Tuesday,

November 16, 2004

Part II

Environmental 

Protection Agency

40 CFR Part 131

Water Quality Standards for Coastal and 

Great Lakes Recreation Waters; Final Rule

67218 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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.

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: 

wilcut.lars@epa.gov.

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:

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 67219

Category Examples of potentially affected entities 

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. 

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 

67220 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 illnesscausing 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 swimmingassociated 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 EPAsponsored 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% 

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 67221

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.)

(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

Acceptable swimming associated 

gastroenteritis rate

per 1000 swimmers 

Steady state 

geometric 

mean indicator

density 

Single sample maximum allowable density 4 5

Designated beach 

area (upper 75% 

C.L.) 

Moderate full body 

contact recreation 

(upper 82% C.L.) 

Lightly used full 

body contact 

recreation (upper 

90% C.L.) 

Infrequently used 

full body contact 

recreation (upper 

95% C.L.) 

Freshwater 

Enterococci ........... 8 33/100 ml 1 ... 61 78 107 151 

E. coli ................... 8 126/100 ml 2 235 298 409 575 

Marine Water 

Enterococci ........... 19 35/100 ml 3 ... 104 158 276 501 

Notes:

1 Calculated to nearest whole number using equation: (mean enterococci density) = antilog10 ((illness rate/1000 people + 6.28)/9.40). 2 Calculated to nearest whole number using equation: (mean E. coli density) = antilog10 ((illness rate/1000 people + 11.74)/9.40). 3 Calculated to nearest whole number using equation: (mean enterococci density) = antilog10 ((illness rate/1000 people ¥0.20)/12.17). 4Single 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. 

5Based 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

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 sitespecific single sample maximums, and 

addressing non-human sources of 

bacteria. This preamble includes a 

general summary of public comments in 

67222 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 

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

A

Indicator 

B

Geometric mean 

C

Single sample maximum

(per 100 ml) 

C1

Designated bathing beach

(75% confidence 

level) 

C2

Moderate use 

coastal recreation 

waters

(82% confidence 

level) 

C3

Light use coastal 

recreation waters

(90% confidence 

level) 

C4

Infrequent use 

coastal recreation 

waters

(95% confidence 

level) 

Enterococci ........................... 35/100 ml a ............................ 104 b 158 b 276 b 501 b

Footnotes to table in paragraph (c)(2): 

aThis 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∧(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

A

Indicator d

B

Geometric mean 

C

Single sample maximum

(per 100 ml) 

C1

Designated bathing beach

(75% confidence 

level) 

C2

Moderate use 

coastal recreation 

waters

(82% confidence 

level) 

C3

Light use coastal 

recreation waters

(90% confidence 

level) 

C4

Infrequent use 

coastal recreation 

waters

(95% confidence 

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): 

67224 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

aThis 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∧(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. cThis value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria. 

dThe 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 

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

67226 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 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 sitespecific 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 sitespecific 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 sitespecific 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 twoyear 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 Nin ̃ o 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 

67228 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 nonhuman 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 EPAapproved 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. 

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

67230 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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. 

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

67232 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 

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

67234 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 1Massachusetts 

South Carolina 1 Minnesota 

Texas Mississippi 

Virginia New York 

Washington 1 North Carolina 

TABLE 4.—CATEGORIZATION OF 35 

STATES/TERRITORIES WITH COASTAL RECREATION WATERS—Continued

Not subject to 40 

CFR 131.41 

Subject to 40 CFR 

131.41 

Ohio 

Oregon 

Pennsylvania 

Puerto Rico 

Rhode Island 

Virgin Islands 

Wisconsin 

1These 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 

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

67236 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 neverto-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 interlaboratory 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, 

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

67238 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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

Category 

Number of Facilities 

Total 

Major 2

Minor 

Municipal Other 3

Coastal ............................................................................................................. 242 233 100 575 

Great Lakes ..................................................................................................... 64 75 20 159 

Total .......................................................................................................... 306 308 120 734 

1Facilities 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 

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

67240 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

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 qualitybased 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 costbenefit 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 costeffective 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 

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

67242 Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 

and recordkeeping requirements, Water 

pollution control.

Dated: November 8, 2004. 

Michael O. Leavitt, 

Administrator.

■ For the reasons set out in the preamble, 

40 CFR part 131 is amended as follows:

PART 131—WATER QUALITY 

STANDARDS

■ 1. The authority citation for part 131 

continues to read as follows:

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

Subpart D—[Amended]

■ 2. Section 131.41 is added to Subpart 

D to read as follows:

§ 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:

A

Indicator d

B

Geometric mean 

C

Single sample maximum

(per 100 ml) 

C1

Designated bathing beach

(75% confidence 

level) 

C2

Moderate use 

costal recreation 

waters

(82% confidence 

level) 

C3

Light use coastal 

recreation waters

(90% confidence 

level) 

C4

Infrequent use 

coastal recreation 

waters

(95% confidence 

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∧(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:

A

Indicator 

B

Geometric mean 

C

Single sample maximum

(per 100 ml) 

C1

Designated bathing beach

(75% confidence 

level) 

C2

Moderate use 

coastal recreation 

waters

(82% confidence 

level) 

C3

Light use coastal 

recreation waters

(90% confidence 

level) 

C4

Infrequent use 

coastal recreation 

waters

(95% confidence 

level) 

Enterococci c ......................... 35/100 ml a ............................ b 104 b 158 b 276 b 501 

Footnotes to table in paragraph (c)(2): 

a. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria. 

Federal Register / Vol. 69, No. 220 / Tuesday, November 16, 2004 / Rules and Regulations 67243

b. Calculated using the following: single sample maximum = geometric mean * 10∧(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 § 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 qualitybased 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 qualitybased 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 qualitybased 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