]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[OW-2004-0010; FRL-7785-6]
RIN 2040-AE63


Water Quality Standards for Coastal and Great Lakes Recreation 
Waters

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to 
establish water quality criteria for bacteria for coastal recreation 
waters in specific States and Territories. The States and Territories 
covered by this proposed rule do not have water quality standards for 
bacteria that comply with the requirements of section 303(i) of the 
Clean Water Act. Under these circumstances, the Act requires EPA to 
promptly propose such standards. The criteria proposed 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. If this proposal is 
promulgated, the Federally designated water quality criteria will be 
added to the States' and Territories' water quality criteria applicable 
to coastal recreation waters. If a State or Territory subsequently 
adopts and EPA approves water quality standards that meet the 
requirements of section 303(i), EPA will withdraw the Federal standards 
for that State's or Territory's coastal recreation waters.

DATES: EPA will accept public comments on this proposed rule until 
August 9, 2004.

ADDRESSES: Submit your comments, identified by Docket ID No. OW-2004-
0010, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Agency Web site: http://www.epa.gov/edocket. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the online instructions for 
submitting comments.
     E-mail: [email protected].
     Fax: (202) 566-0409.
     Mail: Water Quality Standards for Coastal and Great Lakes 
Recreation Waters, Environmental Protection Agency, Mailcode: 4305 T, 
1200 Pennsylvania Ave., NW., Washington, DC 20460. Please include a 
total of three copies.
     Hand Delivery: EPA Docket Center Public Reading Room, EPA/
DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC 
20460. Such deliveries are only accepted during the Docket's normal 
hours of operation, and special arrangements should be made for 
deliveries of boxed information. Please include a total of three 
copies.
    Instructions: Direct your comments to Docket ID No. OW-2004-0010. 
EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the Federal regulations.gov Web sites are 
``anonymous access'' systems, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the May 21, 2002 Federal Register 
(67 FR 38102). For additional instructions on submitting comments, go 
to section I.B. of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: 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., 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. 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.

FOR FURTHER INFORMATION 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. What Should I Consider as I Prepare My Comments for EPA?
II. Background
    A. Statutory and Regulatory Background
    B. 1986 Ambient Water Quality Criteria for Bacteria
III. Proposed Criteria for Pathogen Indicators in Coastal Recreation 
Waters
    A. Scope of Proposed Rule
    B. Proposed Criteria for Pathogen Indicators
    C. Applicability of the Proposed Rule
IV. EPA Review of State and Territorial Standards
    A. How Did EPA Decide Which States and Territories to Include in 
Today's Proposed Rule?
    B. Which States and Territories are Included in Today's Proposed 
Rule?
    C. Under What Conditions Will States and Territories be Removed 
from a Final Rule?
V. Alternative Regulatory Approaches and Implementation Mechanisms
    A. Designating Uses
    B. Compliance Schedules
VI. Economic Analysis
    A. Identifying Affected Facilities
    B. Method for Estimating Potential Compliance Costs
    C. Results
VII. 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

[[Page 41721]]

    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

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 only entities directly affected by 
the proposed rule. People concerned with water quality in Coastal and 
Great Lakes States may be interested in this proposed rule. Facilities 
discharging pollutants to certain waters of the United States in 
Coastal and Great Lakes States could be indirectly affected by this 
proposed rule since water quality standards are used in determining 
water quality-based National Pollutant Discharge Elimination System 
(NPDES) permit limits. In addition, beach managers and businesses in 
beach areas could also be indirectly affected by this proposed rule 
since water quality standards are used in making decisions regarding 
beach advisories and closures. Categories and entities that may 
indirectly be affected include:

------------------------------------------------------------------------
                                              Examples of potentially
                 Category                        affected entities
------------------------------------------------------------------------
Industry.................................  Industries discharging
                                            pollutants to the waters of
                                            the States and Territories
                                            identified in Sec.   131.41.
Municipalities...........................  Publicly-owned treatment
                                            works discharging pollutants
                                            to the waters of the States
                                            and Territories identified
                                            in Sec.   131.41.
Other....................................  Beach owners and managers,
                                            beach goers
------------------------------------------------------------------------

    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 Sec.  131.41 of today's proposed rule. If you 
have questions regarding the applicability of this action to a 
particular entity, consult one of the persons listed in the preceding 
FOR FURTHER INFORMATION CONTACT section.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit information claimed as CBI to EPA 
through EDOCKET, regulations.gov or e-mail. Clearly mark the part or 
all of the information that you claim to be CBI. For CBI information in 
a disk or CD-ROM that you mail to EPA, mark the outside of the disk or 
CD-ROM as CBI and then identify electronically within the disk or CD-
ROM the specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
    i. Identify the rulemaking by docket number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vii. Explain your views as clearly as possible.
    viii. Make sure to submit your comments by the comment period 
deadline identified.
    3. Docket Copying Costs. The first 266 pages are free. Additional 
copying incurs a $25 administrative fee and each additional page is 
$0.15.

II. Background

A. Statutory and Regulatory Background

1. Clean Water Act
    Section 303 (33 U.S.C. 1313) of the Clean Water Act (CWA) 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 CWA. 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 to be made of the water and water quality criteria necessary to 
protect those uses. The designated uses to be considered by States, 
Territories, and authorized Tribes in establishing water quality 
standards are specified in the CWA: Public water supplies, propagation 
of fish and wildlife, recreation, agricultural uses, industrial uses 
and navigation. States, Territories, and authorized Tribes are to 
review their water quality standards at least once every three years 
and, if appropriate, revise or adopt new standards. The results of this 
triennial review must be submitted to EPA, and EPA must approve or 
disapprove any new or revised standards.
    Section 303(c) of the CWA 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 CWA's requirements. EPA regulations implementing CWA 
section 303(c) are published at 40 CFR part 131. Under these rules, the 
minimum elements that must be included in a State's, Territory's, or 
authorized Tribe's 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).
2. The BEACH Act of 2000
    The Beaches Environmental Assessment and Coastal Health (BEACH) Act 
of 2000 amended the CWA 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-

[[Page 41722]]

84-002) is the relevant criteria document published by the 
Administrator under CWA section 304(a).
    Section 303(i)(2)(A) requires that, ``[i]f a State fails to adopt 
water quality 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) to the CWA, 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) 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. Primary contact 
recreation is typically defined by States and Territories to encompass 
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 activity where immersion in the water is likely. The main 
route of exposure to illness-causing organisms in recreational waters 
is through accidental ingestion of fecally-contaminated water while 
engaging in these activities.
    EPA's water quality criteria for bacteria are based on levels of 
indicator bacteria, namely Escherichia coli (E. coli) and enterococci, 
that demonstrate the presence of fecal pollution. Indicator organisms 
such as these have long been used to protect people from illnesses that 
may be contracted 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 is a term for 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. 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 were more accurate predictors of acute 
gastrointestinal illness than levels of fecal coliforms.
    In EPA's epidemiological studies, E. coli and enterococci exhibited 
the strongest correlation to swimming-associated gastroenteritis, the 
former in fresh waters only and the latter in both fresh and marine 
waters (Ambient Water Quality Criteria for Bacteria--1986, January, 
1986, EPA 440/5-84-002; Health Effects Criteria for Fresh Recreational 
Waters, August, 1984, EPA 600/1-84-004; Health Effects Criteria for 
Marine Recreational Waters, August, 1983, EPA 600/1-80-031). 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, 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) .
    Table 1 contains the water quality criteria values for the 
protection of primary contact recreation that EPA recommended in the 
1986 bacteria criteria document (Ambient Water Quality Criteria for 
Bacteria--1986). These values were developed 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 criterion. This illness rate was estimated 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 1986 values that 
appear in Table 1 were based on these approximations. The 1986 bacteria 
criteria document provides geometric mean densities (represented as 
average densities over the swimming season) as well as single sample 
maximum (SSM) values (representing an unacceptably high value for a 
single sample).
    A geometric mean represents the central tendency of a series of 
data points. Using a geometric, as opposed to an arithmetic, mean helps 
to minimize the effect of measurements that might otherwise be 
considered outliers. The best way to interpret a series of bacterial 
measurements taken over a period of time is in comparison to the 
geometric mean. With a large number of measurements, the calculated 
geometric mean is expected to be ``close'' to the ``true'' mean of 
bacterial concentrations in the waterbody. In contrast, a single sample 
with a high value does not necessarily indicate that the waterbody as a 
whole has high bacterial levels. The SSM values in the 1986 bacteria 
criteria document correspond to probabilities of getting a particular 
single sample result when the true mean meets the criterion. A 75% 
confidence level value corresponds to the level above which individual 
sample values would occur only 25% of the time if the mean level in the 
waterbody still meets the standard. Statisticians say that a single 
sample reading at this level indicates, with 75% confidence, that the 
standard is not being met. The best way to interpret any single 
measurement (or small number of measurements) is in comparison to the 
SSM. Selecting a lower SSM (e.g., 75%) for comparison to single 
measurements will result in a more conservative estimate of whether the 
standard is being met. That is, it will set a relatively low bar (75% 
confidence) for a determination that the standard has been exceeded. 
This will be protective of public health but may result in a greater 
number of determinations that the standard was violated. In contrast, 
selecting a higher SSM (e.g., 95%) for comparison to single 
measurements will result in a less cautious (i.e., less protective) 
decision rule but greater certainty that a reading above the SSM really 
does indicate that bacteria levels in the waterbody as a whole exceed 
the standard.
    The 1986 bacteria criteria document includes a table of four SSM 
values for each geometric mean based on beach

[[Page 41723]]

usage, which in turn are based on different confidence levels. In 
general, where there is a greater potential for exposure in a given 
area, a higher degree of protectiveness (i.e., a lower bar for 
determining an exceedance) is warranted. The 1986 bacteria criteria 
document categorizes the four SSMs as follows: ``designated bathing 
beach'' for the 75 percent (most protective) confidence level, 
``moderate use for bathing'' for the 82 percent confidence level, 
``light use for bathing'' for the 90 percent confidence level, and 
``infrequent use for bathing'' for the 95 percent confidence level. The 
lowest SSM was assigned to designated bathing beach areas because a 
high degree of caution should be used to evaluate the statistical 
significance of a measured single value above the criteria for these 
areas. The 1986 bacteria criteria document stated that bathing beach 
areas 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 the 82 percent, 90 percent, and 95 percent confidence 
levels.

                         Table 1.--Criteria for Indicators for Bacteriological Densities
----------------------------------------------------------------------------------------------------------------
                                                              Single sample maximum allowable density
                                                 ---------------------------------------------------------------
                                                                                   Lightly used    Infrequently
     Acceptable swimming          Steady state      Designated     Moderate full     full body    used full body
  associated gastroenteritis     geometric mean     beach area     body contact       contact         contact
    rate per 1000 swimmers     indicator density    (upper 75%      recreation      recreation      recreation
                                                       C.L.)        (upper 82%      (upper 82%      (upper 95%
                                                                       C.L.)           C.L.)           C.L.)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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 should establish its own standard
  deviation for its conditions which would then vary the single sample limit.

III. Proposed Criteria for Pathogen Indicators in Coastal Recreation 
Waters

A. Scope of Proposed Rule

    The requirements of the BEACH Act are limited to ``coastal 
recreation waters,'' which are defined in CWA section 502(21) as the 
Great Lakes and marine coastal recreation waters (including coastal 
estuaries) that are designated under CWA 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 CWA 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. Therefore, 
today's proposal applies only to those Great Lakes and marine waters 
designated by a State or Territory for swimming, bathing, surfing, or 
similar water contact activities.
    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 ambient water quality criteria for bacteria. 
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 conducted a use attainability analysis that supports the decision 
that full attainment of CWA section 101(a) uses (``fishable/
swimmable'') is not feasible for those waters (40 CFR 131.10(g)). For 
example, Ohio has designated all of its portion of Lake Erie as 
``bathing waters.'' In contrast, Pennsylvania has designated a portion 
of Lake Erie as incidental, or secondary, contact recreation. As 
explained in the preceding paragraph, today's proposal 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 CWA 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 CWA 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 CWA 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)).

B. Proposed Criteria for Pathogen Indicators

    EPA's Ambient Water Quality Criteria for Bacteria--1986 were 
developed to protect primary contact recreation uses in ambient waters. 
The criteria have two components: a geometric mean, which has the most 
direct relationship to risk over the course of a recreation season,

[[Page 41724]]

and a single sample maximum (SSM) which is the best value against which 
to compare individual measurements. A geometric mean represents the 
central tendency of a series of measurements: in this case, 
measurements of bacteria levels. This helps to minimize the effect of 
measurements that might otherwise be considered outliers. EPA is 
proposing a geometric mean of 126/100 ml for E. coli in fresh waters 
and four different SSMs, which vary for coastal recreation fresh waters 
based on intensity of use. EPA is proposing a geometric mean of 35/100 
ml for enterococci in marine waters and four different SSMs, which vary 
for coastal recreation marine waters based on intensity of use. These 
are the same values as in the 1986 bacteria criteria document.

                                          Table 2.--Proposed Ambient Fresh Water Quality Criteria for Bacteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     C  single sample maximum (per 100 ml)
                                                                                     -------------------------------------------------------------------
                                                                                                         C2  moderate    C3  light use    C4  infrequent
                                                                       B  geometric    C1  designated    use coastal        coastal        use coastal
                            A  indicator                                   mean        bathing beach      recreation       recreation       recreation
                                                                                      (75% confidence    waters (82%      waters (90%      waters (95%
                                                                                           level)         confidence       confidence       confidence
                                                                                                            level)           level)           level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli............................................................    126/100 ml a            235 b            298 b            409 b           575 b
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(1):
a This value is for use with analytical methods 1106.1 or 1600 or any equivalent viable method.
b Calculated using the following: single sample maximum = geometric mean * 10[supcaret](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.


                                          Table 3.--Proposed Ambient Marine Water Quality Criteria for Bacteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     C  single sample maximum (per 100 ml)
                                                                                     -------------------------------------------------------------------
                                                                                                         C2  moderate    C3  light use    C4  infrequent
                                                                       B  geometric    C1  designated    use coastal        coastal        use coastal
                            A  indicator                                   mean        bathing beach      recreation       recreation       recreation
                                                                                      (75% confidence    waters (82%      waters (90%      waters (95%
                                                                                           level)         confidence       confidence       confidence
                                                                                                            level)           level)           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 1103.1, 1603, or 1604 or any equivalent viable method.
b Calculated using the following: single sample maximum = geometric mean * 10\[supcaret]\ (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.

    With respect to identifying an acceptable risk level, Ambient Water 
Quality Criteria for Bacteria--1986 includes an estimate of the 
historically accepted illness rate associated with the previously 
recommended geometric mean value for the fecal coliform criterion. 
Based on ratios of E. coli and enterococci to fecal coliform densities, 
the historically accepted risk levels for gastrointestinal symptoms 
were estimated to be 0.8% of swimmers at fresh water beaches and 1.9% 
of swimmers at marine beaches. However, the analysis upon which these 
estimates is based is inherently uncertain because there was little 
correlation between illness rate and fecal coliform density. These 
estimated risk levels were used to calculate the specific bacteria 
density values presented in tabular form in the 1986 bacteria criteria 
document. These estimated illness rates are described in the 1986 
bacteria criteria document as approximate and as EPA's best estimates 
at the time. Moreover, it is clear that there is uncertainty both in 
estimating the actual historically-accepted risk levels and in 
translating these values into corresponding concentration criteria for 
E. coli and enterococci in fresh and marine waters. It is also clear 
that because the 1986 bacteria criteria document was published before 
the BEACH Act added section 303(i) to the CWA, the specific values 
presented in tabular form in the 1986 bacteria criteria document were 
only recommendations representing one acceptable choice of risk level 
to apply to the criterion. At the time the 1986 bacteria criteria 
document was published, EPA did not expect that the specific geometric 
mean and SSM values would necessarily be used for establishing uniform 
Federal water quality criteria for coastal recreation waters in 
multiple States, or establish a fixed benchmark for assessing the 
protectiveness of State/Territorial water quality standards for 
bacteria.
    There is no a priori reason to establish a higher level of 
protection for fresh waters than for marine waters. The difference in 
acceptable risk levels in the 1986 bacteria criteria document (8 
illnesses per 1000 swimmers in fresh waters v. 19 per 1000 in marine 
waters) was based solely on the calculated risk levels for the 
previously recommended criterion of 200 fecal coliforms per 100 ml, 
which were different in marine and fresh waters. If the science 
supported a reliable correlation between bacteria concentrations and 
illness rates, the EPA could, in judging whether a fresh water 
criterion is ``as protective of human health as'' EPA's 1986 bacteria 
criteria, consider fresh water criteria associated with risk levels up 
to 1.9% of swimmers to be sufficient. However, EPA cannot determine, 
based on the available data that relate E. coli and enterococci levels 
to illness rates, what bacteria concentration would correlate with risk 
levels over 1.0% in freshwater. Therefore, the data that relate risk 
levels to bacteria concentrations in freshwater are not reliable beyond 
1.0% risk to swimmers. Recent peer review of EPA's analysis of the 
study data relating illness rates to bacteria concentrations supports 
the conclusion that the existing data do not support the

[[Page 41725]]

relationship between rates beyond the level of 1.0% of swimmers and 
their correlating bacteria concentrations (External Peer Review of EPA 
Analysis of Epidemiological Data from EPA Bacteriological Studies, 
February 2004). The peer reviewers said that EPA should not extrapolate 
beyond the 1.0% risk level, based on the observed data. Based on that 
peer-reviewed information, EPA does not believe, at this juncture, that 
it can justify a criterion for fresh water based on any geometric mean 
or SSM higher than the levels associated with an illness rate of 1.0% 
of swimmers as being as protective of human health as EPA's 1986 
bacteria criteria. However, EPA is considering adopting a geometric 
mean and SSM values for fresh water that correspond to an illness rate 
of 1.0% of swimmers, which would be slightly higher than the criteria 
in this proposed rule, which correspond to an illness rate of 0.8% of 
swimmers. The E. coli criteria corresponding to an illness rate of 1.0% 
of swimmers would be a geometric mean of 206/100 ml and SSM values of 
385/100 ml, 489/100 ml, 668/100 ml, and 940/100 ml, corresponding to 
the 75, 82, 90, and 95 percent confidence levels. EPA solicits comment 
on its choice of illness rate for calculating the criteria.
1. Use of the Single Sample Maximum
    EPA is proposing all four SSMs included in the 1986 bacteria 
criteria document for each geometric mean. The SSM values allow 
decision makers to quantitatively determine, based on a single sample, 
when water quality at a particular site may not be associated with 
long-term protective conditions (i.e., when overall bacteria 
concentrations are likely to exceed the protective central tendency). 
This 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 a combined sewer overflow 
outfall). The 1986 bacteria criteria document does not interpret the 
meaning of the term ``single sample maximum''. One interpretation is 
that it is a single value never to be exceeded. EPA is soliciting 
comment on this interpretation.
    An alternative option would be to allow for exceedance of the SSM 
when making attainment decisions because bacterial measurements are 
inherently variable, due to a number of factors that may not 
necessarily reflect underlying water quality. Under this option, an 
unacceptably high value for any given individual sample may be used to 
trigger a beach advisory or closing or additional monitoring, or it 
might be evaluated with other sample results, but would not necessarily 
be used alone to determine nonattainment of the water quality 
standards.
    EPA recognizes that the 1986 bacteria criteria document discusses 
SSMs solely in the context of beach closures. SSMs are particularly 
important in this context because States and Territories generally use 
one or two samples to make beach opening or closure decisions. EPA 
could thus interpret the 1986 bacteria criteria document as 
recommending the use of SSMs only for decisions related to public 
health at beaches. Under this interpretation, the SSMs would be part of 
the water quality criteria, but only used for making beach closure and 
opening decisions. States and Territories could use only the geometric 
mean for other CWA purposes, such as NPDES permitting, TMDLs, and 
waterbody assessments. EPA solicits comment on each of the above 
interpretations of the term ``single sample maximum.'' Based on its 
consideration of these comments, EPA may decide to include an explicit 
interpretation or definition of this term in the final regulatory text.
    The 1986 bacteria criteria document describes the analysis used to 
calculate the criteria. EPA conducted a series of epidemiological 
studies in coastal and Great Lakes waters. At each water studied, EPA 
calculated the geometric mean of the summer bacterial density, and 
correlated this with the summer average gastrointestinal illness rate. 
EPA used this correlation as the basis of the geometric mean criterion. 
Thus, the geometric mean has the most direct relationship to the 
illness rate. With this in mind, EPA could interpret the phrase ``as 
protective of human health as'' the 1986 bacteria criteria document to 
apply only to the geometric mean. Under this interpretation, EPA would 
promulgate only the geometric mean in the final rule. The SSMs would be 
available for use as an implementation tool for making beach opening 
and closure decisions but would not be part of the applicable water 
quality standards. States and Territories would have the flexibility to 
use the SSMs in this or any other application of the water quality 
standards as they deem appropriate. EPA is soliciting comment on this 
interpretation.
2. Categories of Coastal Recreation Waters
    Only one SSM would apply 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. In the 1986 bacteria criteria document, EPA 
associated these categories (corresponding to decreasing exposure 
potential) with increasing confidence level thresholds on which an 
exceedance determination would be based. EPA is proposing the following 
definitions for each category of waterbody:
     Designated bathing beach waters are those coastal 
recreation waters that, during the recreation season, are heavily-used 
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.
     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.
     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.
     Infrequent use coastal recreation waters are those coastal 
recreation waters that are rarely or occasionally used.
    Examples of infrequent use coastal recreation waters might include 
waters that are at remote locations, difficult to access, or 
infrequently used for primary contact recreation due to commerce or 
navigation. States and Territories could, at their discretion, place 
waters in more protective categories. For example, States and 
Territories could choose to provide ``light use'' protection to waters 
that might otherwise be considered ``infrequent use'' waters. EPA is 
soliciting comment on the proposed definitions of the four categories, 
and describes the basis for deriving the definitions in the following 
paragraph.
    The 1986 bacteria criteria document describes designated bathing 
beach waters as those that are frequently lifeguard protected, provide 
parking and other public access, and are heavily used by the public. 
EPA conducted its epidemiological studies using these types of waters. 
The 1986 bacteria criteria document does not define or otherwise 
describe the other usage

[[Page 41726]]

categories. EPA recognizes that in order for the public and beach 
authorities to understand which SSMs apply to which waters, the terms 
in the 1986 bacteria criteria document (designated bathing beach, 
moderate use for bathing, light use for bathing, and infrequent use for 
bathing) need to be defined. EPA reviewed Web sites in various fields 
of study (e.g., meteorology, human health risk characterization, and 
urban planning) that use such terminology to differentiate intensities. 
EPA observed that moderate rainfall is considered to be about 40% of 
heavy rainfall, that moderate alcohol consumption is about 50% of heavy 
consumption, and that moderate traffic is about 50% of heavy traffic 
(``The Effects of Moderate Alcohol Consumption on Mortality After Heart 
Attack,'' www.coloradohealthsite.org/CHNReports/alcohol_heart(1).html; 
``What Constitutes Moderate, Significant, and Major Events?,'' 
www.wxrisk.com/Pages/glossary_geography.htm; ``The Beaufort Wind 
Scale,'' www.crh.noaa.gov/lot/webpage/beaufort). Therefore, EPA 
proposes that moderate use coastal recreation waters be defined as 
waters that are about 50% less intensely used than are designated 
bathing beach waters. EPA also observed that a light breeze is 
considered to be about half that of a moderate breeze, which led to 
EPA's proposal that light use coastal recreation waters have less use 
than moderate use coastal recreation waters.
     a. State Identification of Coastal Recreation Waters by Category. 
EPA intends in today's proposal to objectively define the four 
categories so that the public can clearly identify to which category 
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 proposal to list all those waters in the rule according 
to the four categories defined in 40 CFR 131.41(b). Therefore, EPA is 
proposing not to 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 Web site). Even 
in the absence of such a listing, EPA believes the proposed definitions 
can be objectively applied when CWA actions are taken based on the 
proposed rule. A State or Territory would be required to use the 75 
percent confidence level SSM when developing TMDLs for, or issuing 
permits to facilities discharging into, coastal recreation waters that 
meet the definition of designated bathing beach waters. Similarly, a 
State or Territory would be required to use an SSM that is no less 
stringent than the 95 percent confidence level when developing TMDLs 
for, or issuing permits to facilities discharging into, coastal 
recreation waters that meet the definition of infrequent use coastal 
recreation waters. As States and Territories developed TMDLs and issued 
permits consistent with the SSMs, the public would have the opportunity 
to review and comment upon the application of SSMs as part of the TMDL 
and permitting processes. EPA would use its oversight authority under 
CWA section 402(d) to ensure that States and Territories apply the 
appropriate SSMs when conducting these types of activities.
    EPA's National Beach Guidance and Required Performance Criteria for 
Grants (June, 2002, EPA-823-B-02-004) outlined elements that States and 
Territories with BEACH Act implementation grants are to consider in 
developing tiered monitoring plans. States with BEACH Act 
implementation grants are required to tier their beaches according to 
potential risk to human health and beach use. The monitoring frequency 
and methodology would likely differ depending on how a beach is tiered. 
Because most coastal States and Territories are recipients of BEACH Act 
implementation grants, States and Territories could use their existing 
beach tiering process as a source of information for determining 
frequency in categorizing a coastal recreation water for purposes of 
determining the applicable SSM. EPA is soliciting comment on this 
approach.
    b. Alternative Options for Categorization of Coastal Recreation 
Waters. EPA recognizes that some States and Territories may not have 
enough data regarding the intensity of the use of their coastal 
recreation waters to easily and quickly categorize them according to 
the four categories specified in the proposed rule. For example, some 
States have designated bathing beach waters, but do not further 
categorize the remainder of their coastal recreation waters as to 
intensity of use. Therefore, EPA is considering another approach by 
which the final rule would include only two SSMs for coastal recreation 
waters: the 75 percent confidence level for all designated bathing 
beaches and a single other confidence level (the 82 percent, 90 
percent, or 95 percent confidence level SSM) for all other coastal 
recreation waters. If EPA promulgates this approach in the final 
rulemaking, the rule would include two columns for SSMs, one column for 
designated bathing beach waters and the other column for all other 
coastal recreation waters. EPA would select the specific percent 
confidence levels from the 1986 bacteria criteria document based on 
comments received during the public comment period. In addition, the 
final rule would not include the definitions for moderate, light, and 
infrequent use coastal recreation waters. The final rule would continue 
to include a definition of designated bathing beach waters where the 
SSM corresponding to a 75 percent confidence level would apply. In all 
waters that are not designated bathing beach waters the other SSM would 
apply. As in the proposed option, in implementing SSMs, States and 
Territories would apply the designated bathing beach SSM consistent 
with the proposed definition of designated bathing beach waters in 40 
CFR 131.41(b). EPA expects that a State or Territory would use the 75 
percent confidence level SSM when developing TMDLs for, or issuing 
permits to facilities discharging into, coastal recreation waters that 
meet the definition of designated bathing beach waters, and would use 
the other SSM when conducting these activities for other coastal 
recreation waters. As States and Territories develop TMDLs and issue 
permits consistent with the SSMs, the public would have the opportunity 
to review and comment upon the application of SSMs as part of the TMDL 
and permitting processes. EPA would use its oversight authority under 
CWA section 402(d) to ensure that States and Territories appropriately 
apply the SSMs. EPA is soliciting comment on this approach.
    EPA is also considering promulgating only the 75 percent confidence 
level SSM that would apply to all coastal recreation waters of the 
States and Territories included in the final rulemaking. This approach 
applies the most stringent SSM to all coastal recreation waters and is 
thus more protective than the 1986 bacteria criteria. However, it also 
simplifies the application of the standards by eliminating the need to 
delineate which SSM applies to specific coastal recreation waters. 
Seven States have already adopted the 1986 bacteria criteria for some 
or all of their coastal recreation waters using this approach. However, 
the 1986 bacteria criteria document clearly recognized that ``one size 
does not fit all,'' and that it is reasonable to have different SSMs

[[Page 41727]]

depending on use intensity. EPA is soliciting comment on this approach.
    EPA is also requesting comment on an approach under which an SSM 
would be identified only for designated bathing beach waters. Since 
these are the types of waters in which the epidemiological studies on 
which the criteria are based were conducted, and since the primary 
focus of the 1986 bacteria criteria document is protecting users of 
these types of waters, EPA could interpret the phrase ``as protective 
of human health as'' the 1986 criteria to require an SSM only for 
designated bathing beach waters, with attainment decisions and other 
CWA actions in other coastal recreation waters relying on the geometric 
mean only. EPA is also considering an approach where the SSM is not 
part of the criterion, but rather part of the water quality standards 
implementation process (see Section III.A.1.). If EPA selects this 
approach in the final rule, EPA would not need the proposed definitions 
of designated bathing beach waters, moderate use coastal recreation 
waters, light use coastal recreation waters, or infrequent use coastal 
recreation waters in the final rule because these definitions would 
only be needed in applying an SSM.
    c. Intrastate vs. Interstate Determinations of Use Intensity. EPA's 
proposed SSMs apply to categories based on definitions of intensity, 
and EPA is proposing that they be interpreted on an intrastate basis 
(i.e., the comparison of frequency of use would be made relative to 
only the waters within that State). Using this approach, a State or 
Territory would categorize its most frequently used coastal recreation 
waters as designated bathing beach waters and all others in comparison 
to those. An alternative option that EPA is considering is for States 
and Territories to apply these categories to particular waters using 
interstate comparisons. For example, the number of people at beaches in 
a State with a cooler climate (e.g., Washington) may be considerably 
less than the number of people at beaches in a State with a much warmer 
climate (e.g., Florida). As a result, the number of people at what a 
cooler State would designate as a ``moderate use coastal recreation 
water'' may be more characteristic of the number of people at an 
``infrequent use coastal recreation water'' for a warmer State. States 
and Territories could apply these definitions so as to achieve a 
consistent level of protection at beaches in the same category 
nationally. However, to do so, States and Territories would need 
national beach use information to be able to categorize their coastal 
recreation waters. EPA is not aware that this information is available. 
EPA is soliciting comment on whether these definitions should be 
applied using either an intrastate or interstate (national) comparison 
of frequency of use or whether it should give States and Territories 
the option to choose the basis for comparison. EPA also solicits 
comment on where information on beach usage may be found and whether it 
is appropriate for use in applying the definitions. EPA is also seeking 
comment on the potential consequences of a nationally-based comparison 
in States with cooler climates.
    d. State Calculation of Site-specific SSMs. EPA is proposing SSMs 
based on the 75, 82, 90, and 95 percent confidence levels and is 
proposing to include in the rule the equation to calculate site-
specific SSMs. Bacteria measurements are typically highly variable from 
day to day. As the SSMs are derived based on a distribution around a 
central tendency, the standard deviation of measurements plays an 
important role in the width of that distribution. The standard 
deviations observed in EPA's epidemiological studies may not be the 
same as that for a particular waterbody. Therefore, EPA encourages 
States and Territories to collect enough data to calculate site-
specific standard deviations. EPA recognizes that States and 
Territories might not have the data to calculate their own standard 
deviation; in such a case, those States and Territories would be 
required to use EPA's calculated SSMs.
    EPA is proposing to require that the data set needed to provide a 
site-specific standard deviation used for calculating a revised SSM 
contain at least thirty samples for a single recreation season (see 40 
CFR 131.41(c)(3)). EPA recognizes that the 1986 bacteria criteria 
document contemplates use of a site-specific log standard deviation, 
but notes that the document does not provide any information to guide 
States and Territories in developing a site-specific log standard 
deviation. The 1986 bacteria criteria document references the log 
standard deviations observed in EPA epidemiological studies, but does 
not specify the number of values used to compute the log standard 
deviations. EPA recognizes that the number of values has an effect on 
the confidence one places on the standard deviation. For example, in 
the Technical Support Document for Water Quality-based Toxics Control 
(EPA/505/2-90-001, March 1991, revised June 1992) EPA displays the 
effect of the number of values on the precision of the calculated 
coefficient of variation (standard deviation divided by the mean). This 
display shows that for one coefficient of variation, the 90 percent 
confidence interval around the standard deviation is 62% 
for five values, 42% for 10 values, 30% for 20 
values, and 25% for 30 values, with the confidence 
intervals not changing much for more than 30 values. (See Technical 
Support Document for Water Quality-based Toxics Control, page 55.)
    EPA believes that when a State or Territory calculates an SSM using 
a site-specific log standard deviation, the State or Territory should 
use a site-specific standard deviation that is based on a large enough 
sample size. Ideally, the sample size is large enough that the 
``Central Limit Theorem'' holds. The central limit theorem demonstrates 
that in large enough samples, the distribution of a sample mean 
approximates a normal curve regardless of the shape of the distribution 
from which it is sampled. The larger the sample size, the better the 
approximation to the normal distribution. A sample size of thirty is 
generally accepted by statisticians as the smallest sample size where 
the sample standard deviation will approximate the true standard 
deviation in a statistically meaningful way (Walpole, R.E., Probability 
and Statistics for Engineers and Scientists, 1989). Therefore, EPA 
believes that States and Territories should use at least thirty samples 
to compute the site-specific log standard deviation. EPA recognizes 
that a data set of 30 samples represents a significant amount of data 
for States and Territories to collect. EPA also recognizes that it 
recommended in the Technical Support Document for Water Quality-based 
Toxics Control that permit writers use at least 10 data points for 
calculating site-specific coefficients of variations for effluents when 
developing permit limits. EPA solicits comments on what constitutes an 
adequate data set for calculating site-specific SSMs and whether EPA 
should specify a minimum data requirement in the final rule.
3. Choice of Pathogen Indicator for Fresh Coastal Recreation Waters
    EPA's 1986 bacteria criteria document shows that either enterococci 
or E. coli is an acceptable indicator in fresh waters. EPA is proposing 
E. coli for all Great Lakes States with coastal recreation waters 
because it is consistent with the 1986 bacteria criteria and because 
all Great Lakes States have either adopted or are in the process of 
adopting E. coli as a criterion into their water quality standards. 
Should a Great Lakes State express a preference for enterococci rather 
than E.

[[Page 41728]]

coli before EPA promulgates the final rule, EPA would promulgate the 
equivalent enterococci values for that State's fresh coastal recreation 
waters. EPA is also soliciting comment on whether it would be more 
appropriate to promulgate both E. coli and enterococci criteria for 
Great Lakes States and allow each State to choose which indicator to 
apply to its coastal recreation waters at the time of implementation.

C. Applicability of the Proposed Rule

1. Applies in Addition to any State/Territory Criteria
    Today's proposed Federal 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 proposed criteria apply in addition to any other 
existing CWA-effective criteria for coastal recreation waters already 
adopted (and for those adopted after May 30, 2000, approved by EPA). 
For states and territories included in today's proposal, permitting 
under the National Pollutant Discharge Elimination System (NPDES), as 
well as monitoring and assessment based on applicable CWA water quality 
standards, would need to be based on the applicable standards for 
bacteria in the final rule, in addition to any other applicable 
standards for bacteria previously adopted by the State or Territory to 
protect uses other than primary contact recreation. 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 water body 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 proposal, 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., NPDES, CWA 
section 305(b), and CWA 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, 
provided this does not result in less protective determinations. 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 CWA actions related to protection of 
primary contact recreation on both fecal coliform and the new, 
preferred indicators if the fecal coliform criteria do not provide any 
additional protection. States and Territories are also encouraged to 
expeditiously revise their water quality standards to remove fecal 
coliform criteria that have been replaced by the new indicators in 
their implementation of the CWA. EPA solicits comment on this approach 
to transitioning from existing standards to the new standards in this 
proposed rule.
    EPA recognizes that some States and Territories are in the process 
of adopting water quality standards to be as protective of human health 
as EPA's 1986 bacteria criteria. Once a State or Territory submits the 
adopted standards to EPA, the Agency will use CWA sections 303(c) and 
303(i) to guide its review of the standards. Water quality standards do 
not become effective for Clean Water Act purposes until EPA approves 
them (40 CFR 131.21). Once EPA approved a State's or Territory's 
standards as being as protective of human health as EPA's 1986 bacteria 
criteria, EPA would remove that State or Territory from 40 CFR 131.41. 
However, there will be some indefinite period of time between EPA's 
approval and EPA removing the State or Territory from 40 CFR 131.41. As 
a result, EPA is proposing rule language which would make the EPA-
approved bacteria criteria in State or Territorial water quality 
standards effective for CWA purposes upon their approval such that 
EPA's promulgated criteria would no longer apply. See 40 CFR 
131.41(d)(1). EPA would still plan to remove the State or Territory 
from 40 CFR 131.41 but any delay in that process would not delay the 
approved State criteria in becoming the sole applicable criteria. EPA 
solicits comment on this approach of making the approved State or 
Territorial criteria the applicable criteria without first undertaking 
APA rulemaking to withdraw the Federal rule for that State or 
Territory.
2. Role of State/Territorial General Rules of Applicability
    Section 131.41(d)(2) provides that the Federal criteria in today's 
rule would be subject to States' general rules of applicability in the 
same way and to the same extent as are other Federally-adopted or 
State-adopted numeric criteria for coastal recreation waters. For 
example, if State or Territorial regulations would authorize mixing 
zones in deriving effluent limitations for discharges of bacteria to 
coastal recreation waters, such regulations would apply to permit 
limitations implementing the criteria in today's rule. As another 
example, some State's or Territory's regulations specify the dilution 
equations used to develop TMDLs or calculate permit limits; such 
regulations would apply using the criteria proposed in today's rule. 
EPA is requesting comment on this approach.

IV. EPA Review of State and Territorial Standards

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

    As required by CWA section 303(i)(1)(A), EPA evaluated the water 
quality standards for bacteria for all 35 coastal States and 
Territories using five considerations to determine whether the water 
quality standards are as protective of human health as the Ambient 
Water Quality Criteria for Bacteria--1986. If a State's or Territory's 
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 the proposed rule, EPA is not including the State or 
Territory in the proposed rule. If a State or Territory included in the 
proposed rule adopts criteria satisfying CWA section 303(i), and EPA 
approves them, prior to promulgation of the final rule, EPA will not 
include that State or Territory in the final rule. EPA encourages 
States and Territories that are in the process of adopting such 
criteria to expeditiously complete this process. EPA believes it is 
preferable for a State or Territory to adopt its own such standards 
than for EPA to promulgate Federal standards for that State or 
Territory. The following paragraphs describe the five considerations.
1. Are the Standards Based on EPA's Recommended Indicators?
    EPA interprets CWA section 303(i)(1)(A) to require that States and 
Territories must adopt and submit water quality criteria for 
enterococci in marine waters and either enterococci or E. coli in fresh 
waters. 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

[[Page 41729]]

Water Quality Criteria for Bacteria--1986 is the CWA section 304(a) 
criteria referred to in CWA section 303(i)(1)(A). The Ambient Water 
Quality Criteria for Bacteria--1986 recommended the use of E. coli and 
enterococci as pathogen indicators for fresh waters and enterococci for 
marine waters. This represented a major shift, as fecal coliform had 
historically been the preferred indicator of fecal matter in coastal 
waters. As described in Ambient Water Quality Criteria for Bacteria--
1986, EPA does not believe that fecal coliform is a reliable indicator 
of human illness risk from full body contact recreation in coastal 
recreation waters. Therefore, EPA believes that any State or Territory 
with fecal coliform as the only bacteria criterion for some or all of 
its coastal recreation waters is not fully compliant with the BEACH Act 
and has thus included it in today's proposal. EPA solicits comment on 
its interpretation of 303(i). If the commenter disagrees that States 
and Territories must adopt criteria for E. coli or enterococci, EPA 
requests that the commenter address what type and amount of information 
should be sufficient for EPA to determine that fecal coliform (or any 
other pathogen indicator) is as protective of human health as the 1986 
bacteria criteria. EPA also solicits comment on its assessment of each 
State's and Territory's standards.
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 CWA Section 303(i)?
    States and Territories have the flexibility to determine an 
acceptable risk level within the context of the statutory requirement 
in CWA section 303(i) that their water quality standards be ``as 
protective of human health as'' the 1986 bacteria criteria. That 
flexibility is constrained by the bounds of acceptable risk articulated 
by EPA in Ambient Water Quality Criteria for Bacteria--1986. However, 
as discussed in the legislative history of the BEACH Act, a State's 
criteria may be as protective of human health as the 1986 bacteria 
criteria document ``without being numerically equivalent'' but the 
criteria would have to be scientifically defensible. (S. Rep. No. 106-
366, at 4 (2000)).
    Section III.B. of the preamble explains that the risk levels in the 
1986 bacteria criteria document for gastrointestinal symptoms were 0.8% 
of swimmers at fresh water beaches and 1.9% of swimmers at marine 
beaches. These estimated illness rates are described in the 1986 
bacteria criteria document as approximate and as EPA's best estimates 
at the time. Section III.B. of the preamble explains why EPA believes 
that fresh water criteria corresponding to risk levels up to 1.0% of 
swimmers would satisfy the protectiveness requirement of CWA section 
303(i), and also why EPA cannot determine, based on the available data 
that relate E. coli and enterococci levels to illness rates, what 
bacteria concentration would correlate with risk levels over 1.0% in 
freshwater. EPA solicits comment on its acceptance of criteria 
associated with risk levels up to 1.0% in freshwater.
3. Do the Standards Include Appropriate SSMs?
    In the 1986 bacteria criteria document, EPA recommended that States 
and Territories adopt appropriate SSM values that correspond to 
specific use intensity categories of coastal recreation waters (e.g., 
75 percent confidence level SSM for designated bathing beaches, 82 
percent confidence level SSM for moderate use coastal recreation 
waters, etc.). Tables 2 and 3 in Section III.B include qualitative 
descriptors of beach usage categories associated with different 
confidence levels.
    EPA's Ambient Water Quality Criteria for Bacteria--1986 also 
recommends that States and Territories use a site-specific log standard 
deviation in calculating the SSM in recognition of the possibility that 
States and Territories may observe significant differences in the log 
standard deviation of bacterial measurements. The 1986 bacteria 
criteria document explicitly recommends that States and Territories 
base the SSM values on a site-specific log standard deviation or, if 
site data are insufficient, to use the values EPA observed in its 
studies. EPA believes that States and Territories should not be 
required to rely on frequency distributions observed in EPA's 
epidemiological studies when sufficient site-specific data are 
available. In determining whether State and Territory bacteria criteria 
are as protective of human health as EPA's 1986 bacteria criteria, EPA 
evaluates whether the data set is robust enough to adequately 
characterize the distribution. If a State or Territory chooses not to 
collect adequate data and not calculate site-specific SSM values, the 
State/Territory would need to use the standard deviations from EPA's 
studies in Ambient Water Quality Criteria for Bacteria--1986.
    EPA reviewed State and Territorial submissions of CWA section 
303(i) standards for coastal recreation waters for the adoption of both 
a geometric mean and an SSM value. Because the criteria are used for 
several purposes under the CWA, adoption of both a geometric mean and 
an SSM value gives States and Territories the necessary components to 
implement bacteria criteria when developing water quality-based 
effluent limits, determining whether a waterbody is attaining its water 
quality standards, and issuing beach notifications and advisories. For 
example, the SSM value gives States and Territories a practical tool 
for making daily decisions to open or close beaches. In contrast, a 
geometric mean gives States and Territories a practical tool for 
assuring the appropriate level of treatment at NPDES-regulated 
facilities to protect human health over the long term.
    EPA proposes to consider water quality standards for bacteria for 
coastal recreation waters to be as protective of human health as 
Ambient Water Quality Criteria for Bacteria--1986 if they include at 
least one SSM and if designated bathing areas have an SSM based on at 
least the 75 percent confidence level. EPA reviewed State and 
Territorial standards for SSM values, and found that many States and 
Territories used ``designated beach area'' as a designation for a 
subset of their primary contact recreation waters and assigned the 75 
percent confidence level to those water bodies, while assigning the 95 
percent confidence level to all other water bodies. Other States and 
Territories had three categories, while other States and Territories 
only had one. EPA solicits comments on this approach for evaluating 
State and Territory SSM values in relation to the requirements of the 
BEACH Act.
4. Do the Standards Exempt Fecal Contamination From Non-Human Sources?
    The Ambient Water Quality Criteria for fBacteria--1986 included a 
background discussion of non-human sources under the heading 
``Limitations and Extrapolations of Criteria.'' The text of the 1986 
bacteria criteria document recommends that States and Territories apply 
the E. coli and enterococci criteria to all full body contact 
recreation waters unless (1) sanitary and epidemiological studies show 
the sources of the indicator bacteria to be non-human, and (2) the 
indicator densities are not indicative of a health risk to those 
swimming in such waters. CWA section 303(i) provides that if a State or 
Territory fails to adopt standards ``that are as protective of human 
health as the criteria for pathogens and pathogen

[[Page 41730]]

indicators for coastal recreation waters published by the 
Administrator,'' EPA must promptly propose water quality standards for 
pathogens and pathogen indicators. In reviewing State or Territorial 
water quality standards to determine whether the bacteria criteria are 
``as protective of human health as'' EPA's 1986 bacteria criteria 
document, EPA examined whether the State or Territorial bacteria 
criteria exempted non-human sources. If a State's or Territory's water 
quality standards included such an exemption, EPA looked to see whether 
that exemption has the same basis as that presented in the 1986 
bacteria criteria document, namely, that sanitary and epidemiological 
studies show the sources are non-human and that the bacterial densities 
are not indicative of a health risk to those swimming in such waters. 
EPA is including in today's proposal those States and Territories where 
the criteria include exemptions for non-human sources that are 
inconsistent with the plain language of EPA's 1986 bacteria criteria 
document, as described above.
    EPA's approach in developing this proposed rule has been to rely as 
much as possible on the actual language in the 1986 bacteria criteria 
document. EPA has taken this approach because CWA section 303(i)(2)(A) 
requires EPA to promptly propose criteria for States and Territories 
that are ``as protective of human health as'' EPA's 1986 bacteria 
criteria in cases where a State or Territory has failed to do so. 
However, EPA's scientific understanding of pathogens and pathogen 
indicators has evolved since 1986. As a result, EPA has, over the 
course of the last 18 years, applied its new scientific understanding 
to the formulation of policy in the area of how non-human sources are 
addressed in water quality standards. For example, in EPA's 1994 Water 
Quality Standards Handbook, EPA articulated a policy that States and 
Territories may apply water quality criteria for bacteria to 
waterbodies designated for recreation with the rebuttable presumption 
that the indicators show the presence of human fecal contamination. 
This 1994 policy stated:

    States may apply bacteriological criteria sufficient to support 
primary contact recreation with a rebuttable presumption that the 
indicators show the presence of human fecal pollution. Rebuttal of 
this presumption, however, must be based on a sanitary survey that 
demonstrates a lack of contamination from human sources. The basis 
for this option is the absence of data demonstrating a relationship 
between high densities of bacteriological water quality indicators 
and increased risk of swimming-associated illness in animal-
contaminated waters.

    In short, under this policy, a State or Territory could justify a 
decision not to apply the criteria to a particular waterbody when 
bacterial indicators were found to be of animal origin. EPA is 
soliciting comment on a second approach that uses the rebuttable 
presumption approach articulated in the 1994 Handbook to be ``as 
protective of human health as'' EPA's 1986 bacteria criteria. This 
approach would require States and Territories to presume that the 
source of E. coli or enterococci is of human origin unless a sanitary 
survey demonstrates a lack of contamination from human sources. This 
approach would effectively allow for the exclusion of any animal 
sources if a State or Territory can demonstrate that the source of 
contamination is not human waste.
    Some recent studies suggest there may be some risk posed to humans 
as a result of exposure to non-human fecal contamination, particularly 
those animal sources with which humans regularly come into contact, 
i.e., livestock and other domestic animals. Livestock, domestic pets, 
and wildlife are carriers of human pathogens and can transmit these 
pathogens to surface waters as well as contribute significant numbers 
of indicator bacteria to waterbodies (Centers for Disease Control and 
Prevention Morbidity and Mortality Report Surveillance for Waterborne 
Disease Outbreaks, 1993, 1996, 1998, 2000; Waterborne Pathogens in 
Agricultural Watersheds, USDA, June 2000).
    Outbreaks of enterohemorrhagic E. coli O157:H7, Salmonella, 
Giardia, and Cryptosporidium are frequently of animal origin. Incidents 
where these pathogens have been spread to humans through water have 
been documented in recent years. In the case of E. coli O157:H7, 
several cases have been cited in which fecal contamination from animals 
was the probable source of the pathogen. The most prominent examples 
include contamination of water supplies, including an outbreak in 
Alpine, Wyoming, in June, 1998, affecting 157 people, and a major 
outbreak in Walkerton, Ontario, in May and June of 2000 causing more 
than 2,300 people to become ill and causing seven deaths (Olsen, S.J., 
CDC Emerging Infectious Diseases, Vol. 8, No. 4, April 2002; CDC 
Morbidity and Mortality Weekly Report, 2000; Ontario's Ministry of the 
Attorney General, 2000). In the Alpine, Wyoming case, contamination by 
wildlife of the community water supply is the suspected source, and in 
Walkerton, Ontario, heavy rains causing agricultural runoff to leak 
into city wells is suspected. The 1993 Milwaukee Cryptosporidium 
outbreak is a well-known example of water supply contamination that 
resulted in 403,000 illnesses and approximately 100 deaths. The source 
of the oocysts was not identified, but suspected sources include 
agricultural runoff from dairies in the region, wastewater from a 
slaughterhouse and meat packing plant, and municipal wastewater 
treatment plant effluent (Casman, E.A., Interstate Commission on the 
Potomac River Basin Report No. 96-6, 1996; USDA National Animal Health 
Monitoring System Report: Cryptosporidium parvum Outbreak, 1993). In 
addition, Cryptosporidium was the known cause of 15 other outbreaks 
associated with drinking and recreational water affecting 5,040 
individuals in the U.S. between 1991 and 1994 (Gibson, C.J., 
Parasitology 117 (Supp.): S205-S212, 1998). While many of the reported 
outbreaks have occurred through the consumption of contaminated 
drinking water, other incidences of E. coli O157:H7 infection from 
exposure to surface waters have been documented (CDC Morbidity and 
Mortality Weekly Report, 2000, 2002). While non-human sources are 
capable of transmitting pathogens that can cause the specific kinds of 
gastrointestinal illness identified in EPA's original epidemiological 
studies, the specific risk from these sources has not been fully 
determined.
    The risk presented by fecal contamination of waters by non-human 
sources is possibly less significant than the risk presented by fecal 
contamination of waters by human sources. However, the increasing 
number of cases such as those described above, in which animals are 
suspected as being the likely cause of the contamination and resulting 
illness, present a case for not exempting these sources where human 
contact or consumption are likely to occur. In addition, because the 
presence of bacterial indicators provides evidence of fecal pollution, 
high levels of these indicator organisms originating from animal 
sources may also indicate the presence of pathogens capable of causing 
other human illnesses in addition to acute gastroenteritis.
    Animals are more likely to carry or be infected with human 
pathogens when those animals are in close proximity to humans and their 
waste. The closer the association between animals and humans, the more 
likely it is that human pathogens will pass back and forth between 
humans and animals. The

[[Page 41731]]

more crowded an animal herd, the more likely it is that human pathogens 
will be shared between animals of the herd. These pathogens are 
transmitted to others in the herd because of the direct contact between 
animals and their fecal matter. Fecal contamination from these infected 
herds, unless sufficiently treated or contained, can find its way into 
surface or ground waters and present a potential exposure route for 
people using the contaminated waters for recreation or drinking. This 
scenario potentially applies not only to animal feeding operations but 
also to herds of wildlife (e.g., deer). However, the threat from 
livestock herds is likely to be greater given the larger typical herd 
size and the resultant greater quantity of fecal wastes. Wild herds are 
typically more dispersed and smaller and therefore likely represent a 
smaller risk to watersheds. In addition, wildlife are not typically in 
routine daily contact with humans, as may be the case for livestock and 
other domestic animals. Therefore, EPA is considering a third approach 
for addressing non-human sources of fecal contamination in establishing 
water quality standards that apply the criteria only to bacteria from 
human and non-wildlife animal sources.
    In summary, the preceding paragraphs describe three possible 
approaches in reviewing exemptions for non-human sources of fecal 
contamination:
    (1) Require sanitary and epidemiological studies before excluding 
non-human sources;
    (2) Require only sanitary surveys before excluding non-human 
sources; or
    (3) Exclude only wildlife sources.
    EPA is soliciting comment on all of the above approaches. Should 
EPA revise its approach in the final rule addressing non-human sources 
of E. coli and enterococci, States and Territories that exempt non-
human sources and are included in today's proposal may not be included 
in the final rule.
5. Has EPA Approved the Standards?
    Under section 303(i)(2)(A) of the CWA, EPA must determine whether a 
State or Territory has failed to 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 that are adopted after May 30, 2000, in order for 
those standards to be in effect for CWA purposes. Therefore, EPA must 
have approved State and Territorial standards for enterococci or E. 
coli that are consistent with CWA section 303(i) for the State or 
Territory to be excluded from the proposed rule if the standards were 
adopted after May 30, 2000. State and Territorial standards adopted 
prior to May 30, 2000 that are consistent with CWA section 303(i) are 
in effect for CWA purposes even without explicit EPA approval.

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

    EPA researched the status of water quality standards for bacteria 
for each State and Territory with coastal recreation waters. On April 
20, 2004, EPA sent letters to the Commissioners of every coastal and 
Great Lakes State and Territory to inform them of this impending 
proposed rule and of EPA's understanding at that time of their water 
quality standards. These letters stated that EPA would propose to 
include in this rule all States and Territories with coastal recreation 
waters (i.e., those coastal and Great Lakes waters designated for 
swimming, bathing, surfing and similar water contact activities) that 
do not have CWA-effective water quality standards for pathogen 
indicators as protective of human health as EPA's 1986 bacteria 
criteria. In preparing these letters, EPA conducted a preliminary 
review of the water quality standards of the thirty-five States and 
Territories with coastal recreation waters. In some cases, EPA has 
received additional or updated information since sending the letters. 
EPA's current understanding of each State's and Territory's water 
quality standards is reflected in the discussion in this section. EPA 
solicits comment to confirm whether EPA has accurately characterized 
the current status of water quality standards for coastal recreation 
waters, and seeks information on the progress of States' and 
Territories' adoption of the E. coli and enterococci criteria.
Alabama
    On April 20, 2004, Alabama adopted criteria for all of its coastal 
recreation waters consistent with EPA's 1986 bacteria criteria, and EPA 
approved these on June 25, 2004. The criteria are for enterococci and 
have a geometric mean of 35/100 ml and an SSM of 104 for coastal waters 
designated by Alabama as ``Outstanding Alabama Waters'', ``Swimming'', 
and ``Shellfish Harvesting''. Waters designated by Alabama as ``Public 
Water Supply'' and ``Fish and Wildlife'' include water contact sports 
as a use only from June through September. The enterococci criteria for 
those months have a geometric mean of 35/100 ml and an SSM of 158/100 
ml. From October through May, Public Water Supply and Fish and Wildlife 
waters are not designated for recreation. EPA considers these criteria 
to be as protective of human health as EPA's 1986 bacteria criteria and 
Alabama is therefore not included in this proposal.
Alaska
    Alaska has not adopted criteria as protective of human health as 
EPA's 1986 bacteria criteria. Therefore, EPA is including Alaska in 
today's proposal. Alaska has notified EPA of the State's intention to 
initiate rulemaking to adopt criteria consistent with EPA's 1986 
bacteria criteria by taking public comment in Summer 2004. The State 
anticipates adoption of the criteria into State water quality standards 
by December, 2004.
American Samoa
    On November 16, 1999, American Samoa adopted criteria for all of 
its coastal recreation waters consistent with EPA's 1986 bacteria 
criteria, and EPA approved these on May 2, 2001. The criteria are for 
enterococci with a geometric mean of 35/100 ml and an SSM value of 104/
100 ml for Pago Pago Harbor, Fagatele Bay, and Pala Lagoon; the 
criteria have a geometric mean of 35/100 ml and an SSM value of 124/100 
ml for open coastal waters; and the criteria have a geometric mean of 
35/100 ml and an SSM value of 276/100 ml for those ocean waters beyond 
the 600-foot depth contour seaward. EPA considers these criteria to be 
as protective of human health as EPA's 1986 bacteria criteria, and 
American Samoa is therefore not included in this proposal.
California
    California has adopted criteria consistent with EPA's 1986 bacteria 
criteria for some but not all of its coastal recreation waters. The Los 
Angeles Regional Board (RB4) adopted criteria on July 18, 2002, and EPA 
approved them on September 25, 2002. The RB4 criteria are for 
enterococci and have a geometric mean of 35/100 ml and an SSM of 104/
100 ml. The other Regional Boards with coastal recreation waters have 
not yet adopted bacteria criteria as protective of human health as 
EPA's 1986 bacteria criteria. The California Ocean Plan, which was 
adopted on March 22, 1990, applies enterococcus monitoring requirements 
to nearshore ocean waters; however, it does not establish State water 
quality criteria. State Health Regulations adopted by the State 
pursuant to Assembly Bill 411 apply enterococcus requirements to all 
coastal waters; however, these regulations are separate from State 
water quality standards. Therefore, EPA is including California in 
today's proposal,

[[Page 41732]]

except for waters covered by RB4's approved standards.
Commonwealth of Northern Mariana Islands
    The Commonwealth adopted a geometric mean criterion for enterococci 
on January 20, 1997, and EPA approved it on February 3, 1997. However, 
the Commonwealth has not adopted SSM values. Therefore, EPA is 
including the Commonwealth in today's proposal but only with respect to 
the SSM portion of the rule. EPA could remove the Commonwealth from the 
final rule depending on which SSM option EPA chooses in the final rule. 
The Commonwealth has initiated the rule-making process to adopt SSM 
values. The Commonwealth published the amendment to the standards in 
the Commonwealth Register on April 23, 2004, and the amendment is 
scheduled to be adopted before September, 2004.
Connecticut
    On November 7, 2001, Connecticut adopted criteria for all of its 
coastal recreation waters consistent with EPA's 1986 bacteria criteria, 
and EPA approved these on December 17, 2002. Connecticut's enterococci 
criteria include a geometric mean of 35/100 ml and an SSM of 104/100 ml 
for ``Designated Swimming'' waters, which include areas designated by 
state or local authorities as bathing areas, and a geometric mean of 
35/100 ml and an SSM of 500/100 ml for ``All Other Recreational Uses'', 
which are applied to other coastal waters (see Connecticut Water 
Quality Standards, Appendix B). The Connecticut water quality standards 
include General Standards 8 and 25, which include special additional 
provisions regarding application of Connecticut standards. Standard 8 
provides that water quality criteria do not apply to conditions brought 
about by natural causes which may include normal land uses. Standard 25 
provides that exceedance of bacteria criteria should be investigated by 
means of a sanitary survey or other appropriate means to determine 
sources of elevated indicator bacteria levels. In practice, Connecticut 
uses the numeric criteria established for enterococci in Appendix B of 
the Connecticut WQS regardless of source in coastal recreation waters 
for CWA purposes. For example, Connecticut's 2002 CWA section 303(d) 
list includes waters that are impaired due to bacteria from nonpoint 
sources and waterfowl. EPA considers these criteria to be as protective 
of human health as EPA's 1986 bacteria criteria, and Connecticut is 
therefore not included in this proposal.
Delaware
    Delaware adopted enterococci criteria on July 15, 1999, and EPA 
approved these on December 2, 1999. Delaware's CWA-effective standards 
include criteria for enterococci with a geometric mean of 10/100 ml but 
no corresponding SSM. In addition, the Delaware standards apply only to 
human sources of fecal contamination. Therefore, EPA is including 
Delaware in today's proposal. EPA could remove Delaware from the final 
rule depending on which SSM option and which nonhuman source option EPA 
chooses in the final rule. Delaware is in the process of adopting and 
submitting to EPA revised standards for bacteria.
Florida
    Florida has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including Florida in today's 
proposal. Florida has initiated internal discussions and the State 
plans to initiate adoption of criteria consistent with EPA's 1986 
bacteria criteria this year.
Georgia
    Georgia has not yet adopted criteria consistent with EPA's 
criteria, nor has it initiated any regulatory process to adopt water 
quality standards consistent with EPA's bacteria criteria. Therefore, 
EPA is including Georgia in today's proposal.
Guam
    On June 18, 2002, Guam adopted criteria for all of its coastal 
recreation waters consistent with EPA's 1986 bacteria criteria, and EPA 
approved these on July 24, 2002. The criteria are for enterococci and 
have a geometric mean of 35/100 ml for all marine waters. The SSM is 
104/100 ml for whole body contact recreation waters and is 276/100 ml 
for limited body contact recreation. EPA considers these criteria to be 
as protective of human health as EPA's 1986 bacteria criteria and Guam 
is therefore not included in this proposal.
Hawaii
    Hawaii has adopted criteria consistent with EPA's 1986 bacteria 
criteria for some but not all of its coastal recreation waters. Hawaii 
has adopted, and EPA has approved, a geometric mean criterion of 7 for 
enterococci in non-estuarine marine recreational waters within 300 
meters (1,000 feet) of the shoreline. Hawaii is in the process of 
adopting an SSM criterion for non-estuarine marine waters within 300 
meters of shore and both components of the enterococci criteria for 
coastal estuaries, consistent with EPA's 1986 bacteria criteria. Hawaii 
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 proposal.
Illinois
    Illinois has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including Illinois in today's 
proposal. Illinois has informed EPA that it will initiate the 
rulemaking process to adopt revised standards for bacteria by September 
30, 2004.
Indiana
    On December 13, 1989, Indiana adopted criteria for all of its 
coastal recreation waters consistent with EPA's 1986 bacteria criteria, 
and EPA approved these on May 7, 1990. The criteria are for E. coli and 
include a geometric mean of 125/100 ml and an SSM of 235/100 ml. EPA 
considers these criteria to be as protective of human health as EPA's 
1986 bacteria criteria, and therefore Indiana is not included in this 
proposal.
Louisiana
    Louisiana has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria, nor has the State initiated any regulatory process 
to meet BEACH Act requirements. Therefore, EPA is including Louisiana 
in today's proposal.
Maine
    Maine made effective enterococci criteria for its coastal 
recreation waters classified as ``SB'' and ``SC'', and EPA approved 
these criteria on July 16, 1986. The enterococci criteria include a 
geometric mean of 8/100 ml and a single sample maximum of 54/100 ml in 
the State's waters classified as ``SB.'' Class ``SB'' waters are those 
that are ``suitable for the designated uses of recreation in and on the 
water'' as well as other uses. (ME. REV. STAT. ANN. tit. 38 Sec.  465-B 
(2003)). Additionally, the enterococci criteria include a geometric 
mean of 14/100 ml and an SSM of 94/100 ml for the State's waters 
classified as ``SC.'' Class ``SC'' waters are also those that are ``of 
such quality that they are suitable for recreation in and on the 
water'' as well as other uses. (ME. REV. STAT. ANN. tit. 38 Sec.  465-B 
(2003)). Although Maine's criteria numbers are lower than EPA's, 
Maine's criteria pertain only to enterococci of human origin. Based on 
the non-human source discussion in Section IV.A.4. of this preamble, 
EPA does not believe that Maine's criteria would be as protective of 
human health as EPA's 1986 bacteria criteria in cases

[[Page 41733]]

where the enterococci are of non-human origin. The 1986 bacteria 
criteria document recommends that States and Territories apply the E. 
coli and enterococci criteria to all full body contact recreation 
waters unless both (1) sanitary and epidemiological studies show the 
sources of the indicator bacteria to be non-human, and (2) the 
indicator densities are not indicative of a health risk to those 
swimming in such waters. EPA recognizes that Maine's approach for 
addressing non-human pathogen sources is consistent with an option for 
addressing recreational uses that is included in EPA's 1994 Water 
Quality Standards Handbook, and Maine is cited in this document as an 
example of a State that has successfully implemented such an approach. 
When EPA approved the Maine pathogen standards in 1986, it did so using 
the requirements of 40 CFR 131.5 and 131.6, which requires water 
quality criteria be sufficient to protect the designated uses. However, 
the BEACH Act of 2000 added CWA section 303(i) which requires that the 
pathogen criteria be ``as protective of human health as'' EPA's 1986 
bacteria criteria document. This is a different standard of review than 
articulated in 40 CFR 131.5 for other water quality standards. Based on 
the comparison of Maine's approach for nonhuman sources to that in 
EPA's 1986 bacteria criteria document, and using its proposed non-human 
source option, EPA does not find Maine's approach to be ``as protective 
of human health as'' EPA's bacteria criteria document. Therefore, EPA 
is proposing to include Maine in today's rule for limited purposes. EPA 
could remove Maine's SB and SC waters from the final rule depending on 
which nonhuman source option EPA chooses in the final rule. EPA is 
aware that independent of this proposed rule, it is Maine's intent to 
revise the applicability of its bacteria criteria to include 
enteroccoci from domestic animals as well as enterococci of human 
origin. This revision is expected during Maine's next legislative 
session in January 2005.
    EPA's proposed criteria would not apply to Maine's SB and SC waters 
if the enterococci bacteria are of human origin. In these cases, 
Maine's criteria would apply. Should EPA receive information during the 
public comment period showing that there are only human sources of 
fecal contamination in Maine Class SB and SC coastal recreation waters, 
EPA would remove Maine from the promulgation of the final rule for 
Class SB and SC waters because Maine's criteria would apply to all 
sources of enterococci to coastal recreation waters.
    Maine also has as its most protective class, ``SA'' waters. Class 
SA ``shall be the highest classification and shall be applied to waters 
which are outstanding natural resources'' and ``shall be of such 
quality that they are suitable for designated uses of recreation in and 
on the waters'' as well as other uses. (ME. REV. STAT. ANN. tit. 38 
Sec.  465-B (2003). The bacteria content of Class SA waters ``shall be 
as naturally occurs.'' EPA believes that this narrative criterion for 
bacteria--``as naturally occurs''--is consistent with the objective of 
the CWA at Section 101(a) to ``restore and maintain the chemical, 
physical, and biological integrity of the Nation's waters.'' Naturally 
occurring bacteria levels should not present more risk than the 19 
illnesses per 1000 swimmers accepted in the 1986 bacteria criteria 
document. Although storm water discharges to Class SA waters are 
allowed, EPA understands Maine's standards to not authorize storm water 
discharges that exceed bacteria levels that would otherwise occur 
naturally in the receiving water absent the storm water discharges. For 
these reasons, EPA is not including Maine's Class SA waters in today's 
proposal.
Maryland
    Maryland has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including Maryland in today's 
proposal. Maryland is completing its rulemaking process and expects to 
submit newly adopted criteria to EPA in the near future. Maryland has 
been working with EPA to assure the development of state water quality 
standards that are consistent with EPA's 1986 bacteria criteria.
Massachusetts
    Massachusetts has not yet adopted criteria consistent with EPA's 
1986 bacteria criteria. Therefore, EPA is including Massachusetts in 
today's proposal. Massachusetts has initiated the rulemaking process 
and expects to adopt criteria consistent with EPA's 1986 bacteria 
criteria by December 31, 2004.
Michigan
    On May 20, 1994, Michigan adopted criteria for all of its coastal 
recreation waters consistent with EPA's 1986 bacteria criteria, and EPA 
approved these on August 11, 1994. The State standards include E. coli 
with a geometric mean of 130/100 ml and an SSM value of 300/100 ml for 
total body contact recreation and an SSM of 1000/100 ml for partial 
body contact recreation. Michigan's criteria are considered to be 
within the acceptable risk level range of 0.8% to 1.0%. (This range was 
described in Section IV.A.2.). Therefore, EPA interpreted Michigan's E. 
coli geometric mean of 130/100 ml to be as protective of human health 
as EPA's 1986 bacteria criteria, which recommended a geometric mean of 
126/100 ml. EPA considers these criteria to be as protective of human 
health as EPA's 1986 bacteria criteria, and Michigan is therefore not 
included in this proposal.
Minnesota
    Minnesota has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including Minnesota in today's 
proposal. Minnesota has initiated the rulemaking process and expects to 
adopt criteria consistent with EPA's 1986 bacteria criteria by July 
2005.
Mississippi
    Mississippi has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including Mississippi in today's 
proposal. Mississippi has initiated internal discussions and expects to 
adopt a geometric mean criterion by August 2004. The State will be 
conducting beach user studies in the summer of 2004 to determine the 
appropriate SSM based on usage of certain areas and expects to adopt 
SSM criteria by August 2005.
New Hampshire
    On July 2, 1991, New Hampshire adopted EPA's 1986 bacteria criteria 
for all of its coastal recreation waters and the criteria became 
effective for CWA purposes on August 31, 1991. The standards include 
enterococci and have a geometric mean of 35/100 ml and an SSM of 104/
100 ml for all coastal recreation waters. EPA considers these criteria 
to be as protective of human health as EPA's 1986 bacteria criteria, 
and New Hampshire is therefore not included in this proposal.
New Jersey
    On July 14, 1989, New Jersey adopted criteria for all of its 
coastal recreation waters consistent with EPA's 1986 bacteria criteria, 
and EPA approved these on April 23, 1991. New Jersey's bacteria 
criteria include enterococci and have a geometric mean of 35/100 ml and 
an SSM of 104/100 ml for all coastal recreation waters. For the 
Delaware Bay, New Jersey incorporates by reference the water quality 
standards adopted by the Delaware River Basin Commission (DRBC) 
(N.J.A.C. 7:9B-1.13). The DRBC

[[Page 41734]]

adopted enterococci criteria with a geometric mean of 35/100 ml, but no 
SSM, for the Delaware Bay. However, New Jersey's standards include a 
provision that applies New Jersey water quality criteria to the 
Delaware Bay if the DRBC has not established criteria (N.J.A.C. 7:9B-
1.14(d)). Therefore, New Jersey's water quality standards include an 
SSM that applies to the Delaware Bay in the absence of an SSM in the 
DRBC's standards, as explained in a May 19, 2004, letter from Brad 
Campbell, Commissioner of the New Jersey Department of Environmental 
Protection to Ben Grumbles, Acting Assistant Administrator for Water, 
U.S. EPA. EPA considers New Jersey's criteria to be as protective of 
human health as EPA's 1986 bacteria criteria, and New Jersey is 
therefore not included in this proposal.
New York
    New York has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including New York in today's 
proposal. New York has informed EPA that it will initiate its 
rulemaking process to adopt revised standards for bacteria shortly. The 
State anticipates final adoption of revised bacteria criteria in 2005.
North Carolina
    North Carolina has not yet adopted criteria consistent with EPA's 
1986 bacteria criteria. Therefore, EPA is including North Carolina in 
today's proposal. The State has started internal discussions and has 
exchanged draft language with EPA.
Ohio
    Ohio has adopted a geometric mean consistent with EPA's 1986 
bacteria criteria for all waters in Lake Erie in addition to fecal 
coliform standards. Ohio had previously adopted fecal coliform as its 
recreational water quality criteria. The standards for E. coli include 
a geometric mean of 126/100 ml for designated bathing waters and for 
designated primary contact waters. However, the Ohio water quality 
standards allow the use of either E. coli or fecal coliform and specify 
that compliance with the criteria can be demonstrated by attainment of 
either criterion. Because Ohio's standards allow the use of either 
indicator, and fecal coliform is not as protective of human health as 
EPA's 1986 bacteria criteria, EPA is including Ohio in today's 
proposal. In addition, EPA is including Ohio in today's proposal 
because the State does not have an SSM, as EPA interprets the term (see 
Section III.B.1). Instead, Ohio's standards include E. coli values not 
to be exceeded in more than ten percent of the samples taken during any 
thirty-day period: 235/100 ml for designated bathing waters and 298/100 
ml for designated primary contact waters. These values are identical to 
EPA's SSM values for the 75 and 82 percent confidence levels 
respectively, but they are not expressed as SSMs because they allow 10 
percent of the samples to exceed the SSM.
    Should EPA receive information during the public comment period 
showing that Ohio applies its E. coli criterion for all Clean Water Act 
implementation purposes in Lake Erie, and applies its upper bound 
values in a manner as stringent as the approach EPA takes for the SSM 
in the final rule, EPA would remove Ohio from the final rule.
Oregon
    Oregon has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria, nor has the State initiated any regulatory process 
to meet the BEACH Act requirements. Therefore, EPA is including Oregon 
in today's proposal.
Pennsylvania
    Pennsylvania has not yet adopted criteria consistent with EPA's 
1986 bacteria criteria. Pennsylvania has initiated a modification to 
its Department of Health regulations relating to the bacteriological 
standards and monitoring of its Great Lake public bathing beaches but 
has not yet submitted any revision of its water quality standards to 
EPA. Therefore, EPA is including Pennsylvania in today's proposal.
Puerto Rico
    The Commonwealth of Puerto Rico's water quality criteria for 
recreational waters applies to those Class SB (coastal) waters which 
are intensely used for primary contact recreation, like special bathing 
zones (beaches), and the Class SC waters for which EPA recently 
completed a rulemaking (40 CFR 131.40) to establish a designated use 
and applicable water quality criteria (including the 1986 bacteria 
criteria for enterococci) to protect primary contact recreation. The 
remaining Class SB waters, which are not designated bathing beaches but 
are coastal recreation waters, do not have bacteria criteria as 
protective of human health as EPA's 1986 bacteria criteria. Therefore, 
EPA is including Puerto Rico, except for coastal recreation waters 
intensely used for primary contact recreation and those covered by the 
recent EPA rule, in today's proposal. Puerto Rico has informed EPA of 
its intent to adopt criteria consistent with EPA's 1986 bacteria 
criteria for the remaining Class SB waters.
Rhode Island
    Rhode Island has not yet adopted criteria consistent with EPA's 
1986 bacteria criteria. Therefore, EPA is including Rhode Island in 
today's proposal. Rhode Island has informed EPA of its intent to adopt 
criteria consistent with EPA's 1986 bacteria criteria and has initiated 
the rulemaking process. Rhode Island plans to adopt EPA's criteria by 
the end of 2004.
South Carolina
    South Carolina has not yet adopted criteria consistent with EPA's 
1986 bacteria criteria. Therefore, EPA is including South Carolina in 
today's proposal. South Carolina has initiated the rulemaking process 
and expects to adopt EPA's criteria or submit them for EPA review by 
July 2004.
Texas
    On July 26, 2000, Texas adopted criteria for all of its coastal 
recreation waters consistent with EPA's 1986 bacteria criteria, and EPA 
approved these on June 30, 2004. Texas' bacteria criteria include 
enterococci and have a geometric mean of 35/100 ml and an SSM of 89/100 
ml for all coastal recreation waters. The water quality standards also 
include criteria for fecal coliform. Kathleen Hartnett White, Chair of 
the Texas Commission on Environmental Quality, sent two letters dated 
June 16 and June 29, 2004, explaining Texas' interpretation of the 
State's standards. Ms. White acknowledged that, under these revised 
standards, Texas has discretion to use fecal coliform as an alternative 
recreational indicator. At the time Texas adopted these standards, in 
2000, it included this discretion for three reasons: (1) Texas wanted 
time to transition from monitoring for fecal coliform to enterococci 
for waters designated for contact recreation; (2) Texas was concerned 
about monitoring resources and laboratory equipment needed to sustain 
monitoring for both enterococci and fecal coliform in Oyster Waters, 
and (3) Texas wanted to allow for the possibility that additional data 
and evaluation of the two indicators would show that the Oyster Water 
criterion for fecal coliform would be a protective surrogate for 
enterococci. Ms. White also explained in her June 2004 letters that 
currently the State is monitoring for enterococci in all of its coastal 
recreation waters, including Oyster Waters. In addition, she expressly 
recognized that, at this time, the relationship between fecal coliform

[[Page 41735]]

and enterococci has not been demonstrated for Texas coastal waters. 
Finally, in the letter of June 29, 2004, Texas explicitly states that 
the enterococci criteria are in effect for all CWA purposes for all 
coastal recreation waters, including those designated as Oyster Waters. 
With this additional information, EPA considers enterococci to be the 
applicable criteria in all of Texas' coastal recreation waters for all 
CWA purposes. EPA considers these criteria to be as protective of human 
health as EPA's bacteria criteria, and Texas is therefore not included 
in this proposal.
United States Virgin Islands
    The Virgin Islands have not yet adopted criteria consistent with 
EPA's 1986 bacteria criteria. Therefore, EPA is including the Virgin 
Islands in today's proposal. The Virgin Islands have initiated the 
rulemaking process and expect to adopt EPA's criteria by September 30, 
2004.
Virginia
    On February 12, 2002, Virginia adopted EPA's 1986 bacteria criteria 
for all of its coastal recreation waters, and EPA approved these on 
November 8, 2002. The standards include enterococci and have a 
geometric mean of 35/100 ml for all coastal waters and an SSM value of 
104/100 ml. The standards also have fecal coliform for shellfish waters 
in addition to enterococci. EPA considers the enterococci criteria to 
be as protective of human health as EPA's 1986 bacteria criteria, and 
Virginia is therefore not included in this proposal.
Washington
    Washington has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. In a letter dated May 11, 2004, Washington explained 
its view that the State's data show that where the geometric mean of 
fecal coliform concentrations are at or below 14 counts/100 ml, the 
corresponding geometric mean of enterococci bacteria are at or below 
EPA's 1986 marine criterion of 35 counts/100 ml. EPA is reviewing this 
information and requests comment on it. The data submitted by 
Washington are available in the official public docket for this 
rulemaking. Because EPA has not yet determined that the data 
demonstrate that Washington's standards satisfy the requirements of 
section 303(i), EPA is including Washington in today's proposal.
Wisconsin
    Wisconsin has not yet adopted criteria consistent with EPA's 1986 
bacteria criteria. Therefore, EPA is including Wisconsin in today's 
proposal. Wisconsin has initiated the rulemaking process and intends to 
adopt criteria consistent with EPA's bacteria criteria by winter 2005-
2006.
Tribes
    No Tribes are included in this proposal. EPA has determined there 
are about 40 Federally-recognized Tribes located next to either coastal 
or Great Lakes waters. As of the date of this proposal, none of these 
Tribes have coastal recreation waters (i.e., coastal or Great Lakes 
waters designated for swimming, bathing, surfing or similar water 
contact activities). EPA is not including these Tribes in today's 
proposal because the requirements of CWA section 303(i) only apply to 
coastal recreation waters. EPA recognizes that the criteria in today's 
proposal will help inform Agency decisions related to its review of 
current and future Tribal water quality standards submissions to EPA. 
EPA has contacted those Tribes identified as having coastal or Great 
Lakes waters to inform them of the potential future impact this 
proposal could have on Tribal waters. EPA solicits comment on its 
interpretation of CWA section 303(i) as it applies to coastal Tribal 
waters that have not been designated for swimming, bathing, surfing, or 
similar water contact activities.

C. Under What Conditions Will States and Territories Be Removed From a 
Final Rule?

    As discussed in Section II of this preamble, the water quality 
standards program has been established with an emphasis on State 
primacy. Although this proposed rule has been developed to promulgate 
Federal bacteria criteria for certain States and Territories, EPA 
prefers that States and Territories maintain primacy and revise their 
own standards to meet CWA sections 303(c) and 303(i) requirements. EPA 
is hopeful that today's proposed rulemaking will provide additional 
impetus for States and Territories to adopt the criteria for bacteria 
necessary to comply with CWA section 303(i).
    For States and Territories that adopt criteria that EPA approves as 
meeting CWA section 303(i) requirements before publication of the final 
rulemaking, EPA will not include them in the final rulemaking. At any 
point in the process prior to final promulgation, a State or Territory 
can ensure that it will not be affected by this action by adopting the 
necessary criteria pursuant to State or Territorial law and receiving 
EPA approval. EPA will make every effort to issue timely approval of 
revised criteria submitted before promulgation of the final rule.
    Following a final promulgation of this rule, removal of Federal 
standards for a State or Territory will require rulemaking by EPA 
according to the requirements of the Administrative Procedure Act (5 
U.S.C. 551 et seq.). When a State or Territory adopts standards as 
protective of human health as EPA's 1986 bacteria criteria, EPA will 
undertake such a rulemaking to withdraw the Federal criteria. However, 
as discussed in Section III.C.1, EPA is proposing that State and 
Territorial standards for bacteria approved by EPA pursuant to CWA 
sections 303(c) and 303(i) will be in effect for CWA purposes, and the 
Federal criteria for this rule will no longer apply even before EPA 
withdraws the Federal criteria for that State or Territory.

V. Alternative Regulatory Approaches and Implementation Mechanisms

    In developing a final rule, EPA will consider any data or 
information submitted to the Agency during the comment period. However, 
it is possible that relevant information for particular coastal 
recreation waters covered by this proposed rule may become available 
after completion of this rulemaking. If EPA ultimately promulgates a 
Federal E. coli and enterococci criteria for coastal recreation waters 
for some or all of the States and Territories covered by this proposal, 
there are several ways to ensure that the primary contact recreation 
use and its implementing mechanisms appropriately take into account 
such future information.

A. Designating Uses

    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 the States or Territories for coastal recreation waters 
covered by this proposed rule to determine if the standards meet the 
requirements of the CWA 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 CWA section 
303(c) and the regulations at 40 CFR 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 BEACH Act 
definition of ``coastal recreation waters''.

[[Page 41736]]

    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 with uses not specified in CWA section 
101(a)(2) or with subcategories of designated uses specified in CWA 
section 101(a)(2) that require less stringent criteria (see 40 CFR 
131.10(j)).

B. Compliance Schedules

    A compliance schedule refers to an enforceable sequence of interim 
requirements in a permit leading to ultimate compliance with water 
quality-based effluent limitations (WQBELs) in accordance with the CWA. 
In an NPDES permit, WQBELs are the value determined by selecting the 
most stringent of the effluent limits calculated using all applicable 
water quality criteria for a specific point source to a specific 
receiving water for a given pollutant (See NPDES Permit Writers Manual, 
EPA-833-B-96-003, December, 1996).
    Although many States and Territories have adopted regulations that 
are effective for CWA purposes authorizing compliance schedules for 
WQBELs, some have not done so. Therefore, EPA is proposing that where a 
State or Territory does not have a regulation that is in effect for CWA 
purposes authorizing compliance schedules for WQBELs, this proposed 
rule would authorize, but would not require, the permit issuing 
authority to include such compliance schedules in permits under 
appropriate circumstances. If a State or Territory does have a 
regulation that is in effect for CWA purposes authorizing compliance 
schedules, that compliance schedule regulation would continue to apply 
and would not be affected by today's proposed rule. It may be that a 
State or Territory that does not have a regulation authorizing 
compliance schedules has chosen that it does not want such a 
regulation. Thus, if a State or Territory notifies EPA in writing prior 
to promulgation that it does not want to authorize compliance schedules 
in permits implementing the bacteria criteria, then EPA would exclude 
that State or Territory from the compliance schedule provision 
contained in the final rule. Deferring to each State's or Territory's 
compliance schedule decisions would be consistent with the CWA's 
approach of giving the States and Territories the primary authority 
over water pollution control (CWA section 101(b)).
    In States and Territories where this proposed rule's compliance 
schedule provision would apply, the permitting authority authorized to 
administer the National Pollutant Discharge Elimination System (NPDES) 
program would exercise its discretion when deciding if a compliance 
schedule is justified because of the technical or financial (or other) 
infeasibility of immediate compliance. A provision authorizing 
compliance schedules is included in today's proposed rule because of 
the potential for existing dischargers to have new or more stringent 
effluent limitations for which immediate compliance would not be 
possible or practicable.
    EPA supports the States and Territories in adopting statewide 
provisions independent of or as part of their effort to readopt 
statewide water quality control plans, or in adopting individual basin-
wide compliance schedule provisions. The States and Territories have 
broad discretion to adopt such provisions, including discretion on 
reasonable lengths of time for final compliance with WQBELs. EPA 
recognizes that practical time frames within which to set interim goals 
may be necessary to achieve meaningful, long-term improvements in water 
quality.
    New and Existing Pathogen Dischargers: The provision would allow 
compliance schedules only for an ``existing pathogen discharger'' which 
would be defined as any discharger which is not a ``new pathogen 
discharger.'' EPA is proposing to define a ``new pathogen discharger'' 
as any building, structure, facility, or installation from which there 
is or may be a discharge of pathogens, the construction of which 
commenced after the effective date of the final rule. This definition 
is modeled after the definition of a new Great Lakes discharger at 40 
CFR 132.2 which EPA created to implement the compliance schedule 
provision of 40 CFR Part 132 Appendix F, Procedure 9. The definition of 
``new pathogen discharger'' only includes new sources if the new source 
commences construction after the effective date of the final rule. 
Other new sources that commence construction before the effective date 
of the final rule would be treated as ``existing pathogen 
dischargers.'' EPA solicits comment on the utility of these definitions 
for implementing a compliance schedule for the proposed enterococci and 
E. coli criteria in 40 CFR 131.41.
    For ``existing pathogen dischargers'' whose permits are reissued or 
modified to contain new or more stringent limitations based upon 
certain water quality requirements, the permit could allow up to five 
years to comply with such limitations. The provision would apply to new 
or more stringent effluent limitations based on the criteria in this 
proposed rule. EPA has included ``increasing dischargers'' within the 
category of ``existing pathogen dischargers''' for purposes of this 
rule since ``increasing dischargers'' are existing facilities with a 
change--an increase--in their discharge. Such facilities may include 
those with seasonal variations. ``Increasing dischargers'' will already 
have treatment systems in place for their current discharge, thus, they 
are constrained in the types of efficiencies they can gain from their 
existing treatment system processes. In contrast, a new discharger can 
design and build a new treatment system which most efficiently will 
meet the new water quality-based requirements. Allowing existing 
facilities with an increasing discharge a compliance schedule in 
appropriate circumstances would avoid placing the discharger at a 
competitive disadvantage vis-a-vis other existing dischargers who are 
eligible for compliance schedules.
    Today's proposed rule would not prohibit the use of a short-term 
``shake down period'' for new pathogen dischargers as is provided for 
new sources or new dischargers in 40 CFR 122.29(d)(4). These 
regulations would require that the owner or operator of (1) a new 
source; (2) a new discharger (as defined in 40 CFR 122.2) which 
commenced discharge after August 13, 1979; or (3) a recommencing 
discharger shall install and implement all pollution control equipment 
to meet the conditions of the permit before discharging. The facility 
would also be required to meet all permit conditions in the shortest 
feasible time (not to exceed 90 days). This shake-down period is not a 
compliance schedule, some types of facilities that are eligible for a 
``shake down period'' may also be eligible for a compliance schedule if 
they are existing pathogen dischargers. This approach would be used to 
address violations which may occur during a new facility's start-up, 
especially where permit limits are water quality-based and biological 
treatment is involved.
    The burden of proof to show the necessity of a compliance schedule 
would be on the discharger, and the discharger would be required to 
request approval from the permit issuing authority for a schedule of 
compliance. The discharger should submit a description of the minimum 
required actions or evaluations that must be undertaken in order to 
comply with the new or more restrictive discharge limits. Dates of 
completion for the required actions or evaluations should be included, 
and the proposed schedule

[[Page 41737]]

should reflect the shortest practicable time to complete all minimum 
required actions.
    Duration of Compliance Schedules: Today's proposed rule would 
provide that compliance schedules may provide for up to five years from 
date of permit issuance, reissuance, or modification to meet new or 
more stringent effluent limitations in those circumstances where the 
permittee can demonstrate to the permit authority that an extended 
schedule is warranted. EPA's regulations at 40 CFR 122.47 require 
compliance with standards as soon as possible. This means that permit 
authorities should not allow compliance schedules where the permittee 
fails to demonstrate their necessity. This provision should not be 
considered a default compliance schedule duration for all existing 
facilities. In instances where dischargers find that their current 
level of disinfection or other treatment is not sufficient to achieve 
the E. coli or enterococci criterion, dischargers will need to increase 
their current level of disinfection or evaluate and install new 
treatment technology. EPA believes that five years is sufficient time 
within which to complete this process.
    Under this proposed rule, where a schedule of compliance exceeds 
one year, interim requirements are to be specified and interim progress 
reports would be required to be submitted at least annually to the 
permit issuing authority.
    The proposed rule would allow all compliance schedules to extend up 
to a maximum duration of five years. Under the proposal, an existing 
pathogen discharger may obtain a compliance schedule when the existing 
permit for that discharge is issued, reissued or modified to contain 
more stringent limits based on the water quality criteria in today's 
proposed rule. Such compliance schedules, however, would not be able to 
be extended indefinitely because the compliance schedule provision in 
this rule limits the length of a compliance schedule for any facility 
to a maximum of five years.
    EPA recognizes that where a permit is modified during the permit 
term, and the permittee needs the full five years to comply, the five-
year schedule may extend beyond the term of the modified permit. In 
such cases, the rule allows for the modified permit to contain a 
compliance schedule with an interim limit to be achieved by the end of 
the permit term. When the permit is reissued, the permit authority may 
extend the compliance schedule in the next permit, provided that, 
taking into account the amount of time allowed under the previous 
permit, the entire compliance schedule contained in the permit shall 
not exceed five years. Final permit limits and compliance dates will be 
included in the record for the permit. Final compliance dates for any 
WQBEL must occur within five years from the date of permit issuance, 
reissuance, or modification.
    Antibacksliding: EPA wishes to address the potential concern over 
antibacksliding where revised permit limits based on new information 
are the result of the completion of additional studies. The Agency's 
interpretation of the CWA is that the antibacksliding requirements of 
section 402(o) of the CWA do not apply to revisions to effluent 
limitations made before the scheduled date of compliance for those 
limitations.
    EPA is requesting comment on the setting and use of compliance 
schedules to provide permitted dischargers time to meet their permit 
effluent limitations based on today's proposed bacteria criteria. 
Compliance schedules can be set as part of the water quality standard 
or as part of the implementing regulations; in this specific case, the 
standard is authorizing the use of compliance schedules in cases where 
the permitting authority determines it would be appropriate. EPA is 
interested in views concerning the duration of the schedule. Today's 
proposal limits compliance schedules to a period not to exceed five 
years. It also requires interim limits where the five year term exceeds 
the length of time remaining in the permit after modification and 
requires specific milestones and reporting on an annual basis. EPA is 
interested in whether the limitation of five years for compliance 
schedules is reasonable or should longer schedules be allowed for 
certain permit activities that require extensive studies and 
construction activities (e.g., long term control plans associated with 
combined sewer overflows).

VI. Economic Analysis

    These water quality standards may serve as a basis for development 
of NPDES permit limits. Many of the affected jurisdictions (i.e., 
States and Territories) are the NPDES permitting authorities, which 
retain considerable discretion in implementing standards. EPA evaluated 
the potential costs to NPDES dischargers in affected jurisdictions 
associated with future State and Territorial implementation of EPA's 
Federal standards. This analysis is documented in ``Economic Analysis 
for Proposed Water Quality Standards for Coastal Recreation Waters,''' 
which can be found in the record for this rulemaking.
    Any NPDES-permitted facility that discharges to water bodies 
affected by this proposed rule could potentially incur costs to comply 
with the rule's provisions. 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). EPA addresses discharges of bacteria from municipal separate 
storm sewer systems, combined sewer overflows (CSOs), and sanitary 
sewer overflows (SSOs) to coastal waters in existing and anticipated 
regulations and policies, and has tallied potential control costs as 
part of analyses for these actions. Controls for these types of 
discharges, which are not based on numeric limits are not likely to be 
substantially affected by the revised indicators in the proposed rule, 
at least in the near future. Therefore, to avoid double counting, EPA 
did not estimate costs for such discharges for this rule. EPA did not 
evaluate concentrated animal feeding operations (CAFOs) because section 
301(a) of the CWA prohibits point sources, including CAFOs, from 
discharging to surface waters without a permit (except in compliance 
with CWA section 402 and other specified sections of the CWA), and 
because NPDES permits for CAFOs in turn prohibit discharges except in 
unusual circumstances (i.e., very large storms) that are unlikely to be 
affected by the revised indicators. EPA does not have data to quantify 
the effects of the proposed rule on total maximum daily loads for 
pathogen-impaired waters. Finally, EPA did not evaluate the potential 
for costs to nonpoint sources, such as agricultural runoff, and did not 
attempt to quantify the potential benefits of the proposed rule.
    EPA recognizes that a State or Territory may decide to require 
controls for nonpoint sources (e.g., agricultural runoff) or point 
source discharges (e.g., CSOs and SSOs) due to wet weather events. 
However, as a technical matter, these sources are difficult to model 
and evaluate with respect to potential costs impacts 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

[[Page 41738]]

enterococci after complying with existing regulations and policies may 
not be possible, or would be extremely time and resource intensive. 
Finally, it is likely that any controls needed to meet existing 
standards (i.e., based on fecal coliform) would also address any water 
quality problems indicated by standards based on E. coli or 
enterococci.

A. Identifying Affected Facilities

    EPA identified approximately 850 point source facilities from 28 
States and Territories that may be affected by the proposed rule. Of 
these potentially affected facilities, 362 are classified as major 
dischargers, and 488 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 actually discharge to 
the affected water bodies because location information is not available 
in EPA's PCS database.
    EPA assumed that only facilities located in jurisdictions included 
in the proposed rule that discharge within 2 miles of coastal waters or 
the Great Lakes may be affected. EPA identified these facilities by 
relating facility information to the potentially affected waters using 
GIS software. EPA also assumed that only wastewater treatment plants or 
facilities with similar effluent characteristics (i.e., facilities 
having the potential to discharge bacteria) would potentially be 
affected by the proposed rule. For those facilities for which latitude/
longitude data are not included in PCS, EPA included only facilities 
for which the receiving water body name in PCS indicates a coastal 
water (e.g., Pacific Ocean, Lake Erie). Table 4 summarizes these 
potentially affected facilities by type and category.

                                  Table 4.--Potentially Affected Facilities \1\
----------------------------------------------------------------------------------------------------------------
                                                                       Number of facilities
                                                             ---------------------------------------
                          Category                                                   Minor              Total
                                                               Major \2\  --------------------------
                                                                            Municipal    Other \3\
----------------------------------------------------------------------------------------------------------------
Coastal.....................................................          298          283          108          689
Great Lakes.................................................           64           76           21          161
                                                             --------------
    Total...................................................          362          359          129         850
----------------------------------------------------------------------------------------------------------------
\1\ Facilities from States and Territories included in the proposed rule that discharge within two miles of
  coastal waters or the Great Lakes.
\2\ No major industrial facilities are affected by the proposed rule. However, 6 other facilities (SIC codes
  9711 and 9999) are included because their names indicate that they are wastewater treatment plants.
\3\ Includes the following SICs: 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), 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 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 proposed standards are for the affected waters, and permitting 
authorities have flexibility in implementing the criteria. Facilities 
in some States that have adopted the 1986 criteria have effluent limits 
for E. coli or enterococci, and in other such States, facilities do not 
have bacteria limits. To be conservative (i.e., err on the side of 
higher costs), EPA assumed that potentially affected facilities would 
be required to meet both the applicable geometric mean and SSM 
(although EPA's bacteria implementation guidance indicates that the 
intent of the SSM value is not for permitting).
    PCS 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 is E. coli because E. coli is a type of fecal 
coliform. EPA estimated that facilities with average monthly effluent 
levels, based on the last 3 years of data, exceeding a geometric mean 
of 126 fecal coliform/100 mL, or maximum daily levels exceeding 235 
fecal colonies/100 mL, would need treatment controls to meet potential 
permit limits based on the proposed criteria.
    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 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 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 proposed enterococci criteria. Again, 
EPA compared fecal coliform levels over the last three years to both 
the proposed geometric mean and SSM enterococci criteria values.
    Experiences from facilities currently meeting the proposed E. coli 
and enterococci criteria, as well as the current fecal coliform 
criteria, suggest that chlorination processes can be upgraded or 
adjusted to produce the levels of bacteria necessary for compliance 
with the proposed rule. Therefore, EPA estimated that optimization of 
existing disinfection processes would enable the sample facilities to 
comply with the proposed rule. Process optimization usually involves 
process analysis and process modifications, and EPA's cost estimates 
include both capital and operating and maintenance costs.

[[Page 41739]]

C. Results

    Based on the potential costs for the 15 facilities with flows 
greater than 120 mgd, and extrapolating costs for a sample of 60 
facilities to the remaining 835 facilities potentially affected by the 
proposed rule, EPA estimated a total annual cost of approximately $22 
million ($15 million for coastal facilities, and $7 million for Great 
Lakes facilities). EPA estimates that approximately 110 major and 30 
minor permittees could incur control costs as a result of modified 
permits to comply with the revised criteria. However, this estimate is 
considered conservative because it is based on assumptions regarding 
how States and Territorial will implement the proposed standards that 
may overstate the actual cost impacts and two States (Alabama and 
Texas) included in EPA's cost analysis are not part of today's proposed 
rule.VII.

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 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'' 
because the rule raises novel policy issues arising out of the BEACH 
Act. As such, this action was submitted to OMB for review. Changes made 
in response to OMB suggestions or recommendations will be 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 proposed rule on 
small entities, small entity is defined as: (1) A small business 
according to RFA default definitions for small business (based on SBA 
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 proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. This 
proposed rule will not impose any requirements on small entities. The 
RFA requires analysis of the impacts of a rule on the small entities 
subject to the rule's requirements. See United States Distribution 
Companies v. FERC, 88 F.3d 1105, 1170 (DC Cir. 1996). Today's proposed 
rule establishes no requirements applicable to small entities, and so 
is not susceptible to regulatory flexibility analysis as prescribed by 
the RFA. (``[N]o [regulatory flexibility] analysis is necessary when an 
agency determines that the rule will not have a significant economic 
impact on a substantial number of small entities that are subject to 
the requirements of the rule,'' United Distribution at 1170, quoting 
Mid-Tex Elec. Co-op v. FERC, 773 F.2d 327, 342 (DC Cir. 1985) (emphasis 
added by United Distribution court).) We continue to be interested in 
the potential impacts of the proposed rule on small entities and 
welcome comments on issues related to such impacts.
    CWA 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 NPDES program, 
which limits discharges to navigable waters except in compliance with 
an NPDES permit. The CWA requires that all NPDES permits include any 
limits on discharges that are necessary to meet applicable water 
quality standards.
    Thus, under the CWA, EPA's promulgation of water quality standards 
establishes standards that the State generally implements through the 
NPDES permit process. In this case, EPA Regional Offices are the NPDES 
permitting authority in five of the States and Territories subject to 
today's proposal. EPA Regions 1, 2, 9 and 10 are the permitting 
authorities for Massachusetts, Puerto Rico, the Commonwealth of the 
Northern Mariana Islands, for some permits in Hawaii, and Alaska, 
respectively. As such, EPA Regions 1, 2, 9, and 10 have discretion

[[Page 41740]]

in developing discharge limits as needed to meet the standards. While 
these Regions' implementation of Federally promulgated water quality 
standards may result in new or revised discharge limits being placed on 
small entities, the standards themselves do not apply to any 
discharger, including small entities.
    Today's proposed rule, as explained earlier, does not itself 
establish any requirements that are applicable to small entities. As a 
result of this action, States, Territories, and EPA Regional offices 
will need to ensure that permits they issue include any limitations on 
discharges necessary to comply with the standards established in the 
final rule. In doing so, the States, Territories, and EPA Regions will 
have a number of choices associated with permit writing. While the 
implementation of the rule may ultimately result in some new or revised 
permit conditions for some dischargers, EPA's action today does not 
impose any of these as yet unknown requirements on small entities.

D. Unfunded Mandates Reform Act

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

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have Federalism implications.'' 
``Policies that have Federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This proposed 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 CWA is well established 
and has been used on various occasions in the past. The proposed rule 
would 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 proposed rule 
would not alter the States' or Territories' considerable discretion in 
implementing these water quality standards. Further, this proposed rule 
would not preclude the States and Territories from adopting water 
quality standards that meet the requirements of the CWA, 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 
proposed rule.
    Although Executive Order 13132 does not apply to this rule, EPA did 
consult with representatives of the States and Territories subject to 
CWA section 303(i) in developing this rule. Prior to this proposed 
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 group since 2001 
to assist EPA in developing draft detailed scientific and policy 
guidance (Implementation Guidance for Ambient Water Quality Criteria 
for Bacteria, May 2002 Draft, EPA-823-B-02-003) concerning adoption and 
implementation of EPA's recommended criteria for bacteria. EPA will 
continue to work with the States and Territories before finalizing 
these water quality standards. In the spirit of Executive Order 13132, 
and consistent with EPA policy to promote communications between EPA 
and State and local governments, EPA specifically solicits comment on 
this proposed rule from State and local officials.

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

[[Page 41741]]

tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes.''
    This proposed 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 
proposed 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 
proposal could have on Tribal waters. EPA specifically solicits 
additional comment on this proposed rule from tribal officials.

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 planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    This proposed rule is not subject to the Executive Order because it 
is not economically significant as defined in Executive Order 12866.

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 proposed rule will create a negligible 
increase in nationwide energy consumption for point source facilities 
discharging to coastal recreation waters in affected States. In Section 
VI, EPA presented its estimated incremental costs to permitted 
facilities as a result of the proposed 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 140,000 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., 0.000004% of 
national energy generation).

I. National Technology Transfer and Advancement Act

    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. 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, published in accordance with CWA section 304(a), 
in cases where States fail to do so. Therefore, EPA is not considering 
the use of any voluntary consensus standards.

List of Subjects in 40 CFR Part 131

    Environmental protection, Intergovernmental relations, Reporting 
and recordkeeping requirements, Water pollution control.

    Dated: July 1, 2004.
Michael O. Leavitt,
Administrator.
    For the reasons set out in the preamble, EPA proposes to amend 40 
CFR part 131 as follows:

PART 131--WATER QUALITY STANDARDS

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

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

Subpart D--[Amended]

    2. Section 131.41 is added 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 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

[[Page 41742]]

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 rule 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 [THE EFFECTIVE DATE OF THE RULE].
    (7) Existing pathogen discharger for the purposes of this rule 
means any discharger that is not a new pathogen discharger.
    (c) EPA's section 304(a) ambient water quality criteria for 
bacteria.
    (1) Fresh waters:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     C  Single sample maximum (per 100 ml)
                                                                                     -------------------------------------------------------------------
                                                                                                         C2  Moderate    C3  Light use    C4  Infrequent
                                                                       B  Geometric    C1  Designated    use coastal        coastal        use coastal
                            A  Indicator                                   mean        bathing beach      recreation       recreation       recreation
                                                                                      (75% confidence    waters (82%      waters (90%      waters  (95%
                                                                                           level)         confidence       confidence       confidence
                                                                                                            level)           level)           level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli............................................................  126/100 ml \a\          235 \b\          298 \b\          409 \b\          575 \b\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(1):
\a\ This value is for use with analytical methods 1106.1 or 1600 or any equivalent viable method.
\b\ Calculated using the following: single sample maximum = geometric mean * 10 [supcaret] (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.


    (2) Marine waters:


--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     C  Single sample maximum (per 100 ml)
                                                                                     -------------------------------------------------------------------
                                                                                                         C2  Moderate    C3  Light use    C4  Infrequent
                                                                       B  Geometric    C1  Designated    use coastal        coastal        use coastal
                            A  Indicator                                   mean        bathing beach      recreation       recreation       recreation
                                                                                      (75% confidence    waters (82%      waters (90%      waters (95%
                                                                                           level)         confidence       confidence       confidence
                                                                                                            level)           level)           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 1103.1, 1603, or 1604 or any equivalent viable method.
\b\ Calculated using the following: single sample maximum = geometric mean * 10 [supcaret] (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.


    (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 contain 
criteria approved by EPA as meeting the requirements of Clean Water Act 
section 303(i), 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), Delaware (except for waters with 
human sources of fecal contamination), Florida, Georgia, Hawaii (except 
for non-estuarine coastal recreation waters within 300 meters of the 
shoreline), Louisiana, Maine (except for 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 40 CFR 131.40), Rhode 
Island, South Carolina, United States Virgin Islands, Washington.
    (3) The criteria in column C of paragraph (c)(2) of this section 
apply to marine coastal recreation waters of the following States: 
Commonwealth of the Northern Mariana Islands, Hawaii (for non-estuarine 
coastal recreation waters within 300 meters of shore).
    (f) Schedules of compliance. (1) Subsection (f) applies to any 
State that does not have a regulation in effect for Clean Water Act 
purposes that authorizes compliance schedules subject to this 
paragraph, except for [LIST OF STATES AND TERRITORIES

[[Page 41743]]

THAT TELL EPA IN WRITING THAT THEY DO NOT WANT TO ALLOW A SCHEDULE OF 
COMPLIANCE]. 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 [THE EFFECTIVE DATE OF THE 
RULE] 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 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 (b) of this section as 
soon as possible, taking into account the dischargers' 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. 04-15614 Filed 7-8-04; 8:45 am]
BILLING CODE 6560-50-P