[Federal Register Volume 69, Number 220 (Tuesday, November 16, 2004)]
[Rules and Regulations]
[Pages 67218-67243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25303]
[[Page 67217]]
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Part II
Environmental Protection Agency
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40 CFR Part 131
Water Quality Standards for Coastal and Great Lakes Recreation Waters;
Final Rule
Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 /
Rules and Regulations
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 131
[OW-2004-0010; FRL-7837-5]
RIN 2040-AE63
Water Quality Standards for Coastal and Great Lakes Recreation
Waters
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is promulgating
water quality criteria for bacteria for coastal recreation waters in
specific States and Territories. The States and Territories covered by
this promulgation do not have water quality standards for bacteria that
comply with the requirements of section 303(i)(1)(A) of the Clean Water
Act. Under these circumstances, the Act requires EPA to promptly
propose such standards and to promulgate such standards not later than
90 days after proposal. The criteria promulgated today apply to coastal
and Great Lakes waters that specific States and Territories have
designated for swimming, bathing, surfing, or similar water contact
activities and for which the State or Territory does not have in place
EPA-approved bacteria criteria that are as protective of human health
as EPA's 1986 recommended bacteria criteria. Through this promulgation,
the Federally designated water quality criteria will be added to the
States' and Territories' water quality criteria applicable to coastal
recreation waters.
DATES: This final rule is effective December 16, 2004.
ADDRESSES: EPA has established a docket for this action under DOCKET ID
No. OW-2004-0010. All documents in the docket are listed in the EDOCKET
index at http://www.epa.gov/edocket. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically in EDOCKET or in hard copy at the Water Quality
Standards for Coastal and Great Lakes Recreation Waters Docket, EPA/DC,
EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC 20460.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
Water Quality Standards for Coastal and Great Lakes Recreation Water
Docket is (202) 566-2422.
FOR FURTHER INFORMATION CONTACT: For information concerning today's
rulemaking, contact Lars Wilcut, Standards and Health Protection
Division, Office of Science and Technology (4305 T), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (202) 566-0447; fax number: (202) 566-0409; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. General Information
A. Does This Action Apply to Me?
B. How Can I Get Copies of This Document and Other Related
Information?
II. Background
A. Statutory and Regulatory Background
1. Clean Water Act
2. BEACH Act of 2000
B. 1986 Ambient Water Quality Criteria for Bacteria
III. EPA's Proposed Rule and Solicitation of Comment
A. July 2004 Proposed Rule
B. Public Comments
IV. Criteria That EPA Is Promulgating Today
A. Scope of the Rule
B. Criteria for Pathogen Indicators
1. Selection of Pathogen Indicator
2. Bacteria Criteria Values
3. Use of the Single Sample Maximum
4. Intensity of Use Categories of Coastal Recreation Waters
5. Intrastate vs. Interstate Determinations of Use Intensity
6. State Calculation of Site-Specific Single Sample Maximums
7. Addressing Non-Human Sources of Bacteria
C. Applicability of Today's Rule
1. Applies in Addition to Any State/Territorial Criteria
2. Role of State/Territorial General Rules of Applicability
D. Compliance Schedules
V. EPA Review of State and Territorial Standards
A. How Did EPA Decide Which States and Territories To Include In
Today's Rule?
B. Which States and Territories Are Included in Today's Rule?
C. Under What Conditions Will States and Territories Be Removed
From Today's Rule?
VI. Response to Additional Significant Public Comments
A. 1986 Bacteria Criteria
B. Economics
C. Analytical Methods
D. Effective Date
VII. Alternative Regulatory Approaches and Implementation Mechanisms
VIII. Economic Analysis
A. Identifying Affected Facilities
B. Method for Estimating Potential Compliance Costs
C. Results
IX. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Congressional Review Act
I. General Information
A. Does This Action Apply to Me?
State and Territorial agencies responsible for adopting and
implementing water quality standards in the States and Territories
identified in 40 CFR 131.41 are the entities most directly affected by
today's rule. People concerned with water quality in coastal and Great
Lakes States may be interested in this rulemaking. Facilities
discharging pollutants to certain waters of the United States in
coastal and Great Lakes States could be affected by this rulemaking
because water quality standards are used in determining water quality-
based National Pollutant Discharge Elimination System permit limits. In
addition, beach managers and businesses in beach areas could also be
indirectly affected by this rulemaking because water quality standards
are used in making decisions regarding beach advisories and closures.
Categories and entities that may be affected include:
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Examples of potentially
Category affected entities
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Industry............................... Industries discharging
pollutants to the waters of
the States and Territories
identified in 40 CFR 131.41.
Municipalities......................... Publicly-owned treatment works
or municipal wet weather
discharges (such as combined
sewer overflows) that
discharge pollutants to the
waters of the States and
Territories identified in 40
CFR 131.41.
Other.................................. Beach owners and managers,
beach goers. States identified
in 40 CFR 131.41.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could also be affected. To determine whether
your facility may be affected by this action, you should carefully
examine the language in 40 CFR 131.41 of today's final rule. If you
have questions regarding the applicability of this action to a
particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
B. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under Docket ID No. OW-2004-0010. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
the disclosure of which is restricted by statute. The official public
docket is the collection of materials that is available for public
viewing at the Water Quality Standards for Coastal and Great Lakes
Recreation Waters Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Water Quality Standards for
Coastal and Great Lakes Recreation Waters Docket is (202) 566-2422.
Docket copying costs are as follows: the first 266 pages are free,
additional copying incurs a $25 administrative fee, and each additional
page is $0.15.
2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EDOCKET. You may use
EDOCKET at http://www.epa.gov/edocket/ to view public comments, access
the index listing of the contents of the official public docket, and to
access those documents in the public docket that are available
electronically. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Section I.B.
Once in the system, select ``search,'' then key in the appropriate
docket identification number.
II. Background
A. Statutory and Regulatory Background
1. Clean Water Act
Section 303 (33 U.S.C. 1313) of the Clean Water Act directs States,
Territories, and authorized Tribes, with oversight by EPA, to adopt
water quality standards to protect the public health and welfare,
enhance the quality of water and serve the purposes of the Clean Water
Act. Under section 303, States, Territories, and authorized Tribes are
to develop water quality standards for navigable waters of the United
States within the State, Territory, or authorized Tribe. Section 303(c)
provides that water quality standards shall include the designated use
or uses for the waters and water quality criteria necessary to protect
those uses. Section 303(c)(2)(A) of the Clean Water Act specifies the
uses that States, Territories, and authorized Tribes should consider in
establishing new or revised water quality standards. These uses are
public water supplies, propagation of fish and wildlife, recreational
purposes, agricultural, industrial, and other purposes, and navigation.
States, Territories, and authorized Tribes must review their water
quality standards at least once every three years and, if appropriate,
revise or adopt new standards. States, Territories, and authorized
Tribes must submit the results of this triennial review to EPA, and EPA
must approve or disapprove any new or revised standards.
Section 303(c) of the Clean Water Act authorizes the EPA
Administrator to promulgate water quality standards to supersede State,
Territorial, or authorized Tribal standards that have been disapproved
or in any case where the Administrator determines that a new or revised
standard is needed to meet the Clean Water Act's requirements. EPA
regulations implementing Clean Water Act section 303(c) are published
at 40 CFR Part 131. Under these rules, the minimum elements that
States, Territories, or authorized Tribes must incorporate in their
water quality standards include: use designations for all water bodies
in the State, Territory, or authorized Tribe, water quality criteria
sufficient to protect those use designations, and an antidegradation
policy (see 40 CFR 131.6). Section 303(c)(4) requires the EPA
Administrator to promulgate any new or revised water quality standard
not later than 90 days after publishing a proposed Federal standard
unless prior to this deadline, the State, Territory or authorized Tribe
has adopted a water quality standard that the Administrator determines
to be in accordance with the Clean Water Act.
2. The BEACH Act of 2000
The Beaches Environmental Assessment and Coastal Health (BEACH) Act
of 2000 amended the Clean Water Act in part by adding section 303(i).
Section 303(i)(1)(A) requires that not later than April 10, 2004,
``each State having coastal recreation waters shall adopt and submit to
the Administrator water quality criteria and standards for the coastal
recreation waters of the State for those pathogens and pathogen
indicators for which the Administrator has published criteria under
section 304(a).'' EPA's Ambient Water Quality Criteria for Bacteria--
1986 (EPA 440/5-84-002, January 1986) (the 1986 bacteria criteria
document) is the relevant criteria document published by the
Administrator under Clean Water Act section 304(a).
Section 303(i)(2)(A) requires that, ``[i]f a State fails to adopt
water quality
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criteria and standards in accordance with [section 303(i)(1)(A)] that
are as protective of human health as the criteria for pathogens and
pathogen indicators for coastal recreation waters published by the
Administrator, the Administrator shall promptly propose regulations for
the State setting forth revised or new water quality standards for
pathogens and pathogen indicators described in [section 303(i)(1)(A)]
for coastal recreation waters of the State.''
The BEACH Act also added section 502(21)(A) to the Clean Water Act,
which defines ``coastal recreation waters'' as ``(i) the Great Lakes;
and (ii) marine coastal waters (including coastal estuaries) that are
designated under section 303(c) by a State for use for swimming,
bathing, surfing, or similar water contact activities.'' Section
502(21)(B) explicitly excludes from the definition of coastal
recreation waters ``inland waters; or * * * waters upstream of the
mouth of a river or stream having an unimpaired natural connection with
the open sea.''
B. 1986 Ambient Water Quality Criteria for Bacteria
In 1986, EPA published Ambient Water Quality Criteria for
Bacteria--1986. This document contains EPA's current recommended water
quality criteria for bacteria to protect people from gastrointestinal
illness in recreational waters, i.e., waters designated for primary
contact recreation or similar full body contact uses. States and
Territories typically define primary contact recreation to encompass
recreational activities that could be expected to result in the
ingestion of, or immersion in, water, such as swimming, water skiing,
surfing, kayaking, or any other recreational activity where ingestion
of, or immersion in, the water is likely. The main route of exposure to
illness-causing organisms during recreation in water is through
accidental ingestion of fecally contaminated water while engaging in
these activities.
EPA based its 1986 water quality criteria for bacteria on levels of
indicator bacteria, namely Escherichia coli (E. coli) and enterococci,
which demonstrate the presence of pathogens in fecal pollution that can
cause acute gastrointestinal illness. Public health agencies have long
used indicator organisms such as these to protect people from illnesses
that they may contract from engaging in recreational activities in
surface waters contaminated by fecal pollution. These organisms
generally do not cause illness directly, but have demonstrated
characteristics that make them good indicators of fecal contamination
and thus the potential presence of pathogens capable of causing human
illnesses such as gastroenteritis. Gastroenteritis describes a variety
of diseases that affect the gastrointestinal tract and are rarely life-
threatening. Symptoms of the illness include nausea, vomiting,
stomachache, diarrhea, headache, and fever. Prior to its publication of
the 1986 bacteria criteria document, EPA recommended the use of fecal
coliforms as an indicator organism to protect people from
gastrointestinal illness in recreational waters. The previously
recommended numeric criteria for fecal coliform were a geometric mean
of 200/100 ml, with no more than 10% of the total samples taken during
any 30-day period exceeding 400/100 ml. However, EPA conducted
epidemiological studies and evaluated the use of several organisms as
indicators, including fecal coliforms, E. coli, and enterococci. EPA
subsequently recommended the use of E. coli or enterococci for fresh
recreational waters and enterococci for marine recreational waters
because levels of these organisms more accurately predict acute
gastrointestinal illness than levels of fecal coliforms. On page 5,
EPA's 1986 bacteria criteria document states: ``[E]nterococci showed
the strongest relationship to gastroenteritis. E. coli was a very poor
second and all of the other indicators, including total coliforms and
fecal coliforms showed very weak correlations to gastroenteritis.''
In EPA's epidemiological studies, E. coli and enterococci exhibited
the strongest correlation to swimming-associated gastroenteritis, the
former in freshwaters only and the latter in both fresh and marine
waters (1986 bacteria criteria document; Health Effects Criteria for
Fresh Recreational Waters, EPA 600/1-84-004, August 1984; Health
Effects Criteria for Marine Recreational Waters, EPA 600/1-80-031,
August 1983). In marine waters, the stronger correlation may be due to
enterococci's ability to survive longer than coliforms, similar to the
pathogens of concern. In addition, fecal coliforms are sometimes
detected where fecal contamination is absent, possibly resulting in
inaccurate assessments of recreational safety. For example, Klebsiella
spp., a bacterial organism that is part of the fecal coliform group but
which is generally not harmful to humans and does not occur with fecal
contamination, is often present in pulp and paper and textile mill
effluents (Archibald, F., Water Qual. Res. J. Canada 35(1):1-22, 2000;
Dufour, Journal WPCF, 48:872-879, 1976).
Table 1 contains the water quality criteria values for the
protection of primary contact recreation that EPA recommended in the
1986 bacteria criteria document. EPA developed these values based on
the concentrations of E. coli and enterococci from EPA-sponsored
epidemiological studies that roughly correlated to the estimated
illness rate associated with EPA's previously recommended fecal
coliform criteria. EPA estimated this illness rate to be approximately
0.8% of swimmers exposed in freshwater and 1.9% of swimmers exposed in
marine waters. EPA's 1986 bacteria criteria document indicates the
illness rates are ``only approximate'' and that the Agency based the
1986 values that appear in Table 1 on these approximations. The 1986
bacteria criteria document provides geometric mean densities as well as
four different single sample maximum values (representing values below
which an increasing percentage of single values are expected to fall if
the mean (average) of all samples equals the geometric mean criterion).
The higher the single sample maximum, the lower the probability that a
single sample exceeding that value would occur as part of the normal
random variability of samples around the geometric mean. Single sample
maximums are water quality assessment tools that provide a sense of
when a single value that comes from a waterbody may be part of a
bacterial density with a geometric mean concentration higher than that
specified by the water quality criteria. For instance, if the geometric
mean concentration in the water at a marine beach is 35/100 ml, then
there is an 18% probability that the concentration of enterococci in a
single sample would be over 158/100 ml. One could thus consider a
single sample with this value to be indicative of bacterial densities
with a geometric mean above 35/100 ml, but there would be a non-trivial
chance of being wrong in this determination. Statisticians say this
conclusion can be drawn ``with 82% confidence.''
The 1986 bacteria criteria document includes, for each geometric
mean, a table of four single sample maximum values that are appropriate
for different levels of beach usage. In general, where a given area has
a greater potential for more people to be exposed, that area may
warrant a higher degree of protectiveness (i.e., a lower single sample
maximum). The 1986 bacteria criteria document categorizes the levels of
beach usage corresponding to the four single sample maximums as
follows: ``designated bathing beach'' for the 75%
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(most protective) confidence level, ``moderate use for bathing'' for
the 82% confidence level, ``light use for bathing'' for the 90%
confidence level, and ``infrequent use for bathing'' for the 95%
confidence level. Note that the lowest confidence level corresponds to
the highest level of protection because it leads to a more
precautionary judgment to treat the waterbody as exceeding the mean
criterion, even though there is less statistical confidence that this
is the case. EPA assigned the lowest single sample maximum to
designated bathing beach areas because a high degree of caution should
be used to evaluate the status of such areas, giving greater weight to
a measured single value above the geometric mean, even though the
statistical significance of this single measurement may be weak. EPA
believes this is appropriate because more people are likely to become
ill at heavily used areas if they exceed the criteria. The 1986
bacteria criteria document described bathing beach areas as those areas
that are ``frequently lifeguard protected, provide parking and other
public access and are heavily used by the public.'' The document does
not specifically describe in greater detail the potential use frequency
differences of ``moderate,'' ``lightly used,'' and ``infrequently
used'' full body contact recreation waters.
Table 1.--1986 Criteria for Indicators for Bacteriological Densities
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Acceptable Single sample maximum allowable density \4\ \5\
swimming ---------------------------------------------------------------------------
associated Steady state Moderate full Lightly used full Infrequently used
gastroenteritis geometric mean Designated beach body contact body contact full body contact
rate per 1000 indicator density area (upper 75% recreation (upper recreation (upper recreation (upper
swimmers C.L.) 82% C.L.) 90% C.L.) 95% C.L.)
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Freshwater
Enterococci................... 8 33/100 ml \1\........ 61 78 107 151
E. coli....................... 8 126/100 ml \2\....... 235 298 409 575
Marine Water
Enterococci................... 19 35/100 ml \3\........ 104 158 276 501
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Notes:
\1\ Calculated to nearest whole number using equation: (mean enterococci density) = antilog10 ((illness rate/1000 people + 6.28)/9.40).
\2\ Calculated to nearest whole number using equation: (mean E. coli density) = antilog10 ((illness rate/1000 people + 11.74)/9.40).
\3\ Calculated to nearest whole number using equation: (mean enterococci density) = antilog10 ((illness rate/1000 people -0.20)/12.17).
\4\ Single sample limit = antilog10 (log10 indicator geometric mean density/100 ml + (factor determined from areas under the normal probability curve
for the assumed level of probability * log10 standard deviation)).
The appropriate factors for the indicated one sided confidence levels are:
75% C.L.-.675
82% C.L.-.935
90% C.L.-1.28
95% C.L.-1.65.
\5\ Based on the observed log standard deviations during the EPA studies: 0.4 for freshwater E. coli and enterococci; and 0.7 for marine water
enterococci. Each jurisdiction may establish its own standard deviation for its conditions which would then vary the single sample limit.
III. EPA's Proposed Rule and Solicitation of Comment
A. July 2004 Proposed Rule
On July 9, 2004, EPA published a proposal entitled ``Water Quality
Standards for Coastal and Great Lakes Recreation Waters'' (see 69 FR
41720). At that time, EPA proposed to promulgate E. coli and
enterococci standards for coastal recreation waters in States that had
not adopted water quality standards for those waters that are as
protective of human health as EPA's 1986 bacteria criteria.
EPA proposed a geometric mean of 126/100 ml for E. coli in fresh
coastal recreation waters and a geometric mean of 35/100 ml for
enterococci in marine coastal recreation waters. EPA also proposed four
different single sample maximums in both fresh and marine coastal
recreation waters. Each single sample maximum was assigned to a
category of coastal recreation water based on intensity of use. EPA
proposed to interpret the single sample maximums as maximum values that
would not be allowed to be exceeded, but requested comment on various
other interpretations. EPA did not propose particular waters to which a
specific single sample maximum would apply; rather, EPA proposed that
States and Territories would determine which single sample maximum
would apply to each of its coastal recreation waters. The criteria
values for fresh and marine coastal recreation waters are the same
values that are found in the 1986 bacteria criteria document.
EPA did not include coastal or Great Lakes States and Territories
in the proposed rule if their current standards met each of five
criteria: the standards are based on EPA's 1986 recommended pathogen
indicators; the standards are derived from a scientifically-defensible
methodology linked quantitatively to an acceptable risk level under
Clean Water Act section 303(i); the standards include appropriate
single sample maximums; the standards do not address fecal
contamination from non-human sources in a way inconsistent with the
1986 bacteria criteria; and EPA approved the standards. If a State or
Territory met all five criteria, EPA proposed to not include that State
or Territory in the rule.\1\
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\1\ In the case of Washington State, EPA has determined that a
fecal coliform standard of 14/100 ml for marine waters is ``as
protective as'' EPA's 1986 bacteria criteria. (See section V.A.1 of
this preamble.)
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B. Public Comments
The comment period for this rule closed on August 9, 2004. EPA
received 55 comments on the proposed rule from a variety of sources,
including academic associations, environmental groups, municipal
wastewater associations, industry, State agencies, local governments,
and private citizens. Most of the comments focused on the following
issues: choice of pathogen indicator, promulgation of a geometric mean
and four single sample maximums for the indicators, use of the single
sample maximum, intensity of use categories of coastal recreation
waters, intrastate vs. interstate determinations of use intensity,
State calculation of site-specific single sample maximums, and
addressing non-human sources of bacteria. This preamble includes a
general summary of public comments in
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the discussions of the various issues addressed here. EPA has prepared
a ``Comment Response Document'' that includes responses to comments
submitted on the proposed rule, which is in the docket for today's
rule.
IV. Criteria That EPA Is Promulgating Today
A. Scope of the Rule
EPA is promulgating the rule to apply, as proposed, to Great Lakes
and marine coastal recreation waters (including coastal estuaries)
designated by a State or Territory under Clean Water Act 303(c) for
swimming, bathing, surfing, or similar water contact activities. As
explained in the preamble to the proposed rule (69 FR 41723), the
requirements of the BEACH Act are limited to ``coastal recreation
waters,'' which are defined in Clean Water Act section 502(21) as the
Great Lakes and marine coastal recreation waters (including coastal
estuaries) that are designated under Clean Water Act section 303(c) by
a State for use for swimming, bathing, surfing, or similar water
contact activities. The definition explicitly excludes ``inland waters
or waters upstream of the mouth of a river or stream having an
unimpaired natural connection with the open sea.'' EPA interprets Clean
Water Act section 502(21) to apply only to those Great Lakes waters
that are designated for swimming, bathing, surfing, or similar water
contact activities, consistent with the purpose of the BEACH Act to
protect the public from the health risks associated with swimming in
polluted water.
The BEACH Act clearly envisioned and intended that States,
Territories, and authorized Tribes with coastal recreation waters adopt
into their water quality standards bacteria criteria as protective of
human health as EPA's 1986 bacteria criteria. Under EPA's water quality
standards regulations at 40 CFR Part 131, States, Territories, and
authorized Tribes have broad discretion to designate specific uses to
specific waters. They are not required to designate all waters for
swimming, bathing, surfing, or similar water contact activities (i.e.,
primary contact recreation), as long as they have complied with the
requirements of the Clean Water Act and EPA's implementing regulations
for designating uses. Today's rule applies only to those waters
designated by a State or Territory for swimming, bathing, surfing, or
similar water contact activities, not to waters designated for uses
that only involve incidental contact. However, States, Territories, and
authorized Tribes are to continue to work towards the goal of achieving
full attainment of Clean Water Act section 101(a) uses (``fishable/
swimmable'') in waters that do not currently attain such uses. Further,
any waters with designated uses that do not include the uses specified
in Clean Water Act section 101(a)(2) must be re-examined every three
years to determine if any new information has become available (40 CFR
131.20(a)). If such new information indicates that the uses specified
in Clean Water Act section 101(a)(2) are attainable, the State,
Territory, or authorized Tribe is required to revise its water quality
standards accordingly. EPA expects States, Territories, and authorized
Tribes to continue this process and revise their water quality
standards where appropriate. States, Territories, and authorized Tribes
may remove a designated use that is not an existing use if it conducts
a use attainability analysis to demonstrate that the designated use is
not attainable (40 CFR 131.10(g)).
EPA received few comments on the scope of the rule. One commenter
suggested that the rule should not apply to State waters outside of the
areas where swimming normally occurs, citing as an example Hawaii's
water quality standards, which are consistent with EPA's 1986 bacteria
criteria but apply only to those swimming waters within 300 meters of
shore. This commenter also suggested that the criteria should only have
to apply at depths of less than 150 feet. EPA does not find these
comments persuasive in light of the clear language of Clean Water Act
sections 303(i) and 502(21), which together require the adoption of
criteria for all of the coastal or Great Lakes waters designated by the
State for use for swimming, bathing, surfing, or similar water contact
activities even if, as a factual matter, the waters designated for
swimming are not frequently or typically used for swimming.
One commenter expressed concern that the rule could establish a
binding precedent for EPA's review of pathogen criteria for inland
waters that do not fall within the definition of a coastal recreation
water. As discussed above, section 303(i) of the Clean Water Act does
not apply to inland waters other than the Great Lakes because such
waters are explicitly excluded from the definition of ``coastal
recreation waters'' in section 502(21) of the Clean Water Act. For all
other waters (i.e., waters that are not coastal recreation waters),
section 303(c) of the Clean Water Act and EPA's implementing
regulations at 40 CFR part 131 require States, Territories, and
authorized Tribes to adopt criteria that are scientifically defensible
and sufficient to protect the designated uses of those waters. When EPA
reviews a State's, Territory's or authorized Tribe's new or revised
water quality standards, EPA applies its regulations at 40 CFR 131.5
and 131.6. EPA's decision on future State or Territorial submissions
will be based on the information supporting those submissions. EPA's
decisions in today's rule should not be considered as binding on States
and Territories adopting bacteria criteria for inland waters other than
the Great Lakes.
B. Criteria for Pathogen Indicators
1. Selection of Pathogen Indicator
For States and Territories covered by today's rule, EPA is
promulgating water quality criteria using the pathogen indicators of
enterococci for marine waters and both enterococci and E. coli for
freshwaters. EPA interprets Clean Water Act section 303(i)(1)(A) to
require States and Territories to adopt and submit water quality
criteria for enterococci in marine waters and either enterococci or E.
coli in fresh waters because it requires States and Territories to
submit criteria ``for the pathogens and pathogen indicators for which
the Administrator has published criteria under section 304(a).'' EPA's
1986 bacteria criteria document is the relevant Clean Water Act section
304(a) criteria referred to in Clean Water Act section 303(i)(1)(A). It
recommends the use of enterococci in marine waters and E coli or
enterococci in fresh waters for the protection of primary contact
recreation. Clean Water Act section 303(i)(2)(A) requires EPA to
promptly propose regulations for the State setting forth revised or new
water quality standards for pathogens and pathogen indicators described
in Clean Water Act section 303(i)(1)(A) for coastal recreation waters
of the State for those States that fail to adopt criteria that are as
protective of human health as the criteria referenced in section
303(i)(1)(A).
In the proposal (69 FR 41727), EPA proposed to adopt only E. coli
for freshwaters because most of the States and Territories that had
adopted or were in the process of adopting the 1986 bacteria criteria
had chosen to use E. coli instead of enterococci. However, EPA also
solicited comment on whether to promulgate criteria based on both
indicators for freshwater and to allow States and Territories to choose
which indicator to apply to its coastal recreation waters at the time
of
[[Page 67223]]
implementation. EPA received comments from the New York Department of
Environmental Conservation (DEC) and the Pennsylvania Department of
Environmental Protection (DEP) requesting EPA to do so. Both of these
State agencies have responsibility for promulgating State water quality
standards. New York DEC explained that the New York Department of
Health had recently adopted regulations adding both E. coli and
enterococci as the criteria for its freshwater bathing beaches, and
that the New York DEC was in the process of deciding which of the two
indicators it would adopt for its water quality standards in the Great
Lakes. Consequently, New York DEC requested that EPA's final rule
include values for both indicators and allow the State to select either
at the time of implementation. Pennsylvania DEP explained that the
Pennsylvania Department of Health had adopted E. coli criteria for
public bathing beaches, but also requested that EPA promulgate a final
rule allowing Great Lakes States to choose either E. coli or
enterococci criteria at the time of implementation. Pennsylvania DEP
offered no reason for its request. None of the other States included in
the proposal with fresh coastal recreation waters commented on this
aspect of the proposal.
As requested by these States, EPA is promulgating criteria for both
indicators and allowing New York and Pennsylvania determine which
indicator to apply for each waterbody. EPA also determined that it is
reasonable to extend this flexibility to all of the Great Lakes States
covered by this rule. Accordingly, EPA has added the freshwater
criteria values for enterococci to the table in 40 CFR 131.41(c)(1) as
well as a footnote to the table explicitly recognizing that the State
may decide which indicator, E. coli or enterococci, will be the
applicable criterion for its freshwater coastal recreation water (i.e.,
which criteria apply to the Great Lakes waters within the State's
jurisdiction). Until a State makes that determination, E. coli will be
the applicable indicator.
EPA is providing this flexibility to all Great Lakes States in the
rule because the Great Lakes States have a history of cooperating to
protect the Great Lakes resource, and may find a need to agree on a
consistent pathogen indicator for the Great Lakes. Because both the E.
coli and enterococci freshwater criteria in the 1986 bacteria criteria
have the same illness rate they provide equal protection against acute
gastrointestinal illness. In light of these considerations, EPA does
not want to create a barrier to this cooperation by promulgating only
one of the two freshwater criteria in some Great Lakes States and both
indicators in other Great Lakes States.
2. Bacteria Criteria Values
EPA is promulgating a geometric mean of 35/100 ml for enterococci
in marine coastal recreation waters and four different single sample
maximums, which vary for marine coastal recreation waters based on
intensity of use as shown in Table 2. These are the same values as in
the 1986 bacteria criteria document and in the proposed rule.
Table 2.--Ambient Marine Water Quality Criteria for Bacteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
C Single sample maximum (per 100 ml)
-------------------------------------------------------------------------------
C1 Designated C2 Moderate use C3 Light use C4 Infrequent use
A Indicator B Geometric mean bathing beach coastal recreation coastal recreation coastal recreation
(75% confidence waters (82% waters (90% waters (95%
level) confidence level) confidence level) confidence level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enterococci............................... 35/100 ml a................. 104 b 158 b 276 b 501 b
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(2):
a This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
b Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.7.
For fresh coastal recreation waters, EPA is also promulgating a
geometric mean of 126/100 ml for E. coli and a geometric mean of 33/100
ml for enterococci with four different single sample maximums, which
vary based on intensity of use. As described above, only the criteria
for one of these indicators will apply in freshwaters at the choice of
the State. These values are shown in Table 3, and are the same values
as in the 1986 bacteria criteria document. For E. coli, these values
are the same as those that EPA proposed. EPA is also promulgating
criteria for enterococci in freshwater based on the request of two
Great Lakes States and used the values from the 1986 bacteria criteria
document for these enterococci criteria.
Table 3.--Ambient Freshwater Quality Criteria for Bacteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
C Single sample maximum (per 100 ml)
---------------------------------------------------------------------------
C2 Moderate use C3 Light use C4 Infrequent
A Indicator d B Geometric mean C1 Designated coastal coastal use coastal
bathing beach recreation waters recreation waters recreation waters
(75% confidence (82% confidence (90% confidence (95% confidence
level) level) level) level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli..................................... 126/100 ml a.................. b 235 b 298 b 409 b 575
Enterococci................................. 33/100 ml c................... b 61 b 78 b 107 b 151
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(1):
[[Page 67224]]
a This value is for use with analytical methods 1103.1, 1603, or 1604 or any equivalent method that measures viable bacteria.
b Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.4.
c This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
d The State may determine which of these indicators applies to its fresh coastal recreation waters. Until a State makes that determination, E. coli will
be the applicable indicator.
In proposed 40 CFR 131.41(c), EPA included footnotes to the
geometric mean values for E. coli and enterococci stating that ``[t]his
value is for use with [specified] analytical methods * * * or any
equivalent viable method.'' The specified methods are based on
measurement of viable bacteria. New analytical methods that rely on
genetic material for measurement may yield different results that are
not appropriately calibrated to the numeric criteria in today's rule.
To address this concern, EPA is identifying, as in the proposal, the
specific methods that must be used to apply the bacteria criteria.
In today's rule, EPA is also making two minor changes to this
aspect of the proposal. First, EPA had incorrectly identified the
analytical methods for enterococci as being for E. coli and the
analytical methods for E. coli as being for enterococci, and is
correcting this technical error in the footnotes in the final rule.
Second, EPA has revised the footnotes to explain more clearly what the
methods are. The footnotes state: ``This value is for use with
[specific methods] or any equivalent method that measures viable
bacteria.''
EPA notes that today's rule does not specify the duration over
which the geometric mean is calculated. The criteria in the tables at
40 CFR 131.41(c) are identical to those in table 4 of the 1986 bacteria
criteria document, which does not specify the duration for computing
the geometric mean. The 1986 bacteria criteria document discusses the
duration over which the mean is calculated in two places. The first is
in the discussion of the basis for the criteria (page six). Here, EPA
calculated the geometric mean bacteria density over a summer swimming
season (recreation season). The second place is in the summary of the
criteria (page 16) where EPA stated that ``[b]ased on a statistically
sufficient number of samples (generally not less than 5 samples equally
spaced over a 30-day period), the geometric mean.* * *'' EPA considers
this statement in the 1986 bacteria criteria document to provide
guidance on how a regulatory agency could compute the geometric mean,
and not as a definition of the specific period over which the mean must
be computed. For the geometric mean to be only computed over a 30-day
period would mean that regulatory agencies would need to sample more
than once a month, which is contrary to the guidance on monitoring
provided in the 1986 bacteria criteria document. EPA expects from
current practice by States and Territories that they will compute the
geometric mean on either a monthly or recreation season basis.
EPA is not specifying in the final rule how the averaging period
for the geometric must be applied. EPA recommends that the averaging
period be applied as a ``rolling'' or ``running'' average. EPA expects
that most States will in fact apply the averaging period as a rolling
average; however, EPA also recognizes that it would be technically
appropriate to apply the averaging period on a set basis such as
monthly or recreation season. EPA therefore has concluded that it is
appropriate to allow the States to exercise discretion in deciding how
to apply the averaging period for the geometric mean.
3. Use of the Single Sample Maximum
EPA is promulgating the single sample maximum values that it
proposed without change, but is clarifying its expectations with regard
to how these values could be used in the context of beach notification
and closure decisions, and in the context of the implementation of
other Clean Water Act programs. EPA expects that the single sample
maximum values would be used for making beach notification and closure
decisions. EPA recognizes, however, that States and Territories also
use criteria in their water quality standards for other purposes under
the Clean Water Act in order to protect and improve water quality.
Other than in the beach notification and closure decision context, the
geometric mean is the more relevant value for ensuring that appropriate
actions are taken to protect and improve water quality because it is a
more reliable measure, being less subject to random variation, and more
directly linked to the underlying studies on which the 1986 bacteria
criteria were based. Nevertheless, the single sample maximum can play a
role in identifying potential pollution episodes, especially in waters
that are prone to short-term spikes in bacteria concentrations, e.g.,
waters that may be affected by a combined sewer overflow outfall.
Having identified that a water is prone to short-term spikes in
bacteria concentrations due to pollution episodes, States and
Territories have significant flexibility in how they address those
episodes consistent with the Clean Water Act and implementing
regulations. (Note that additional guidance on making water quality
standard attainment status determinations may be found in EPA's
guidance to States on integrated reporting of water quality for
sections 303(d) and 305(b) purposes.)
EPA received considerable comment on this topic. Some comments
addressed the issue of whether the single sample maximum should be part
of the criteria that applies in all applications, including beach
closure, waterbody assessment, Total Maximum Daily Load establishment,
and National Pollutant Discharge Elimination System permitting
decisions, or instead was only designed for beach notification and
closure decisions. Most commenters expressed their interpretation of
the 1986 bacteria criteria document as discussing the single sample
maximum only in the context of making beach decisions based on limited
data. Several of these commenters argue that the geometric mean
criterion was included in the 1986 bacteria criteria document for
protection against acute gastrointestinal illness in other contexts,
and that the single sample maximum was included as a tool to implement
the criteria in beach monitoring situations, and therefore, was not
necessary to provide protection in other contexts. Other commenters
asserted that the single sample maximum should be used for all Clean
Water Act purposes.
EPA notes that the 1986 bacteria criteria document clearly
identifies the single sample maximum values as part of the criteria, in
addition to the geometric mean values. Therefore, consistent with
section 303(i)(2)(A) of the Clean Water Act, EPA is promulgating them
today. EPA recognizes that the single sample maximum discussion in the
1986 bacteria criteria document refers only to beach monitoring, and
does not discuss how or whether the single sample maximum should be
implemented for other Clean Water Act applications, such as
establishing Total Maximum Daily Loads or National Pollutant Discharge
Elimination System permit limitations. EPA agrees that the single
sample maximum values in the criteria
[[Page 67225]]
are best used for making beach notification and closure decisions.
However, as noted above, they may, but need not, also play a role in
implementing other Clean Water Act programs. Except in the beach
notification and closure context, EPA expects that States will
determine how to use the single sample maximum criteria in the context
of their broader programs implementing the Clean Water Act.
For beach monitoring and beach notification and closure decisions,
beach managers frequently need to make beach decisions based on one or
very few data points. Thus, having a trigger level for a single sample
value enables beach managers to make an immediate decision for the
protection of public health at beaches. The beach manager will
frequently not be able to obtain sufficient samples to compute a
geometric mean for the purposes of making a decision to close a beach
or issue a beach advisory. Of the 2,823 beaches reporting information
to EPA in 2002, 65% reported that pathogen levels were monitored at
least once per week (EPA's Beach Watch Program: 2002 Swimming Season,
EPA 823-F-03-007, May 2003, http://www.epa.gov/waterscience/beaches/beachwatch2003-newformat.pdf). This means that at 35% of the beaches,
the beach managers had fewer than four samples each month for making
decisions to open or close the beach and in many cases only had one
sample in any week. Furthermore, beach management programs need to be
able to respond rapidly to short-term changes in water quality. Because
a geometric mean provides information pertaining to water quality that
looks backwards in time, it is not necessarily useful in determining
whether a beach is safe for swimming on a particular day.
EPA's National Beach Guidance and Required Performance Criteria for
Grants (EPA-823-B-02-004, June 2002) requires States and Territories
receiving Clean Water Act section 406 implementation grants to either
immediately issue a public notification or, if there are reasons to
doubt the accuracy of the first sample, resample when any sample
surpasses a water quality standard at beaches. Although this
requirement pertains only to the States and Territories receiving these
grants, given that the States and Territories covered by this rule
receive Clean Water Act section 406 implementation grants, it reflects
the actions that States and Territories will be expected to take when a
sample shows an exceedance of the applicable single sample maximum in
today's rule. (EPA notes that all 35 eligible coastal States and
Territories received grants in 2003, and most have received these
grants in 2004.) In other words, States and Territories will use a
single sample maximum to trigger a notification or closure action at
beaches; whether the action taken is an advisory or a closure depends
on the decision rules established by the State, Territory or local
beach management authority, although the National Beach Guidance and
Required Performance Criteria for Grants requires the State or
Territory to provide a notification of the exceedance. Using a single
sample maximum is especially important for beaches that are
infrequently monitored or prone to short-term spikes in bacteria
concentrations, e.g., waters that may be affected by combined sewer
overflow outfalls. Thus, consistent with the 1986 bacteria criteria
document, EPA expects that States and Territories would apply the
single sample maximums for making beach notification decisions as
values that if exceeded would trigger a notification or closure action
at the beach.
Numerous commenters said that application of the single sample
maximum values in the criteria as never-to-be-surpassed limitations in
other contexts could lead to consequences which were not contemplated
in the 1986 bacteria criteria document, including, for example, Total
Maximum Daily Loads and National Pollutant Discharge Elimination System
permit limitations which might be technologically and economically
unattainable at a particular location. EPA agrees that the 1986
bacteria criteria document did not discuss using the single sample
maximum as a never-to-be-surpassed value for all implementation
applications under the Clean Water Act.
In developing the 1986 bacteria criteria document, EPA derived
single sample maximums as upper percentiles of the frequency
distributions around the geometric mean. The 1986 bacteria criteria
document recognizes that there will be instances where the
concentration of bacteria in one or more individual samples will be
higher than the acceptable geometric mean concentration. This is to be
expected when dealing with water quality criteria expressed as average
concentrations over a period of time. For example, in a waterbody with
a 30-day average concentration exactly at the water quality criterion,
it can be expected that approximately half of the samples collected
will have a concentration above the criterion concentration (e.g., 126/
100 ml for E. coli), while the other half of the samples will have
lower concentrations. Thus, that the value of one sample is greater
than the numerical value of the geometric mean criterion, or even the
numerical value of the single sample maximum, does not necessarily
indicate that the geometric mean criterion has actually been exceeded.
Furthermore, the single sample maximum values in the 1986 bacteria
criteria document were not developed as acute criteria; rather, they
were developed as a statistical construction to allow decision makers
to make informed decisions to open or close beaches based on small data
sets. This does not mean single sample maximums serve no purpose
outside of beach notification decisions. For example, they may give
States and Territories the ability to make waterbody assessments where
they have limited data for a waterbody. However, the single sample
maximums were not designed to provide a further reduction in the design
illness level provided for by the geometric mean criterion.
Based on the derivation of the single sample maximums as
percentiles of a distribution around the geometric mean, using the
single sample maximums as values not to be surpassed for all Clean
Water Act applications, even when the data set is large, could impart a
level of protection much more stringent than intended by the 1986
bacteria criteria document. For example, in marine waters the geometric
mean criterion for enterococci is 35/100 ml, and the single sample
maximum is 104/100 ml at designated bathing beach waters based on the
75th percentile of the distribution of individual values around the
mean. If that single sample maximum were used as a value-not-to-be-
surpassed, it would become a maximum value and all other values in the
statistical distribution of individual measurements would have to be
less than the maximum. EPA typically uses the 99th percentile of a
distribution to derive regulatory maximums. Assuming a waterbody had
the same standard deviation in concentrations of bacteria employed in
deriving the single sample maximums (e.g., 0.7 for marine waters), the
waterbody geometric mean needed to keep the waterbody concentration
below 104/100 ml 99% of the time would be 2/100 ml. This would be far
more stringent than the level of protection provided by the actual
geometric mean criterion for enterococci of 35/100 ml. Therefore, EPA
intends that States and Territories should retain the discretion to use
single sample maximum values as they deem appropriate in the context of
Clean Water Act implementation programs other than beach notification
and
[[Page 67226]]
closure, consistent with the Clean Water Act and its implementing
regulations.
The final rule does not constrain States and Territories
flexibility in how they use the single sample maximum values in the
context of Clean Water Act implementation programs such as Total
Maximum Daily Loads and National Pollutant Discharge Elimination System
permit requirements, as long as the geometric mean criteria for E. coli
and enterococci are met. The flexibility afforded to States and
Territories in applying the single sample maximum values in the
National Pollutant Discharge Elimination System permitting program does
not mean that maximum daily or seven-day average permit limits for
bacteria are inappropriate for National Pollutant Discharge Elimination
System permits. EPA notes that maximum daily and 7-day average effluent
limits can be calculated based on 30-day average conditions and an
understanding of effluent variability. See Section 5.4.4 of EPA's
Technical Support Document for Water Quality-based Toxics Control (EPA-
505-2-90-001, March 1991). (These procedures are based on statistical
methodologies similar to those employed in deriving the single sample
maximums in the 1986 water quality criteria for bacteria.) EPA's
recommendation that the single sample maximum values in the 1986
bacteria criteria document should be used primarily for making beach
notification and closure decisions does not constrain States' use of
maximum daily permit limits in accordance with current State permitting
procedures.
EPA received a few comments about the specific use of single sample
maximums in making waterbody assessment decisions, for example, in the
development of Clean Water Act section 305(b) reports or developing
section 303(d) lists. One commenter stated that the single sample
maximum should not be used solely as the means for deciding if a
waterbody was impaired. Another commenter stated that one sample should
not be used to characterize a waterbody. Yet another commenter
suggested that the single sample maximum only be used when there were
insufficient data to compute a geometric mean.
In general, EPA agrees with these comments. As discussed above, EPA
recognizes the utility of single sample maximums where there are
insufficient data (generally fewer than five samples over a given
period) to compute a geometric mean for the purposes of assessing
waterbodies, and expects that States and Territories will use single
sample maximums in these instances. While it is far preferable for
States and Territories to obtain more robust data for making decisions
about waterbody impairments (the 1986 bacteria criteria document
recommends determining the geometric mean using generally not less than
5 samples equally spaced over a 30-day period), EPA recognizes that in
some instances States and Territories will have limited data and may
decide to use the single sample maximums or other similarly derived
statistical constructs for making waterbody impairment decisions.
4. Intensity of Use Categories of Coastal Recreation Waters
EPA is promulgating the same intensity of use categories of coastal
recreation waters as in the proposal, specifically, the four categories
of waters with a corresponding single sample maximum as described in
the 1986 bacteria criteria document. Only one single sample maximum
applies to each category of coastal recreation water: designated
bathing beach waters, moderate use coastal recreation waters, light use
coastal recreation waters, and infrequent use coastal recreation
waters. EPA is also promulgating the definitions of the categories as
proposed. By providing definitions for the four categories, EPA
provides clear guidance to States and Territories and information for
the public to identify the category in which each coastal recreation
water belongs based on its intensity of use for primary contact
recreation.
EPA does not have sufficient information regarding frequency of use
of each specific coastal recreation water covered by this rule to list
all those waters in the rule according to the four categories defined
in 40 CFR 131.41(b). Therefore, EPA does not list individual coastal
recreation waters by intensity of use category. EPA recommends that
States and Territories evaluate existing use information and identify
which individual coastal recreation waters belong to each category and
make this information publicly available (e.g., on a State's or
Territory's website). As explained in the preamble to the proposed rule
(69 FR 41726), States and Territories could use their existing beach
tiering process for BEACH Act implementation grants as a source of
information for determining frequency in categorizing a coastal
recreation water for purposes of determining the applicable single
sample maximum.
Today's rule does not require that States and Territories apply the
definitions at 40 CFR 131.41(b) such that the State or Territory finds
at least one water for each of the four categories of waters. A State
or Territory could, at its discretion, apply the single sample maximum
for designated bathing beaches (the lowest single sample maximum) to
all its coastal recreation waters because this approach would be more
protective of human health than the structure for single sample
maximums in 40 CFR 131.41(b) and (c). Thus, a State or Territory that
had commented that it preferred that EPA promulgate only one category
of waters could exercise its discretion and apply the single sample
maximum for designated bathing beaches to all of its waters.
Alternatively, a State or Territory may choose to place their coastal
recreation waters in only two of the four single sample maximum
categories, such as the 75% confidence level single sample maximum for
designated bathing beaches and the 95% confidence level single sample
maximum for all other coastal recreation waters, if the recreational
usage of the waters matches the definitions at 40 CFR 131.41(b). This
approach would be appropriate if the State or Territory determined that
the ``infrequent use'' definition was the most appropriate
categorization for its coastal recreation waters that were not
identified as designated bathing beaches. Although the rule does not
specify which State waters belong in which use category, the
definitions in the rule must be used to determine which single sample
maximum would apply to a particular coastal recreation water.
A number of comments requested that EPA promulgate only the 75%
confidence level criterion for all coastal recreation waters because
having only one single sample maximum would provide for consistency in
all coastal recreation waters, and provide the same level (and highest
level) of protection to all users of coastal recreation waters, no
matter what the use intensity of that particular water might be.
EPA declines to take this approach in today's rule. EPA
acknowledges the reasons expressed in the comments. However, EPA
believes this would be more restrictive than necessary to ensure that
the promulgated water quality criteria are as protective of human
health as the 1986 bacteria criteria document, which provides single
sample maximums for four categories of waters. Thus, such an approach
would unnecessarily restrict the flexibility of States and Territories
to determine when to impose standards more protective than EPA's 1986
bacteria criteria. EPA normally defers to a State's or Territory's
decision on what criteria apply to protect a designated use subject to
the State or Territory
[[Page 67227]]
providing information to show that the water quality criteria are
sufficient to protect the designated uses, and for coastal recreation
waters, that the water quality criteria are as protective of human
health as the criteria for the pathogen or pathogen indicators that EPA
has published. EPA does not consider the benefits of identical
standards in the States and Territories covered by this rule to
outweigh the negative effects of unnecessarily constraining the
flexibility that the Clean Water Act and EPA's rules give States and
Territories in establishing water quality standards, particularly
because there is already variation in the single sample maximums in use
among States and Territories that are not covered by today's rule.
5. Intrastate vs. Interstate Determinations of Use Intensity
In today's final rule, as in the proposal, single sample maximums
apply to categories of waters based on intensity of use. These
categories are based on intrastate comparisons of frequency of use
(i.e., relative to the other waters within that State or Territory).
Using this approach, a State or Territory will identify its designated
bathing beach waters first and then evaluate all other waters in
comparison to those waters. However, today's rule does not require that
a State or Territory use all four categories of intensity of use.
Rather, EPA expects that States and Territories will first identify
portions of waters as designated bathing beaches based on the factors
listed in 40 CFR 131.41(b)(2) and then categorize the remaining waters
based on their intensity of use relative to those beaches. In
interpreting the phrase ``heavily used,'' EPA expects States will make
reasonable judgments about the level of use at a given beach. EPA does
not intend that States should exclude heavily used waters from the
designated bathing beach category merely because they can identify
other beaches, either within the State or in other States, that are
more heavily used.
While several commenters supported intrastate comparison of
intensity of use, others suggested using an interstate comparison of
intensity of use because beach use varies significantly across States
and Territories. While EPA recognizes that beach use intensity varies
significantly across the nation, EPA does not agree that interstate
comparisons are the best approach for categorizing use intensity. An
interstate approach could result in some States or Territories
comparing their beaches only to the most heavily used beaches in the
nation and determining that they have no beaches warranting protection
at the 75% confidence level. Rather, States and Territories will need
to evaluate the intensity of use of their own beaches, independent of
beaches in the rest of the nation, and assign the beaches to categories
based on the definitions provided in 40 CFR 131.41(b). This does not
mean that there is any minimum number or percentage of beaches that
must be placed in the designated bathing beach category. Rather, States
should identify those beaches, if any, in the State which satisfy the
criteria for this category and then assign the remaining waters to one
or more of the lower intensity of use categories as appropriate.
Intrastate comparison of use will allow States and Territories the
flexibility to provide the level of protection that is appropriate to
visitors to beaches with different intensities of use.
In today's rule, EPA is also making a minor change to this aspect
of the proposed rule. The Agency added text to the definition of
``designated bathing beach'' in 40 CFR 131.41(b)(2) to provide
expressly that the determination of ``heavy use'' is based on an
evaluation of use within the State, which is consistent with the above
discussion.
6. State Calculation of Site-Specific Single Sample Maximums
EPA is promulgating, as proposed, default single sample maximums
based on the 75, 82, 90, and 95% confidence levels, along with the
equation to calculate site-specific single sample maximums. EPA
calculated the values for the single sample maximums in tables 2 and 3
using the standard deviations observed during the EPA epidemiological
studies. The Agency recognizes that standard deviations observed in
EPA's epidemiological studies may not coincide with that for a
particular waterbody. States and Territories may decide to collect data
to calculate site-specific standard deviations. To compute the site-
specific log standard deviation in a statistically meaningful way as
explained in the preamble to the proposed rule (69 FR 41727), today's
rule requires that the States and Territories collect at least 30
samples in a single recreation season (see 40 CFR 131.41(c)(3)). If
this requirement is met, the State or Territory may use the resulting
site-specific standard deviation to calculate a corresponding single
sample maximum.
EPA considers that the calculation of site-specific single sample
maximums as specified in 40 CFR 131.41(c)(3) provides enough detail on
the calculation that States and Territories can implement the provision
of the rule without needing to adopt it as a site-specific water
quality criterion. As a result, States and Territories do not need EPA
review and approval under 40 CFR Part 131 in their application of 40
CFR 131.41(c)(3).
All commenters that addressed this issue supported EPA's proposal
to require 30 samples to derive a site-specific standard deviation;
however, one commenter stated that States and Territories should be
allowed to collect the samples over two recreation seasons if there
were not significant differences in bacteria concentrations over the
two-year period. The commenter explained that States and Territories
may find it difficult to collect 30 samples in one recreation season.
EPA recognizes the difficulty in collecting the required number of
samples over a single recreation season, but the Agency has nonetheless
concluded that collecting this data during a single season is necessary
in order to capture the variability inherent in bacteria concentrations
at a site over the period of a single season without introducing
additional variability from extreme weather conditions such as drought
or El Nino conditions. Using 30 samples over more than one recreation
season could affect the outcome of the single sample maximum such that
it may not be as protective of human health as EPA's 1986 bacteria
criteria.
7. Addressing Non-Human Sources of Bacteria
EPA is adopting the approach preferred in the proposal for
addressing non-human sources of bacteria. In today's rule, EPA added
footnote ``e'' to 40 CFR 131.41(c)(1) and footnote ``c'' to 40 CFR
131.41(c)(2) to describe this approach for addressing non-human sources
of bacteria. The footnotes state: ``These values apply to [E. coli or
enterococci] regardless of origin unless a sanitary survey shows that
sources of the indicator bacteria are non-human and an epidemiological
study shows that the indicator densities are not indicative of a human
health risk.'' Specifically, States and Territories must apply the E.
coli and enterococci criteria to all coastal recreation waters. If,
however, sanitary surveys and epidemiological studies show the sources
of the indicator bacteria to be non-human and the indicator densities
do not indicate a human health risk, then it is reasonable for the
State or Territory to not consider those sources of fecal contamination
in determining whether the standard is being attained. This is the
approach taken in the 1986
[[Page 67228]]
bacteria criteria document. It would be reasonable for a State or
Territory to use existing epidemiological studies rather than conduct
new or independent epidemiological studies for every waterbody if it is
scientifically appropriate to do so.
EPA also anticipates that a State or Territory that has conducted a
sanitary survey and an epidemiological study to show that the sources
of the indicator bacteria in a waterbody are non-human and that the
indicator densities do not indicate a health risk to those swimming in
the waters, will apply the criteria in today's rule where a change in
circumstances affecting the waterbody makes it appropriate to do so.
For example, the criteria would apply to a waterbody in which there is
a subsequent sewer line break or other later occurrence that results in
the introduction in the waterbody of bacteria that is a human health
risk to those using the waters for primary contact recreation.
EPA is promulgating this approach because Clean Water Act section
303(i)(2)(A) requires EPA to propose criteria which are ``as protective
of human health as'' EPA's 1986 bacteria criteria in cases where a
State or Territory has failed to do so. While EPA's scientific
understanding of pathogens and pathogen indicators has evolved since
1986, data characterizing the public health risk associated with non-
human sources is still too limited for the Agency to promulgate another
approach.
Almost half of the commenters addressed some or all of the
approaches to exempting non-human sources of fecal contamination
described in the proposed rule (69 FR 41729-41731). Several commenters
expressed support for EPA's preferred approach. EPA agrees that the
criteria should apply unless sanitary surveys and epidemiological
studies show the sources of the indicator bacteria to be non-human and
that the indicator densities are not indicative of a human health risk.
This is the approach taken in the 1986 bacteria criteria document.
Some commenters expressed a preference for not allowing any
exclusion of non-human sources from the criteria. They emphasized the
significance of the human health risk associated with any type of fecal
contamination and asserted that this approach would be most protective
of human health. EPA does not agree that this approach is necessary for
States to adopt if an epidemiological study demonstrates that non-human
sources do not pose a risk to human health at a given waterbody.
Several commenters supported a non-human source exclusion based on
sanitary surveys only. In general, these commenters expressed concern
about the cost of epidemiological studies, especially in areas where
evidence of human fecal contamination was absent. EPA has found the
scientific understanding of the human health risks associated with non-
human sources of fecal contamination is still too incomplete to
promulgate this option. In the proposed rule (69 FR 41730-41731), EPA
cited several instances where studies have attributed disease outbreaks
to non-human sources of fecal contamination. Given the potential human
health risk from non-human sources of fecal contamination, EPA
concludes that this option would not be as protective of human health
as the 1986 bacteria criteria.
Some commenters supported exclusion of bacteria from wildlife
sources from the criteria because wildlife sources may pose less of a
risk to human health than human sources or domestic animal and
livestock sources. Other commenters raised issues with the reliability
of current bacteria source tracking methods that may be needed to
support this exclusion. EPA finds the scientific understanding of the
human health risks associated with wildlife sources of fecal
contamination still too incomplete to support promulgation of this
option. Once again, EPA concludes that this option is not as protective
as the 1986 bacteria criteria.
Many commenters expressed the need for more research on non-human
sources. Commenters emphasized two major areas of needed research:
research on bacterial source tracking methods to better distinguish
between different types of bacteria contamination and research on the
health risks associated with different types of non-human fecal
contamination. EPA expects to conduct research in these areas as time
and resources allow. EPA also encourages others to continue to conduct
research in these areas.
C. Applicability of Today's Rule
1. Applies in Addition to Any State/Territorial Criteria
EPA is promulgating the rule as proposed with respect to the
interaction of today's criteria with existing State and Territorial
water quality criteria. Under today's rule, the promulgated criteria do
not replace existing bacteria criteria for coastal recreation waters
already adopted by States and Territories (and for those adopted after
May 30, 2000, approved by EPA). Rather, today's promulgated criteria
apply for Clean Water Act purposes in addition to any existing State or
Territorial criteria already applicable to those waters. This will
ensure that, where commercial shellfishing and primary contact
recreation occur in the same coastal recreation waters, both uses will
be adequately protected by existing State and Territorial standards
(which generally still use fecal coliform) and the new standards for
either E. coli or enterococci. States and Territories may also continue
to use existing criteria for fecal coliform to supplement the new
indicators for the purposes of waterbody assessment and other purposes
where ambient data are needed. The dual sets of bacteria criteria also
will enable regulatory decisions and actions to continue while
collecting data for the newly adopted E. coli or enterococci criteria.
For States and Territories included in today's rule, EPA expects that
States and Territories will be actively collecting data on E. coli and/
or enterococci and working to incorporate E. coli and/or enterococci
water quality criteria into their water quality programs, e.g.,
National Pollutant Discharge Elimination System, Clean Water Act
section 305(b), and Clean Water Act section 303(d) programs. As they
accomplish this, States and Territories may phase out their use of
fecal coliform as a supplemental indicator to protect primary contact
recreation. While EPA cannot remove or revise existing State or
Territorial standards, EPA believes that it would not be an efficient
use of resources for States and Territories to base Clean Water Act
actions related to protection of primary contact recreation on both
fecal coliform and the new, preferred indicators. However, if States
believe their existing standards are as protective as the criteria in
today's rule, they may submit data to EPA to support this
determination, and if EPA then determines that the State standards are
at least as protective as the criteria in today's rule, EPA will
withdraw the Federal criteria for that State. (See section V.C.) States
and Territories are encouraged to expeditiously revise their water
quality standards to remove fecal coliform criteria as an indicator for
primary contact recreation where it has been replaced by the new
indicators in their implementation of the Clean Water Act. Today's rule
also provides in 40 CFR 131.41(d)(1) that new EPA-approved bacteria
criteria in State or Territorial water quality standards become the
effective Clean Water Act criteria upon their approval, replacing the
criteria in today's rule.
[[Page 67229]]
EPA received very few comments on this topic. All commenters
addressing this topic supported EPA's proposal that once EPA approves a
State's or Territory's standards as being as protective of human health
as EPA's 1986 bacteria criteria, the EPA-approved bacteria criteria in
State or Territorial water quality standards would become effective for
Clean Water Act purposes and EPA's promulgated criteria would no longer
apply. EPA will still remove the State or Territory from 40 CFR 131.41,
but any delay in that process would not delay the approved State
criteria from becoming the sole applicable criteria for Clean Water Act
purposes.
2. Role of State/Territorial General Rules of Applicability
Today's rule, like the proposal, makes today's criteria subject to
States' and Territories' general rules of applicability in the same way
and to the same extent as are other Federally-adopted or State-adopted
numeric criteria. EPA received a few comments on this topic and these
generally pertained to mixing zones. One commenter suggested that the
final rule prohibit the use of mixing zones to comply with today's
criteria. The commenter said that the use of mixing zones would not be
as protective of human health as the 1986 bacteria criteria. Another
commenter supported allowing States to apply their existing mixing zone
provisions.
EPA appreciates the concerns of commenters regarding human health
risks of exposure to fecal contamination within mixing zones. However,
EPA has determined that the Agency's existing guidance provides
sufficient direction to permitting authorities as they implement State
or Territorial mixing zone policies. EPA's Water Quality Standards
Handbook: Second Edition (EPA-823-B-94-005a, August 1994) as well as
EPA's Technical Support Document for Water Quality Based Toxics Control
(EPA-505-2-90-001, March 1991) advise against the use of mixing zones
where the location may pose a significant health risk. These documents
stress the importance of determining the appropriate placement and size
of mixing zones depending on the potential effects to human health and
the environment. As a result, EPA is not prohibiting the application of
mixing zones in the final rule in cases where they would be allowed
under existing State and Territorial programs.
D. Compliance Schedules
Where a State or Territory does not have a regulation that is in
effect for Clean Water Act purposes authorizing compliance schedules
for water quality-based effluent limits, EPA proposed to authorize, but
not require, the permit issuing authority to include compliance
schedules in permits under appropriate circumstances. EPA also proposed
that if a State or Territory has a regulation in effect authorizing
compliance schedules for Clean Water Act purposes then that compliance
schedule regulation could be used in implementing the water quality
standards in this rule; it would not be affected by the final rule.
Because EPA recognizes that a State or Territory without a regulation
authorizing compliance schedules may not want such a regulation, in the
preamble to the proposed rule, EPA asked such States to notify EPA
prior to promulgation. No State or Territory notified EPA that it does
not want the ability to use the compliance schedule provision in
today's rule. Therefore, EPA is not including in today's final rule any
regulatory text identifying States or Territories that do not want a
compliance schedule provision for their standards.
EPA received several comments in support of the allowance for
compliance schedules. One commenter requested that EPA remove the
requirement that a permittee request a compliance schedule; this
commenter believed that the permitting authority could determine
whether the permittee needed time to comply with the new effluent
limitation based on the criterion. EPA disagrees that it needs to make
this change because the rule does not impose a requirement for a
request. The rule at 40 CFR 131.41(f)(3) provides permittees with the
opportunity to request a compliance schedule where the permittee
reasonably believes it will be infeasible to immediately achieve the
new limitation, but it does not require them to do so. The permitting
authority also has the discretion to suggest the need for compliance
schedules as part of the permit even if the permittee does not initiate
a request for one.
One commenter supported the definition of a new pathogen
discharger. Another commenter requested clarification that the
definition does not apply to relocated combined sewer overflow
outfalls. EPA agrees that the definition does not apply to relocated
combined sewer overflow outfalls. The rule at 40 CFR 131.41(f)(2) does
not authorize compliance schedules for new pathogen dischargers because
EPA recognizes that a new discharger could design and build a new
treatment system, which will meet the new water quality-based
requirements more efficiently (69 FR 41736). However, a relocated
combined sewer overflow outfall is not a new discharge, rather it is an
existing discharge being released at an alternate location. The
relocating of the outfall does not necessarily provide an opportunity
for the discharger to apply additional controls or reduce pathogen
loads to the extent anticipated for a new pathogen discharger. EPA's
Combined Sewer Overflow Control Policy, published on April 11, 1994,
recommends that Long Term Control Plans consider relocating overflow
away from sensitive areas wherever physically possible and economically
achievable (59 FR 18688, 18692). In today's final rule, EPA has added
text to the definition of a ``new pathogen discharger'' in 40 CFR
131.41(b)(6) to provide expressly that ``[i]t does not include
relocation of existing combined sewer overflow outfalls.''
Many commenters addressed the length of the compliance schedule.
Some commenters supported capping the length of the compliance schedule
at five years, while one commenter suggested that three years should be
sufficient. Other commenters suggested that compliance schedules longer
than five years may be necessary, or that the rule should not specify
the length of a compliance schedule, but rather allow the permitting
authority to exercise discretion in determining how much time is
necessary for each discharger. Finally, several commenters noted that
combined sewer overflow systems may need compliance schedules longer
than five years, and that the compliance schedule provision of the rule
should be consistent with EPA's Combined Sewer Overflow Control Policy
and the requirements of Clean Water Act section 402(q).
EPA has determined that five years is a reasonable limit on the
length of a compliance schedule within a National Pollutant Discharge
Elimination System permit. EPA expects that most continuous dischargers
will look to optimize their existing disinfection treatment, and that
five years is sufficient time to do so. As discussed in section VIII,
EPA believes that experiences from facilities with bacteria effluent
limits that are currently meeting the E. coli and enterococci criteria,
as well as the current fecal coliform criteria, suggest that
disinfection processes can be upgraded or adjusted to produce the
levels of bacteria necessary for compliance with the rule. EPA has used
five years for compliance schedules where permittees were expected to
design, construct, and operate new treatment processes, and not just
optimize their current treatment. (See 40 CFR 131.38(e)(6) and
[[Page 67230]]
40 CFR Part 132, Appendix F, Procedure 9.B.1.)
EPA does not regard the five-year cap on compliance schedules as
inconsistent with either EPA's Combined Sewer Overflow Control Policy
or Clean Water Act section 402(q). Section 402(q) requires that
National Pollutant Discharge Elimination System permits conform to
EPA's Combined Sewer Overflow Control Policy published on April 11,
1994 (59 FR 18688). EPA's Combined Sewer Overflow Control Policy
recommends that permittees develop a construction and financing
schedule for implementation of combined sewer overflow controls (59 FR
18694). The Combined Sewer Overflow Control Policy recommends that
permitting (and water quality standards setting) authorities include,
in an appropriate enforceable mechanism, compliance dates, on the
soonest practicable schedule, for requirements to implement Long Term
Control Plans (59 FR 18696). In addition, permits need to include water
quality-based effluent limits requiring compliance by no later than the
date allowed under the water quality standards that apply. The Combined
Sewer Overflow Control Policy itself does not require compliance
schedules in water quality standards (or otherwise constrain the
authority of water quality standard setting agencies). Finally, the
Combined Sewer Overflow Control Policy recommends, in cases where water
quality standards do not allow compliance schedules and the permittee
cannot, on the effective date of the permit, comply with effluent
limitations established in the permit, that the compliance schedule be
placed in a judicial order for major permittees (59 FR 18697). EPA
recognizes that combined sewer overflow systems often need more than
five years to meet the requirements of the Clean Water Act. In these
situations, the permitting authority can provide sufficient time for
the combined sewer overflow system to comply by using the enforceable
mechanisms identified in the Combined Sewer Overflow Control Policy.
Finally, in today's final rule, EPA is making two corrections to
the proposed rule at 40 CFR 131.41(f)(3)-(4) to refer to paragraph (c)
as the paragraph containing the water quality criteria for bacteria.
V. EPA Review of State and Territorial Standards
A. How Did EPA Decide Which States and Territories To Include in
Today's Rule?
EPA evaluated the water quality standards for bacteria for all 35
coastal States and Territories with coastal recreation waters to
determine whether the water quality standards for such waters are as
protective of human health as the 1986 bacteria criteria document, as
required by Clean Water Act section 303(i)(1)(A). If a State's or
Territory's approved water quality standards for bacteria for coastal
recreation waters are as protective of human health as the 1986
bacteria criteria as of the signature date of today's rule, EPA is not
including the State or Territory in the promulgated rule.
EPA described the five considerations used to evaluate the State
and Territorial water quality standards in detail in the proposed rule
(69 FR 41728-41731). Today, EPA uses the same five considerations to
evaluate State and Territorial water quality standards for inclusion in
the final rule. The following five sections summarize the
considerations.
1. Are the standards based on EPA's recommended indicators of E. coli
and enterococci as pathogen indicators for freshwaters and enterococci
for marine waters?
As discussed in section IV.B.1 of the preamble to today's rule, EPA
is promulgating water quality criteria for E. coli and enterococci for
use as standards for State and Territorial coastal and Great Lakes
recreation waters. These are the indicator bacteria for which EPA
published criteria in the 1986 bacteria criteria document.
EPA received a number of comments asserting that a fecal coliform
water quality criterion of 14/100 ml for the protection of a
shellfishing use should generally be as protective of human health as
the enterococci criterion of 35/100 ml. Some of these commenters
referenced the statement in the 1986 bacteria criteria document that
EPA selected the value of the enterococci criterion to be no more
protective of human health than the then current fecal coliform
criterion of 200/100 ml for recreation protection in support of their
argument that if there is equal protection between the 1986 bacteria
criteria and a fecal coliform value of 200/100 ml, then a fecal
coliform value of 14/100 ml should be even more protective of human
health than an enterococci value of 35/100 ml for marine waters. EPA
disagrees that this statement in the 1986 bacteria criteria document
provides a basis for determining that a fecal coliform criterion of 14/
100 ml is ``as protective as'' an enterococci criterion of 35/100 ml.
EPA explicitly acknowledged in the 1986 bacteria criteria document that
these illness rates for fecal coliform were only approximations, but
were the best available estimates. (The fecal coliform criteria were
developed long before EPA calculated the corresponding estimated
illness rates.) EPA used these estimated illness rates for one purpose:
to select illness rates for the enterococci and E. coli criteria in
marine and fresh waters that would be least likely to cause a change in
the stringency of the water quality standards for bacteria. However,
that discussion in the 1986 bacteria criteria document must be
considered along with the purpose of the 1986 bacteria criteria
document: to recommend that States replace their fecal coliform
criteria for recreation with enterococci or E. coli criteria because
studies showed low correlation between fecal coliform densities and
illness rates. In EPA's view, it would not be reasonable to rely on the
equivocal discussion regarding the after-the-fact approximation of an
illness rate for fecal coliform in light of the unequivocal conclusion
of the entire document: That the fecal coliform criteria for recreation
is not a reliable indicator of illness to swimmers.
One commenter, the Washington Department of Ecology, supplied EPA
with recently-collected ambient water monitoring data for both fecal
coliform and enterococci, and stated that the data for enterococci and
fecal coliform, when compared to each other, show that, in Washington
State coastal recreation waters, when fecal coliform concentrations
were at 14/100 ml or less (a level substantially below the 200/100 ml
level that EPA recommended prior to 1986), the enterococci
concentrations were almost always at 35/100 ml or less. The State
currently has a fecal coliform criterion of 14/100 ml as a geometric
mean and 43/100 ml as a value not to be exceeded more than 10% of the
time for its Class AA and A waters, which for marine waters are the
only classes with primary recreation uses. The data submitted to EPA
are from 37 locations in the King County area of the Puget Sound for
the years 1995 through 2004, 155 locations in the Kitsap County area of
the Puget Sound and its embayments for early 1997, and 36 locations
across the Puget Sound, Strait of Juan de Fuca, and two Pacific Ocean
embayments from November 2000 through July 2001.
[[Page 67231]]
EPA reviewed the data provided by the Washington Department of
Ecology. EPA analyzed the data that were collected from stations
located close to shore and within the upper two meters of depth,
because these are the areas where people most frequently swim. EPA also
excluded data that the State identified as invalid. From these data,
there are 3535 samples with both fecal coliform and enterococci
bacterial counts. From these samples, EPA calculated 241 summertime
geometric means for both fecal coliform and enterococci for the data
from King County. EPA could not calculate summertime geometric means
for the other locations because there were insufficient data in these
data sets to do so.
These geometric mean calculations show that, for King County, the
attainment of the State's current fecal coliform geometric mean
criterion of 14/100 ml always assures attainment of an enterococci
geometric mean of 35/100 ml. Further, there were 67 of 191 relevant
occasions (35% of the time) when the State's fecal coliform geometric
mean criterion was exceeded but the geometric mean enterococci
criterion was not.
The data also show that attainment of the State's current fecal
coliform criterion also ensures attainment of the enterococci 75th
percentile single sample maximum criterion (04/100 ml) in 99% of the
samples collected at all locations in Washington. Of 2194 relevant data
points, the State's upper bound fecal coliform criterion of 43/100 ml
assures attainment of the Federal enterococci 75th percentile single
sample maximum criterion on 2166 occasions. Finally, there were 570 of
2736 relevant occasions (21% of the samples) when use of the State's
fecal coliform criterion could be used to close a beach or issue an
advisory but the Federal enterococci criterion (expressed as a single
sample maximum) would not support closure or an advisory. Based on this
analysis, EPA agrees that the data provided by the State of Washington
for the Puget Sound, Strait of Juan de Fuca, and the Pacific Ocean
embayments shows that use of the State's 14/100 ml fecal coliform
criterion is as protective of human health as the 1986 bacteria
criteria for the State of Washington.
In the proposed rule, EPA solicited comment on its interpretation
that Clean Water Act section 303(i) requires States and Territories to
adopt criteria for E. coli or enterococci to comply with the provisions
of that section. Section 303(i)(1)(A) requires that States and
Territories submit criteria `` * * * for the pathogens and pathogen
indicators for which the Administrator has published criteria under
section 304(a).'' EPA's Ambient Water Quality Criteria for Bacteria--
1986 is considered to be the Clean Water Act section 304(a) criteria
referred to in Clean Water Act section 303(i)(1)(A). The Ambient Water
Quality Criteria for Bacteria--1986 strongly recommended the use of E.
coli and enterococci as pathogen indicators for fresh waters and
strongly recommended enterococci for marine waters.
Clean Water Act section 303(i)(2)(A) requires EPA to propose water
quality standards regulations for a State ``[i]f a State fails to adopt
water quality criteria and standards * * * that are as protective of
human health as the criteria for pathogens and pathogen indicators for
coastal recreation waters published by the Administrator * * * ''
(emphasis added). EPA solicited comment on whether section 303(i)(2)(A)
could be read to require that EPA need only promulgate for a State or
Territory if the State or Territory failed to adopt any criteria (not
necessarily E. coli or enterococci) that were as protective of human
health as EPA's 1986 bacteria criteria. In other words, EPA solicited
comment on whether it was required to promulgate E. coli or enterococci
under section 303(i)(2)(A) in situations where a State or Territory
adopted a low fecal coliform criterion for protection of primary
contact recreation that was demonstrated to provide protection equal to
the protection provided by EPA's 1986 bacteria criteria. EPA has
reconsidered its interpretation and believes that there is some
ambiguity in section 303(i)(2)(A) and that given this ambiguity that it
should interpret section 303(i)(2)(A) as allowing EPA to approve
standards based on other indicators provided they are as protective as
EPA's 1986 bacteria criteria because this approach is most consistent
with the purposes of the Clean Water Act. Thus, EPA is taking the
position that EPA is not required to promulgate E. coli or enterococci
criteria if a State demonstrates that other criteria, based on other
bacteria indicators, are as protective of human health as EPA's 1986
bacteria criteria. That is, if a State or Territory adopts criteria,
even though they are not for E. coli or enterococci, that are
demonstrated to be as protective of human health as EPA's 1986 bacteria
criteria, section 303(i)(2)(A) does not require EPA to promulgate
criteria for E. coli or enterococci. Promulgation of criteria for E.
coli or enterococci in that situation would not provide any greater
level of public health protection. Protection of public health was
Congress's primary intent in enacting the BEACH Act. Therefore, if a
State or Territory can show that in waters in which the State or
Territory intends to protect primary contact recreation uses with its
criteria for fecal coliform, that such uses will be protected at a
level equal to or greater than the protection provided by EPA's 1986
bacteria criteria for enterococci and E. coli, EPA does not believe
Congress intended EPA to promulgate water quality criteria for
pathogens or pathogen indicators for those waters in that State or
Territory where this has been demonstrated. The facts presented by the
Washington Department of Ecology highlight the reasonableness of this
interpretation.
In addition, EPA considers it to be an appropriate exercise of
Federal discretion to take this approach with Washington State.
Congress intended through Clean Water Act section 303(c) to give States
the paramount role in weighing any available credible information for
establishing water quality standards that are protective of the
designated uses of their waters. Congress maintained this same approach
in Clean Water Act section 303(i) by giving States the responsibility
to adopt water quality standards for protecting human health, with
EPA's role being to promulgate standards for those States that had not
adopted standards as protective of human health as the 1986 bacteria
criteria. This interpretation is supported by the legislative history
of Clean Water Act section 303(i). For example, S. Rep. No. 106-366
states in the section-by-section analysis of the Act:
These provisions are consistent with the applicable requirements
of the Clean Water Act and specifically section 303(c) and the
regulations implementing that section. States must incorporate into
their water quality standards, water quality criteria for pathogens
and pathogen indicators that are at least as protective of human
health as criteria EPA publishes under section 304(a). The State's
criteria may be as protective as those of EPA without being
numerically equivalent. However, if a State adopts criteria
differing from those published by EPA, the State has a duty to
defend the criteria from a scientific perspective. EPA's approval or
disapproval of the criteria is based upon the information provided
by the State. (S. Rep. No. 106-366, at 4 (2000)).
EPA believes that this language demonstrates Congress's intent that
section 303(i) be interpreted within the broader context of section
303, and that section 303(i) not be interpreted to preclude a State's
adopting alternative criteria from those published by EPA
[[Page 67232]]
under section 304(a), provided that the State demonstrates (and EPA
agrees) that the alternative criteria are as protective of human health
as EPA's published criteria.
H. Rep. No. 106-98 has similar language in its section-by-section
analysis as follows:
The Committee intends that the legal standard for determining
when a State water quality standard is consistent with the
applicable requirements of the Clean Water Act be governed by the
existing requirements of section 303(c) of the Clean Water Act, and
the regulations implementing that section. This standard has been
interpreted to mean that State water quality criteria must be at
least as protective of human health as EPA's water quality criteria.
Thus, a State must incorporate into its water quality standards
water quality criteria for pathogens and pathogen indicators that
are at least as protective as criteria that EPA has published under
section 304(a), including EPA's 1986 criteria for enterococcus and
Escherichia coli. (H. Rep. No. 106-98, at 8 (1999)).
Here again, EPA believes Congress is clarifying its intent that State
criteria to be approvable under section 303(i), must be at least as
protective as EPA's 1986 bacteria criteria, but not necessarily the
same as the 1986 criteria.
With respect to the State of Washington, EPA looked at the process
that the State took in reviewing its fecal coliform standards for
protecting recreation uses in marine waters. The State did this as part
of its triennial review of water quality standards. The State undertook
a multi-year process starting in the summer of 1996 and finishing in
2003. In this period, the State convened a multi-stakeholder technical
workgroup to examine the technical merits of the State's bacteria
criteria, and documented the technical and policy issues evaluated by
the work-group and its predecessor (see http://www.ecy.wa.gov/pubs/0010072.pdf). The State used this information to focus discussions with
numerous advisory panels both internal and external to the Washington
Department of Ecology. The State held a formal 60-day public review and
comment period on proposed revisions to its water quality standards
(including adoption of EPA's recommended enterococci criteria for Class
AA and Class A marine waters), and as part of the public notification
process, directly mailed out approximately 3320 announcements, 550
email announcements, and 621 CDs to potential interested citizens,
regulated businesses, governmental officials, and every city, county,
and Tribe in the State. The State conducted eight public workshops and
hearings regarding proposed changes to its standards at locations
across the State. Finally, the State made all documents available to
the public at its Web site at http://www.ecy.wa.gov/programs/wq/swqs/supporting_docs/supporting_docs.html.
Based on the input from the various stakeholders in the State and
the paired monitoring data for fecal coliform and enterococci, the
State concluded that its fecal coliform criteria for marine waters is
protective of the recreation use in these waters, and also is at least
as protective of human health as EPA's 1986 bacteria criteria. Many
stakeholders in Washington share this conclusion, as expressed in the
public comments by many stakeholders on the State's proposed water
quality standards (see http://www.ecy.wa.gov/programs/wq/swqs/supporting_docs/public_comments.html) and comments by a Puget Sound
public interest group and a Northern Pacific Ocean shellfish group on
EPA's proposed rule. Given this conclusion, the State and some
stakeholders were concerned that the State adoption of the enterococci
standard and the attendant new monitoring that this would entail would
limit the State's ability to monitor as comprehensively for fecal
coliform as it does currently and thus provide the maximum assurance
that its waters are meeting its protective 14/100 ml fecal coliform
standard. However, this rule does not require monitoring.
As discussed previously in this preamble, EPA reviewed the State's
data and determined that it shows that the State's fecal coliform
criterion is as protective as the 1986 bacteria criteria. Accordingly,
EPA considers it appropriate and consistent with Congressional intent
to exclude Washington from today's Federal promulgation because the
State has fully met its obligations under the Clean Water Act using a
full and open public process and is ensuring protection of human health
in the coastal recreation waters of Washington.
EPA considers its analysis of the data provided by the State of
Washington to only be relevant to the State's waters. EPA does not
agree that the Washington data show that use of a fecal coliform
criterion of 4/100 ml is as protective of human health as the 1986
bacteria criteria for any other coastal recreation waters in the United
States because the conditions of the Washington State waters may differ
from waters of other States. The relationship between fecal coliform
and enterococci in the data provided by the Washington Department of
Ecology is an empirical relationship, and reflects the conditions of
the water from which the samples were collected. EPA cannot determine
without water-specific data the extent to which the Washington State
waters where the samples were collected are representative of other
waters in other parts of the United States. The Washington data reflect
the pathogen sources in that area, the local rainfall which has an
effect on pathogen loadings, the tidal flushing in the waters, and the
temperature of the waters. Further, as noted above, the legislative
history indicates that any State wishing to adopt criteria other than
those in the 1986 bacteria criteria document, `` has a duty to defend
the criteria from a scientific perspective'' and specifically to
demonstrate that they are as protective of human health as EPA's 1986
bacteria criteria.
No other comments received by EPA included the type and amount of
information that EPA views as necessary to demonstrate that fecal
coliform criteria (or any other pathogen indicator) in any other State
or Territory are as protective of human health as the 1986 bacteria
criteria. However, if following promulgation of this rule, some other
State or Territory provides data to EPA sufficient to make this
demonstration, EPA will approve such other criteria as meeting the
requirements of section 303(i) and withdraw today's Federal criteria
from that State's coastal recreation waters. EPA cautions, however,
that given the focus of the BEACH Act on the specific indicators in
EPA's 1986 bacteria criteria document, there is a substantial burden of
proof for States wishing to adopt criteria based on alternative
indicators. EPA believes that both the process and quantity of
information and data provided by Washington State in making this
determination may provide guidance to any other State that wished to
make a similar showing.
2. Are the Standards for E. coli and Enterococci Derived From a
Scientifically-Defensible Methodology That Links Them Quantitatively to
an Acceptable Risk Level Under Clean Water Act Section 303(i)?
As discussed in section IV.B.2 of the preamble to today's rule, EPA
is promulgating water quality criteria that correspond to an illness
rate of 0.8% for swimmers in freshwater and 1.9% for swimmers in marine
waters. In deciding which States and Territories have already adopted
water quality criteria as protective of human health as these criteria,
EPA considered an illness rate of 1.0% of swimmers to be as protective
as the 1986 bacteria criteria in determining whether to include a State
or Territory in the rule. EPA explained
[[Page 67233]]
its reasons for this consideration in the proposed rule (69 FR 41724-
41725). EPA would consider State or Territorial bacterial criteria for
fresh coastal recreation waters to not be as protective of human health
if the risk level of the criteria was above 1.0%.
Some commenters addressed this topic. Of these, a majority agreed
with EPA that a 1.0% illness rate in swimmers in freshwater is as
protective of human health as the 1986 bacteria criteria for different
reasons. One commenter said that a 1.0% illness rate would result in
only a small increase in risk of illness and that would still be below
the risk of illness in marine waters. Another commenter stated that the
difference between 0.8% and 1.0% was well within the inherent
variability in the criteria. One commenter expressed support for the
1.0% risk level but only if EPA had examined and analyzed all available
updated epidemiological data in identifying an acceptable risk level.
As explained in the proposal (69 FR 41724-41725), EPA conducted an
external peer review of EPA's analysis of the epidemiological data from
EPA's bacteriological studies on which the 1986 bacteria criteria
document is based.
Of the commenters who did not agree that the 1.0% illness rate was
as protective of human health of the 1986 bacteria criteria, most
argued that there is no logical reason to allow for different
acceptable illness rates in marine and freshwater. One commenter said
that the increase from 0.8% to 1.0% in freshwater would increase the
incidence of gastrointestinal illness by 25%. Three commenters believed
that the illness rate for freshwater should be 0.8%, while one
commenter felt that EPA should promulgate additional geometric mean and
single sample maximum values relative to other risk levels. EPA
disagrees that it should only consider an illness rate of 0.8% to be as
protective of human health as the 1986 bacteria criteria document. As
explained in the proposal, EPA does not see any a priori reason to
require a greater level of protection for freshwaters than for marine
waters, which account for the vast majority of swimming days in coastal
recreation waters subject to section 303(i) of the Clean Water Act. See
the proposed rule (69 FR 41724) for further discussion of EPA's
reasoning.
3. Do the Standards Include Appropriate Single Sample Maximums for All
Coastal Recreation Waters?
As discussed in sections IV.B.3 and IV.B.4 of the preamble to
today's rule, EPA is promulgating water quality criteria that include
separate single sample maximums for four categories of waters based on
intensity of use, which allows the State or Territory to assign waters
to the four use intensity categories. In determining whether existing
State or Territorial water quality standards for coastal recreation
waters are as protective of human health as EPA's 1986 bacteria
criteria, EPA determined whether the water quality standards include a
single sample maximum for all coastal recreation waters and if
designated bathing beaches have a single sample maximum based on at
least the 75% confidence level. EPA considers this approach to be as
protective as the 1986 bacteria criteria and also consistent with the
criteria as discussed in section IV.B of the preamble to today's rule.
EPA included in the rule any State or Territory that does not cover all
coastal recreation waters with a single sample maximum and that for
designated bathing beaches does not have a single sample maximum based
on at least the 75% confidence level. EPA does not expect a State or
Territory to use all four of the use categories identified in the
criteria document for its standards to be at least as protective as the
1986 bacteria criteria. For example, a State that applied the 75%
confidence based maximum to all waters would clearly be as protective
as the 1986 bacteria criteria, even though it would only have a single
use category.
Most commenters agreed with this approach. Those that disagreed
with it commented that the single sample maximum should not be a part
of the water quality criteria but rather available for use as an
implementation tool for monitoring at beaches. EPA addressed these
comments in sections IV.B.3 and IV.B.4 of today's preamble.
EPA notes that all of the 35 coastal and Great Lakes States and
Territories have identified coastal recreation waters where there are
beaches or similar points of access (National List of Beaches, EPA-823-
R-04-004, 69 FR 24597, May 4, 2004). Also, all 35 of these States and
Territories have received Clean Water Act section 406 grants since 2002
for monitoring and notification of beach advisories or closures at
beaches adjacent to coastal recreation waters. Today's rule specifies
that the highest use category with a single sample maximum based on the
75% confidence level applies to all beaches meeting the definition of
designated bathing beaches in 40 CFR 131.41(b)(2) (``* * * coastal
recreation waters that, during the recreation season are heavily-used
(based on an evaluation of use within the State) and may have: a
lifeguard, bathhouse facilities, or public parking for beach access'')
and that the other use categories apply to lower use waters
accordingly. Based on the applications for Clean Water Act section 406
grants, EPA expects that many coastal and Great Lakes States will have
at least some beaches in the higher use categories.
4. Do the Standards Exempt Fecal Contamination From Non-Human Sources?
For the reasons discussed in section IV.B.7 of the preamble to
today's rule, EPA is promulgating the exemption for non-human sources
expressed in the 1986 bacteria criteria document. EPA is including in
today's rule those States and Territories for which the criteria
include exemptions for non-human sources that are inconsistent with the
exemption provision in the criteria document, as promulgated in today's
final rule. EPA addressed comments on this issue in section IV.B.7 of
the preamble to this rule.
5. Has EPA Approved the Standards?
Under section 303(i)(1)(A) of the Clean Water Act, States and
Territories must adopt water quality standards as protective of human
health as EPA's 1986 bacteria criteria. Moreover, under 40 CFR 131.21,
EPA must approve State or Territorial water quality standards adopted
after May 30, 2000, in order for those standards to be in effect for
Clean Water Act purposes. Therefore, EPA must have approved State and
Territorial standards for enterococci or E. coli adopted after May 30,
2000, as consistent with Clean Water Act section 303(i) in order for
EPA to exclude the State or Territory from the final rule. State and
Territorial standards adopted prior to May 30, 2000, that are
consistent with Clean Water Act section 303(i) are in effect for Clean
Water Act purposes even without explicit EPA approval.
B. Which States and Territories Are Included in Today's Rule?
The proposed rule contains a State-by-State summary of the status
of each State or Territory (69 FR 41731-41735). EPA did not include any
Tribes in the proposal because although there are Federally-recognized
Tribes located next to either coastal or Great Lakes waters, none of
those Tribes have coastal recreation waters as defined in 40 CFR
131.41(b)(1). (See 69 FR 41735.)
Today, EPA is promulgating a rule that is identical with respect to
the water quality criteria values to what EPA proposed. While there
were some changes in other provisions of the rule,
[[Page 67234]]
none of these affected EPA's determination with regard to specific
States. Therefore, EPA is not excluding any other States from the final
rule based on changes in the provisions of the final rule.
Table 4 contains a summary of the status of each of the 35 States
and Territories under today's rule. EPA considered three possible
reasons for a change in a State's or Territory's status from that
described in the proposal: (1) Since the publication of the proposed
rule, the State or Territory may have adopted (and EPA approved) water
quality standards that are as protective of human health as the 1986
bacteria criteria; (2) the State's or Territory's water quality
standards may now be viewed as being as protective of human health in
light of EPA's final decision with respect to the application of the
single sample maximum in the final rule; and (3) new information
submitted following publication of the proposal may have caused EPA to
reassess its previous determination. During the period between
publication of the proposal and the final rule, four States--Delaware,
Hawaii, Maryland, and South Carolina--and the Commonwealth of the
Northern Mariana Islands adopted revised water quality criteria for
pathogens. In addition, the State of Washington provided information
that caused EPA to reassess its determination as to whether the State's
fecal coliform criterion of 14/100 ml is as protective of human health
as the 1986 bacteria criteria. Below, EPA describes the status of these
States and Territory and provides an update on the status of several
other States working to adopt water quality standards, as described in
the preamble to the proposed rule.
Table 4.--Categorization of 35 States/Territories With Coastal
Recreation Waters
------------------------------------------------------------------------
Not subject to 40 CFR 131.41 Subject to 40 CFR 131.41
------------------------------------------------------------------------
Alabama Alaska
American Samoa California
Connecticut Florida
Delaware \1\ Georgia
Guam Hawaii
Indiana Illinois
Michigan Louisiana
New Hampshire Maine
New Jersey Maryland
Northern Mariana Islands \1\ Massachusetts
South Carolina \1\ Minnesota
Texas Mississippi
Virginia New York
Washington \1\ North Carolina
Ohio
Oregon
Pennsylvania
Puerto Rico
Rhode Island
Virgin Islands
Wisconsin
------------------------------------------------------------------------
\1\ These States were removed from 40 CFR 131.41 following publication
of the proposed rule.
Commonwealth of the Northern Mariana Islands
The Attorney General for the Commonwealth of the Northern Mariana
Islands certified the adoption of revisions to their water quality
standards on September 30, 2004. These revisions add single sample
maximum standards of 104/100 ml for Class AA waters and 276/100 ml for
Class A waters in the Commonwealth of the Northern Mariana Islands.
Along with the bacteria standards that Commonwealth of the Northern
Mariana Islands adopted and EPA approved in 1997, the revised standards
will fully satisfy the requirements of the Clean Water Act. On October
28, 2004, EPA approved the revised standards and the Commonwealth of
the Northern Mariana Islands is not included in the rule.
Delaware
On September 17, 2004, Delaware submitted to EPA newly adopted
criteria for all its coastal recreation waters. The State's criteria
specify a geometric mean of 35/100 ml and a single sample maximum of
104/100 ml for enterococci for all primary contact recreation marine
waters. Delaware's regulations also limit the application of the
criteria when the bacteria comes from wildlife sources. The State has
submitted documentation to EPA in support of its source tracking
methodology for bacteria, together with epidemiological work on illness
rates from bacteria of wildlife origin. The State uses the source
information to apply a factor to bacteria from wildlife sources that
accounts for illness risk from such bacteria. EPA reviewed the
submitted criteria in accordance with this rule and on November 4,
2004, approved the specific numeric criteria as meeting the
requirements of both sections 303(c) and 303(i) of the Clean Water Act.
EPA is discussing the State's methodology for source tracking with the
State and is reviewing it to determine whether it meets the
requirements of the Clean Water Act and this rule. Until EPA approves
this limitation, for purposes of the Clean Water Act, Delaware's
bacteria criteria for primary contact recreation apply to enterococci
bacteria regardless of the source. As a result, Delaware is not
included in today's rule.
Hawaii
On September 21, 2004, Hawaii adopted bacteria criteria for its
coastal estuaries, and a single sample maximum for coastal waters
within 300 meters (1000 feet) of the shore. The criteria are for
enterococci and have a geometric mean of 33/100 ml and a single sample
maximum of 89/100 ml in coastal estuaries. These newly adopted criteria
also contain a single sample maximum of 100/100 ml in coastal waters
within 300 meters from shore to complement the existing geometric mean
for coastal waters. On October 28, 2004, EPA approved these criteria.
However, Hawaii still has no numeric criteria protecting State waters
beyond 300 meters from shore, although these waters are designated for
recreation in the State's water quality standards. Therefore, EPA is
including Hawaii in this rule but only for the lack of criteria in
State waters beyond 300 meters from shore.
Maryland
On July 5, 2004, Maryland adopted new criteria for all its coastal
recreation waters. These criteria specify a geometric mean of 35/100 ml
enterococci for all recreation waters and at least a single sample
maximum of 104/100 ml for those waters that are designated natural
bathing areas under the State regulations. EPA is reviewing these
criteria in accordance with this rule and is consulting with the State
regarding the intent and meaning of the State regulations. EPA and
Maryland have not concluded discussions of the applicability of the
State criteria. Because Maryland does not yet have approved criteria,
EPA is including Maryland in this rule. If EPA determines that
Maryland's standards comply with Clean Water Act 303(i), they will
become immediately effective for Clean Water Act purposes, as specified
in 40 CFR 131.41(d)(1).
South Carolina
On June 25, 2004, South Carolina adopted criteria for all of its
coastal recreation waters consistent with EPA's 1986 bacteria criteria.
The criteria are for enterococci and have a geometric mean of 35/100
ml, a single sample
[[Page 67235]]
maximum of 104/100 ml for coastal waters designated by South Carolina
as Classes SFH (Shellfish Harvesting) and SA, and a single sample
maximum of 501/100ml for coastal waters designated by South Carolina as
Class SB. However, the South Carolina water quality standard delays the
applicability of the enterococci criteria for permit effluent limits
until such time that EPA publishes analytical methods for enterococci
in effluents. On October 7, 2004, EPA disapproved part of the South
Carolina standards and approved the remainder of the standards that
pertain to pathogens and pathogen indicators. EPA considers the
approved water quality standards to be as protective of human health as
EPA's 1986 bacteria criteria, and South Carolina is not included in the
rule.
Washington
The Washington Department of Ecology submitted data consisting of
paired samples of fecal coliform and enterococci measurements collected
in Puget Sound, the Strait of Juan de Fuca, and the Pacific Ocean
embayments. The Department of Ecology considers this information as
sufficient to demonstrate that use of the State's fecal coliform
criterion of 14/100 ml ensures that enterococci concentrations are
below the 1986 bacteria criteria, and requested that EPA consider the
State's fecal coliform criterion to be as protective of human health as
the 1986 bacteria criteria. As discussed in section V.A.1 of the
preamble, EPA reviewed these data and has determined that the
Washington fecal coliform criterion of 14/100 ml is as protective of
human health as the 1986 bacteria criteria. The Washington fecal
coliform criterion applies to all marine waters with primary contact
recreation use, and thus applies to all coastal recreation waters.
Therefore, Washington is not included in the rule.
Maine
EPA is also making a minor change with respect to including Maine
in today's final rule. As explained in the preamble to the proposal (69
FR 41733), EPA intended to exclude Maine's Class SA waters from
coverage under the rule; however, EPA failed to list Maine's Class SA
waters as excluded in the regulatory text of 40 CFR 131.41(e)(2). EPA
has corrected this omission in today's final rule.
Other States
EPA identified two other States or Territories that, at the time of
proposal, intended to adopt EPA's 1986 bacteria criteria by September
30, 2004. These were Illinois and the Virgin Islands. However, neither
Illinois nor the Virgin Islands adopted the criteria and received EPA
approval as of the signature of today's rule.
C. Under What Conditions Will States and Territories Be Removed From
Today's Rule?
State and Territorial standards for bacteria approved by EPA
pursuant to Clean Water Act sections 303(c) and 303(i) will be in
effect for Clean Water Act purposes, and the Federal criteria for 40
CFR 131.41 will no longer apply. EPA recognizes that once it approves
the water quality standards of the State or Territory, the Code of
Federal Regulations will still include a reference to the State in 40
CFR 131.41 until EPA formally withdraws the State or Territory from the
Federal rule, and thereby the Code of Federal Regulations. However, the
State and Territorial standards for bacteria approved by EPA pursuant
to Clean Water Act sections 303(c) and 303(i) will be in effect for
Clean Water Act purposes (and not the Federal criteria at 40 CFR
131.41) between the time EPA approves the State standards and formal
withdrawal of the State or Territory from the rule.
A State or Territory may adopt and submit partial water quality
standards for EPA's review and approval under today's rule. EPA
envisions two types of partial water quality standards submittals with
different results. If a State adopts and submits water quality
standards that meet all the requirements discussed in today's rule but
the standards apply only to a portion of the State's coastal recreation
waters, EPA expects to approve the State standards for the coastal
recreation waters to which they apply, and today's Federal standards
would continue to apply to all coastal recreation waters that are not
addressed in the submittal. The combination of the approved State and
Federal standards serve to meet the requirements of Clean Water Act
section 303(i). If a State adopts and submits standards for all of its
coastal recreation waters but the standards do not satisfy all of the
considerations described in today's rule as necessary for EPA to make a
determination that the State standards are as protective of human
health as the 1986 bacteria criteria, EPA expects to disapprove the
entire submittal and today's Federal standards would continue to apply
to the State's coastal recreation waters. For example, a State might
adopt water quality standards that contain only a geometric mean for
marine waters of 35/100 ml for enterococci and not a single sample
maximum provision. This would not be sufficient to satisfy section
303(i). EPA anticipates that it would be administratively unworkable to
approve State standards in piecemeal fashion and to supplement
piecemeal State standards with components of today's rule, as in the
example of a State that adopts a State geometric mean but must still
retain a Federal single sample maximum for its coastal recreation
waters.
VI. Response to Additional Significant Public Comments
EPA has prepared a Comment Response Document, which addresses the
comments that EPA received and is included in the docket for today's
rule. Below, EPA provides a summary of its responses to four additional
categories of significant comments.
A. 1986 Bacteria Criteria
Some commenters raised concerns about EPA's 1986 bacteria criteria.
The bulk of the comments questioned the reliability of the studies on
which EPA based the criteria. Some remarked that the studies evaluated
in the criteria document did not appropriately select test sites
because the test sites were all located on the East Coast and therefore
may not represent conditions on the West Coast; the test sites had only
one source of pollution (human); and no control sites were used. In
addition, commenters characterized the data as anecdotal rather than
clinical in nature (e.g., blood and stool samples) and suggested that
the studies did not ensure that the reported illnesses were due to
pathogens relating to bathing in the water. Others questioned EPA's
chosen risk levels. One commenter suggested other possible indicators.
Others commented on the lack of EPA follow-up epidemiological studies
since 1986.
EPA acknowledges these comments, but notes that Clean Water Act
section 303(i) requires States and Territories with coastal recreation
waters to adopt water quality criteria for bacteria as protective of
human health as the criteria published by EPA under Clean Water Act
section 304(a). Section 303(i) was added to the Clean Water Act in 2000
by the BEACH Act. At the time the BEACH Act was enacted, the current
Clean Water Act section 304(a) criteria were EPA's 1986 bacteria
criteria because these are EPA's only currently recommended bacteria
criteria for protection of primary contact recreation waters. The
legislative history makes it clear that Congress recognized that EPA's
1986 bacteria criteria have flaws, but also that Congress wanted States
to adopt standards based on them by April 10, 2004, despite those
flaws,
[[Page 67236]]
presumably because Congress thought the 1986 bacteria criteria are
better than what it characterized as ``outdated'' criteria used by some
States. (See H. Rep. No. 106-98, at 6 (1999); see generally S. Rep. No.
106-366 (2000) and H. Rep. No. 106-98.)
EPA had reviewed its original studies supporting its recommended
1986 water quality criteria for bacteria and the literature on human
health research conducted since EPA completed the original studies of
health effects associated with swimming in marine and freshwater, as
discussed on pages 10-13 of the Implementation Guidance for Ambient
Water Quality Criteria for Bacteria (EPA-823-B-02-003, May 2002 Draft)
. Based on these reviews, EPA has confirmed that the 1986 EPA
recommended water quality criteria for bacteria are protective of human
health against acute gastrointestinal illness.
The epidemiological studies used to develop the criteria were
themselves peer reviewed. The marine studies were peer reviewed in the
Journal of the American Public Health Association. EPA's Office of
Research and Development reviewed the freshwater studies. The Harvard
School of Public Health evaluated the epidemiology test protocol for
both fresh and marine studies, and the University of Pittsburgh Center
for Excellence provided an independent review of the results of the
epidemiology studies. Finally, the 1986 bacteria criteria were reviewed
by the public when EPA published a Federal Register notice concerning
the criteria (49 FR 21987, May 24, 1984).
While Congress directed in Clean Water Act section 303(i) that, by
April 9, 2004, States and Territories adopt criteria as protective as
EPA's current criteria, Congress also recognized that ``EPA's 1986
criteria need to be updated to improve the scientific basis for
identifying pathogens in coastal waters.'' S. Rep. No. 106-366, at 2.
To address this concern, Congress amended Clean Water Act section
304(a) to require EPA to ``publish [within five years of enactment of
the BEACH Act] new or revised water quality criteria for pathogens and
pathogen indicators (including a revised list of testing methods, as
appropriate), based on the results of the studies conducted * * * for
the purpose of protecting human health in coastal recreation waters.''
See Clean Water Act section 304(a)(9). Thus, while Congress recognized
that the 1986 bacteria criteria need improvement, Congress still
required States and Territories to adopt water quality standards as
protective of human health as the 1986 bacteria criteria. EPA is
currently conducting epidemiological studies on potential health risks
resulting from exposure to pathogens or pathogen indicators in coastal
recreation waters, as required under this section of the Clean Water
Act. Once EPA publishes these new criteria, EPA expects that States and
Territories will begin to adopt water quality standards as protective
of human health as the new criteria for coastal and Great Lakes
recreation waters, as required by Clean Water Act section 303(i)(1)(B).
B. Economics
Some commenters noted that, if the rule imposes single sample
maximums as ``not-to-be-exceeded'' values, the geometric mean component
of the criteria would be significantly different from the geometric
mean values in most State current fecal coliform bacteria criteria for
recreation. For fecal coliform criteria to protect recreational uses,
most State criteria include a geometric mean value and a threshold
value not to be exceeded in more than 10% of the samples. Some
commenters state that there will be a substantial cost difference to
regulated entities if the rule imposes single sample maximums for E.
coli or enterococci as ``not-to-be exceeded'' values, noting that EPA's
economic analysis in the proposal does not address the cost of
controlling discharges from combined sewer overflows, sanitary sewer
overflows, and municipal separate storm sewer systems to meet such
single sample maximums, and that EPA's cost estimates for controlling
these sources in other regulatory and policy actions are not based on a
single sample maximum as a never-to-be exceeded criterion for Clean
Water Act purposes.
Today's rule does not treat single sample maximums as a requirement
that may never be exceeded in all instances. Single sample maximums are
values that indicate, with a certain degree of confidence, that a
waterbody may exceed the geometric mean. The State can collect
additional data on a receiving water if it believes that the violation
of the single sample maximum does not indicate violation of the
geometric mean, as described in the preamble to today's rule.
For its economic analysis, EPA evaluated the potential controls for
publicly owned treatment plants and industrial facilities likely to
discharge bacteria to meet permit limits based on the single sample
maximums as never-to-be exceeded values to provide a conservatively
high estimate of cost. In reality, States and Territories have
flexibility in implementing the criteria in National Pollutant
Discharge Elimination System permits. EPA also assumed that none of the
States covered by the rule had adopted E. coli or enterococci as the
applicable water quality standard whereas several of the States in
today's rule have water quality standards for E. coli or enterococci
already in place for some of their coastal recreation waters. This also
led to a higher estimate of cost than may actually be incurred. EPA
addresses discharges of bacteria from municipal separate storm sewers,
combined sewer overflows, sanitary sewer overflows, and nonpoint
sources (e.g., agriculture) to coastal waters in existing regulations
and policies, and has tallied potential control costs to comply with
those regulations and policies as part of analyses for those actions.
In general, the best management practices or treatment controls for wet
weather discharges that are designed to meet fecal coliform standards
in a waterbody are also the best management practices or treatment
controls used to address E. coli and enterococci. Because of the
substantial variability in bacterial indicators and the site-specific
effectiveness of control measures, EPA is not able to determine at this
time if additional measures will ultimately be necessary to meet
criteria based on the new indicators. Compliance with pathogen
standards is best achieved through an adaptive management approach
based on cost-effective management practices and control measures
coupled with on-going monitoring and revision of control plans as
necessary.
C. Analytical Methods
EPA received a few comments on the topic of analytical methods. One
commenter expressed concern that EPA has not published EPA-approved
analytical methods for measuring enterococci and E. coli in effluent.
EPA recognizes that it has not yet published analytical methods for
measuring enterococci and E. coli in effluents. EPA published its
methods for measuring enterococci and E. coli in ambient waters on July
21, 2003, and is now in the process of proposing methods for measuring
these pathogen indicators in effluent. EPA has completed its inter-
laboratory study of method 1600 for enterococci and method 1603 for E.
coli in secondary treated effluents, and has determined that the
variability found in this study support publication of a proposed
method for effluents. EPA is moving expeditiously to promulgate these
methods.
Three commenters noted that the inter-laboratory study for
enterococci and E. coli methods discussed above did not address pulp
and paper effluents,
[[Page 67237]]
and that these effluents are suspected of containing E. coli and
enterococci independent of fecal matter. As a result, the commenters
suggest that EPA complete validation studies of enterococci and E. coli
methods for pulp and paper effluents before requiring States to
implement the criteria in National Pollutant Discharge Elimination
System permits for pulp and paper facilities. EPA disagrees that it
must complete additional validation studies before States use the
criteria for permits. EPA has completed its inter-laboratory validation
for EPA Methods 1600 and 1603 for effluents, and is in the process of
proposing these methods. In addition, EPA is currently completing its
inter-laboratory validation for EPA Methods 1103.1 and 1106.1 in
effluents, and intends to propose them after the validation process is
completed. EPA did not specifically use pulp and paper effluent
matrices in the study. EPA method validation studies typically include
several representative matrices and are not intended to include every
potential effluent matrix to which a method may be applicable. In
addition, EPA notes that its National Pollutant Discharge Elimination
System regulations do not require that compliance monitoring for
National Pollutant Discharge Elimination System permits be based on
EPA-approved methods. 40 CFR 122.41(j)(4) provides that monitoring
results must be conducted according to test procedures approved under
40 CFR Part 136 unless other test procedures have been specified in the
permit. States implementing the criteria in National Pollutant
Discharge Elimination System permits may thus specify some other
analytical method that the permittee is to use for compliance
monitoring. Of course, any such method must be scientifically
defensible, which usually means that it has been tested and verified by
some other recognized standard setting or method development body.
Permittees who believe that a particular method is not appropriate or
reliable for their effluent may present documentation of this concern
to the permitting authority for consideration in determining compliance
monitoring requirements.
D. Effective Date
Section 553 of the Administrative Procedure Act provides that a
substantive rule shall be published not less than 30 days before its
effective date, except under certain circumstances. EPA is promulgating
today's rule with an effective date of 30 days after publication in the
Federal Register in order to make the water quality criteria effective
as soon as possible and available for use in assessing beach safety and
for other Clean Water Act purposes. This will serve to protect human
health at coastal recreation waters.
EPA received two comments on this issue. One commenter requested
that EPA delay promulgating the rule until July 2005 and another
commenter suggested that EPA delay the effective date for 90 days so
that a State could complete its own promulgation of water quality
standards based on the 1986 bacteria criteria. EPA disagrees that it
should allow more than 30 days because this would delay the time at
which States and Territories will begin using today's water quality
criteria to govern decisions about opening and closing beaches and for
other Clean Water Act purposes. EPA understands the interest of the
commenters in having their State standards serve as the effective
standards for Clean Water Act purposes. If a State adopts, and EPA
approves, standards satisfying Clean Water Act section 303(i) shortly
after the effective date of this rule, the State criteria will
immediately replace the criteria in today's rule for Clean Water Act
purposes within the State, consistent with 40 CFR 131.41(d)(i). EPA
does not expect that a short window during which Federal standards are
in effect will unduly disrupt on-going State water quality standards
programs. Therefore, EPA is making the rule effective 30 days after
publication in the Federal Register.
VII. Alternative Regulatory Approaches and Implementation Mechanisms
States and Territories have considerable discretion in designating
uses. A State or Territory may find that changes in use designations
are warranted. EPA will review any new or revised use designations
adopted by States or Territories for coastal recreation waters covered
by this rule to determine if the standards meet the requirements of the
Clean Water Act and implementing regulations. In adopting recreation
uses, the States and Territories may wish to consider additional
categories of recreation uses. If States and Territories change the
designated use of a waterbody consistent with Clean Water Act section
303(c) and the regulations at 40 CFR Part 131, such that they are no
longer designated for swimming, bathing, surfing, or similar water
contact activities, then the waterbody would not be covered by the
Clean Water Act definition of ``coastal recreation waters'' or this
rule.
EPA reminds the States and Territories that they must conduct use
attainability analyses as required by 40 CFR 131.10(g) when adopting
water quality standards that do not include the uses specified in Clean
Water Act section 101(a)(2) or with subcategories of the designated
uses specified in Clean Water Act section 101(a)(2) that require less
stringent criteria (see 40 CFR 131.10(j)), than those currently in
effect.
VIII. Economic Analysis
These water quality standards may serve as a basis for development
of National Pollutant Discharge Elimination System permit limits. Many
of the affected jurisdictions (i.e., States and Territories) are the
National Pollutant Discharge Elimination System permitting authorities,
which retain considerable discretion in implementing standards. EPA
evaluated the potential costs to National Pollutant Discharge
Elimination System dischargers in affected jurisdictions associated
with State and Territorial implementation of today's standards. This
analysis is documented in ``'Economic Analysis for Final Water Quality
Standards for Coastal Recreation Waters,''' which can be found in the
record for this rulemaking.
Any National Pollutant Discharge Elimination System-permitted
facility that discharges to waterbodies affected by this rule could
potentially incur compliance costs. The types of affected facilities
may include industrial facilities and publicly owned treatment works
(POTWs) discharging sanitary wastewater to surface waters (i.e., point
sources). In addition, EPA addresses discharges of bacteria from
municipal separate storm sewer systems, combined sewer overflows, and
sanitary sewer overflows to coastal waters in existing regulations and
policies, and has tallied potential control costs as part of the
analyses for those actions. EPA expects that States and municipalities
will continue to use the same types of controls to come into compliance
with the revised criteria as are currently used for compliance with
existing regulations and policies. Available evidence suggests that if
discharges are controlled in such a way that fecal coliform criteria
are met, it is likely that enterococci and E. coli criteria would also
be met, and there would not be an increase in impaired waters,
resulting in additional Total Maximum Daily Loads, though not enough is
known about the relationship between sources, controls, and the various
indicators to conclude this with any certainty at this time. EPA did
not evaluate the costs of this rule to Concentrated Animal Feeding
[[Page 67238]]
Operations because the regulations for Concentrated Animal Feeding
Operations prohibit discharges except in unusual circumstances (i.e.,
very large storms) and therefore those entities are unlikely to incur
any additional costs as a result of today's rule. EPA did not evaluate
the potential for costs to nonpoint sources, such as agricultural
runoff. Finally, EPA did not attempt to quantify the potential benefits
of the rule.
EPA recognizes that a State or Territory may decide to require
controls for nonpoint sources (e.g., agricultural runoff). However, it
is difficult to model and evaluate the potential costs impacts of this
rule to those sources because they are intermittent, highly variable,
and occur under different hydrologic or climatic conditions than
continuous discharges from industrial and municipal facilities, which
EPA evaluates under critical low flow or drought conditions. Also, data
on instream and discharge levels of bacteria after States have
implemented controls to meet current water quality standards based on
fecal coliform are not available. Therefore, trying to determine which
sources would not achieve standards based on E. coli or enterococci
after complying with existing regulations and policies may not be
possible, and would be extremely time and resource intensive. Finally,
it is likely that controls needed to meet existing criteria (assumed
for the purpose of costing to be fecal coliform for all States covered
by the rule) would also address water quality problems indicated by
criteria for E. coli or enterococci.
A. Identifying Affected Facilities
EPA identified approximately 734 point source facilities that may
be affected by the rule. Of these potentially affected facilities, 306
are classified as major dischargers, and 428 are minor dischargers. EPA
did not include general permit facilities in its analysis because data
for such facilities are extremely limited, and flows are usually
negligible. Furthermore, EPA could not determine if any of these
facilities with general permits actually discharge to the affected
water bodies because facility location information is not available in
EPA's Permit Compliance System database.
Of the facilities located in jurisdictions included in the rule,
EPA evaluated that subset of facilities with individual permits that
discharge within two miles of coastal waters or the Great Lakes. EPA
identified these facilities by relating facility information to the
potentially affected waters using Geographic Information System
software. EPA also assumed that only wastewater treatment plants or
facilities with similar effluent characteristics (i.e., facilities
having the potential to discharge bacteria in the form of fecal matter)
may be affected. For those facilities for which latitude/longitude data
are not included in the Permit Compliance System, EPA included only
facilities for which the receiving waterbody name in the Permit
Compliance System indicates a coastal water (e.g., Pacific Ocean, Lake
Erie). Table 5 summarizes these potentially affected facilities by type
and category.
Table 5.--Potentially Affected Facilities \1\
----------------------------------------------------------------------------------------------------------------
Number of Facilities
------------------------------------------------
Category Minor Total
Major \2\ --------------------------------
Municipal Other \3\
----------------------------------------------------------------------------------------------------------------
Coastal......................................... 242 233 100 575
Great Lakes..................................... 64 75 20 159
-----------------
Total....................................... 306 308 120 734
----------------------------------------------------------------------------------------------------------------
\1\ Facilities from States and Territories included in the rule that discharge within two miles of coastal
waters or the Great Lakes.
\2\ No major industrial facilities are affected by the rule. However, 4 other facilities (SIC codes 9711 and
9999) are included because their names indicate that they are wastewater treatment plants.
\3\ Includes the following standard industrial classifications: eating places (5812), drinking places (5813),
operators of nonresidential buildings (6512), operators of apartment buildings (6513), operators of dwellings
other than apartment buildings (6514), operators of residential mobile home sites (6515), hotels and motels
(7011), recreational vehicle parks and campsites (7033), organization hotels and lodging houses (7041),
physical fitness facilities (7991), amusement and recreation services (7999), skilled nursing care facilities
(8051), general medical and surgical hospitals (8062), elementary and secondary schools (8211), colleges,
universities, and professional schools (8221), civic, social, and fraternal associations (8641), private
households (8811). Also includes the following SICs if the facility name suggests that they may discharge
sanitary waste: operative builders (1531), sanitary services, not elsewhere classified (4959), real estate
agents and managers (6531), business associations (8611), religious organizations (8661), services not
elsewhere classified (8999), air and water resource and solid waste management (9511), national security
(9711), and nonclassifiable establishments (9999).
B. Method for Estimating Potential Compliance Costs
To estimate costs, EPA evaluated the 15 major municipal facilities
with design flows greater than 120 mgd, thus ensuring that the
facilities with the potential for the largest costs would be evaluated.
For the remaining facilities, EPA evaluated a sample of facilities to
represent discharger type and category.
The Permit Compliance System does not contain E. coli or
enterococci effluent data for any of the sample facilities. Therefore,
to evaluate potential costs associated with the E. coli criteria, EPA
assumed that 100% of the fecal coliform measured at the sample
facilities is E. coli because E. coli is a type of fecal coliform. EPA
assumed that all potentially affected facilities need effluent limits
that are required to meet both the applicable geometric mean and single
sample maximum values promulgated in today's rule. Based on the last 3
years of data, EPA thus estimated that facilities with average monthly
effluent levels exceeding a geometric mean of 126/100 ml, or maximum
daily levels exceeding 235/100 ml, would most likely need treatment
controls to meet potential permit limits based on today's rule.
Enterococci are fecal bacteria in the fecal streptococcus group,
and their relationship to fecal coliform bacteria is uncertain.
Therefore, for coastal facilities, EPA used data and information in the
literature regarding the ratio of fecal coliform to enterococci in
untreated sewage, and the inactivation of both of these bacteria at
minimum disinfection levels, to identify the concentrations of fecal
coliform (as related to enterococci) that may indicate a need for
controls. Data in the literature indicate that the ratio of fecal
coliform to fecal streptococcus in untreated sewage ranges from about 4
to 28. EPA
[[Page 67239]]
used the most conservative (i.e., erring on the side of overestimating
costs) ratio of 4 (i.e., fecal coliform levels are 4 times fecal
streptococcus levels) to estimate the fecal coliform levels at which
facilities would need treatment to comply with the enterococci
criteria. A ratio of 4 translates to fecal coliform levels of 140 fecal
coliform per 100 ml (4 * 35 = 140/100 ml); however, for consistency
with the Great Lakes analysis, EPA estimated costs based on meeting a
more stringent value of 126 fecal coliform per 100 ml. In addition, EPA
assumed that coastal facilities with maximum fecal coliform effluent
values exceeding 235 colonies per 100 ml would need treatment controls
(even though 235/4 = 59, which is more stringent than the single sample
maximum value of 104 in the final rule).
Experiences from four facilities currently having effluent
limitations to meet E. coli and enterococci criteria, as well as the
current fecal coliform criteria, suggest that chlorination processes
can be upgraded or adjusted to treat the levels of bacteria necessary
for compliance with effluent limitations based on today's rule.
Therefore, EPA estimated that optimization of existing disinfection
processes would enable the sample facilities to comply with the rule.
Process optimization usually involves process analysis and process
modifications, and EPA's cost estimates include both capital and
operating and maintenance costs.
C. Results
Based on the results for the 15 facilities with flows greater than
120 mgd, and extrapolating the sample results to the remaining
potentially affected facilities, EPA estimated a total annual cost of
approximately $20 million ($13 million for coastal facilities, and $7
million for Great Lakes facilities). EPA estimates that approximately
70 major and 20 minor permittees could incur control costs as a result
of permit modifications to include limits based on the criteria in
today's rule.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action.'' As
such, this action was submitted to OMB for review. Changes made in
response to OMB suggestions or recommendations are documented in the
public record.
B. Paperwork Reduction Act
This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
It does not include any information collection, reporting, or record-
keeping requirements.
Burden means the total time, effort or financial resources expended
by persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR Part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C.
601 et seq., generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations and small
governmental jurisdictions.
For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business according to
RFA default definitions for small business (based on Small Business
Administration size standards); (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. As discussed
below, these water quality standards do not directly apply to any
discharger, including small entities.
Clean Water Act section 303(i)(2)(A) requires that if a State or
Territory fails to adopt water quality criteria and standards in
accordance with paragraph (1)(A) that are as protective of human health
as the criteria for pathogen indicators for coastal recreation waters
published by the Administrator, the Administrator shall promptly
propose regulations for the State or Territory setting forth revised or
new water quality standards for pathogen indicators described in
paragraph (1)(A) for coastal recreation waters of the State or
Territory. These State standards (or EPA-promulgated standards) are
implemented through various water quality control programs including
the National Pollutant Discharge Elimination System program, which
limits discharges to navigable waters except in compliance with a
National Pollutant Discharge Elimination System permit. The Clean Water
Act requires that all National Pollutant Discharge Elimination System
permits include any limits on discharges that are necessary to meet
applicable water quality standards.
In cases in which a discharger (including a small entity) is
discharging pathogens into waters subject to these standards, the
permitting authority will
[[Page 67240]]
need to determine whether the discharge is or may be discharged at a
level which will cause, contribute to, or have the reasonable potential
to cause an exceedance of the applicable water quality standard. In
making that determination, the permitting authority would need to
consider the factors listed in 40 CFR 122.44(d)(1)(ii). Whether a
permitting authority will need to require a water quality-based
effluent limit depends on the analysis of these factors, which will
vary based on the specific facts of each permit decision. Based on that
analysis, if the permitting authority finds that the discharger causes,
contributes to, or has the reasonable potential to cause an exceedance
of the applicable water quality standard, after the application of any
required technology-based effluent limits, then the permitting
authority will need to impose a water quality-based effluent limit to
meet the applicable water quality standard. (See Clean Water Act
section 301(b)(1)(C); 40 CFR 122.44(d).) Therefore, as a practical
matter, today's rule may or may not necessitate a change in the permit,
depending on the specific circumstances. While the Clean Water Act and
its implementing regulations may trigger the need for new or revised
discharge limits based on the water quality standards in today's rule
to be placed on small entities in some cases, the standards themselves
do not directly apply to any discharger, including small entities.
In the ``Economic Analysis for Final Water Quality Standards for
Coastal Recreation Waters,'' EPA presents an analysis which supports a
conclusion that today's rule will likely affect only a few small
entities. (See the docket for today's rule.)
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. The definition of ``State'' for the
purposes of the Unfunded Mandates Reform Act includes ``a territory or
possession of the United States.'' Under section 202 of the Unfunded
Mandates Reform Act, EPA generally must prepare a written statement,
including a cost-benefit analysis, for proposed and final rules with
``Federal mandates'' that may result in expenditures to State, local,
and Tribal governments, in the aggregate, or to the private sector, of
$100 million or more in any one year. Before promulgating an EPA rule
for which a written statement is needed, section 205 of the Unfunded
Mandates Reform Act generally requires EPA to identify and consider a
reasonable number of regulatory alternatives and adopt the least
costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the Unfunded Mandates Reform Act a small government
agency plan. The plan must provide for notifying potentially affected
small governments, enabling officials of affected small governments to
have meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising small governments on compliance with
the regulatory requirements.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the Unfunded Mandates Reform Act) that may
result in expenditures to State, local and Tribal governments, or the
private sector, in the aggregate of $100 million or more in any one
year. Therefore, this rule is not subject to the requirements of
sections 202 and 205 of the Unfunded Mandates Reform Act.
EPA has determined that this rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. Thus, this rule is not subject to the requirements of
section 203 of the Unfunded Mandates Reform Act.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have Federalism implications.''
``Policies that have Federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have Federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. EPA's authority and
responsibility to promulgate Federal water quality standards when State
standards do not meet the requirements of the Clean Water Act is well
established and has been used on various occasions in the past. The
final rule does not substantially affect the relationship of EPA and
the States and Territories, or the distribution of power or
responsibilities between EPA and the various levels of government. The
final rule does not alter the States' or Territories' considerable
discretion in implementing these water quality standards. Further, this
rule does not preclude the States and Territories from adopting water
quality standards that meet the requirements of the Clean Water Act,
either before or after promulgation of the final rule, thus eliminating
the need for Federal standards. Thus, Executive Order 13132 does not
apply to this rule.
Although Executive Order 13132 does not apply to this rule, in the
spirit of Executive Order 13132 and consistent with EPA's policy to
promote communication between EPA and State and local governments, EPA
did consult with representatives of the States and Territories subject
to Clean Water Act section 303(i) in developing this rule. Prior to
this rulemaking action, EPA had numerous phone calls, meetings and
exchanges of written correspondence with the States to discuss EPA's
concerns with the States' bacteria criteria, compliance with the BEACH
Act, and the Federal rulemaking process. In June 2000, EPA and the
Association of State and Interstate Water Pollution Control
Administrators (ASIWPCA) established a State/EPA Work Group on Water
Quality Standards, composed of selected senior State and EPA managers,
to provide input to EPA on water quality standards issues. The group
has met approximately three times per year since then, beginning with a
meeting in September 2000. At every meeting the group has discussed the
scientific, programmatic, and policy aspects of bacteria criteria for
both coastal and non-coastal recreation waters, and has provided useful
input to EPA on these topics. Members of this group, together with
other interested State participants, have also served as an ad-hoc work
[[Page 67241]]
group since 2001 to assist EPA in developing draft detailed scientific
and policy guidance (Implementation Guidance for Ambient Water Quality
Criteria for Bacteria (EPA-823-B-02-003, May 2002 Draft)) concerning
adoption and implementation of EPA's recommended criteria for bacteria.
Today's final rule reflects State and Territorial input, and EPA has
responded to State and Territorial comment on various topics in the
preamble to today's rule and in the Comment Response Document, which is
part of the record for this rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.''
This final rule does not have Tribal implications. It will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal government and Indian Tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian Tribes, as specified in Executive Order 13175.
There are four authorized Indian Tribes with coastal or Great Lakes
waters; however, they have not yet adopted water quality standards, and
therefore, have no designated coastal recreation waters within their
jurisdiction. These Tribes are therefore not subject to today's rule.
Thus, Executive Order 13175 does not apply to this rule.
EPA has contacted those Tribes identified as having coastal or
Great Lakes waters to inform them of the potential future impact this
could have on Tribal waters.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the rule on children, and explain why the
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by the Agency.
This rule is not subject to the Executive Order because it is not
economically significant as defined in Executive Order 12866, and
because the Agency does not have reason to believe the environmental
health or safety risks addressed by this action present a
disproportionate risk to children. As explained in section II.B of the
preamble to today's rule, EPA developed the water quality criteria
promulgated in today's rule based on concentrations of E. coli and
enterococci from EPA-sponsored epidemiological studies reflecting all
reported illnesses, including those of children. In the marine and
freshwater studies, the range of the number of children under age 10
was between 15% and 25% of the total study population. Children in the
age range 10 to 19 years old made up a slightly higher percentage of
the study population. During the studies, information on
gastroenteritis, respiratory symptoms, and other symptoms were
collected for all participants, including children. EPA designed the
1986 bacteria criteria to protect all age groups.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This rule is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy. EPA
estimates that compliance with the final rule will create a negligible
increase in nationwide energy consumption for point source facilities
discharging to coastal recreation waters in affected States. In section
VIII, EPA presented its estimated incremental costs to permitted
facilities as a result of the final rule. Some of these costs include
energy use associated with increased maintenance of disinfection tanks.
EPA estimates that the increased energy use from these activities would
be about 99,000 kilowatt hours. Net production by electric power
generation facilities in the United States in 2002 was 3,858,452
million kilowatt hours (Energy Information Administration, Department
of Energy, http://www.eia.doe.gov/neic/quickfacts/quickelectric.htm).
EPA estimates that the additional energy requirements of EPA's rule are
insignificant (i.e., 0.000003% of national energy generation).
I. National Technology Transfer and Advancement Act
As noted in the proposal, section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (``NTTAA''), Public Law 104-113,
section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA directs EPA to provide Congress, through
OMB, explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
While ambient water quality criteria may be considered technical
standards, EPA is not aware of any voluntary consensus standards
relating to bacteria criteria to protect human health and none were
brought to our attention in comments on the proposed rule. Furthermore,
even if there were such voluntary consensus standards, the BEACH Act
specifically directs EPA to promulgate Federal standards based on its
own bacteria criteria, in accordance with Clean Water Act section
304(a), in cases where States fail to do so. Therefore, EPA is not
considering the use of any voluntary consensus standards.
J. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A ``major rule''
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective December 16, 2004.
List of Subjects in 40 CFR Part 131
Environmental protection, Intergovernmental relations, Reporting
[[Page 67242]]
and recordkeeping requirements, Water pollution control.
Dated: November 8, 2004.
Michael O. Leavitt,
Administrator.
0
For the reasons set out in the preamble, 40 CFR part 131 is amended as
follows:
PART 131--WATER QUALITY STANDARDS
0
1. The authority citation for part 131 continues to read as follows:
Authority: 33 U.S.C. 1251 et seq.
Subpart D--[Amended]
0
2. Section 131.41 is added to Subpart D to read as follows:
Sec. 131.41 Bacteriological criteria for those states not complying
with Clean Water Act section 303(i)(1)(A).
(a) Scope. This section is a promulgation of the Clean Water Act
section 304(a) criteria for bacteria for coastal recreation waters in
specific States. It is not a general promulgation of the Clean Water
Act section 304(a) criteria for bacteria. This section also contains a
compliance schedule provision.
(b) Definitions. (1) Coastal Recreation Waters are the Great Lakes
and marine coastal waters (including coastal estuaries) that are
designated under section 303(c) of the Clean Water Act for use for
swimming, bathing, surfing, or similar water contact activities.
Coastal recreation waters do not include inland waters or waters
upstream from the mouth of a river or stream having an unimpaired
natural connection with the open sea.
(2) Designated bathing beach waters are those coastal recreation
waters that, during the recreation season, are heavily-used (based upon
an evaluation of use within the State) and may have: a lifeguard,
bathhouse facilities, or public parking for beach access. States may
include any other waters in this category even if the waters do not
meet these criteria.
(3) Moderate use coastal recreation waters are those coastal
recreation waters that are not designated bathing beach waters but
typically, during the recreation season, are used by at least half of
the number of people as at typical designated bathing beach waters
within the State. States may also include light use or infrequent use
coastal recreation waters in this category.
(4) Light use coastal recreation waters are those coastal
recreation waters that are not designated bathing beach waters but
typically, during the recreation season, are used by less than half of
the number of people as at typical designated bathing beach waters
within the State, but are more than infrequently used. States may also
include infrequent use coastal recreation waters in this category.
(5) Infrequent use coastal recreation waters are those coastal
recreation waters that are rarely or occasionally used.
(6) New pathogen discharger for the purposes of this section means
any building, structure, facility, or installation from which there is
or may be a discharge of pathogens, the construction of which commenced
on or after December 16, 2004. It does not include relocation of
existing combined sewer overflow outfalls.
(7) Existing pathogen discharger for the purposes of this section
means any discharger that is not a new pathogen discharger.
(c) EPA's section 304(a) ambient water quality criteria for
bacteria.
(1) Freshwaters:
--------------------------------------------------------------------------------------------------------------------------------------------------------
C Single sample maximum (per 100 ml)
---------------------------------------------------------------------------
C3 Light use C4 Infrequent
A Indicator d B Geometric mean C1 Designated C2 Moderate use coastal use coastal
bathing beach costal recreation recreation waters recreation waters
(75% confidence waters (82% (90% confidence (95% confidence
level) confidence level) level) level)
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli e................................... 126/100 mil a................. b 235 b 298 b 409 b 575
Enterococci e............................... 33/100 ml c................... b 61 b 78 b 107 b 151
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnotes to table in paragraph (c)(1):
a. This value is for use with analytical methods 1103.1, 1603, or 1604 or any equivalent method that measures viable bacteria.
b. Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.4.
c. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
d. The State may determine which of these indicators applies to its freshwater coastal recreation waters. Until a State makes that determination, E.
coli will be the applicable indicator.
e. These values apply to E. coli or enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non-human
and an epidemiological study shows that the indicator densities are not indicative of a human health risk.
(2) Marine waters:
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C Single sample maximum (per 100 ml)
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C1 Designated C2 Moderate use C3 Light use C4 Infrequent use
A Indicator B Geometric mean bathing beach coastal recreation coastal recreation coastal recreation
(75% confidence waters (82% waters (90% waters (95%
level) confidence level) confidence level) confidence level)
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Enterococci c............................. 35/100 ml a................. b 104 b 158 b 276 b 501
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Footnotes to table in paragraph (c)(2):
a. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.
[[Page 67243]]
b. Calculated using the following: single sample maximum = geometric mean * 10[caret](confidence level factor * log standard deviation), where the
confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.7.
c. These values apply to enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non-human and an
epidemiological study shows that the indicator densities are not indicative of a human health risk.
(3) As an alternative to the single sample maximum in paragraph
(c)(1) or (c)(2) of this section, States may use a site-specific log
standard deviation to calculate a single sample maximum for individual
coastal recreation waters, but must use at least 30 samples from a
single recreation season to do so.
(d) Applicability. (1) The criteria in paragraph (c) of this
section apply to the coastal recreation waters of the States identified
in paragraph (e) of this section and apply concurrently with any
ambient recreational water criteria adopted by the State, except for
those coastal recreation waters where State regulations determined by
EPA to meet the requirements of Clean Water Act section 303(i) apply,
in which case the State's criteria for those coastal recreation waters
will apply and not the criteria in paragraph (c) of this section.
(2) The criteria established in this section are subject to the
State's general rules of applicability in the same way and to the same
extent as are other Federally-adopted and State-adopted numeric
criteria when applied to the same use classifications.
(e) Applicability to specific jurisdictions. (1) The criteria in
paragraph (c)(1) of this section apply to fresh coastal recreation
waters of the following States: Illinois, Minnesota, New York, Ohio,
Pennsylvania, Wisconsin.
(2) The criteria in paragraph (c)(2) of this section apply to
marine coastal recreation waters of the following States: Alaska,
California (except for coastal recreation waters within the
jurisdiction of Regional Board 4), Florida, Georgia, Hawaii (except for
coastal recreation waters within 300 meters of the shoreline),
Louisiana, Maine (except for SA waters and SB and SC waters with human
sources of fecal contamination), Maryland, Massachusetts, Mississippi,
New York, North Carolina, Oregon, Puerto Rico (except for waters
classified by Puerto Rico as intensely used for primary contact
recreation and for those waters included in Sec. 131.40), Rhode
Island, United States Virgin Islands.
(f) Schedules of compliance. (1) This paragraph (f) applies to any
State that does not have a regulation in effect for Clean Water Act
purposes that authorizes compliance schedules for National Pollutant
Discharge Elimination System permit limitations needed to meet the
criteria in paragraph (c) of this section. All dischargers shall
promptly comply with any new or more restrictive water quality-based
effluent limitations based on the water quality criteria set forth in
this section.
(2) When a permit issued on or after December 16, 2004, to a new
pathogen discharger as defined in paragraph (b) of this section
contains water quality-based effluent limitations based on water
quality criteria set forth in paragraph (c) of this section, the
permittee shall comply with such water quality-based effluent
limitations upon the commencement of the discharge.
(3) Where an existing pathogen discharger reasonably believes that
it will be infeasible to comply immediately with a new or more
restrictive water quality-based effluent limitations based on the water
quality criteria set forth in paragraph (c) of this section, the
discharger may request approval from the permit issuing authority for a
schedule of compliance.
(4) A compliance schedule for an existing pathogen discharger shall
require compliance with water quality-based effluent limitations based
on water quality criteria set forth in paragraph (c) of this section as
soon as possible, taking into account the discharger's ability to
achieve compliance with such water quality-based effluent limitations.
(5) If the schedule of compliance for an existing pathogen
discharger exceeds one year from the date of permit issuance,
reissuance or modification, the schedule shall set forth interim
requirements and dates for their achievement. The period between dates
of completion for each requirement may not exceed one year.
If the time necessary for completion of any requirement is more
than one year and the requirement is not readily divisible into stages
for completion, the permit shall require, at a minimum, specified dates
for annual submission of progress reports on the status of interim
requirements.
(6) In no event shall the permit issuing authority approve a
schedule of compliance for an existing pathogen discharge which exceeds
five years from the date of permit issuance, reissuance, or
modification, whichever is sooner.
(7) If a schedule of compliance exceeds the term of a permit,
interim permit limits effective during the permit shall be included in
the permit and addressed in the permit's fact sheet or statement of
basis. The administrative record for the permit shall reflect final
permit limits and final compliance dates. Final compliance dates for
final permit limits, which do not occur during the term of the permit,
must occur within five years from the date of issuance, reissuance or
modification of the permit which initiates the compliance schedule.
[FR Doc. 04-25303 Filed 11-15-04; 8:45 am]
BILLING CODE 6560-50-P