15366 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9, 122, 123, 131, and 132

[FRL–5173–7]

RIN 2040–AC08

Final Water Quality Guidance for the

Great Lakes System

AGENCY: U.S. Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: EPA is publishing Final Water

Quality Guidance for the Great Lakes

System. Great Lakes States and Tribes

will use the water quality criteria,

methodologies, policies, and procedures

in the Guidance to establish consistent,

enforceable, long-term protection for

fish and shellfish in the Great Lakes and

their tributaries, as well as for the

people and wildlife who consume them.

The Guidance was initially developed

by the Great Lakes States, EPA, and

other Federal agencies in open dialogue

with citizens, local governments, and

industries in the Great Lakes ecosystem.

It will affect all types of pollutants, but

will target especially the types of longlasting pollutants that accumulate in the

food web of large lakes.

The Guidance consists of water

quality criteria for 29 pollutants to

protect aquatic life, wildlife, and human

health, and detailed methodologies to

develop criteria for additional

pollutants; implementation procedures

to develop more consistent, enforceable

water quality-based effluent limits in

discharge permits, as well as total

maximum daily loads of pollutants that

can be allowed to reach the Lakes and

their tributaries from all sources; and

antidegradation policies and

procedures.

Under the Clean Water Act, the States

of Illinois, Indiana, Michigan,

Minnesota, New York, Ohio,

Pennsylvania, and Wisconsin must

adopt provisions into their water quality

standards and NPDES permit programs

within two years (by March 23, 1997)

that are consistent with the Guidance, or

EPA will promulgate the provisions for

them. The Guidance for the Great Lakes

System will help establish consistent,

enforceable, long-term protection from

all types of pollutants, but will place

short-term emphasis on the types of

long-lasting pollutants that accumulate

in the food web and pose a threat to the

Great Lakes System. The Guidance

includes minimum water quality

criteria, antidegradation policies, and

implementation procedures that provide

a coordinated ecosystem approach for

addressing existing and possible

pollutant problems and improves

consistency in water quality standards

and permitting procedures in the Great

Lakes System. In addition, the Guidance

provisions help establish consistent

goals or minimum requirements for

Remedial Action Plans (RAPs) and

Lakewide Management Plans (LaMPs)

that are critical to the success of

international multi-media efforts to

protect and restore the Great Lakes

ecosystem.

EFFECTIVE DATE: April 24, 1995.

ADDRESSES: The public docket for this

rulemaking, including applicable

Federal Register documents, public

comments in response to these

documents, the Final Water Quality

Guidance for the Great Lakes System,

Response to Comments Document, other

major supporting documents, and the

index to the docket are available for

inspection and copying at U.S. EPA

Region 5, 77 West Jackson Blvd.,

Chicago, IL 60604 by appointment only.

Appointments may be made by calling

Wendy Schumacher (telephone 312–

886–0142).

Information concerning the Great

Lakes Initiative (GLI) Clearinghouse is

available from Ken Fenner, Water

Quality Branch Chief, (WQS–16J), U.S.

EPA Region 5, 77 W. Jackson Blvd.,

Chicago, IL 60604 (312–353–2079).

Copies of the Information Collection

Request for the Guidance are available

by writing or calling Sandy Farmer,

Information Policy Branch, EPA, 401 M

St., S.W. (Mail Code 2136), Washington,

DC 20460 (202–260–2740).

Selected documents supporting the

Guidance are also available for viewing

by the public at locations listed in

section XI of the preamble.

Selected documents supporting the

Guidance are available by mail upon

request for a fee. Selected documents

are also available in electronic format at

no incremental cost to users of the

Internet. See section XI of the preamble

for additional information.

FOR FURTHER INFORMATION CONTACT:

Kenneth A. Fenner, Water Quality

Branch Chief (WQS–16J), U.S. EPA

Region 5, 77 W. Jackson Blvd., Chicago,

IL 60604 (312–353–2079).

SUPPLEMENTARY INFORMATION

Preamble Outline

I. Introduction

II. Background

III. Purpose of the Guidence

A. Use the Best Available Science to

Protect Human Health, Aquatic Life, and

Wildlife

B. Recognize the Unique Nature of the

Great Lakes Basin Ecosystem

C. Promote Consistency in Standards and

Implementation Procedures While

Allowing Appropriate Flexibility to

States and Tribes

D. Establish Equitable Strategies to Control

Pollution Sources

E. Promote Pollution Prevention Practices

F. Provide Accurate Assessment of Costs

and Benefits

IV. Sumarry of the Final Guidance

A. Water Quality Criteria and

Methodologies

1. Protection of Aquatic Life

2. Protection of Human Health

3. Protection of Wildlife

4. Bioaccumulation Methodology

B. Implementation Procedures

1. Site-Specific Modifications

2. Variances from Water Quality Standards

for Point Sources

3. TMDLs and Mixing Zones

4. Additivity

5. Determining the Need for WQBELs

(Reasonable Potential)

6. Intake Pollutants

7. WET

8. Loading Limits

9. Levels of Quantification

10. Compliance Schedules

C. Antidegradation Provisions

D. Regulatory Requirements

V. Costs, Cost-Effectiveness and Benefits

A. Costs

B. Cost-Effectiveness

C. Benefits

VI. Regulatory Flexibility Act

VII. Enhancing the Intergovernmental

Partnership Under Executive Order

12875

VIII. Paperwork Reduction Act

IX. Endangered Species Act

X. Judicail Review of Provisions not

Amended

XI. Supporting Documents

I. Introduction

Section 118(c)(2) of the Clean Water

Act (CWA) (Pub. L. 92–500 as amended

by the Great Lakes Critical Programs Act

of 1990 (CPA), Pub. L. 101–596,

November 16, 1990) required EPA to

publish proposed and final water

quality guidance on minimum water

quality standards, antidegradation

policies, and implementation

procedures for the Great Lakes System.

In response to these requirements, EPA

published the Proposed Water Quality

Guidance for the Great Lakes System

(proposed Guidance) in the Federal

Register on April 16, 1993 (58 FR

20802). EPA also published four

subsequent documents in the Federal

Register identifying corrections and

requesting comments on additional

related materials (April 16, 1993, 58 FR

21046; August 9, 1993, 58 FR 42266;

September 13, 1993, 58 FR 47845; and

August 30, 1994, 59 FR 44678). EPA

received over 26,500 pages of

comments, data, and information from

over 6,000 commenters in response to
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15367

these documents and from meetings

with members of the public.

After reviewing and analyzing the

information in the proposal and these

comments, EPA has developed the Final

Water Quality Guidance for the Great

Lakes System (final Guidance),

published in this document and

codified in 40 CFR part 132, which

includes six appendixes of detailed

methodologies, policies, and

procedures. This preamble describes the

background and purpose of the final

Guidance, and briefly summarizes the

major provisions. Detailed discussion of

EPA’s reasons for issuing the final

Guidance, analysis of comments and

issues, description of specific changes

made to the proposed Guidance, and

further description of the final

Guidance, are provided in ‘‘Final Water

Quality Guidance for the Great Lakes

System: Supplementary Information

Document’’ (SID), (EPA, 1995, 820–B–

95–001) and in additional technical and

supporting documents which are

available in the docket for this

rulemaking. Copies of the SID and other

supporting documents are also available

from EPA in electronic format, or in

printed form for a fee upon request; see

section XI of this preamble.

II. Background

The Great Lakes are one of the

outstanding natural resources of the

world. They have played a vital role in

the history and development of the

United States and Canada, and have

physical, chemical, and biological

characteristics that make them a unique

ecosystem. The Great Lakes

themselves—Lakes Superior, Huron,

Michigan, Erie and Ontario and their

connecting channels—plus all of the

streams, rivers, lakes and other bodies of

water that are within the drainage basin

of the Lakes collectively comprise the

Great Lakes System.

The System spans over 750 miles

across eight States—New York,

Pennsylvania, Ohio, Michigan, Indiana,

Illinois, Wisconsin and Minnesota—and

the Province of Ontario. The Lakes

contain approximately 18 percent of the

world’s and 95 percent of the United

States’ fresh surface water supply. The

Great Lakes are a source of drinking

water and energy, and are used for

recreational, transportation, agricultural

and industrial purposes by the more

than 46 million Americans and

Canadians who inhabit the Great Lakes

region, including 29 Native American

tribes. Over 1,000 industries and

millions of jobs are dependent upon

water from the Great Lakes. The Great

Lakes System also supports hundreds of

species of aquatic life, wildlife and

plants along more than 4,500 miles of

coastline which boast six National Parks

and Lakeshores, six National Forests,

seven National Wildlife Refuges, and

hundreds of State parks, forests and

sanctuaries.

Because of their unique features, the

Great Lakes are viewed as important to

the residents of the region, and to the

Nation as a whole. The natural

resources of the region have contributed

to the development of its economy. The

Lakes’ natural beauty and aquatic

resources form the basis for heavy

recreational activity. The Great Lakes

Basin Ecosystem—the interacting

components of air, land, water and

living organisms, including humans,

that live within the Great Lakes drainage

basin—is a remarkably diverse and

unique ecosystem important in the

global ecology.

In the past few decades, the presence

of environmental contaminants in the

Great Lakes has been of significant

concern. In spite of the fact that the

Great Lakes contain 5,500 cubic miles of

water that cover a total surface area of

94,000 square miles, they have proved

to be sensitive to the effects of

pollutants that accumulate in them. The

internal responses and processes that

operate in the Great Lakes because of

their depth and long hydraulic

residence times cause pollutants to

recycle between biota, sediments and

the water column.

The first major basin-wide

environmental problem in the Great

Lakes emerged in the late 1960s, when

increased nutrients had dramatically

stimulated the growth of green plants

and algae, reduced dissolved oxygen

levels, and accelerated the process of

eutrophication. As oxygen levels

continued to drop, certain species of

insects and fish were displaced from

affected areas of the Great Lakes Basin

Ecosystem. Environmental managers

determined that a lakewide approach

was necessary to adequately control

accelerated eutrophication. From the

late 1960s through the late 1970s,

United States and Canadian regulatory

agencies agreed on measures to limit the

loadings of phosphorus, including

effluent limits on all major municipal

sewage treatment facilities, limitations

on the phosphorus content in household

detergents, and reductions in nonpoint

source runoff loadings. As a result of all

of these efforts, open lake phosphorus

concentrations have declined, and

phosphorus loadings from municipal

sewage treatment facilities have been

reduced by an estimated 80 to 90

percent. These reductions have resulted

in dramatic improvements in nearshore

water quality and measurable

improvements in open lake conditions.

More recently, scientists and public

leaders have reached a general

consensus that the presence of

environmentally persistent,

bioaccumulative contaminants is a

serious environmental threat to the

Great Lakes Basin Ecosystem. Beginning

in 1963, adverse environmental impacts

in the form of poor reproductive success

and high levels of the pesticide DDT

were observed in herring gulls in Lake

Michigan. Through ongoing research,

scientists have detected 362

contaminants in the Great Lakes System.

Of these, approximately one third have

toxicological data showing that they can

have acute or chronic toxic effects on

aquatic life, wildlife and/or human

health. Chemicals that have been found

to bioaccumulate at levels of concern in

the Great Lakes include, but are not

limited to, polychlorinated biphenyls

(PCBs), mercury, DDT, dioxin,

chlordane, and mirex. The main route of

exposure to these chemicals for humans

is through the consumption of Great

Lakes fish.

Potential adverse human health

effects by these pollutants resulting

from the consumption of fish include

both the increased risk of cancer and the

potential for systemic or noncancer risks

such as kidney damage. EPA has

calculated health risks to populations in

the Great Lakes basin from consumption

of contaminated fish based on exposure

to eight bioaccumulative pollutants:

chlordane, DDT, dieldrin,

hexachlorobenzene, mercury, PCBs,

2,3,7,8–TCDD, and toxaphene. These

chemicals were chosen based on their

potential to cause adverse human health

effects (i.e., cancer or disease) and the

availability of information on fish tissue

contaminant concentrations from the

Great Lakes.

Based on these data, EPA estimates

that the lifetime cancer risks for Native

Americans in the Great Lakes System

due to ingestion of contaminated fish at

current concentrations range from 1.8 ×

10¥3 (Lake Superior) (1.8 in one

thousand) to 3.7 × 10¥2 (Lake Michigan)

(3.7 in 100). Estimated risks to low

income minority sport anglers range

from 2.5 × 10¥3 (2.5 in one thousand)

(Lake Superior) to 1.2 × 10¥2 (1.2 in

100) (Lake Michigan). Estimated risks

for other sport anglers range from 9.7 ×

10¥4 (9.7 in ten thousand) (Lake

Superior) to 4.5 × 10¥3 (4.5 in one

thousand) (Lake Michigan). (See section

I.B.2.a of the SID.) In comparison, EPA

has long maintained that 1 × 10¥4 (one

in ten thousand) to 1 × 10¥6 (one in 1

million) is an appropriate range of risk

to protect human health.
15368 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

EPA also estimates a high potential

risk of systemic (noncancer) injury to

populations in the Great Lakes basin

due to ingestion of fish contaminated

with these pollutants at current

concentrations. The systemic adverse

health effects associated with the

assessed contaminants are described in

section I.B of the SID.

Although the Great Lakes States and

EPA have moved forward to deal with

these problems, control of persistent,

bioaccumulative pollutants proved to be

more complex and difficult than dealing

with nutrients. As a result,

inconsistencies began to be apparent in

the ways various States developed and

implemented controls for the pollutants.

By the mid-1980s, such inconsistencies

became of increasing concern to EPA

and State environmental managers.

EPA began the Great Lakes Water

Quality Initiative (‘‘Initiative’’) in

cooperation with the Great Lakes States

to establish a consistent level of

environmental protection for the Great

Lakes ecosystem, particularly in the area

of State water quality standards and the

National Pollutant Discharge

Elimination System (NPDES) programs.

In the spring of 1989, the Council of

Great Lakes Governors unanimously

agreed to participate in the Initiative

with EPA, because the Initiative

supported the principles and goals of

the Great Lakes Toxic Substances

Control Agreement (Governors’

Agreement). Signed in 1986 by the

Governors of all eight Great Lakes

States, the Governors’ Agreement

affirmed the Governors’ intention to

manage and protect the resources of the

Great Lakes basin through the joint

pursuit of unified and cooperative

principles, policies and programs

enacted and adhered to by each Great

Lakes State.

The Initiative provided a forum for a

regional dialogue to establish minimum

requirements that would reduce

disparities between State water quality

controls in the Great Lakes basin. The

scope of the Initiative included

development of proposed Great Lakes

water quality guidance—Great Lakesspecific water quality criteria and

methodologies to protect aquatic life,

wildlife and human health, procedures

to implement water quality criteria, and

an antidegradation policy.

Three committees were formed to

oversee the Initiative. A Steering

Committee (composed of directors of

water programs from the Great Lakes

States’ environmental agencies and

EPA’s National and Regional Offices)

discussed policy, scientific, and

technical issues, directed the work of

the Technical Work Group and ratified

final proposals. The Technical Work

Group (consisting of technical staff from

the Great Lakes States’ environmental

agencies, EPA, the U.S. Fish and

Wildlife Service, and the National Park

Service) prepared proposals on elements

of the Guidance for consideration by the

Steering Committee. The Public

Participation Group (consisting of

representatives from environmental

groups, municipalities, industry and

academia) observed the deliberations of

the other two committees, advised them

of the public’s concerns, and kept its

various constituencies apprised of

ongoing activities and issues. These

three groups were collectively known as

the Initiative Committees. From the

start, one goal of the Initiative

Committees was to develop the

Guidance elements in an open public

forum, drawing upon the extensive

expertise and interest of individuals and

groups within the Great Lakes

community.

The Initiative efforts were well

underway when Congress amended

section 118 of the CWA in 1990 through

the CPA. The general purpose of these

amendments was to improve the

effectiveness of EPA’s existing programs

in the Great Lakes by identifying key

treaty provisions agreed to by the

United States and Canada in the Great

Lakes Water Quality Agreement

(GLWQA), imposing statutory deadlines

for the implementation of these key

activities, and increasing Federal

resources for program operations in the

Great Lakes System.

Section 118(c)(2) requires EPA to

publish proposed and final water

quality guidance for the Great Lakes

System. This Guidance must conform

with the objectives and provisions of the

GLWQA (a binational agreement

establishing common water quality

objectives for the Great Lakes) and be no

less restrictive than provisions of the

CWA and National water quality criteria

and guidance. The Guidance must

specify minimum requirements for the

waters in the Great Lakes System in

three areas: (1) water quality standards

(including numerical limits on

pollutants in ambient Great Lakes

waters to protect human health, aquatic

life and wildlife); (2) antidegradation

policies; and (3) implementation

procedures.

The Great Lakes States must adopt

water quality standards, antidegradation

policies and implementation procedures

for waters within the Great Lakes

System which are consistent with the

final Guidance within two years of

EPA’s publication. In the absence of

such action, EPA is required to

promulgate any necessary requirements

within that two-year period. In addition,

when an Indian Tribe is authorized to

administer the NPDES or water quality

standards program in the Great Lakes

basin, it will also need to adopt

provisions consistent with the final

Guidance into their water programs.

On December 6, 1991, the Initiative

Steering Committee unanimously

recommended that EPA publish the

draft Guidance ratified by that group in

the Federal Register for public review

and comment. The agreement that the

draft Great Lakes Guidance was ready

for public notice did not represent an

endorsement by every State of all of the

specific proposals. Rather, all parties

agreed on the importance of proceeding

to publish the draft Great Lakes

Guidance in order to further solicit

public comment. State Steering

Committee members indicated their

intent to develop and submit specific

comments on the proposed Guidance

during the public comment period. EPA

worked to convert the agreements

reached in principle by the Steering

Committee into a formal package

suitable for publication in the Federal

Register as proposed Guidance. EPA

generally used the draft proposal

ratified by the Steering Committee as

the basis for preparing the Federal

Register proposal package.

Modifications were necessary, however,

to reflect statutory and regulatory

requirements and EPA policy

considerations, to propose procedures

for State and Tribal adoption of the final

Guidance, to provide suitable

discussion of various alternative

options, and to accommodate necessary

format changes. Where modifications

were made, the preamble to the

proposal described both the

modification and the original Steering

Committee-approved guidelines, and

invited public comment on both. All

elements approved by the Steering

Committee were either incorporated in

the proposed rule or discussed in the

preamble to the proposal.

III. Purpose of the Guidance

The final Guidance represents a

milestone in the 30 years of effort

described above on the part of the Great

Lakes stakeholders to define and apply

innovative, comprehensive

environmental programs in protecting

and restoring the Great Lakes. In

particular, this publication of the final

Guidance culminates six years of

intensive, cooperative effort that

included participation by the eight

Great Lakes States, the environmental

community, academia, industry,

municipalities and EPA Regional and

National offices.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15369

The final Guidance will help establish

consistent, enforceable, long-term

protection with respect to all types of

pollutants, but will place short-term

emphasis on the types of long-lasting

pollutants that accumulate in the food

web and pose a threat to the Great Lakes

System. The final Guidance will

establish goals and minimum

requirements that will further the next

phase of Great Lakes programs,

including the Great Lakes Toxic

Reduction Effort’s integrated, multimedia ecosystem approach.

EPA and State development of the

Guidance—from drafting through

proposal and now final publication—

was guided by several general principles

that are discussed below.

A. Use the Best Available Science to

Protect Human Health, Aquatic Life,

and Wildlife

EPA and the Initiative Committees

have been committed throughout the

Initiative to using the best available

science to develop programs to protect

the Great Lakes System. In the 1986

Governors’ Agreement, the Governors of

the Great Lakes States recognized that

the problem of persistent toxic

substances was the foremost

environmental issue confronting the

Great Lakes. They also recognized that

the regulation of toxic contaminants was

scientifically complex because the

pollutants are numerous, their pathways

into the Lakes are varied, and their

effects on the environment, aquatic life

and human health are not completely

understood. Based on the importance of

the Great Lakes Basin Ecosystem and

the documented adverse effects from

toxic contamination, however, the

Governors directed their environmental

administrators to jointly develop an

agreement and procedure for

coordinating the control of toxic

releases and achieving greater

uniformity of regulations governing

such releases within the Great Lakes

basin.

As discussed further above, the

Initiative was subsequently created to

begin work on these goals. EPA and the

Great Lakes States, with input from

interested parties in the basin, began

collecting and analyzing data,

comparing regulatory requirements and

technical guidance in their various

jurisdictions, and drafting specific

methodologies and procedures to

control the discharge of toxic

contaminants. The provisions of the

final Guidance were based in large part

on these prior efforts of the Initiative

Committees, and incorporate the best

available science to protect human

health, wildlife and aquatic life in the

Great Lakes System. For example, the

final Guidance includes new criteria

and a methodology developed by the

Initiative Committees to specifically

protect wildlife; incorporates recent

data on the bioavailability of metals into

the aquatic life criteria and

methodologies; incorporates Great

Lakes-specific data on fish consumption

rates and fish lipid contents into the

human health criteria; and provides a

methodology to determine the

bioaccumulation properties of

individual pollutants. Additionally,

EPA understands that the science of risk

assessment is rapidly improving.

Therefore, in order to ensure that the

scientific basis for the criteria

methodologies is always current and

peer reviewed, EPA will review the

methodologies and revise them as

appropriate every three years.

B. Recognize the Unique Nature of the

Great Lakes Basin Ecosystem

The final Guidance also reflects the

unique nature of the Great Lakes Basin

Ecosystem by establishing special

provisions for chemicals of concern.

EPA and the Great Lakes States believe

it is reasonable and appropriate to

establish special provisions for the

chemicals of most concern because of

the physical, chemical and biological

characteristics of the Great Lakes

System, and the documented

environmental harm to the ecosystem

from the past and continuing presence

of these types of pollutants. The

Initiative Committees devoted

considerable effort to identifying the

chemicals of most concern to the Great

Lakes System—persistent,

bioaccumulative pollutants termed

‘‘bioaccumulative chemicals of concern

(BCCs)’’—and developing the most

appropriate criteria, methodologies,

policies, and procedures to address

them. The special provisions for BCCs,

initially developed by the Initiative

Committees and incorporated into the

final Guidance, include antidegradation

procedures, to ensure that future

problems are minimized; general phaseout and elimination of mixing zones for

BCCs, except in limited circumstances,

to reduce their overall loadings to the

Lakes; more extensive data generation

requirements to ensure that they are not

under-regulated for lack of data; and

development of water quality criteria

that will protect wildlife that feed on

aquatic prey.

The final Guidance is designed not

only to begin to address existing

problems, but also to prevent emerging

and potential problems posed by

additional chemicals in the future

which may damage the overall health of

the Great Lakes. The experience with

such pollutants as DDT and PCBs

indicates that it takes many decades to

overcome the damage to the ecosystem

caused by even short-term discharges,

and that prevention would have been

dramatically less costly than clean-up.

Issuance of the final Guidance alone

will not solve the existing long-term

problems in the Great Lakes System

from these contaminants. Full

implementation of provisions consistent

with the final Guidance will, however,

provide a coordinated ecosystem

approach for addressing possible

pollutant problems before they produce

adverse and long-lasting basin-wide

impacts, rather than waiting to see what

the future impacts of the pollutants

might be before acting to control them.

The comprehensive approach used in

the development of the final Guidance

provides regulatory authorities with

both remedial and preventive ways of

gauging the actions and potential effects

of chemical stressors upon the Great

Lakes Basin Ecosystem. The

methodologies, policies and procedures

contained in the final Guidance provide

mechanisms for appropriately

addressing both pollutants that have

been or may in the future be

documented as chemicals of concern.

C. Promote Consistency in Standards

and Implementation Procedures While

Allowing Appropriate Flexibility to

States and Tribes

Promoting consistency in standards

and implementation procedures while

providing for appropriate State

flexibility was the third principle in

State and EPA development of the final

Guidance. The underlying rationale for

the Governors’ Agreement, the

Initiative, and the requirements set forth

in the CPA was a recognition of the

need to promote consistency through

adoption of minimum water quality

standards, antidegradation policies, and

implementation procedures by Great

Lakes States and Tribes to protect

human health, aquatic life and wildlife.

Although provisions in the CWA

provide for the adoption of and periodic

revisions to State water quality criteria,

such provisions do not necessarily

ensure that water quality criteria of

adjoining States are consistent within a

shared water body. For example,

ambient water quality criteria in place

in six of the eight Great Lakes States to

protect aquatic life from acute effects

range from 1.79 μg/L to 15.0 μg/L for

cadmium, and from 0.21 μg/L to 1.33

μg/L for dieldrin. Other examples of

variations in acute aquatic life criteria

include nickel, which ranges from

290.30 μg/L to 852.669 μg/L; lindane,
15370 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

with a range of no criteria in place to

1.32 μg/L; and mercury, ranging from

0.5 μg/L to 2.4 μg/L. Similar ranges and

disparities exist for chronic aquatic life

criteria, and for water quality criteria to

protect human health.

Disparities also exist among State

procedures to translate water quality

criteria into individual discharge

permits. Wide variations exist, for

example, in procedures for the granting

of mixing zones, interpretation of

background levels of pollutants,

consideration of pollutants present in

intake waters, controls for pollutants

present in concentrations below the

level of detection, and determination of

appropriate levels for pollutants

discharged in mixtures with other

pollutants. Additionally, when

addressing the accumulation of

chemicals by fish that will be consumed

by humans and wildlife, some States

consider accumulation through multiple

steps in the food chain

(bioaccumulation) while others consider

only the single step of concentration

from the water column

(bioconcentration). Further disparities

exist in different translator

methodologies in deriving numeric

values for implementing narrative water

quality criteria; different assumptions

when calculating total maximum daily

loads (TMDLs) and wasteload

allocations (WLAs), including different

assumptions about background

concentrations, mixing zones, receiving

water flows, or environmental fate; and

different practices in deciding what

pollutants need to be regulated in a

discharge, what effect detection limits

have on compliance determinations,

and how to develop whole effluent

toxicity limitations.

These inconsistencies in State

standards and implementation

procedures have resulted in the

disparate regulation of point source

discharges. In the Governors’

Agreement, the Governors recognized

that the water resources of the basin

transcend political boundaries and

committed to taking steps to manage the

Great Lakes as an integrated ecosystem.

The Great Lakes States, as participants

in the Initiative Committees,

recommended provisions, based on

their extensive experience in

administering State water programs and

knowledge of the significant differences

in these programs within the basin, that

were ultimately included in the

proposed Guidance. The final Guidance

incorporates the work begun by the

Initiative Committees to identify these

disparities and improve consistency in

water quality standards and permit

procedures in the Great Lakes System.

Although improved consistency in

State water programs is a primary goal

of the final Guidance, it is also

necessary to provide appropriate

flexibility to States and Tribes in the

development and implementation of

water programs. In overseeing States’

implementation of the CWA, EPA has

found that reasonable flexibility is not

only necessary to accommodate sitespecific situations and unforeseen

circumstances, but is also appropriate to

enable innovation and progress as new

approaches and information become

available. Many commenters, including

the Great Lakes States, urged EPA to

evaluate the appropriate level of

flexibility provided to States and Tribes

in the proposed Guidance provisions.

EPA reviewed all sections of the

proposed Guidance and all comments

received to determine the appropriate

level of flexibility needed to address

these concerns while still providing a

minimum level of consistency between

the State and Tribal programs. Based on

this review, the final Guidance provides

flexibility for State and Tribal adoption

and implementation of provisions

consistent with the final Guidance in

many areas, including the following:

—Antidegradation: Great Lakes States

and Tribes may develop their own

approaches for implementing the

prohibition against deliberate actions

of dischargers that increase the mass

loading of BCCs without an approved

antidegradation demonstration.

Furthermore, States and Tribes have

flexibility in adopting antidegradation

provisions regarding non-BCCs.

—TMDLs: Great Lakes States and Tribes

may use assessment and remediation

plans for the purposes of appendix F

to part 132 if the State or Tribe

certifies that the assessment and

remediation plan meets certain

TMDL-related provisions in the final

Guidance and public participation

requirements applicable to TMDLs,

and if EPA approves such plan. Thus,

States have the flexibility in many

cases to use LAMPs, RAPs and State

Water Quality Management Plans in

lieu of TMDLs.

—Intake Credits: Great Lakes States and

Tribes may consider the presence of

intake water pollutants in establishing

water quality-based effluent limits

(WQBELs) in accordance with

procedure 5 of appendix F.

—Site-Specific Modifications: Great

Lakes States and Tribes may adopt

either more or less stringent

modifications to human health,

wildlife, and aquatic life criteria and

bioaccumulation factors (BAFs) based

on site-specific circumstances

specified in procedure 1 of appendix

F. All criteria, however, must be

sufficient not to cause jeopardy to

threatened or endangered species

listed or proposed to be listed under

the Federal Endangered Species Act.

—Variances: Great Lakes States and

Tribes may grant variances from water

quality standards based on the factors

identified in procedure 2 of appendix

F.

—Compliance Schedules: Great Lakes

States and Tribes may allow existing

Great Lakes dischargers additional

time to comply with permit limits in

order to collect data to derive new or

revised Tier I criteria and Tier II

values in accordance with procedure

9 of appendix F.

—Mixing Zones: Great Lakes States and

Tribes may authorize mixing zones for

existing discharges of BCCs after the

10-year phase-out period in

accordance with procedure 3.B of

appendix F, if the permitting

authority determines, among other

things, that the discharger has

reduced its discharge of the BCC for

which a mixing zone is sought to the

maximum extent possible. Water

conservation efforts that result in

overall reductions of BCCs are also

allowed even if they result in higher

effluent concentrations.

—Scientific Defensibility Exclusion:

Great Lakes States and Tribes may

apply alternate procedures consistent

with Federal, State, and Tribal

requirements upon demonstration

that a provision in the final Guidance

would not be scientifically defensible

if applied to a particular pollutant in

one or more sites. This provision is in

§ 132.4(h) of the final Guidance.

—Reduced Detail: In many instances,

EPA has revised the proposed

Guidance to reduce the amount of

detail in the provisions without

sacrificing the objectives of the

provisions. Examples of such

revisions include simplification of

procedures for developing TMDLs in

procedure 3 of appendix F, and

simplification of procedures for

determining reasonable potential to

exceed water quality standards in

procedure 5.B of appendix F.

—Other Provisions: Flexibility is also

present in provisions for the exercise

of best professional judgment by the

Great Lakes States and Tribes when

implementing many individual

provisions in the final Guidance

including: determining the

appropriate uncertainty factors in the

human health and wildlife criteria

methodologies; selection of data sets

for establishing water quality criteria;

identifying reasonable and prudent
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15371

measures in antidegradation

provisions; and specifying

appropriate margins of safety when

developing TMDLs. In all cases, of

course, State and Tribal provisions

would need to be scientifically

defensible and consistent with all

applicable regulatory requirements.

D. Establish Equitable Strategies to

Control Pollution Sources

Many commenters argued that the

proposed Guidance unfairly focused on

point source discharges. They asserted

that nonpoint sources or diffuse sources

of pollution, such as air emissions, are

responsible for most of the loadings of

some pollutants of concern in the Great

Lakes, that increased regulation of point

sources will be inequitable and

expensive, and that the final Guidance

will not result in any environmental

improvement given the large,

continuing contribution of toxic

pollutants by nonpoint sources.

EPA recognizes that regulation of

point source discharges alone cannot

address all existing or future

environmental problems from toxic

pollutants in the Great Lakes. In

addition to discharges from point

sources, toxic pollutants are also

contributed to the Great Lakes from

industrial and municipal emissions to

the air, resuspension of pollutants from

contaminated sediments, urban and

agricultural runoff, hazardous waste and

Superfund sites, and spills. Restoration

and maintenance of a healthy ecosystem

will require significant efforts in all of

these areas. EPA, Canada and the Great

Lakes States and Tribes are currently

implementing or developing many

voluntary and regulatory programs to

address these and other nonpoint

sources of environmental contaminants

in the Great Lakes.

Additionally, EPA intends to use the

scientific data developed in the final

Guidance and new or revised water

quality criteria subsequently adopted by

Great Lakes States and Tribes in

evaluating and determining appropriate

levels of control in other environmental

programs. For example, EPA’s future

biennial reports under section 112(m) of

the Clean Air Act will consider the

extent to which air discharges cause or

contribute to exceedances of water

quality criteria in assessing whether

additional air emission standards or

control measures are necessary to

prevent serious adverse effects.

Similarly, once provisions consistent

with the final Guidance are adopted by

the Great Lakes States or Tribes, they

will serve as applicable or relevant and

appropriate requirements (ARARs) for

on-site responses under the

Comprehensive Environmental

Response, Compensation and Liability

Act (CERCLA). EPA will also consider

the data and criteria developed for the

final Guidance, including the

information on BCCs, in developing or

evaluating LaMPs and RAPs under

section 118 of the CWA and Article VI,

Annex 2 of the GLWQA; determination

of corrective action requirements under

sections 3004(u), 3008(h), or 7003 of the

Solid Waste Disposal Act; new or

existing chemical reviews under the

Toxic Substances Control Act (TSCA);

pesticide reviews under the Federal

Insecticide, Fungicide and Rodenticide

Act (FIFRA); and reporting requirements

for toxic releases under the Emergency

Planning and Community Right-toKnow Act (EPCRA).

The final Guidance also includes

provisions to address the contribution of

pollutants by nonpoint sources. First,

the water quality criteria to protect

human health, wildlife and aquatic life,

and the antidegradation provisions

apply to the waters in the Great Lakes

System regardless of whether discharges

to the water are from point or nonpoint

sources. Accordingly, any regulatory

programs for nonpoint sources that

require compliance with water quality

standards would also be subject to the

criteria and antidegradation provisions

of the final Guidance once they are

adopted into State or Tribal standards.

Second, several elements of the final

Guidance would, after State, Tribal or

Federal promulgation, require or allow

permitting authorities to consider the

presence of pollutants in ambient

waters—including pollutants from

nonpoint source dischargers—in

establishing WQBELs for point sources.

For example, permit authorities may

consider the presence of other point or

nonpoint source discharges when

evaluating whether to grant a variance

from water quality criteria.

Additionally, the provisions for TMDLs

address nonpoint sources by specifying

that the loading capacity of a receiving

water that does not meet water quality

standards for a particular pollutant be

allocated, where appropriate, among

nonpoint as well as point sources of the

pollutant, including, at a minimum, a

margin of safety to account for technical

uncertainties in establishing the TMDL.

The development of TMDLs is the

preferred mechanism for addressing

equitable division of the loading

capacities of these nonattained waters.

Because TMDLs have not been

completed for most nonattained waters,

however, the final Guidance promotes

the development of TMDLs through a

phased approach, where appropriate,

and provides for short-term regulatory

relief to point source dischargers in the

absence of TMDLs through intake

credits, variances, and other water

quality permitting procedures.

EPA received numerous comments on

the problem posed in controlling

mercury in particular. Many

commenters stated that since the

primary source of mercury is now

atmospheric deposition, point sources

contribute only a minor portion of the

total loading of mercury to the Great

Lakes System and further restriction of

point source discharges would have no

apparent effect in improving water

quality. Although EPA believes that

there is sufficient flexibility in the

Guidance to handle the unique

problems posed by mercury (e.g., water

quality variances, phased TMDLs,

intake credits), EPA is committed to

developing a mercury permitting

strategy to provide a holistic,

comprehensive approach for dealing

with this pollutant. EPA will publish

this strategy no later than two years

following publication of this Guidance.

There are also many ongoing

voluntary and regulatory activities that

address nonpoint sources of toxic

pollutants to the Great Lakes System,

including activities taken under the

Clean Air Act Amendments of 1990

(CAAA), the CWA, and State regulatory

and voluntary programs. Some of these

activities are summarized in the

preamble to the proposed Guidance (58

FR 20826–32) and section I.D of the SID.

In addition to the many ongoing

activities, EPA and the Great Lakes

States, Tribes, and other federal

agencies are pursuing a multi-media

program to prevent and to further

reduce toxic loadings from all sources of

pollution to the Great Lakes System,

with an emphasis on nonpoint sources.

This second phase of the Great Lakes

Water Quality Initiative, called the Great

Lakes Toxic Reduction Effort (GLTRE),

will build on the open, participative

public dialogue established during the

development of the final Guidance.

Through the GLTRE, the Federal, State,

and Tribal agencies intend to coordinate

and enhance the effectiveness of

ongoing actions and existing tools to

prevent and reduce nonpoint source and

wet-weather point source contributions

of toxic pollutants in the Great Lakes

System. A special emphasis will be

placed on BCCs identified in the final

Guidance.

A partial list of ongoing actions that

are being or could be focused on BCCs

includes: implementation of the CAAA

to reduce atmospheric deposition of

toxics; Resource Conservation and

Recovery Act and CERCLA remedial

actions to reduce loadings of toxics from
15372 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

hazardous waste sites; increased focus

(through the GLTRE) on toxic pollutants

emanating from combined sewer

overflows and stormwater outfalls;

application in the Great Lakes basin of

the National Contaminated Sediment

Management Strategy; implementation

of spill prevention planning practices to

minimize this potential source of

loadings to the Great Lakes; improved

reporting of toxic pollutants under the

Toxic Release Inventory; public

education on the dangers of mercury

and other BCCs; pesticide registration

and re-registration processes;

development of a ‘‘mass balance’’ model

for fate and transport of pollutants in

the Great Lakes; and, development of a

‘‘virtual elimination strategy.’’ These

programs will prevent and further

reduce mass loadings of pollutants and

facilitate equitable division of the costs

of any necessary control measures

between point and nonpoint sources.

In addition to the GLTRE, which is

basin-wide in scope, a primary vehicle

for coordinating Federal and State

programs at the local level for meeting

water quality standards and restoring

beneficial uses for the open waters of

the Great Lakes are LaMPS. LaMPs will

define media specific program actions to

further reduce loadings of toxic

substances, assess whether these

programs will ensure restoration and

attainment of water quality standards

and designated beneficial uses, and

recommend any media-specific program

enhancements as necessary.

Additionally, LaMPs will be

periodically updated and revised to

assess progress in implementing mediaspecific programs, assess the reductions

in toxic loadings to the Great Lakes

System through these programs,

incorporate advances in the

understanding of the System based on

new data and information, and

recommend specific adjustments to

media programs as appropriate.

E. Promote Pollution Prevention

Practices

The final Guidance also promotes

pollution prevention practices

consistent with EPA’s National

Pollution Prevention Strategy and the

Pollution Prevention Action Plan for the

Great Lakes. The Pollution Prevention

Act of 1990 declares as National policy

that reducing the sources of pollution is

the preferred approach to environmental

protection. When source reductions are

not possible, however, recycling,

treating and properly disposing of

pollutants in an environmentally safe

manner complete the hierarchy of

management options designed to

prevent pollution from entering the

environment.

Consistent with the goals of the

Pollution Prevention Act, EPA

developed the Great Lakes Pollution

Prevention Action Plan (April, 1991).

The Great Lakes Pollution Prevention

Action Plan highlights how EPA, in

partnership with the States, will

incorporate pollution prevention into

actions designed to reduce the use and

release of toxic substances in the Great

Lakes basin.

The final Guidance builds upon these

two components of the Great Lakes

program by promoting the development

of pollution prevention analysis and

activities in the level of detection,

mixing zone, and antidegradation

sections of the final Guidance. Also, the

decision to provide special provisions

for BCCs implements EPA’s

commitment to pollution prevention by

reducing the discharge of these

pollutants in the future. This preventive

step not only makes good environmental

management sense, but is appropriate

based on the documented adverse

effects that the past and present

discharge of these pollutants has

produced in the Great Lakes basin.

F. Provide Accurate Assessment of Costs

and Benefits

In developing the final Guidance, EPA

identified and carefully evaluated the

anticipated costs and benefits from

implementation of the major provisions.

EPA received many comments on the

draft cost and benefit studies conducted

as part of the proposed Regulatory

Impact Analysis (RIA) required by

Executive Order 12291, and its

successor, Executive Order 12866.

Based upon consideration of those

comments and further analysis, EPA has

revised the RIA. The results of this

analysis are summarized in section V of

this preamble.

IV. Summary of the Final Guidance

The final Guidance will establish

minimum water quality standards,

antidegradation policies, and

implementation procedures for the

waters of the Great Lakes System in the

States of Illinois, Indiana, Michigan,

Minnesota, New York, Pennsylvania,

Ohio and Wisconsin, including waters

within the jurisdiction of Indian Tribes.

Specifically, the final Guidance

specifies numeric criteria for selected

pollutants to protect aquatic life,

wildlife and human health within the

Great Lakes System and provides

methodologies to derive numeric

criteria for additional pollutants

discharged to these waters. The final

Guidance also contains minimum

procedures to translate the proposed

ambient water quality criteria into

enforceable controls on discharges of

pollutants, and a final antidegradation

policy.

The provisions of the final Guidance

are not enforceable requirements until

adopted by States or Tribes, or

promulgated by EPA for a particular

State or Tribe. The Great Lakes States

and Tribes must adopt water quality

standards, antidegradation policies, and

implementation procedures for waters

within the Great Lakes System

consistent with the (as protective as)

final Guidance or be subject to EPA

promulgation. Great Lakes Tribes

include any Tribe within the Great

Lakes basin for which EPA has

approved water quality standards under

section 303 or has authorized to

administer a NPDES program under

section 402 of the CWA. No Indian

Tribe has been authorized to administer

these water programs in the Great Lakes

basin as of this time. If a Great Lakes

State fails to adopt provisions consistent

with the final Guidance within two

years of this publication in the Federal

Register (that is, by March 23, 1997),

EPA will publish a final rule at the end

of that time period identifying the

provisions of the final Guidance that

will apply to waters and discharges

within that jurisdiction. Additionally,

when an Indian Tribe is authorized to

administer the NPDES or water quality

standards program in the Great Lakes

basin, it will also need to adopt

provisions consistent with the final

Guidance into their water programs.

The following sections provide a brief

summary of the provisions of the final

Guidance. A more complete discussion

of the final Guidance, including EPA’s

analysis of major comments, issues, and

a description of specific changes made

to the proposed Guidance, are contained

in the SID.

The parenthetical note at the

beginning of each section provides

references to the primary provisions in

the final Guidance being discussed in

the section, and to discussions in the

SID. The final Guidance is codified as

40 CFR 132, including appendixes A

through F. Note that appendix F

consists of procedures 1 through 9. For

ease of reference, sections in appendix

F may be referred to by appending the

section designation to the procedure

number. For example, section A.1 of

procedure 1 may be referred to as

procedure 1.A.1 of appendix F.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15373

A. Water Quality Criteria and

Methodologies

1. Protection of Aquatic Life

(§§ 132.3(a), 132.3(b), 132.4(a)(2);

Tables 1 and 2 to part 132; appendix A

to part 132; section III, SID)

The final Guidance contains numeric

criteria to protect aquatic life for 15

pollutants, and a two-tiered

methodology to derive criteria (Tier I) or

values (Tier II) for additional pollutants

discharged to the Great Lakes System.

Aquatic life criteria are derived to

establish ambient concentrations for

pollutants, which, if not exceeded in the

Great Lakes System, will protect fish,

invertebrates, and other aquatic life

from adverse effects due to that

pollutant. The final Guidance includes

both acute and chronic criteria to

protect aquatic life from acute and

chronic exposures to pollutants.

Tier I aquatic life criteria for each

chemical are based on laboratory

toxicity data for a variety of aquatic

species (e.g., fish and invertebrates)

which are representative of species in

the freshwater aquatic environment as a

whole. The Guidance also includes a

Tier II methodology to be used in the

absence of the full set of data needed to

meet Tier I data requirements. For

pollutants for which Tier I criteria have

not been adopted into State or Tribal

water quality standards, States must use

methodologies consistent with either

the Tier I or Tier II methodologies,

depending on the data available, in

conjunction with whole effluent toxicity

requirements in the final Guidance (see

section IV.B.5 of this preamble), to

implement their existing narrative water

quality criteria that prohibit toxic

pollutants in toxic amounts in all

waters. The Great Lakes States and

Tribes are not required to use the Tier

II methodology to adopt numeric criteria

into their water quality standards.

Use of the two-tiered final Guidance

methodologies in these situations will

enable regulatory authorities to translate

narrative criteria to derive TMDLs and

individual NPDES permit limits on a

more uniform basis. EPA and the States

determined that there is a need to

regulate pollutants more consistently in

the Great Lakes System when faced with

limited numbers of criteria. Many of the

Great Lakes States are already

employing procedures similar to the

approach in the final Guidance to

implement narrative criteria. EPA

determined the Tier II approach

improves upon existing mechanisms by

utilizing all available data.

The two-tiered methodology allows

the application of the final Guidance to

all pollutants, except those listed in

Table 5 of part 132 (see section IV.E of

this preamble). The Tier I aquatic life

methodology includes data

requirements very similar to those used

in current guidelines for developing

National water quality criteria guidance

under section 304(a) of the CWA. For

example, both require that acceptable

toxicity data for aquatic species in at

least eight different families

representing differing habitats and

taxonomic groups must exist before a

Tier I numeric criterion can be derived.

The Tier II aquatic life methodology is

used to derive Tier II values which can

be calculated with fewer toxicity data

than Tier I. Tier II values can, in certain

instances, be based on toxicity data from

a single taxonomic family, provided the

data are acceptable. The Tier II

methodology generally produces more

stringent values than the Tier I

methodology, to reflect greater

uncertainty in the absence of additional

toxicity data. As more data become

available, the derived Tier II values tend

to become less conservative. That is,

they more closely approximate Tier I

numeric criteria. EPA and the States

believe it is desirable to continue to

supplement toxicity data to ultimately

derive Tier I numeric criteria.

One difference from the existing

National water quality criteria

guidelines is that the final Guidance

methodology for aquatic life deletes the

provision in the National guidelines to

use a Final Residue Value (FRV) in

deriving a criterion. The FRV is

intended to prevent concentrations of

pollutants in commercially or

recreationally important aquatic species

from affecting the marketability of those

species or affecting wildlife that

consume them by preventing the

exceedance of applicable Food and Drug

Administration action levels and

concentrations that affect wildlife. The

final Guidance provides specific,

separate methodologies to protect

wildlife and human health (discussed

below) which EPA believes will provide

more accurate and appropriate levels of

protection than the FRVs.

For pollutants without Tier I criteria

but with enough data to derive Tier II

values for aquatic life, the proposal

would have required permittees to meet

permit limits based on both Tier II

values and whole effluent toxicity

(WET) testing. In response to comments,

the final Guidance clarifies that States

and Tribes may adopt provisions

allowing use of indicator parameter

limits consistent with 40 CFR

122.44(d)(1)(vi)(C). When deriving

limits to meet narrative criteria, States

and Tribes have the option of using an

indicator parameter limit, including use

of a WET limit under appropriate

conditions, in lieu of a Tier II-based

limit. If use of an indicator parameter is

allowed, the State or Tribe must ensure

that the indicator parameter will attain

the ‘‘applicable water quality standard’’

(as described in 40 CFR

122.44(d)(1)(vi)(C). The ‘‘applicable

water quality standard’’ in this instance

would be the State’s or Tribe’s narrative

water quality standard that protects

aquatic life.

Finally, the aquatic criteria for metals

in the proposed Guidance were

expressed as total recoverable

concentrations. The final Guidance

expresses the criteria for metals in

dissolved form because the dissolved

metal more closely approximates the

bioavailable fraction of metal in the

water column than does the total

recoverable metal. The dissolved criteria

are obtained by multiplying the chronic

and/or acute criterion by appropriate

conversion factors in Table 1 or 2. This

is consistent with many comments on

the issue and with the policy on metals

detailed in ‘‘Office of Water Policy and

Technical Guidance on Interpretation

and Implementation of Aquatic Life

Metals Criteria’’ (October 1, 1993). A

document describing the methodology

to convert total recoverable metals

criteria to dissolved metals criteria was

published in the Federal Register on

August 30, 1994 (59 FR 44678). If a State

or Tribe fails to adopt approvable

aquatic life criteria for metals, EPA will

promulgate criteria expressed as

dissolved concentrations.

EPA Region 5, in cooperation with

EPA Regions 2 and 3 and Headquarters

offices, and the Great Lakes States and

Tribes, will establish a Great Lakes

Initiative (GLI) Clearinghouse to assist

States and Tribes in developing numeric

Tier I water quality criteria for aquatic

life, human health and wildlife and Tier

II water quality values for aquatic life

and human health. As additional

toxicological data and exposure data

become available or additional Tier I

numeric criteria and Tier II values are

calculated by EPA, States, or Tribes,

Region 5 will ensure that this

information is disseminated to the Great

Lakes States and Tribes. EPA believes

operation of the GLI Clearinghouse will

help ensure consistency during

implementation of the final Guidance.

2. Protection of Human Health

(§§ 132.3(c), 132.4(a)(4); Table 3 to

part 132; appendix C to part 132; section

V of the SID)

The final Guidance contains numeric

human health criteria for 18 pollutants,

and includes Tier I and Tier II

methodologies to derive cancer and
15374 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

non-cancer human health criteria for

additional pollutants. The proposed

Guidance contained numeric criteria for

20 pollutants, but two pollutants were

deleted because they do not meet the

more restrictive minimum data

requirements for BAFs used in the final

Guidance.

Tier I human health criteria are

derived to establish ambient

concentrations of chemicals which, if

not exceeded in the Great Lakes System,

will protect individuals from adverse

health impacts from that chemical due

to consumption of aquatic organisms

and water, including incidental water

consumption related to recreational

activities in the Great Lakes System. For

each chemical, chronic criteria are

derived to reflect long-term

consumption of food and water from the

Great Lakes System. Tier II values are

intended to provide a conservative,

interim level of protection in the

establishment of a permit limit, and are

distinguished from the Tier I approach

by the amount and quality of data used

for derivation.

The final Guidance differs from

current National water quality criteria

guidelines when calculating the

assumed human exposure through

consumption of aquatic organisms. The

final Guidance uses BAFs predicted

from biota-sediment accumulation

factors (BSAFs) in addition to fieldmeasured BAFs, and uses a food chain

multiplier (FCM) to account for

biomagnification when using measured

or predicted bioconcentration factors

(BCFs). BAFs are discussed further in

section IV.A.4. of this preamble.

Human health water quality criteria

for carcinogens are typically expressed

in concentrations associated with a

plausible upper bound of increased risk

of developing cancer. In practice, the

level of cancer risk generally accepted

by EPA and the States typically ranges

between 10¥4 (one in one thousand)

and 10¥6 (one in one million). In

contrast, as discussed in section II

above, the cancer risk from ingestion of

contaminated fish at current

concentrations in the Great Lakes

System are as high as 1.2 × 10¥2 (1.2 in

100). The proposed and final Guidance

establishes 10¥5 (one in one hundred

thousand) as the risk level used for

deriving criteria and values for

individual carcinogens. This is within

the range historically used in EPA

actions, and approved for State actions,

designed to protect human health. The

majority of the Great Lakes States use

10¥5 as a baseline risk level in

establishing their water quality

standards.

The methodology is designed to

protect humans who drink water or

consume fish from the Great Lakes

System. The portion of the methodology

addressing fish consumption includes a

factor describing how much fish

humans consume per day. The final

Guidance includes a Great Lakesspecific fish consumption rate of 15

grams per day, based upon several fish

consumption surveys from the Great

Lakes, including a recent study by West

et al. that was discussed in a Federal

Register document on August 30, 1994

(59 FR 44678). This rate differs from the

6.5 grams per day rate which is used in

the National water quality criteria

guidelines as a National average

consumption value. The 15 grams per

day represents the mean consumption

rate of regional fish caught and

consumed by the Great Lakes sport

fishing population.

Commenters argued that a 15 gram

per day assumption in the methodology

would not adequately protect

populations that consume greater than

this amount (e.g., low-income minority

anglers and Native Americans), and that

such an approach therefore would be

inconsistent with Executive Order

12898 regarding environmental justice

(February 16, 1994, 59 FR 7629). EPA

believes that the human health criteria

methodology, including the fish

consumption rate, will provide adequate

health protection for the public,

including more highly exposed subpopulations. In carrying out regulatory

actions under a variety of statutory

authorities, including the CWA, EPA

has generally viewed an upper bound

incremental cancer risk in the range of

10¥4 to 10¥6 as adequately protective of

public health. As discussed above, the

human health criteria methodology is

based on a risk level of 10¥5. Therefore,

if fish are contaminated at the level

permitted by criteria derived under the

final Guidance, individuals eating up to

10 times (i.e., 150 grams per day) the

assumed fish consumption rate would

still be protected at the 10¥4 risk level.

Available data indicate that, even

among low-income minorities who as a

group consume more fish than the

population on average, the

overwhelming majority (approximately

95 percent) consume less than 150

grams per day. The final Guidance

requires, moreover, that States and

Tribes modify the human health criteria

on a site-specific basis to provide

additional protection appropriate for

highly exposed sub-populations. Thus,

where a State or Tribe finds that a

population of high-end consumers

would not be adequately protected by

criteria derived using the 15 gram per

day assumption (e.g., where the risk was

greater than 10¥4), the State or Tribe

would be required to modify the criteria

to provide appropriate additional

protection. The final Guidance also

requires States and Tribes to adopt

provisions to protect human health from

the potential adverse effects of mixtures

of pollutants in effluents, specifically

including mixtures of carcinogens.

Understood in the larger context of the

human health methodology and the

final Guidance as a whole, therefore,

EPA believes that the 15 gram per day

fish consumption rate provides

adequate health protection for the

public, including highly exposed

populations, and that the final Guidance

is therefore consistent with Executive

Order 12898.

In developing bioaccumulation

factors, the proposed Guidance used a

5.0 percent lipid value for fish

consumed by humans, based on Great

Lakes-specific data. The current

National methodology uses a 3.0 percent

lipid value. The final Guidance uses a

3.10 percent lipid value for trophic level

4 fish and 1.82 for trophic level 3 fish.

These percent lipid values are based on

an analysis of the West et al. study cited

above and data from State fish

contaminant monitoring programs.

The final Guidance contains specific

technical guidelines concerning the

range of uncertainty factors that may be

applied by the State and Tribal agencies

on the basis of their best professional

judgment. The final Guidance places a

cap of 30,000 on the combined product

of uncertainty factors that may be

applied in the derivation of non-cancer

Tier II values and a combined

uncertainty factor of 10,000 for Tier I

criteria. The likely maximum combined

uncertainty factor for Tier I criteria in

most cases is 3,000. The SID discusses

further the use of the uncertainty factors

in the derivation of human health

criteria and values.

The proposed Guidance used an 80

percent relative source contribution

(RSC) from surface water pathways for

BCCs, and a 100 percent RSC for all

other pollutants, in deriving noncancer

criteria. The RSC concept is applied in

the National drinking water regulations

and is intended to account, at least in

part, for exposures from other sources

for those bioaccumulative pollutants for

which surface water pathways are likely

to be major contributors to human

exposure. The final Guidance uses the

more protective 80 percent RSC for all

pollutants in deriving noncancer

criteria. This change was made because

of concern that for non-BCCs as well as
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15375

BCCs, there may be other sources of

exposures for noncarcinogens.

3. Protection of Wildlife

(§§ 132.3(d), 132.4(a)(5); Table 4 to

part 132; appendix D to part 132;

section VI of the SID)

The final Guidance contains numeric

criteria to protect wildlife for four

pollutants and a methodology to derive

Tier I criteria for additional BCCs.

Wildlife criteria are derived to establish

ambient concentrations of chemicals

which, if not exceeded, will protect

mammals and birds from adverse

impacts from that chemical due to

consumption of food and/or water from

the Great Lakes System.

These are EPA’s first water quality

criteria specifically for the protection of

wildlife. The methodology is based

largely on the noncancer human health

paradigm. It focuses, however, on

endpoints related to reproduction and

population survival rather than the

survival of individual members of a

species. The methodology incorporates

pollutant-specific effect data for a

variety of mammals and birds and

species-specific exposure parameters for

two mammals and three birds

representative of mammals and birds

resident in the Great Lakes basin which

are likely to experience significant

exposure to bioaccumulative

contaminants through the aquatic food

web.

In the proposal, EPA included a twotiered approach similar to that for

aquatic life and human health. In

response to comments, the final

Guidance requires States and Tribes to

adopt provisions consistent with only

the Tier I wildlife methodology, and

only to apply this methodology for BCCs

(see section IV.A.4 below). The TSD

provides discretionary guidelines for the

use of Tier I and Tier II methodologies

for other pollutants. The wildlife

methodology was limited to the BCCs

because these are the chemicals of

greatest concern to the higher trophic

level wildlife species feeding from the

aquatic food web in the Great Lakes

basin. This decision is consistent with

comments made by the EPA Science

Advisory Board (SAB) who agreed that

the initial focus for wildlife criteria

development should be on persistent,

bioaccumulative organic contaminants

(USEPA, 1994, EPA-SAB-EPEC-ADV–

94–001).

Numerous commenters were

concerned that the mercury criterion for

wildlife was not scientifically

appropriate. After review of all

comments and a reevaluation of all the

data, the mercury criterion for wildlife

has been increased from 180 pg/L to

1300 pg/L. EPA believes the 1300 pg/L

is protective of wildlife in the Great

Lakes System.

In developing bioaccumulation

factors, the proposed Guidance used a

7.9 percent lipid value for fish

consumed by wildlife. The final

Guidance uses a 10.31 percent lipid

value for trophic level 4 fish and 6.46

for trophic level 3 fish. These percent

lipid values are based on the actual prey

species consumed by the representative

wildlife species specified in the

methodology, and are used to estimate

the BAFs for the trophic levels which

those species consume. The percent

lipid is based on the preferential

consumption patterns of wildlife and

cross-referenced with fish weight and

size and appropriate percent lipid. This

approach is a more accurate reflection of

the lipid content of the fish consumed

by wildlife species than the approach

used in the proposal.

4. Bioaccumulation Methodology

(§ 132.4(a)(3); appendix B to part 132;

section IV of the SID)

The proposed Guidance incorporated

BAFs in the derivation of criteria and

values to protect human health and

wildlife. Bioaccumulation refers to the

uptake and retention of a substance by

an aquatic organism from its

surrounding medium and from food. For

certain chemicals, uptake through the

aquatic food chain is the most important

route of exposure for wildlife and

humans. The wildlife criteria and the

human health criteria and values

incorporate appropriate BAFs in order

to more accurately account for the total

exposure to a chemical. Current EPA

guidelines for the derivation of human

health water quality criteria use BCFs,

which measure only uptake from water,

when field-measured BAFs are not

available. EPA believes, however, that

the BAF is a better predictor of the

concentration of a chemical within fish

tissues in the Great Lakes System

because it includes consideration of the

uptake of contaminants from all routes

of exposure.

The proposed Guidance included a

hierarchy of three methods for deriving

BAFs for non-polar organic chemicals:

field-measured BAFs; predicted BAFs

derived by multiplying a laboratorymeasured BCF by a food-chain

multiplier; and BAFs predicted by

multiplying a BCF calculated from the

log Kow by a food-chain multiplier. For

inorganic chemicals, the proposal

would have required either a fieldmeasured BAF or laboratory-measured

BCF. On August 30, 1994, EPA

published a document in the Federal

Register (59 FR 44678) requesting

comments on revising the hierarchy of

methods for deriving BAFs for organic

chemicals, and issues pertaining to the

model used to assist in predicting BAFs

when a field-measured BAF is not

available. Based on the comments

received, the final Guidance modifies

the proposed hierarchy by adding a

predicted BAF based on a BSAF as the

second method in the hierarchy. BSAFs

may be used for predicting BAFs from

concentrations of chemicals in surface

sediments. In addition, the final

Guidance uses a model to assist in

predicting BAFs that includes both

benthic and pelagic food chains thereby

incorporating exposures of organisms to

chemicals from both the sediment and

the water column. The model used in

the proposal only included the pelagic

food chain, and therefore, did not

account for exposure to aquatic

organisms from sediment.

The proposed Guidance used the total

concentration of a chemical in the

ambient water when deriving BAFs for

organic chemicals. In the preamble to

the proposed Guidance and in the

Federal Register document cited above,

EPA requested comments on deriving

BAFs in terms of the freely dissolved

concentration of the chemical in the

ambient water. Based on comments

received from the proposal and the

document, the final Guidance uses the

freely dissolved concentration of a

chemical instead of the total

concentration in the derivation of BAFs

for organic chemicals. Use of the freely

dissolved concentration will improve

the accuracy of extrapolations between

water bodies.

Finally, as discussed in section II of

this preamble, bioaccumulation of

persistent pollutants is a serious

environmental threat to the Great Lakes

Basin Ecosystem. Because of these

concerns, the proposed Guidance would

have required that pollutants with

human health BAFs greater than 1000

receive increased attention and more

stringent controls within the Great

Lakes System. These pollutants are

termed BCCs. EPA identified 28 BCCs in

the proposed Guidance. The additional

controls for BCCs are specified in

certain of the implementation

procedures and the antidegradation

procedures, and are discussed further in

the SID. The final Guidance continues

to include increased attention on and

more stringent controls for BCCs within

the Great Lakes System. The final

Guidance identifies 22 BCCs that are

targeted for special controls instead of

the 28 in the proposed Guidance. Six

BCCs were deleted from the proposed

list because of concern that the methods

used to estimate the BAFs may not
15376 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

account for the metabolism or

degradation of the pollutants in the

environment. States and Tribes may

identify more BCCs as additional BAF

data become available. The final

Guidance designates as BCCs only those

chemicals with human health BAFs

greater than 1000 that were derived

from either a field-measured BAF or a

predicted BAF based on a fieldmeasured BSAF (for non-metals) or from

a field-measured BAF or a laboratorymeasured BCF (for metals). Fieldmeasured BAFs and BSAFs, unlike

BAFs based only on laboratory analyses

or calculations, account for the effects of

metabolism.

B. Implementation Procedures

(§§ 132.4(a)(7), 132.4(e); appendix F to

part 132; section VIII of the SID)

This section of the preamble discusses

nine specific procedures contained in

the final Guidance for implementing

water quality standards and developing

NPDES permits to attain the standards.

1. Site-Specific Modifications

(Procedure 1 of appendix F to part 132;

section VIII.A of the SID)

The proposed Guidance would have

allowed States and Tribes to adopt sitespecific modifications to water quality

criteria and values under certain

circumstances. States and Tribes could

modify aquatic life criteria to be either

more stringent or less stringent when

local water quality characteristics

altered the biological availability or

toxicity of a pollutant, or where local

species’ sensitivities differed from

tested species. Less stringent

modifications to chronic aquatic life

criteria could also be made to reflect

local physical and hydrological

conditions. States and Tribes could also

modify BAFs and human health and

wildlife criteria to be more stringent, but

not less stringent than the final

Guidance.

The final Guidance retains most of the

above provisions, but in addition allows

less stringent modifications to acute

aquatic life criteria and values to reflect

local physical and hydrological

conditions, less stringent modifications

to BAFs in developing human health

and wildlife criteria, and the use of fish

consumption rates lower than 15 grams

per day if justified. The final Guidance

also specifies that site-specific

modifications must be made to prevent

water quality that would cause jeopardy

to endangered or threatened species that

are listed or proposed under the ESA,

and prohibits any less-stringent sitespecific modifications that would cause

such jeopardy. Other issues related to

the ESA are discussed in section IX of

this preamble.

2. Variances from Water Quality

Standards for Point Sources

(Procedure 2 of appendix F to part 132;

section VIII.B of the SID)

The final Guidance allows Great

Lakes States and Tribes to adopt

variances from water quality standards,

applicable to individual existing Great

Lakes dischargers for up to five years,

where specified conditions exist. For

example, a variance may be granted

when compliance with a criterion

would result in substantial and

widespread social and economic

impacts or where certain stream

conditions prevent the attainment of the

criterion. No significant changes were

made in this section from the proposed

Guidance.

3. TMDLs and Mixing Zones

(Procedure 3 of appendix F to part 132;

section VIII.C of the SID)

Section 303(d) of the CWA and

implementing regulations at 40 CFR

130.7 require the establishment of

TMDLs for waters not attaining water

quality standards after implementation

of existing or planned pollution

controls. The TMDL quantifies the

maximum allowable loading of a

pollutant to a water body and allocates

the loading capacity to contributing

point and nonpoint sources (including

natural background) such that water

quality standards for that pollutant will

be attained. A TMDL must incorporate

a margin of safety (MOS) that accounts

for uncertainty about the relationship

between pollutant loads and water

quality. TMDLs may involve single

point sources or multiple sources (e.g.,

point sources and nonpoint sources)

and may be established for geographic

areas that range in size from large

watersheds to relatively small water

body segments.

The proposal attempted to develop a

single, consistent approach for

developing TMDLs to be used by all

States and Tribes in the Great Lakes

System. Current practice in the eight

Great Lakes States includes distinct

technical procedures and program

approaches that differ in scale,

emphasis, scope and level of detail. Two

options for TMDL development were

proposed. One, Option A, focused on

first evaluating the basin as a whole and

then conducting individual site-by-site

adjustments as necessary to ensure

attainment of water quality standards at

each location in the basin. The other,

Option B, focused on evaluating limits

needed for individual point sources

with supplemental emphasis on basinwide considerations as necessary. Both

approaches are consistent with the

CWA, but result in different

methodologies for TMDL development.

Both options proposed that within 10

years of the effective date of the final

Guidance (i.e., two five-year NPDES

permit terms), mixing zones would be

prohibited for BCCs for existing point

source discharges to the Great Lakes

System. Further, both proposed that

mixing zones be denied for new point

source discharges of BCCs as of the

effective date of the final Guidance.

Both options also specified procedures

for determining background levels of

pollutants present in ambient waters. In

addition, the proposal would have

tightened the relationship between

TMDL development and NPDES permit

issuance by providing that TMDLs be

established for each pollutant causing

an impairment in a water body prior to

the issuance or reissuance of any

NPDES permits for that pollutant.

The final Guidance merges both

Options A and B into one single set of

minimum regulatory requirements for

TMDL development. In general, the

final TMDL procedures are less detailed

than the proposal, and offer more

flexibility for States and Tribes in

establishing TMDLs. The final TMDL

procedures contain elements from both

Options A and B that were deemed

critical for a minimum level of

consistency among the Great Lakes

States and Tribes. These critical

elements include: mixing zone

specifications, design flows, and

procedures for determining background

concentrations.

The final Guidance also includes a

prohibition on mixing zones for BCCs

after 12 years in most circumstances.

Maintaining these restrictions on the

availability of mixing zones is

consistent with both the Steering

Committee’s policy views and the binational GLWQA goal of virtual

elimination of persistent,

bioaccumulative toxics. Because of the

unique nature of the Great Lakes

ecosystem, documented ecological

impacts, and the need for consistency,

EPA believes that the general

prohibition on mixing zones for BCCs is

reasonable and appropriate. However, a

new exception is allowed if a facility

with an existing BCC discharge can

demonstrate that it is reducing that

discharge to the maximum extent

feasible (considering technical and

economic factors) but cannot meet

WQBELs for that discharge without a

mixing zone. EPA, in conjunction with

stakeholders within the Great Lakes

Basin, will develop guidance for use by
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15377

States and Tribes in exercising the

exception provision with special focus

on the technical and economic

feasibility criteria. This guidance will

also consider the notice, public hearing,

monitoring and pollution prevention

demonstration elements of the

exception criteria.

The final Guidance also retains many

of the proposed provisions for

calculating background concentrations

used in TMDLs and WLAs established

in the absence of TMDLs. The procedure

addressing data points below the level

of detection, however, has been

modified so that it no longer specifies

the use of default values (i.e., half of the

level of detection).

The final TMDL procedures do not

require that TMDLs be established for

point sources prior to the issuance/

reissuance of NPDES permits. The final

Guidance defers to the existing National

program for determining when a TMDL

is required. Lastly, the final Guidance

allows assessment and remediation

plans that are approved by EPA under

40 CFR 130.6 to be used in lieu of a

TMDL for purposes of appendix F as

long as they meet the general conditions

of a TMDL as outlined by procedure 3

of appendix F, and the public

participation requirements applicable to

TMDLs.

4. Additivity

(Procedure 4 of appendix F to part 132;

section VIII.D of the SID)

EPA has traditionally developed

numeric water quality criteria on a

single pollutant basis. While some

potential environmental hazards involve

significant exposure to only a single

compound, most instances of

contamination in surface waters involve

mixtures of two or more pollutants. The

individual pollutants in such mixtures

can act or interact in various ways

which may affect the magnitude and

nature of risks or effects on human

health, aquatic life and wildlife. WET

tests are available to generally address

interactive effects of mixtures on aquatic

organisms. EPA’s 1986 ‘‘Guidelines for

the Health Risk Assessment of Chemical

Mixtures’’ set forth principles and

procedures for human health risk

assessment of chemical mixtures. There

are currently no technical guidelines on

how to assess effects on wildlife from

chemical mixtures.

The preamble for the proposed

Guidance discussed several possible

approaches to address additive effects

from multiple pollutants. Proposed

regulatory language was provided for

two specific options, each with separate

provisions related to aquatic life,

wildlife and human health. One

approach was developed by the

Initiative Committees, modified to

delete the application of toxicity

equivalency factors (TEFs) for PCBs to

wildlife. The other approach was

developed by EPA. Neither approach

addressed the possible toxicologic

interactions between pollutants in a

mixture (e.g., synergism or antagonism)

because of the limited data available on

these interactive effects. In the absence

of contrary data, both approaches

recommended that the risk to human

health from individual carcinogens in a

mixture be considered additive, and that

a 10¥5 risk level be adopted as a cap for

the cancer risk associated with

mixtures. Both approaches also

proposed using TEFs to assess the risk

to humans and wildlife from certain

chemical classes. The TEF approach

converts the concentration of individual

components in a mixture of chemicals

to an ‘‘equivalent’’ concentration

expressed in terms of a reference

chemical. Both approaches used the 17

TEFs for dioxins and furans identified

in the 1989 EPA document, ‘‘Estimating

Risks Associated with Exposures to

Mixtures of Chlorinated Dibenzo-pDioxins and -Dibenzofurans,’’ and the

1989 update.

The final Guidance includes a general

requirement for States and Tribes to

adopt an additivity provision consistent

with procedure 4 of appendix F to

protect human health from the potential

additive adverse effects from both the

noncarcinogenic and carcinogenic

components of chemical mixtures in

effluents. The final Guidance also

requires the use of the 17 TEFs included

in the proposed Guidance to protect

human health from the potential

additive adverse effects in effluents.

5. Determining the Need for WQBELs

(Reasonable Potential)

(Procedure 5 of appendix F to part 132;

section VIII.E of the SID)

EPA’s existing regulations require

NPDES permits to include WQBELs to

control all pollutants or pollutant

parameters which the permitting

authority determines are or may be

discharged at a level which will cause,

have the reasonable potential to cause or

contribute to an excursion of any

applicable water quality standard. If the

permitting authority determines that a

discharge has the reasonable potential to

cause or contribute to an excursion of an

applicable numeric water quality

criterion, it must include a WQBEL for

the individual pollutant in the permit.

In the absence of an adopted numeric

water quality criterion for an individual

pollutant, the permitting authority must

derive appropriate WQBELs from the

State or Tribal narrative water quality

criterion by either calculating a numeric

criterion for the pollutant; applying

EPA’s water quality criteria developed

under section 304(a) of the CWA,

supplemented with other information

where necessary; or establishing effluent

limitations on an indicator pollutant.

See 40 CFR 122.44(d)(1).

The final Guidance implements these

National requirements by specifying

procedures for determining whether a

discharge has the reasonable potential to

cause or contribute to an exceedance of

Tier I criteria or Tier II values based on

facility-specific effluent data. The final

Guidance also specifies procedures for

determining whether permitting

authorities must generate or require

permittees to generate data sufficient to

calculate Tier II values when specified

pollutants of concern in the Great Lakes

System are known or suspected of being

discharged, but neither Tier I criteria

nor Tier II values have been derived due

to a lack of toxicological data. EPA

believes that the data necessary to

calculate Tier II values for aquatic life,

wildlife and human health currently

exists for most of the specified

pollutants of concern.

The final Guidance maintains all the

basic requirements from the proposed

procedure. Some minor changes are that

the procedure no longer includes a

special provision for effluent dominated

streams, and the procedure allows a

broader range of statistical approaches

to be used when evaluating effluent

data, which provides added simplicity

and flexibility to States and Tribes.

Another change from the proposal is

the relationship in the final Guidance

between the reasonable potential and

TMDL procedures. Numerous

commenters pointed out that the

proposed Guidance indicated that

TMDLs would be required for any water

receiving effluent from a discharger

found to exhibit reasonable potential.

Given the fact that there are many

waterbodies in the Great Lakes basin for

which TMDLs have not been developed,

and the obvious need for permitting to

proceed in the interim until TMDLs are

completed, the final Guidance provides

that the permitting authority can

establish waste load allocations and

WQBELs in the absence of a TMDL or

an assessment and remediation plan

developed and approved in accordance

with procedure 3.A of appendix F. A

more detailed discussion of the

assessment and remediation plan and its

relationship to a TMDL can be found in

section VIII.C.2 of the SID. Procedures

for establishing such WLAs are therefore

addressed in the final Guidance.
15378 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

6. Intake Pollutants

(Procedures 5.D and 5.E of appendix F

to part 132; section VIII.E of the SID)

The proposed Guidance allowed a

permitting authority to determine that

the return of an identified intake water

pollutant to the same body of water

under specified circumstances does not

cause, have the reasonable potential to

cause, or contribute to an excursion

above water quality standards, and

therefore, that a WQBEL would not be

required for that pollutant. Under the

proposal, this ‘‘pass through’’ of intake

water pollutants would be allowed if the

facility returns the intake water

containing the pollutant of concern to

the same waterbody; does not contribute

additional mass of pollutant; does not

increase the concentration of the intake

water pollutant; and does not discharge

at a time or location, or alter the

pollutant in a manner which would

cause adverse impacts to occur that

would not occur if the pollutant were

left in-stream.

EPA received numerous comments on

the proposal. Some commenters argued

that the proposed provision was too

narrow because relief would not be

available if the facility added any

amount of the pollutant to the

discharge, even where the facility was

not contributing any additional mass or

concentration to the waterbody than

was contained in the intake water. After

consideration of public comments, EPA

decided to expand the intake pollutant

provisions to include not only a

reasonable potential procedure like the

one contained in the proposal, but also

a provision that allows the permitting

authority to take into account the

presence of pollutants in intake water in

deriving WQBELs. Specifically, the final

Guidance authorizes the permitting

authority to establish limits based on a

principle of ‘‘no net addition’’ (i.e., the

limit would allow the mass and

concentration of the pollutant in the

discharge up to the mass and

concentration of the pollutant in the

intake water). This provision would be

available where the facility’s discharge

is to the same body of water as the

intake water, and could be applied for

up to 12 years after publication of the

final Guidance. After that time, if a

TMDL or comparable plan that meets

the requirements of procedure 3 of

appendix F has not been completed, the

facility’s WQBEL must be established in

accordance with the ‘‘baseline’’

provisions in procedure 5.F.2 of

appendix F. This time limit provides a

period of relief for dischargers that are

not causing increased impacts on the

waterbody by virtue of their discharge

that would not have occurred had the

pollutant remained in-stream, while

maintaining the incentive for

development of a comprehensive

assessment and remediation plan for

achieving attainment of water quality

standards, which EPA believes is a

critical element of the final Guidance for

addressing pollutants for which a large

contributor to non-attainment is

nonpoint source pollution.

The final Guidance allows States and

Tribes to address intake pollutants in a

manner consistent with assessment and

remediation plans that have been

developed through mechanisms other

than TMDLs in order to provide

flexibility where such plans

comprehensively address the point and

non-point sources of non-attainment in

a waterbody and the means for attaining

compliance with standards.

EPA believes that 12 years provides

sufficient time for States to develop and

complete the water quality assessments

that would serve as the basis for

establishing effluent limits (including

‘‘no net addition’’ limits, where

appropriate) under procedure 3.A of

appendix F. However, EPA also

recognizes that unforeseen events could

delay State completion of these

assessments, and therefore will, at 7

years following promulgation, in

consultation with the States, evaluate

the progress of the assessments. If this

evaluation shows that completion of the

assessments may not be accomplished

by the 12 year date, EPA will revisit

these provisions, and consider

proposing extensions if appropriate.

Under the final Guidance, the

permitting authority can permit the

discharge of intake pollutants to a

different body of water that is in nonattainment provided limitations require

the discharge to meet a WQBEL for the

pollutant equal to the pollutant’s water

quality criterion. Because interwaterbody transfers of pollutants

introduce pollutants to the receiving

water that would not be present in that

waterbody in the absence of the

facility’s discharge, EPA does not

believe that relief for such pollutants

comparable to the ‘‘no net addition’’

approach would be appropriate.

However, to address the concern raised

by commenters about facilities with

multiple sources of intake water, the

permitting authority may use a flowweighted combination of these

approaches when the facility has comingled sources of intake water from

the same and different bodies of water.

EPA maintains that the preferred

approach to deal with non-attainment

waters, particularly when multiple

sources contribute a pollutant for which

the receiving water exceeds the

applicable criterion, is development of a

TMDL or comparable assessment and

remediation plan. The above ‘‘no net

addition’’ permitting approach provides

additional flexibility in situations where

a TMDL or comparable plan has not yet

been developed. Other existing relief

mechanisms include variances to water

quality standards, removal of nonexisting uses, and site-specific criteria.

7. WET

(Procedure 6 of appendix F to part 132;

section VIII.F of the SID)

Existing EPA regulations define WET

as ‘‘the aggregate toxic effect of an

effluent measured directly by a toxicity

test.’’ These regulations require WET

limits to be included in permits in most

circumstances in which the WET of a

discharge has the reasonable potential to

cause or contribute to an in-stream

excursion above either a State’s numeric

criteria for toxicity or narrative criteria

for water quality (40 CFR 122.2,

122.44(d)(1)). The regulations allow

States and Tribes the flexibility to

control for WET with either numeric or

narrative criteria. Current technical

guidelines recommend that no discharge

should exceed 0.3 acute toxic units

(TUa = 100/LC50) at the edge of an

acute mixing zone and 1.0 chronic toxic

units (TUc = 100/NOEC, the No

Observed Effect Concentration) at the

edge of a chronic mixing zone.

The proposed Guidance would have

continued to allow States and Tribes the

flexibility to choose to control WET

with either numeric or narrative criteria,

but specified that no discharge could

exceed 1.0 TUa at the point of discharge

(i.e., no acute mixing zones) and 1.0 TUc

at the edge of a chronic mixing zone

(with some exceptions). In addition, the

proposal contained minimum

requirements for appropriate test

methods to measure WET and for permit

conditions, and procedures for

determining whether or not limits for

WET are necessary.

The final Guidance differs principally

from the proposal in requiring States

and Tribes to adopt 0.3 TUa and 1.0 TUc

either as numeric criteria or as an

equivalent numeric interpretation of

narrative criteria. The final Guidance

also allows the use of acute mixing

zones for the application of the acute

criterion. This approach will promote

consistency among States and Tribes in

controlling WET, while still permitting

considerable flexibility regarding

implementation measures, consistent

with current National policies and

guidelines.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15379

8. Loading Limits

(Procedure 9 of appendix F to part 132;

section VIII.G of the SID)

The final Guidance provides that

WQBELs be expressed in terms of both

concentration and mass loading rate,

except for those pollutants that cannot

appropriately be expressed in terms of

mass. These provisions clarify the

application of existing Federal

regulations at 40 CFR 122.45(f), and are

consistent with current EPA guidance

which requires the inclusion of any

limits determined necessary based on

best professional judgment to meet

water quality standards, including,

where appropriate, mass loading rate

limits. They are also consistent with the

antidegradation policy for the Great

Lakes System in appendix E of the final

Guidance.

9. Levels of Quantification

(Procedure 8 of appendix F to part 132;

section VIII.H of the SID)

Many of the pollutants of concern in

the Great Lakes System cause

unacceptable toxic effects at very low

concentrations. This results in instances

where WQBELs are below levels of

reliable quantification. When this

occurs, the permitting authority may not

be able to determine whether the

pollutant concentration is above or

below the WQBEL. The final Guidance

requires adoption of pollutant

minimization programs (PMPs) for such

permits to increase the likelihood that

the concentration of the pollutant is as

close to the effluent limit as possible.

The PMP is an ongoing, iterative process

that requires, among other things,

internal wastestream monitoring and

submission of status reports. The use of

PMPs for facilities with pollutants

below the level of quantification is

consistent with existing EPA guidance.

Unlike the proposal, however, the

final Guidance eliminates additional

minimum requirements for BCCs. For

example, the final Guidance

recommends but does not require biouptake studies that had been proposed

to assess impacts to the receiving water

and evaluate the effectiveness of the

PMP.

10. Compliance Schedules

(Procedure 9 of appendix F to part 132;

section VIII.I of the SID)

The final Guidance includes a

procedure that allows Great Lakes States

and Tribes to include schedules of

compliance in permits for existing Great

Lakes dischargers for effluent

limitations based on new water quality

criteria and certain other requirements.

Generally, compliance schedules may

provide for up to five years to comply

with the effluent limitation in question

and may, in specified cases, allow the

compliance schedule to go beyond the

term of the permit. Existing Great Lakes

dischargers are those whose

construction commenced before March

23, 1997. Thus the term, existing Great

Lakes discharges, covers expanding

dischargers who were ineligible for

compliance schedules under the

proposal. The final Guidance also

provides the opportunity for States and

Tribes to allow dischargers additional

time to comply with effluent limitations

based on Tier II values while

conducting studies to justify

modifications of those limitations.

C. Antidegradation Provisions

(§ 132.4(a)(6); appendix E to part 132;

section VII of the SID)

EPA’s existing regulations, at 40 CFR

131.6, establish an antidegradation

policy as one of the minimum

requirements of an acceptable water

quality standards submittal. Section

131.12 describes the required elements

of an antidegradation policy. These are:

protection of water quality necessary to

maintain existing uses, protection of

high quality waters (those where water

quality exceeds levels necessary to

support propagation of fish, shellfish,

and wildlife and recreation in and on

the waters) and protection of water

quality in those water bodies identified

as outstanding National resources.

The proposed Guidance provided

detailed procedures for implementing

antidegradation that were not part of the

existing regulations. The detailed

implementation procedures were

intended to result in greater consistency

in how antidegradation was applied

throughout the Great Lakes System. The

proposed Guidance specified, among

other things, how high quality waters

should be identified, what activities

should and should not require review

under antidegradation, and the

information necessary to support a

request to lower water quality and the

procedures to be followed by a Tribe or

State in making a decision whether or

not to allow a lowering of water quality.

The final Guidance maintains the

overall structure of the proposed

Guidance while allowing Tribes and

States greater flexibility in how

antidegradation is implemented. As in

the proposal, the final Guidance is

composed of an antidegradation

standard, antidegradation

implementation procedures,

antidegradation demonstration and

antidegradation decision. However,

many of the detailed requirements

found in the proposed Guidance appear

in the SID accompanying the final

Guidance as nonbinding guidelines,

including provisions specific to nonBCCs.

Key elements of the proposed

Guidance that are retained in the final

Guidance for BCCs include:

identification of high quality waters on

a pollutant-by-pollutant basis;

requirements for States and Tribes to

adopt an antidegradation standard

consistent with the final Guidance for

BCCs; minimum requirements for

conducting an antidegradation review of

any activity expected to result in a

significant lowering of water quality due

to BCCs, minimum requirements for

notifying permitting authorities of

increases in discharges of BCCs; and,

minimum requirements for an

antidegradation demonstration

consisting of a pollution prevention

analysis, an alternative treatment

analysis and a showing that the

significant lowering of water quality

will allow for important social and

economic development. Significant

changes from the proposed Guidance

include: encouraging, but not requiring,

States and Tribes to adopt provisions

consistent with the antidegradation

standard and implementation

procedures for non-BCCs; replacement

of numeric existing effluent qualitybased (EEQ) limits as a means of

implementing antidegradation for BCCs

with a narrative description of the types

of activities that will trigger an

antidegradation review; and greater

flexibility in the implementation,

demonstration and decision

components. A detailed discussion of

the basis for each of the changes is

provided in Section VII the SID.

D. Regulatory Requirements

(Part 132; Tables 5 and 6 to part 132;

section II of the SID)

The Great Lakes States must adopt

water quality standards, antidegradation policies, and

implementation procedures for waters

within the Great Lakes System which

are consistent with the final Guidance

within two years of this publication. If

a Great Lakes State fails to adopt such

standards, policies, and procedures,

section 118(c)(2)(C) of the CWA requires

EPA to promulgate them not later than

the end of that two-year period.

Additionally, when an Indian Tribe is

authorized to administer the NPDES or

water quality standards program in the

Great Lakes basin, it will also need to

adopt provisions consistent with the

final Guidance into its water program.

Part 132 establishes requirements and

procedures to implement section

118(c)(2)(C). Sections 132.3 and 132.4
15380 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

require Great Lakes States and Tribes to

adopt criteria, methodologies, policies,

and procedures consistent with the

criteria, methodologies, policies, and

procedures contained in part 132—that

is, the definitions in § 132.2, the

numeric criteria in Tables 1 through 4,

the criteria development methodologies

in appendixes A through D, the

antidegradation policy in appendix E,

and the implementation procedures in

appendix F. Section 132.5 specifies the

procedures for States and Tribes to

make their submissions to EPA, and for

EPA to approve or disapprove the

submissions. The section specifies that

in reviewing submissions, EPA will

consider provisions of State and Tribal

submissions to be ‘‘consistent with’’ the

final Guidance if each provision is as

protective as the corresponding

provision of the final Guidance. If a

State or Tribe fails to make a

submission, or if provisions of the

submission are not consistent with the

final Guidance, § 132.5 provides that

EPA will publish a final rule in the

Federal Register identifying the final

Guidance provisions that will apply to

discharges within the particular State or

Federal Indian Reservation.

Section 132.4 specifies that water

quality criteria adopted by States and

Tribes consistent with the final

Guidance will apply to all waters of the

Great Lakes System, regardless of

designated uses of the waters in most

cases, with some variations in human

health criteria depending on whether

the waters are designated for drinking

water use. Section 132.4 also contains

certain exceptions in applying the final

Guidance methodologies and

procedures. First, States and Tribes do

not have to adopt and apply the final

Guidance methodologies and

procedures for the 14 pollutants listed

in Table 5 of part 132. EPA believes that

some or all of the methodologies and

procedures are not scientifically

appropriate for these pollutants.

Second, if a State or Tribe demonstrates

that the final Guidance methodologies

or procedures are not scientifically

defensible for a particular pollutant, the

State or Tribe may use alternate

methodologies or procedures so long as

they meet all applicable Federal, State,

and Tribal laws. Third, § 132.4 specifies

that for wet-weather point sources,

States and Tribes generally do not have

to adopt and apply the final Guidance

implementation procedures. The

exception is the TMDL general

condition for wet weather events.

Fourth, pursuant to section 510 of the

CWA, part 132 specifies that nothing in

the final Guidance prohibits States or

Tribes from adopting provisions more

stringent than the final Guidance.

As discussed further in section IX of

this preamble, § 132.4 also provides that

State and Tribal submissions will need

to include any provisions that EPA

determines, based on EPA’s authorities

under the CWA and the results of

consultation with the U.S. Fish and

Wildlife Service (FWS) under section 7

of the ESA, are necessary to ensure that

water quality is not likely to cause

jeopardy to any endangered or

threatened species listed under the ESA.

Part 132 extends the requirements of

section 118(c)(2)(C) to Indian Tribes

within the Great Lakes basin for which

EPA has approved water quality

standards under section 303 of the CWA

or which EPA has authorized to

administer an NPDES program under

section 402 of the CWA. EPA believes

that inclusion of Great Lakes Tribes in

this way is necessary and appropriate to

be consistent with section 518 of the

CWA. The reasons for EPA’s proposal

are discussed further in the preamble to

the proposed Guidance (58 FR 20834),

and section II.D.3 of the SID. As a

practical matter, no Great Lakes Tribes

currently have approved water quality

standards or authorized NPDES

programs, so the submission

requirements of part 132 do not apply

to any Great Lakes Tribes. Tribes that

are approved or authorized in the

future, however, will need to adopt

provisions consistent with the final

Guidance in their water programs.

V. Costs, Cost-Effectiveness and Benefits

(Section IX of the SID)

Under Executive Order 12866 (58 FR

51735, October 4, 1993), EPA 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,

competition, jobs, the environment,

public health or safety, or State, local,

or Tribal governments or communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

Pursuant to the terms of Executive

Order 12866, it has been determined

that this rule is a ‘‘significant regulatory

action’’ because it raises novel policy

issues arising out of the development of

a comprehensive ecosystem-based

approach for a large geographic area

involving several States, Tribal

governments, local governments, and a

large number of regulated dischargers.

This approach, including the Great

Lakes Water Quality Initiative which

developed the core concepts of the final

Guidance, is a unique and precedential

approach to the implementation of

environmental programs. As such, this

action was submitted to OMB for review

pursuant to Executive Order 12866.

Changes made in response to OMB

suggestions or recommendations will be

documented in the public record.

The following is a summary of major

elements of the ‘‘Regulatory Impact

Analysis of the Final Great Lakes Water

Quality Guidance’’ (RIA) (EPA 820–B–

95–011) that has been prepared in

compliance with Executive Order

12866. Further discussion is included in

section IX of the SID, and in the full

RIA, which is available in the docket for

this rulemaking.

The provisions of the final Guidance

are not enforceable requirements until

adopted by States or Tribes, or

promulgated by EPA for a particular

State or Tribe. Therefore, this

publication of the final Guidance does

not have an immediate effect on

dischargers. Until actions are taken to

promulgate and implement these

provisions (or equally protective

provisions consistent with the final

Guidance), there will be no economic

effect on any dischargers. For the

purposes of the RIA, EPA’s analysis of

costs and benefits assumes that either

State or EPA promulgations occur

consistent with the final Guidance

within the next two years.

Under the CWA, costs cannot be a

basis for adopting water quality criteria

that will not be protective of designated

uses. If a range of scientifically

defensible criteria that are protective

can be identified, however, costs may be

considered in selecting a particular

criterion within that range. Costs may

also be relevant under the

antidegradation standard as applied to

high quality waters.

EPA has assessed compliance costs

for facilities that could be affected by

provisions adopted by States or Tribes

consistent with the final Guidance. EPA

has also assessed basin-wide risk

reduction benefits to sport anglers and

Native American subsistence anglers in

the basin, and benefits for three case

study sites in the Great Lakes System.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15381

The methodology used in each

assessment and the results of these

assessments are discussed below.

EPA solicited public comment and

supporting data on the RIA

methodology used to estimate both costs

and benefits for implementation of the

proposed Guidance. EPA evaluated

these comments and supporting data as

well as comments provided by OMB

and revised the RIA methodology prior

to performing these assessments for the

final Guidance.

A. Costs

Based on the information provided by

each State and a review of the permit

files, EPA identified about 3,800 direct

dischargers that could be affected by

State or Tribal adoption or subsequent

EPA promulgation, if necessary, of

requirements consistent with the final

Guidance. Of these, about 590 are major

dischargers and the remaining 3,210 are

minor dischargers. Of the 590 majors,

about 275 are industrial facilities and

315 are publicly owned treatment works

(POTWs). Out of these dischargers, EPA

used a stratified random sampling

procedure to select 59 facilities (50

major and nine minor) that it considered

representative of all types and sizes of

facilities in the basin.

EPA divided the major facilities into

nine industrial categories and a category

for POTWs. The nine industrial

categories are: mining, food and food

products, pulp and paper, inorganic

chemical manufacturing, organic

chemical manufacturing/petroleum

refining, metals manufacturing,

electroplating/metal fabrication, steam

electric power plants, and

miscellaneous facilities.

For each major and minor facility in

the sample, EPA estimated incremental

costs to comply with subsequently

promulgated provisions consistent with

the final Guidance, using a baseline of

compliance with the requirements of

section 303(c)(2)(B) of the CWA. Using

a decision matrix, costs were developed

for two different scenarios—a ‘‘lowend’’ cost scenario and a ‘‘high-end’’

cost scenario—to account for the range

of regulatory flexibility available to

States and Tribes when adopting and

implementing provisions consistent

with the final Guidance. In addition, the

decision matrix specified assumptions

used for selection of control options in

the cost analysis such as optimization of

existing treatment processes and

operations, in-plant pollutant

minimization and prevention, and ‘‘end

of pipe’’ effluent treatment.

The annualized costs for direct and

indirect dischargers to implement the

final Guidance are estimated to be

between $60 million (low end) and $380

million (high end) (first quarter 1994

dollars). EPA believes the costs for

implementing the final Guidance, which

balance pollution prevention, ‘‘end-ofpipe’’ treatment and regulatory

flexibility, will approach the low end of

the cost range. Costs are unlikely to

reach the high end of the cost range

because State and Tribal authorities are

likely to choose implementation options

that provide some degree of relief to

point source dischargers, especially

because in many cases the nonpoint

source contributions will be significant.

Furthermore, cost estimates for both

scenarios, but especially for the highend scenario, may be overstated because

in cases where the final Guidance

provides States and Tribes flexibility in

selecting less costly approaches when

implementing provisions consistent

with the final Guidance, the most costly

approach was used to estimate the costs.

This approach was used to reduce

uncertainty in the cost analysis for the

final Guidance.

Under the low-end cost scenario,

major industrial facilities and POTWs

would account for about 65 percent of

the costs, indirect dischargers about 33

percent, and minor dischargers about

two percent. Among the major

dischargers three categories would

account for most of the costs—POTWs

(39 percent), pulp and paper (14

percent), and miscellaneous (eight

percent). The average per plant costs for

different industry categories range from

zero to $168,000. The two highest

average cost categories are pulp and

paper ($151,000) and miscellaneous

($168,000). Although major POTWs

make up a large portion of the total cost,

the average cost per plant under the

low-end scenario is not among the

highest at $75,000 per facility. About

half of the low-end costs are associated

with pollution prevention activities, and

about half are for capital and operating

costs for wastewater treatment.

For the high-end cost scenario, direct

dischargers account for 98 percent of the

total estimated cost, and indirect

dischargers account for two percent.

This shift in proportion of costs between

direct and indirect dischargers and

between the low and the high estimates

are due to the assumption that more

direct dischargers will need to use endof-pipe treatment under the high-end

scenario. In addition, it was assumed

that a smaller proportion of indirect

dischargers (10 percent) would be

impacted under the high-end scenario,

since municipalities are adding end-ofpipe treatment which should reduce the

need for source controls (i.e., reduce the

need for increased pretreatment

program efforts) by indirect discharges.

Less than 10 percent of the high-end

costs are associated with pollution

prevention activities, and over 90

percent are for capital and operating

costs for wastewater treatment.

Under the high-end scenario for the

direct dischargers, municipal major

dischargers are expected to incur just

under 70 percent of total costs, and

industrial major dischargers account for

29 percent of total costs. Minor direct

dischargers are estimated to incur less

than one percent of the total costs. The

two major industrial categories with the

largest total annualized cost are the pulp

and paper (23 percent of total) and

miscellaneous (three percent) categories.

The food and food products and metal

finishing categories are estimated to

incur less than 1 percent of the total

annualized cost.

Under the high-end scenario, the

average annual cost per major municipal

facility is just over $822,000 per facility.

Average annualized costs for industrial

majors vary widely across categories,

with the highest average cost estimated

for pulp and paper ($1,583,000 per

plant) and miscellaneous ($433,700 per

plant) categories. Regardless of the

scenario, the average costs for minor

facilities are negligible at an estimated

$500 per facility.

The costs described above account for

the costs of eliminating mixing zones for

BCCs except in narrow circumstances,

costs related to implementation of Tier

II values, and specific calculated costs

related to intake credits. The cost

assessment also projects the potential

cost savings across the different

scenarios that facilities may realize if

States or Tribes use existing regulatory

relief mechanisms to modify or

eliminate the need for a WQBEL for an

identified pollutant (e.g., variances,

TMDLs, site-specific modifications to

criteria, and changes in designated

uses).

In addition to the cost estimates

described above, EPA estimated the cost

to comply with requirements consistent

with the antidegradation provisions of

the final Guidance. This potential future

cost is expressed as a ‘‘lost opportunity’’

cost for facilities impacted by the

antidegradation requirements. This cost

could result in the addition of about $22

million each year.

B. Cost-Effectiveness

EPA estimated the cost-effectiveness

of the final Guidance in terms of the

cost of reducing the loadings of toxic

pollutants from point sources. The costeffectiveness (cost per pound removed)

is derived by dividing the annualized

costs of implementing the final
15382 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

Guidance by the toxicity-weighted

pounds (pound-equivalents) of

pollutants removed. Pound-equivalents

are calculated by multiplying pounds of

each pollutant removed by the toxic

weight (based on the toxicity of copper)

for that pollutant.

It is estimated that implementation of

provisions consistent with the final

Guidance would be responsible for the

reduction of about six to eight million

toxic pounds per year, or 16 to 22

percent of the toxic-weighted baseline

for the low- and high-end scenarios,

respectively. The cost-effectiveness of

the scenarios, over the baseline, is quite

good, ranging from $10 to $50 per

pound-equivalent.

Approximately 80 percent of the

pollutant load reduction from

implementation of the final Guidance,

regardless of the scenario, is attributable

to reducing BCCs as a result of PMPs

and end-of-pipe treatment. The largest

pollutant load reductions occur for

chlordane, dieldrin, heptachlor, lead,

and pentachlorobenzene.

In a separate analysis, EPA also

investigated the cost-effectiveness of

regulating point and nonpoint sources

of mercury and PCBs, two contaminants

associated with fish advisories in the

Great Lakes basin. Although data and

resource constraints limited the findings

from these analyses, the preliminary

results indicate that point sources may

factor cost-effectively into pollutant

reduction scenarios. For both

contaminants, the cost-effectiveness of

point and nonpoint source controls are

likely to be highly site-specific.

C. Benefits

The benefits analysis is intended to

provide insight into both the types and

potential magnitude of the economic

benefits expected to arise as a result of

implementation of provisions adopted

by States and Tribes consistent with the

final Guidance. To the extent feasible,

empirical estimates of the potential

magnitude of the benefits are developed

and then compared to the estimated

costs of implementing provisions

adopted by States and Tribes consistent

with the final Guidance.

The benefits analysis is based on a

case study approach, using benefits

transfer applied to three case studies.

The case study approach was used

because it is more amenable to

meaningful benefit-cost analyses than

are studies of larger aggregate areas.

Although the results obtained for a case

study site may not apply uniformly to

the entire Great Lakes basin, the case

study approach does provide a

pragmatic and realistic perspective of

how implementation of the final

Guidance can generate benefits, the

types of benefits anticipated, and how

these benefits compare to costs.

The case studies include: (1) the

lower Fox River drainage, including

Green Bay, located on Lake Michigan in

northeastern Wisconsin; (2) the Saginaw

River and Saginaw Bay, located on Lake

Huron in northeastern Michigan; and (3)

the Black River, located on Lake Erie in

north-central Ohio. The case studies

were selected from a list of candidate

sites (i.e., designated Areas of Concern

(AOCs) in the Great Lakes basin) on the

basis of data availability and the

relevance of the water quality problems

to the final Guidance (i.e., areas in

which problems were more likely to be

associated with on-going point source

discharges rather than historic loadings

from Superfund sites and other sources).

Geographic diversity was also

considered in selecting the sites so that

the analyses might better promote a

broad perspective of the final

Guidance’s benefits and costs.

For each of the three case studies,

EPA estimated future toxics-oriented

water quality benefits, and then

attributed a percentage of these benefits

to implementation of the final

Guidance. The attribution of benefits

was based only on the estimated

reduction in loadings from point

sources at the case study sites and

information on the relative contribution

of point sources to total loadings in the

basin. EPA did not attempt to calculate

the longer-term benefits to human

health, wildlife, and aquatic life once

the final Guidance provisions are fully

implemented by nonpoint sources as

well as point sources and the minimum

protection levels are attained in the

ambient water.

In the Fox River and Green Bay case

study, total annual undiscounted

benefits attributable to the final

Guidance range from $0.3 million to

$8.5 million (first quarter 1994 dollars).

Human health benefits account for

between 29 percent and 72 percent of

the estimated benefits, recreational

fishing accounts for between eight

percent and 45 percent, and nonuse/

ecologic benefits account for between

nine percent and 23 percent. Municipal

and industrial dischargers in this case

study are estimated to incur annualized

costs of about $3.6 million.

In the Saginaw River/Bay case study,

total annual undiscounted benefits

range from $0.2 million to $7.7 million.

Recreational fishing benefits account for

between 36 percent and 60 percent of

the estimated benefits, non-use benefits

account for between 18 percent and 30

percent, and human health benefits

account for between eight percent and

36 percent. Total annualized costs to

municipal and industrial dischargers are

estimated to be about $2.6 million.

In the Black River case study, total

annual undiscounted benefits range

from $0.4 million to $1.5 million.

Recreational fishing benefits account for

between 48 percent and 63 percent of

the estimated benefits, and nonuse

benefits account for between 32 percent

and 44 percent. Total annualized costs

to municipal and industrial dischargers

are estimated to be $2.1 million.

An inherent limitation of the case

study approach is the inability to

extrapolate from a limited set of riverbased sites to the Great Lakes basin as

a whole. Accordingly, extrapolation of

the case study results to the Great Lakes

basin is not recommended. However, as

noted above, the three case studies were

selected on the basis of data availability,

the relative importance of point source

discharges to the watersheds’ problems,

and an attempt to portray spatial

diversity throughout the Great Lakes

basin. Thus, there is no reason to

conclude that the selected sites are not

reflective of the basin, even though

benefits (and costs) tend to be highly

site-specific. In addition, the benefits

extend from the case study rivers into

the larger, open-water environment of

the Great Lakes.

The representativeness of the case

study sites was assessed by comparing

the percentage of total benefits

estimated to accrue in the case study

areas to the percentage of basin-wide

costs incurred by the case study sites.

Benefits-related measures (such as

population, recreational angling days,

and nonconsumptive recreation days)

were used in place of total benefits for

this analysis because there is no

estimate of benefits for the entire Great

Lakes basin. The three case studies

combine to account for nearly 14

percent of the total cost of the final

Guidance, nearly 17 percent of the

loadings reductions, and from four

percent to 10 percent of the benefits

proxies (i.e., basin-wide population,

recreational angling, nonconsumptive

recreation, and commercial fishery

harvest). Thus, the three case studies

may represent a reasonably

proportionate share of costs and

benefits.

In addition to the case study analyses,

a basin-wide risk assessment was

conducted for Great Lakes anglers. EPA

collected data and information on the

consumption of Great Lakes basin fish

to estimate baseline risk levels and

reductions in risks due to

implementation of the final Guidance

for two populations at risk: Great Lakes

sport anglers (including minority and
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15383

low-income anglers) and Native

Americans engaged in subsistence

fishing in the basin. For sport anglers,

EPA estimated that the projected

reduction in loadings from point

sources based on controls consistent

with the final Guidance would result in

a reduction of annual excess lifetime

cancer cases (potential cancer cases

assuming a 70-year lifetime exposure

period) of 2.2 to 4.1 for low-income

minorities in lakeshore counties; 0.4 to

0.8 for other minorities in lakeshore

counties; and 21.9 to 41.9 for all other

sport anglers. For Native American

subsistence anglers, EPA estimated that

reductions from point source loadings

attributable to the final Guidance would

result in a reduction of excess lifetime

cancer cases of between 0.1 and 0.3

using a low fish ingestion scenario and

0.5 to 1.1 using a high fish ingestion

scenario. Note that these estimates do

not include the long-term benefits

(including reduced cancer cases) that

will result once the final Guidance

provisions are fully implemented and

the minimum protection levels are

attained in the ambient water.

In total, using the most conservative

consumption scenario for Native

Americans, these reductions represent

between 0.35 and 0.67 excess cancer

cases per year, and potential basin-wide

benefits of the final Guidance for this

one benefits category of between $0.7

million and $6.7 million per year, based

on the estimated value of a statistical

life of between $2.0 million and $10.0

million. Comparison to case study

results, which were based on a more

comprehensive sample of facilities

within case study areas than was

possible for the entire basin, indicates

these values likely underestimate the

potential risk reduction benefits of the

final Guidance at the basin level. For

example, if the average percentage load

reduction for PCBs for the three case

studies is used to reflect reductions in

PCBs for the basin, the reduction in

excess cancer cases increases to between

three and six cases per year, and

potential benefits increase to between

$6.6 and $60 million per year.

The reduction in pollutant loadings

for PCBs was likely understated in the

basin-wide analysis because the analysis

did not count pollutant load reduction

benefits when the current State-based

permit limit and the final Guidancebased permit limit were both below the

pollutant analytical method detection

limit (MDL). Only three sample facilities

in the population of 59 sample facilities

used to project basin-wide costs and

human health benefits had State-based

permit limits for PCBs. Since the current

State-based permit limit and the final

Guidance-based permit limit were

below the MDL in all three facilities,

‘‘zero’’ reduction in PCB loadings for the

basin was estimated. This, of course, is

an artifact of the methodology and the

size of the sample population selected

for the analysis, and would not occur,

as demonstrated in the case study

analysis, if a larger sample population

had been used.

VI. Regulatory Flexibility Act

Under the Regulatory Flexibility Act

(RFA), EPA generally is required to

conduct a final regulatory flexibility

analysis (FRFA) describing the impact

of the regulatory action on small entities

as part of the final rulemaking.

However, under section 605(b) of the

RFA, if EPA certifies that the rule will

not have a significant economic impact

on a substantial number of small

entities, EPA is not required to prepare

a FRFA.

Implementation of the final Guidance

is dependent upon future promulgation

of provisions consistent with it by State

or Tribal agencies or, if necessary, EPA.

Until actions are taken to promulgate

and implement these provisions, or

equally protective provisions consistent

with the final Guidance, there will be no

economic effect of this rule on any

entities, large or small. For that reason,

and pursuant to Section 605(b) of the

RFA, EPA is certifying that this rule

itself will not have a significant

economic impact on a substantial

number of small entities.

Although EPA is certifying that this

rule will not have a significant

economic impact on a substantial

number of small entities, and therefore

is not required to prepare a FRFA, it is

nevertheless including for public

information in the RIA a discussion of

the possible economic effects to small

entities that could result from State or

Tribal adoption of provisions consistent

with the final Guidance or subsequent

EPA promulgation, if necessary. As

discussed above, small facilities are

projected to incur costs of only

approximately $500 per facility to

comply with subsequently promulgated

requirements that are consistent with

the final Guidance. Accordingly, EPA

believes there will be no significant

economic impact on a substantial

number of small entities as a result of

State or Tribal implementation of the

final Guidance.

VII. Enhancing the Intergovernmental

Partnership Under Executive Order

12875

In compliance with Executive Order

12875 (58 FR 58093, October 28, 1993),

EPA has involved State, Tribal, and

local governments in the development

of the final Guidance.

As described in section II above, the

core elements of the final Guidance

were developed by the Great Lakes

States, EPA, and other Federal agencies

in open dialogue with citizens, local

governments, and industries in the

Great Lakes ecosystem over a five-year

period through the Initiative. The

Initiative process marks the first time

that EPA has developed a major

rulemaking effort in the water program

through a regional public forum. The

Initiative process is described further in

the preamble to the proposed Guidance

(58 FR 20820–23) and section II of this

preamble.

In addition to the participation by

State and local governments in the

initial development of the proposed

Guidance and in the public comment

process, several activities have been

carried out since the publication of the

proposed Guidance. These include:

(1) On April 26, 1994, EPA held a

public meeting to solicit additional

information from interested parties on

the proposed Guidance. As part of

EPA’s outreach efforts to State, Tribal

and local governments, a special

invitation was sent inviting elected

officials and other State, Tribal and

local representatives to participate in

the public meeting. EPA specifically

welcomed Tribal and local officials and

opened the floor to them to hear and

discuss their specific concerns and

views on the final Guidance.

(2) A series of meetings and

teleconferences were held with Great

Lakes States in early 1994 to discuss

their comments on several issues,

including development of water quality

criteria, State adoption requirements,

WET, BAFs, additivity, compliance

schedules, anti-backsliding, nonpoint

sources, and international concerns.

(3) In October, 1994, EPA met with

each individual State in the Great Lakes

basin to discuss the nature, form, and

scope of the proposed Guidance, and

State concerns with implementation of

the provisions under consideration. The

following issues were discussed at each

of the meetings: intake credits,

antidegradation and EEQ, wildlife

criteria, excluded pollutants (e.g.,

ammonia and chlorine), elimination of

mixing zones, site-specific

modifications, fish consumption,

appropriate degrees of flexibility for

implementation (e.g., guidance vs.

regulation), and implementation

procedures.

(4) In 1994 and 1995, EPA met with

representatives of the National Wildlife

Federation to discuss EPA’s activities in

developing the final Guidance in
15384 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

accordance with the terms of a consent

decree governing the schedule for

development of the final Guidance.

(5) In 1994, EPA also met with elected

officials and other representatives from

several local communities in the Great

Lakes basin to discuss issues regarding

the economic impact of the proposed

Guidance on local communities and

POTWs. Issues discussed include cost

impacts associated with implementing

water quality criteria, methodologies,

and implementation procedures; dealing

with pollution from nonpoint sources;

public outreach to control pollutants

such as mercury instead of costly endof-pipe treatment; and applicability of

provisions in the final Guidance to the

National water quality program.

(6) EPA held an additional 18

consultations with the regulated

community throughout 1994. Such

meetings allowed representatives of

dischargers to share additional data,

which has been placed in the docket for

this rulemaking, and concerns about a

range of issues, including cost concerns,

that the dischargers expect to arise in

implementation of the final Guidance.

(7) In 1994, EPA met with State

representatives to conduct initial

planning for implementation of the GLI

Clearinghouse. All Great Lakes States

agreed to participate in this effort,

which will involve the sharing of

toxicological and other data to assist in

the development of additional water

quality criteria and values.

The results of the above efforts have

assisted in the development of the final

Guidance through broad communication

with a full range of interested parties,

sharing of additional information, and

incorporation of features to improve the

implementation of the final Guidance.

EPA has estimated the total annual

State government burden to implement

the final Guidance as approximately

5,886 hours, resulting in a State

government cost of $175,992 annually.

Such burden and costs were estimated

based upon the burden and costs

associated with developing water

quality criteria, review of

antidegradation policy demonstrations,

review of approvable control strategies

and BCC monitoring data, and review of

variance requests. The total annual local

government burden is estimated to be

42,296 hours with an associated cost of

$2,008,624. All of the burden and costs

to local governments are associated with

being a regulated entity as an operator

of a POTW.

VIII. Paperwork Reduction Act

The information collection

requirements in this final Guidance

have been approved by OMB under the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq., and have been assigned

OMB control number 2040–0180. EPA

has prepared an Information Collection

Request (ICR) document (ICR No.

1639.02). A copy of ICR 1639.02 may be

obtained by writing to Ms. Sandy

Farmer, Information Policy Branch, EPA

2136, Washington, D.C. 20460, or by

calling (202) 260–2740.

The annual public reporting and

record keeping burden for this

regulation is estimated to be 128,787

hours for the affected 3,795 permittees,

or an average of 34 hours. This includes

the total annual burden to local

governments as POTW operators,

estimated to be 45,296 hours. The total

annual burden to State governments is

estimated to be 5,886 hours. These

estimates include time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Send comments regarding the burden

estimate or any other aspect of this

collection of information, including

suggestions for reducing this burden to

Chief, Information Policy Branch, Mail

Code 2136, U.S. Environmental

Protection Agency, 401 M St., S.W.,

Washington, DC 20460; and to the

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Washington, DC 20503.

In this rulemaking EPA is also

amending the table of currently

approved ICR control numbers issued

by OMB for various regulations into 40

CFR 9.1. This amendment updates the

table to accurately display those

information requirements promulgated

under the CWA. The affected

regulations are codified at 40 CFR parts

122, 123, 131, and 132. EPA will

continue to present OMB control

numbers in a consolidated table format.

The table will be codified in 40 CFR

part 9 of EPA’s regulations and in each

40 CFR volume containing EPA

regulations. The table lists the section

numbers with reporting and

recordkeeping requirements, and the

current OMB control numbers. This

display of the OMB control numbers

and their subsequent codification in the

CFR satisfies the requirements of the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.) and OMB’s implementing

regulations at 5 CFR part 1320.

The ICR for this rulemaking was

previously subject to public notice and

comment prior to OMB approval. As a

result, EPA finds that there is ‘‘good

cause’’ under section 553(b)(B) of the

Administrative Procedure Act (5 U.S.C.

553(b)(B)) to amend this table without

prior notice and comment. Due to the

technical nature of the table, further

notice and comment would be

unnecessary.

IX. Endangered Species Act

Pursuant to section 7(a)(2) of the ESA,

EPA consulted with the FWS

concerning EPA’s publication of the

final Guidance. EPA and the FWS have

now completed both informal and

formal consultation conducted over a

two-year period.

As a result of the consultation, as well

as an analysis of comments, EPA

modified several provisions of the final

Guidance. The procedure for sitespecific modifications provides that

Great Lakes States and Tribes must

make site-specific modifications to

criteria and values where necessary to

ensure the resulting water quality does

not cause jeopardy to listed or proposed

species. Similarly, the antidegradation

policy and implementation procedures

restrict certain actions States and Tribes

may take to allow lowering of water

quality in high quality waters, or to

adopt variances or mixing zones.

Additionally, the regulatory

requirements were modified to require

Great Lakes States and Tribes to include

in their part 132 submissions any

provisions that EPA determines, based

on EPA’s authorities under the CWA

and the results of consultation under

section 7 of the ESA, are necessary to

ensure that water quality is not likely to

cause jeopardy to listed species. EPA

and the FWS also agreed on how further

consultations will be conducted as the

final Guidance is implemented. The two

agencies also agreed that EPA will

undertake a review of water quality

standards and implementation of those

standards for ammonia and chlorine in

the Great Lakes basin as part of EPA’s

responsibilities under section 303(c) of

the CWA.

During the consultation, two issues

were identified that required formal

consultation, as defined in 40 CFR part

402. These issues were: the absence of

toxicological data concerning effects of

contaminants on three species of

freshwater mussels in the Great Lakes

basin, and the adequacy of the wildlife

criteria methodology to protect three

endangered or threatened wildlife

species in the basin. On February 21,

1995, the FWS provided EPA with a

written Biological Opinion (Opinion) on

these issues. The Opinion is available in

the docket for this rulemaking. On both

issues, the FWS concluded that the

water quality resulting from

implementation of the final Guidance

will not cause jeopardy to the listed

species. To minimize the amount or

extent of any incidental take that might
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15385

occur, the FWS consulted closely with

EPA to develop a coordinated approach.

The final Opinion specified reasonable

and prudent measures that the FWS

considers necessary or appropriate to

minimize such impact. EPA has agreed

to implement the measures, and the

FWS and EPA will continue to work

cooperatively during the

implementation.

X. Judicial Review of Provisions Not

Amended

In some situations, EPA has

renumbered or included other editorial

changes to regulations that have been

promulgated in past rulemakings.

Additionally, to provide for ease in

reading changes to existing regulations,

EPA has in some cases repeated entire

sections, including portions not

changed. The promulgation of this final

rule, however, does not provide another

opportunity to seek judicial review on

the substance of the existing regulations.

XI. Supporting Documents

All documents that are referenced in

this preamble are available for

inspection and photocopying in the

docket for this rulemaking at the

address listed at the beginning of this

preamble. A reasonable fee will be

charged for photocopies.

Selected documents supporting the

final Guidance are also available for

viewing by the public at locations listed

below:

Illinois: Illinois State Library, 300

South 2nd Street, Springfield, IL 62701

(217–785–5600)

Indiana: Indiana Department of

Environmental Management, Office of

Water Management, 100 North Senate

Street, Indianapolis, IN 46204 (317–

232–8671)

Michigan: Library of Michigan,

Government Documents Service, 717

West Allegan, Lansing, MI 48909 (517–

373–1300); Detroit Public Library,

Sociology and Economics Department,

5201 Woodward Avenue, Detroit, MI

48902 (313–833–1440)

Minnesota: Minnesota Pollution

Control Agency, Library, 520 Lafayette,

St. Paul, MN (612–296–7719)

New York: U.S. EPA Region 2 Library,

Room 402, 26 Federal Plaza, New York,

NY 10278 (212–264–2881); U.S. EPA

Public Information Office, Carborundum

Center, Suite 530, 345 Third Street,

Niagara Falls, NY 14303 (716–285–

8842); New York State Department of

Environmental Conservation (NYSDEC),

Room 310, 50 Wolf Road, Albany, NY

12333 (518–457–7463); NYSDEC,

Region 6, 7th Floor, State Office

Building, 317 Washington Street,

Watertown, NY 13602 (315–785–2513);

NYSDEC, Region 7, 615 Erie Boulevard

West, Syracuse, NY 13204 (315–426–

7400); NYSDEC, Region 8, 6274 East

Avon-Lima Road, Avon, NY 14414

(716–226–2466); NYSDEC, Region 9,

270 Michigan Avenue, Buffalo, NY

14203 (716–851–7070)

Ohio: Ohio Environmental Protection

Agency Library—Central District Office,

1800 Watermark Road, Columbus, OH

43215 (614–644–3024); U.S. EPA

Eastern District Office, 25809 Central

Ridge Road, Westlake, OH 44145 (216–

522–7260)

Pennsylvania: Pennsylvania

Department of Environmental

Resources, 230 Chestnut Street,

Meadville, PA 16335 (814–332–6945);

U.S. EPA Region 3 Library, 8th Floor,

841 Chestnut Building, Philadelphia,

PA 19107–4431 (215–597–7904)

Wisconsin: Water Resources Center,

University of Wisconsin-Madison, 2nd

Floor, 1975 Willow Drive, Madison, WI

(608–262–3069)

EPA is also making a number of

documents available in electronic

format at no incremental cost to users of

the Internet. These documents include

the contents of this Federal Register

document, the SID, many documents

listed below, and other supporting

materials.

The documents listed below are also

available for a fee upon written request

or telephone call to the National

Technical Information Center (NTIS),

U.S. Department of Commerce, 5285

Port Royal Road, Springfield, VA 22161

(telephone 800–553–6847 or 703–487–

4650). Alternatively, copies may be

obtained for a fee upon written request

or telephone call to the Educational

Resources Information Center/

Clearinghouse for Science, Mathematics,

and Environmental Education (ERIC/

CSMEE), 1200 Chambers Road, Room

310, Columbus, OH 43212 (614–292–

6717). When ordering, please include

the NTIS or ERIC/CSMEE accession

number.

A. Final Water Quality Guidance for

the Great Lakes System: Supplementary

Information Document (SID). NTIS

Number: PB95187266. ERIC Number:

D046.

B. Great Lakes Water Quality

Initiative Criteria Document for the

Protection of Aquatic Life in Ambient

Water. NTIS Number: PB95187282.

ERIC Number: D048.

C. Great Lakes Water Quality

Initiative Technical Support Document

for the Procedure to Determine

Bioaccumulation Factors. NTIS Number:

PB95187290. ERIC Number: D049.

D. Great Lakes Water Quality

Initiative Criteria Document for the

Protection of Human Health. NTIS

Number: PB95187308. ERIC Number:

D050.

E. Great Lakes Water Quality Initiative

Technical Support Document for

Human Health Criteria and Values.

NTIS Number: PB95187316. ERIC

Number: D051.

F. Great Lakes Water Quality Initiative

Criteria Document for the Protection of

Wildlife: DDT; Mercury; 2,3,7,8–TCDD;

PCBs. NTIS Number: PB95187324. ERIC

Number: D052.

G. Great Lakes Water Quality

Initiative Technical Support Document

for Wildlife Criteria. NTIS Number:

PB95187332. ERIC Number: D053.

H. Assessment of Compliance Costs

Resulting from Implementation of the

Final Great Lakes Water Quality

Guidance. NTIS Number: PB95187340.

ERIC Number: D054.

I. Regulatory Impact Analysis of the

Final Great Lakes Water Quality

Guidance. NTIS Number: PB95187357.

ERIC Number: D055.

List of Subjects

40 CFR Part 9

Reporting and recordkeeping

requirements.

40 CFR Part 122

Administrative practice and

procedure, Confidential business

information, Great Lakes, Hazardous

substances, Reporting and

recordkeeping requirements, Water

pollution control.

40 CFR Part 123

Administrative practice and

procedure, Confidential business

information, Great Lakes, Hazardous

substances, Indians-lands,

Intergovernmental relations, Penalties,

Reporting and recordkeeping

requirements, Water pollution control.

40 CFR Part 131

Great Lakes, Reporting and

recordkeeping requirements, Water

pollution control.

40 CFR Part 132

Administrative practice and

procedure, Great Lakes, Indians-lands,

Intergovernmental relations, Reporting

and recordkeeping requirements, Water

pollution control.

Dated: March 13, 1995.

Carol M. Browner,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I, parts 9,

122, 123, and 131 are amended, and part

132 is added as follows:
15386 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

PART 9—OMB APPROVALS UNDER

THE PAPERWORK REDUCTION ACT

1. The authority citation for part 9

continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136–136y;

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,

1321, 1326, 1330, 1342, 1344, 1345 (d) and

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,

1971–1975 Comp. p. 973; 42 U.S.C. 241,

242b, 243, 246, 300f, 300g, 300g–1, 300g–2,

300g–3, 300g–4, 300g–5, 300g–6, 300j–1,

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,

6901–6992k, 7401–7671q, 7542, 9601–9657,

11023, 11048.

2. Section 9.1 is amended as follows:

a. By adding in numerical order the

entry ‘‘122.44(r)’’ under the heading

‘‘EPA Administered Permit Programs:

The National Pollutant Discharge

Elimination System’’.

b. By revising the entries under the

heading ‘‘State Permit Requirements’’;

c. By adding in numerical order the

entries ‘‘131.1’’ and ‘‘131.5’’ and by

revising the entries ‘‘131.20’’, ‘‘131.21’’

and ‘‘131.22’’ under the heading ‘‘Water

Quality Standards Regulations’’; and

d. By adding in numerical order a

new heading and new entries for ‘‘Water

Quality Guidance for the Great Lakes

System’’ to read as follows:

§ 9.1 OMB approvals under the Paperwork

Reduction Act.

* * * * *

40 CFR citation OMB control

No.

EPA Administered Permit Programs: The

National Pollutant Discharge Elimination

System

* * * * *

122.44(r) ................................. 2040–0180

* * * * *

State Permit Requirements

123.21–123.24 ........................ 2040–0057,

2040–0170

123.25 ..................................... 2040–0004,

2040–0110,

2040–0170,

2040–0180

123.26–123.29 ........................ 2040–0057,

2040–0170

123.43 ..................................... 2040–0057,

2040–0170

123.44 ..................................... 2040–0057,

2040–0170,

2040–0180

123.45 ..................................... 2040–0057,

2040–0170

123.62 ..................................... 2040–0057,

2040–0170,

2040–0180

123.63 ..................................... 2040–0057,

2040–0170,

2040–0180

123.64 ..................................... 2040–0057,

2040–0170

40 CFR citation OMB control

No.

Water Quality Standards Regulation

131.1 ....................................... 2040–0180

131.5 ....................................... 2040–0180

* * * * *

131.20 ..................................... 2040–0049

131.21 ..................................... 2040–0049,

2040–0180

131.22 ..................................... 2040–0049

* * * * *

Water Quality Guidance for the Great Lakes

System

132.1 ....................................... 2040–0180

132.2 ....................................... 2040–0180

132.3 ....................................... 2040–0180

132.4 ....................................... 2040–0180

132.5 ....................................... 2040–0180

Appendix A ........................... 2040–0180

Appendix B ............................ 2040–0180

Appendix C ............................ 2040–0180

Appendix D ............................ 2040–0180

Appendix E ............................ 2040–0180

Appendix F ............................ 2040–0180

* * * * *

PART 122—EPA ADMINISTERED

PERMIT PROGRAMS: THE NATIONAL

POLLUTANT DISCHARGE

ELIMINATION SYSTEM

3. The authority citation for part 122

continues to read as follows:

Authority: The Clean Water Act, 33 U.S.C.

1251 et seq.

4. Section 122.44 is amended by

adding a new paragraph (r) to read as

follows:

§ 122.44 Establishing limitations,

standards, and other permit conditions

(applicable to State NPDES programs, see

§ 123.25).

* * * * *

(r) Great Lakes. When a permit is

issued to a facility that discharges into

the Great Lakes System (as defined in 40

CFR 132.2), conditions promulgated by

the State, Tribe, or EPA pursuant to 40

CFR part 132.

PART 123—STATE PROGRAM

REQUIREMENTS

5. The authority citation for part 123

continues to read as follows:

Authority: Clean Water Act, 33 U.S.C. 1251

et seq.

6. Section 123.25 is amended by

removing ‘‘and’’ at the end of paragraph

(a)(36), removing the period at the end

of paragraph (a)(37) and adding ‘‘; and’’

in its place, and adding a new paragraph

(a)(38) to read as follows:

§ 123.25 Requirements for permitting.

(a) * * *

(38) For a Great Lakes State or Tribe

(as defined in 40 CFR 132.2), 40 CFR

part 132 (NPDES permitting

implementation procedures only).

* * * * *

7. Section 123.44 is amended by

adding a new paragraph (c)(9) to read as

follows:

§ 123.44 EPA review of and objections to

State permits.

* * * * *

(c) * * *

(9) For a permit issued by a Great

Lakes State or Tribe (as defined in 40

CFR 132.2), the permit does not satisfy

the conditions promulgated by the State,

Tribe, or EPA pursuant to 40 CFR part

132.

* * * * *

8. Section 123.62 is amended by

adding a new paragraph (f) to read as

follows:

§ 123.62 Procedures for revision of State

programs.

* * * * *

(f) Revision of a State program by a

Great Lakes State or Tribe (as defined in

40 CFR 132.2) to conform to section 118

of the CWA and 40 CFR part 132 shall

be accomplished pursuant to 40 CFR

part 132.

9. Section 123.63 is amended by

adding a new paragraph (a)(6) and

adding and reserving paragraph (b) to

read as follows:

§ 123.63 Criteria for withdrawal of State

programs.

(a) * * *

(6) Where a Great Lakes State or Tribe

(as defined in 40 CFR 132.2) fails to

adequately incorporate the NPDES

permitting implementation procedures

promulgated by the State, Tribe, or EPA

pursuant to 40 CFR part 132 into

individual permits.

(b) [Reserved]

PART 131—WATER QUALITY

STANDARDS

10. The authority citation for part 131

continues to read as follows:

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

11. Section 131.1 is revised to read as

follows:

§ 131.1 Scope.

This part describes the requirements

and procedures for developing,

reviewing, revising, and approving

water quality standards by the States as

authorized by section 303(c) of the

Clean Water Act. Additional specific

procedures for developing, reviewing,

revising, and approving water quality

standards for Great Lakes States or Great

Lakes Tribes (as defined in 40 CFR

132.2) to conform to section 118 of the
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15387

Clean Water Act and 40 CFR part 132,

are provided in 40 CFR part 132.

12. Section 131.5 is amended by

revising paragraph (a)(5), by

redesignating paragraph (b) as paragraph

(c), and by adding a new paragraph (b)

to read as follows:

§ 131.5 EPA Authority.

(a) * * *

(5) Whether the State submission

meets the requirements included in

§ 131.6 of this part and, for Great Lakes

States or Great Lakes Tribes (as defined

in 40 CFR 132.2) to conform to section

118 of the Act, the requirements of 40

CFR part 132.

(b) If EPA determines that the State’s

or Tribe’s water quality standards are

consistent with the factors listed in

paragraphs (a)(1) through (a)(5) of this

section, EPA approves the standards.

EPA must disapprove the State’s or

Tribe’s water quality standards and

promulgate Federal standards under

section 303(c)(4), and for Great Lakes

States or Great Lakes Tribes under

section 118(c)(2)(C) of the Act, if State

or Tribal adopted standards are not

consistent with the factors listed in

paragraphs (a)(1) through (a)(5) of this

section. EPA may also promulgate a new

or revised standard when necessary to

meet the requirements of the Act.

* * * * *

13. Section 131.21 is amended by

revising paragraph (b) to read as follows:

§ 131.21 EPA review and approval of water

quality standards.

* * * * *

(b) The Regional Administrator’s

approval or disapproval of a State water

quality standard shall be based on the

requirements of the Act as described in

§§ 131.5 and 131.6, and, with respect to

Great Lakes States or Tribes (as defined

in 40 CFR 132.2), 40 CFR part 132.

* * * * *

14. Part 132 is added as follows:

PART 132—WATER QUALITY

GUIDANCE FOR THE GREAT LAKES

SYSTEM

Sec.

132.1 Scope, purpose, and availability of

documents.

132.2 Definitions.

132.3 Adoption of criteria.

132.4 State adoption and application of

methodologies, policies and procedures.

132.5 Procedures for adoption and EPA

review.

132.6 Application of part 132 requirements

in Great Lakes States and Tribes.

[Reserved]

Tables to Part 132

Appendix A to Part 132—Great Lakes Water

Quality Initiative Methodologies for

Development of Aquatic Life Criteria and

Values

Appendix B to Part 132—Great Lakes Water

Quality Initiative Methodology for

Development of Bioaccumulation Factors

Appendix C to Part 132—Great Lakes Water

Quality Initiative Methodology for

Development of Human Health Criteria

and Values

Appendix D to Part 132—Great Lakes Water

Quality Initiative Methodology for the

Development of Wildlife Criteria

Appendix E to Part 132—Great Lakes Water

Quality Initiative Antidegradation Policy

Appendix F to Part 132—Great Lakes Water

Quality Initiative Implementation

Procedures

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

§ 132.1 Scope, purpose, and availability of

documents.

(a) This part constitutes the Water

Quality Guidance for the Great Lakes

System (Guidance) required by section

118(c)(2) of the Clean Water Act (33

U.S.C. 1251 et seq.) as amended by the

Great Lakes Critical Programs Act of

1990 (Pub. L. 101–596, 104 Stat. 3000 et

seq.). The Guidance in this part

identifies minimum water quality

standards, antidegradation policies, and

implementation procedures for the

Great Lakes System to protect human

health, aquatic life, and wildlife.

(b) The U.S. Environmental Protection

Agency, Great Lakes States, and Great

Lakes Tribes will use the Guidance in

this part to evaluate the water quality

programs of the States and Tribes to

assure that they are protective of water

quality. State and Tribal programs do

not need to be identical to the Guidance

in this part, but must contain provisions

that are consistent with (as protective

as) the Guidance in this part. The

scientific, policy and legal basis for

EPA’s development of each section of

the final Guidance in this part is set

forth in the preamble, Supplementary

Information Document, Technical

Support Documents, and other

supporting documents in the public

docket. EPA will follow the guidance set

out in these documents in reviewing the

State and Tribal water quality programs

in the Great Lakes for consistency with

this part.

(c) The Great Lakes States and Tribes

must adopt provisions consistent with

the Guidance in this part applicable to

waters in the Great Lakes System or be

subject to EPA promulgation of its terms

pursuant to this part.

(d) EPA understands that the science

of risk assessment is rapidly improving.

Therefore, to ensure that the scientific

basis for the methodologies in

appendices A through D are always

current and peer reviewed, EPA will

review the methodologies and revise

them, as appropriate, every 3 years.

(e) Certain documents referenced in

the appendixes to this part with a

designation of NTIS and/or ERIC are

available for a fee upon request to the

National Technical Information Center

(NTIS), U.S. Department of Commerce,

5285 Port Royal Road, Springfield, VA

22161. Alternatively, copies may be

obtained for a fee upon request to the

Educational Resources Information

Center/Clearinghouse for Science,

Mathematics, and Environmental

Education (ERIC/CSMEE), 1200

Chambers Road, Room 310, Columbus,

Ohio 43212. When ordering, please

include the NTIS or ERIC/CSMEE

accession number.

§ 132.2 Definitions.

The following definitions apply in

this part. Terms not defined in this

section have the meaning given by the

Clean Water Act and EPA implementing

regulations.

Acute-chronic ratio (ACR) is a

standard measure of the acute toxicity of

a material divided by an appropriate

measure of the chronic toxicity of the

same material under comparable

conditions.

Acute toxicity is concurrent and

delayed adverse effect(s) that results

from an acute exposure and occurs

within any short observation period

which begins when the exposure begins,

may extend beyond the exposure

period, and usually does not constitute

a substantial portion of the life span of

the organism.

Adverse effect is any deleterious effect

to organisms due to exposure to a

substance. This includes effects which

are or may become debilitating, harmful

or toxic to the normal functions of the

organism, but does not include nonharmful effects such as tissue

discoloration alone or the induction of

enzymes involved in the metabolism of

the substance.

Bioaccumulation is the net

accumulation of a substance by an

organism as a result of uptake from all

environmental sources.

Bioaccumulation factor (BAF) is the

ratio (in L/kg) of a substance’s

concentration in tissue of an aquatic

organism to its concentration in the

ambient water, in situations where both

the organism and its food are exposed

and the ratio does not change

substantially over time.

Bioaccumulative chemical of concern

(BCC) is any chemical that has the

potential to cause adverse effects which,

upon entering the surface waters, by

itself or as its toxic transformation
15388 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

product, accumulates in aquatic

organisms by a human health

bioaccumulation factor greater than

1000, after considering metabolism and

other physicochemical properties that

might enhance or inhibit

bioaccumulation, in accordance with

the methodology in appendix B of this

part. Chemicals with half-lives of less

than eight weeks in the water column,

sediment, and biota are not BCCs. The

minimum BAF information needed to

define an organic chemical as a BCC is

either a field-measured BAF or a BAF

derived using the BSAF methodology.

The minimum BAF information needed

to define an inorganic chemical,

including an organometal, as a BCC is

either a field-measured BAF or a

laboratory-measured BCF. BCCs

include, but are not limited to, the

pollutants identified as BCCs in section

A of Table 6 of this part.

Bioconcentration is the net

accumulation of a substance by an

aquatic organism as a result of uptake

directly from the ambient water through

gill membranes or other external body

surfaces.

Bioconcentration factor (BCF) is the

ratio (in L/kg) of a substance’s

concentration in tissue of an aquatic

organism to its concentration in the

ambient water, in situations where the

organism is exposed through the water

only and the ratio does not change

substantially over time.

Biota-sediment accumulation factor

(BSAF) is the ratio (in kg of organic

carbon/kg of lipid) of a substance’s

lipid-normalized concentration in tissue

of an aquatic organism to its organic

carbon-normalized concentration in

surface sediment, in situations where

the ratio does not change substantially

over time, both the organism and its

food are exposed, and the surface

sediment is representative of average

surface sediment in the vicinity of the

organism.

Carcinogen is a substance which

causes an increased incidence of benign

or malignant neoplasms, or substantially

decreases the time to develop

neoplasms, in animals or humans. The

classification of carcinogens is

discussed in section II.A of appendix C

to part 132.

Chronic toxicity is concurrent and

delayed adverse effect(s) that occurs

only as a result of a chronic exposure.

Connecting channels of the Great

Lakes are the Saint Mary’s River, Saint

Clair River, Detroit River, Niagara River,

and Saint Lawrence River to the

Canadian Border.

Criterion continuous concentration

(CCC) is an estimate of the highest

concentration of a material in the water

column to which an aquatic community

can be exposed indefinitely without

resulting in an unacceptable effect.

Criterion maximum concentration

(CMC) is an estimate of the highest

concentration of a material in the water

column to which an aquatic community

can be exposed briefly without resulting

in an unacceptable effect.

EC50 is a statistically or graphically

estimated concentration that is expected

to cause one or more specified effects in

50 percent of a group of organisms

under specified conditions.

Endangered or threatened species are

those species that are listed as

endangered or threatened under section

4 of the Endangered Species Act.

Existing Great Lakes discharger is any

building, structure, facility, or

installation from which there is or may

be a ‘‘discharge of pollutants’’ (as

defined in 40 CFR 122.2) to the Great

Lakes System, that is not a new Great

Lakes discharger.

Federal Indian reservation, Indian

reservation, or reservation means all

land within the limits of any Indian

reservation under the jurisdiction of the

United States Government,

notwithstanding the issuance of any

patent, and including rights-of-way

running through the reservation.

Final acute value (FAV) is (a) a

calculated estimate of the concentration

of a test material such that 95 percent

of the genera (with which acceptable

acute toxicity tests have been conducted

on the material) have higher GMAVs, or

(b) the SMAV of an important and/or

critical species, if the SMAV is lower

than the calculated estimate.

Final chronic value (FCV) is (a) a

calculated estimate of the concentration

of a test material such that 95 percent

of the genera (with which acceptable

chronic toxicity tests have been

conducted on the material) have higher

GMCVs, (b) the quotient of an FAV

divided by an appropriate acute-chronic

ratio, or (c) the SMCV of an important

and/or critical species, if the SMCV is

lower than the calculated estimate or

the quotient, whichever is applicable.

Final plant value (FPV) is the lowest

plant value that was obtained with an

important aquatic plant species in an

acceptable toxicity test for which the

concentrations of the test material were

measured and the adverse effect was

biologically important.

Genus mean acute value (GMAV) is

the geometric mean of the SMAVs for

the genus.

Genus mean chronic value (GMCV) is

the geometric mean of the SMCVs for

the genus.

Great Lakes means Lake Ontario, Lake

Erie, Lake Huron (including Lake St.

Clair), Lake Michigan, and Lake

Superior; and the connecting channels

(Saint Mary’s River, Saint Clair River,

Detroit River, Niagara River, and Saint

Lawrence River to the Canadian Border).

Great Lakes States and Great Lakes

Tribes, or Great Lakes States and Tribes

means the States of Illinois, Indiana,

Michigan, Minnesota, New York, Ohio,

Pennsylvania, and Wisconsin, and any

Indian Tribe as defined in this part

which is located in whole or in part

within the drainage basin of the Great

Lakes, and for which EPA has approved

water quality standards under section

303 of the Clean Water Act or which

EPA has authorized to administer an

NPDES program under section 402 of

the Clean Water Act.

Great Lakes System means all the

streams, rivers, lakes and other bodies of

water within the drainage basin of the

Great Lakes within the United States.

Human cancer criterion (HCC) is a

Human Cancer Value (HCV) for a

pollutant that meets the minimum data

requirements for Tier I specified in

appendix C of this part.

Human cancer value (HCV) is the

maximum ambient water concentration

of a substance at which a lifetime of

exposure from either: drinking the

water, consuming fish from the water,

and water-related recreation activities;

or consuming fish from the water, and

water-related recreation activities, will

represent a plausible upper-bound risk

of contracting cancer of one in 100,000

using the exposure assumptions

specified in the Methodologies for the

Development of Human Health Criteria

and Values in appendix C of this part.

Human noncancer criterion (HNC) is

a Human Noncancer Value (HNV) for a

pollutant that meets the minimum data

requirements for Tier I specified in

appendix C of this part.

Human noncancer value (HNV) is the

maximum ambient water concentration

of a substance at which adverse

noncancer effects are not likely to occur

in the human population from lifetime

exposure via either: drinking the water,

consuming fish from the water, and

water-related recreation activities; or

consuming fish from the water, and

water-related recreation activities using

the Methodologies for the Development

of Human Health Criteria and Values in

appendix C of this part.

Indian Tribe or Tribe means any

Indian Tribe, band, group, or

community recognized by the Secretary

of the Interior and exercising

governmental authority over a Federal

Indian reservation.

LC50 is a statistically or graphically

estimated concentration that is expected
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15389

to be lethal to 50 percent of a group of

organisms under specified conditions.

Load allocation (LA) is the portion of

a receiving water’s loading capacity that

is attributed either to one of its existing

or future nonpoint sources or to natural

background sources, as more fully

defined at 40 CFR 130.2(g). Nonpoint

sources include: in-place contaminants,

direct wet and dry deposition,

groundwater inflow, and overland

runoff.

Loading capacity is the greatest

amount of loading that a water can

receive without violating water quality

standards.

Lowest observed adverse effect level

(LOAEL) is the lowest tested dose or

concentration of a substance which

resulted in an observed adverse effect in

exposed test organisms when all higher

doses or concentrations resulted in the

same or more severe effects.

Method detection level is the

minimum concentration of an analyte

(substance) that can be measured and

reported with a 99 percent confidence

that the analyte concentration is greater

than zero as determined by the

procedure set forth in appendix B of 40

CFR part 136.

Minimum Level (ML) is the

concentration at which the entire

analytical system must give a

recognizable signal and acceptable

calibration point. The ML is the

concentration in a sample that is

equivalent to the concentration of the

lowest calibration standard analyzed by

a specific analytical procedure,

assuming that all the method-specified

sample weights, volumes and

processing steps have been followed.

New Great Lakes discharger is any

building, structure, facility, or

installation from which there is or may

be a ‘‘discharge of pollutants’’ (as

defined in 40 CFR 122.2) to the Great

Lakes System, the construction of which

commenced after March 23, 1997.

No observed adverse effect level

(NOAEL) is the highest tested dose or

concentration of a substance which

resulted in no observed adverse effect in

exposed test organisms where higher

doses or concentrations resulted in an

adverse effect.

No observed effect concentration

(NOEC) is the highest concentration of

toxicant to which organisms are

exposed in a full life-cycle or partial

life-cycle (short-term) test, that causes

no observable adverse effects on the test

organisms (i.e., the highest

concentration of toxicant in which the

values for the observed responses are

not statistically significantly different

from the controls).

Open waters of the Great Lakes

(OWGLs) means all of the waters within

Lake Erie, Lake Huron (including Lake

St. Clair), Lake Michigan, Lake Ontario,

and Lake Superior lakeward from a line

drawn across the mouth of tributaries to

the Lakes, including all waters enclosed

by constructed breakwaters, but not

including the connecting channels.

Quantification level is a measurement

of the concentration of a contaminant

obtained by using a specified laboratory

procedure calibrated at a specified

concentration above the method

detection level. It is considered the

lowest concentration at which a

particular contaminant can be

quantitatively measured using a

specified laboratory procedure for

monitoring of the contaminant.

Quantitative structure activity

relationship (QSAR) or structure activity

relationship (SAR) is a mathematical

relationship between a property

(activity) of a chemical and a number of

descriptors of the chemical. These

descriptors are chemical or physical

characteristics obtained experimentally

or predicted from the structure of the

chemical.

Risk associated dose (RAD) is a dose

of a known or presumed carcinogenic

substance in (mg/kg)/day which, over a

lifetime of exposure, is estimated to be

associated with a plausible upper bound

incremental cancer risk equal to one in

100,000.

Species mean acute value (SMAV) is

the geometric mean of the results of all

acceptable flow-through acute toxicity

tests (for which the concentrations of

the test material were measured) with

the most sensitive tested life stage of the

species. For a species for which no such

result is available for the most sensitive

tested life stage, the SMAV is the

geometric mean of the results of all

acceptable acute toxicity tests with the

most sensitive tested life stage.

Species mean chronic value (SMCV)

is the geometric mean of the results of

all acceptable life-cycle and partial lifecycle toxicity tests with the species; for

a species of fish for which no such

result is available, the SMCV is the

geometric mean of all acceptable early

life-stage tests.

Stream design flow is the stream flow

that represents critical conditions,

upstream from the source, for protection

of aquatic life, human health, or

wildlife.

Threshold effect is an effect of a

substance for which there is a

theoretical or empirically established

dose or concentration below which the

effect does not occur.

Tier I criteria are numeric values

derived by use of the Tier I

methodologies in appendixes A, C and

D of this part, the methodology in

appendix B of this part, and the

procedures in appendix F of this part,

that either have been adopted as

numeric criteria into a water quality

standard or are used to implement

narrative water quality criteria.

Tier II values are numeric values

derived by use of the Tier II

methodologies in appendixes A and C of

this part, the methodology in appendix

B of this part, and the procedures in

appendix F of this part, that are used to

implement narrative water quality

criteria.

Total maximum daily load (TMDL) is

the sum of the individual wasteload

allocations for point sources and load

allocations for nonpoint sources and

natural background, as more fully

defined at 40 CFR 130.2(i). A TMDL sets

and allocates the maximum amount of

a pollutant that may be introduced into

a water body and still assure attainment

and maintenance of water quality

standards.

Tributaries of the Great Lakes System

means all waters of the Great Lakes

System that are not open waters of the

Great Lakes, or connecting channels.

Uncertainty factor (UF) is one of

several numeric factors used in

operationally deriving criteria from

experimental data to account for the

quality or quantity of the available data.

Uptake is acquisition of a substance

from the environment by an organism as

a result of any active or passive process.

Wasteload allocation (WLA) is the

portion of a receiving water’s loading

capacity that is allocated to one of its

existing or future point sources of

pollution, as more fully defined at 40

CFR 130.2(h). In the absence of a TMDL

approved by EPA pursuant to 40 CFR

130.7 or an assessment and remediation

plan developed and approved in

accordance with procedure 3.A of

appendix F of this part, a WLA is the

allocation for an individual point

source, that ensures that the level of

water quality to be achieved by the

point source is derived from and

complies with all applicable water

quality standards.

Wet weather point source means any

discernible, confined and discrete

conveyance from which pollutants are,

or may be, discharged as the result of a

wet weather event. Discharges from wet

weather point sources shall include

only: discharges of storm water from a

municipal separate storm sewer as

defined at 40 CFR 122.26(b)(8); storm

water discharge associated with

industrial activity as defined at 40 CFR

122.26(b)(14); discharges of storm water

and sanitary wastewaters (domestic,
15390 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

commercial, and industrial) from a

combined sewer overflow; or any other

stormwater discharge for which a permit

is required under section 402(p) of the

Clean Water Act. A storm water

discharge associated with industrial

activity which is mixed with process

wastewater shall not be considered a

wet weather point source.

§ 132.3 Adoption of criteria.

The Great Lakes States and Tribes

shall adopt numeric water quality

criteria for the purposes of section

303(c) of the Clean Water Act applicable

to waters of the Great Lakes System in

accordance with § 132.4(d) that are

consistent with:

(a) The acute water quality criteria for

protection of aquatic life in Table 1 of

this part, or a site-specific modification

thereof in accordance with procedure 1

of appendix F of this part;

(b) The chronic water quality criteria

for protection of aquatic life in Table 2

of this part, or a site-specific

modification thereof in accordance with

procedure 1 of appendix F of this part;

(c) The water quality criteria for

protection of human health in Table 3

of this part, or a site-specific

modification thereof in accordance with

procedure 1 of appendix F of this part;

and

(d) The water quality criteria for

protection of wildlife in Table 4 of this

part, or a site-specific modification

thereof in accordance with procedure 1

of appendix F of this part.

§ 132.4 State adoption and application of

methodologies, policies and procedures.

(a) The Great Lakes States and Tribes

shall adopt requirements applicable to

waters of the Great Lakes System for the

purposes of sections 118, 301, 303, and

402 of the Clean Water Act that are

consistent with:

(1) The definitions in § 132.2;

(2) The Methodologies for

Development of Aquatic Life Criteria

and Values in appendix A of this part;

(3) The Methodology for Development

of Bioaccumulation Factors in appendix

B of this part;

(4) The Methodologies for

Development of Human Health Criteria

and Values in appendix C of this part;

(5) The Methodology for Development

of Wildlife Criteria in appendix D of this

part;

(6) The Antidegradation Policy in

appendix E of this part; and

(7) The Implementation Procedures in

appendix F of this part.

(b) Except as provided in paragraphs

(g), (h), and (i) of this section, the Great

Lakes States and Tribes shall use

methodologies consistent with the

methodologies designated as Tier I

methodologies in appendixes A, C, and

D of this part, the methodology in

appendix B of this part, and the

procedures in appendix F of this part

when adopting or revising numeric

water quality criteria for the purposes of

section 303(c) of the Clean Water Act for

the Great Lakes System.

(c) Except as provided in paragraphs

(g), (h), and (i) of this section, the Great

Lakes States and Tribes shall use

methodologies and procedures

consistent with the methodologies

designated as Tier I methodologies in

appendixes A, C, and D of this part, the

Tier II methodologies in appendixes A

and C of this part, the methodology in

appendix B of this part, and the

procedures in appendix F of this part to

develop numeric criteria and values

when implementing narrative water

quality criteria adopted for purposes of

section 303(c) of the Clean Water Act.

(d) The water quality criteria and

values adopted or developed pursuant

to paragraphs (a) through (c) of this

section shall apply as follows:

(1) The acute water quality criteria

and values for the protection of aquatic

life, or site-specific modifications

thereof, shall apply to all waters of the

Great Lakes System.

(2) The chronic water quality criteria

and values for the protection of aquatic

life, or site-specific modifications

thereof, shall apply to all waters of the

Great Lakes System.

(3) The water quality criteria and

values for protection of human health,

or site-specific modifications thereof,

shall apply as follows:

(i) Criteria and values derived as

HCV-Drinking and HNV-Drinking shall

apply to the Open Waters of the Great

Lakes, all connecting channels of the

Great Lakes, and all other waters of the

Great Lakes System that have been

designated as public water supplies by

any State or Tribe in accordance with 40

CFR 131.10.

(ii) Criteria and values derived as

HCV-Nondrinking and HNVNondrinking shall apply to all waters of

the Great Lakes System other than those

in paragraph (d)(3)(i) of this section.

(4) Criteria for protection of wildlife,

or site-specific modifications thereof,

shall apply to all waters of the Great

Lakes System.

(e) The Great Lakes States and Tribes

shall apply implementation procedures

consistent with the procedures in

appendix F of this part for all applicable

purposes under the Clean Water Act,

including developing total maximum

daily loads for the purposes of section

303(d) and water quality-based effluent

limits for the purposes of section 402, in

establishing controls on the discharge of

any pollutant to the Great Lakes System

by any point source with the following

exceptions:

(1) The Great Lakes States and Tribes

are not required to apply these

implementation procedures in

establishing controls on the discharge of

any pollutant by a wet weather point

source. Any adopted implementation

procedures shall conform with all

applicable Federal, State and Tribal

requirements.

(2) The Great Lakes States and Tribes

may, but are not required to, apply

procedures consistent with procedures

1, 2, 3, 4, 5, 7, 8, and 9 of appendix F

of this part in establishing controls on

the discharge of any pollutant set forth

in Table 5 of this part. Any procedures

applied in lieu of these implementation

procedures shall conform with all

applicable Federal, State, and Tribal

requirements.

(f) The Great Lakes States and Tribes

shall apply an antidegradation policy

consistent with the policy in appendix

E for all applicable purposes under the

Clean Water Act, including 40 CFR

131.12.

(g) For pollutants listed in Table 5 of

this part, the Great Lakes States and

Tribes shall:

(1) Apply any methodologies and

procedures acceptable under 40 CFR

part 131 when developing water quality

criteria or implementing narrative

criteria; and

(2) Apply the implementation

procedures in appendix F of this part or

alternative procedures consistent with

all applicable Federal, State, and Tribal

laws.

(h) For any pollutant other than those

in Table 5 of this part for which the

State or Tribe demonstrates that a

methodology or procedure in this part is

not scientifically defensible, the Great

Lakes States and Tribes shall:

(1) Apply an alternative methodology

or procedure acceptable under 40 CFR

part 131 when developing water quality

criteria; or

(2) Apply an alternative

implementation procedure that is

consistent with all applicable Federal,

State, and Tribal laws.

(i) Nothing in this part shall prohibit

the Great Lakes States and Tribes from

adopting numeric water quality criteria,

narrative criteria, or water quality

values that are more stringent than

criteria or values specified in § 132.3 or

that would be derived from application

of the methodologies set forth in

appendixes A, B, C, and D of this part,

or to adopt antidegradation standards

and implementation procedures more
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15391

stringent than those set forth in

appendixes E and F of this part.

§ 132.5 Procedures for adoption and EPA

review.

(a) Except as provided in paragraph

(c) of this section, the Great Lakes States

and Tribes shall adopt and submit for

EPA review and approval the criteria,

methodologies, policies, and procedures

developed pursuant to this part no later

than September 23, 1996.

(b) The following elements must be

included in each submission to EPA for

review:

(1) The criteria, methodologies,

policies, and procedures developed

pursuant to this part;

(2) Certification by the Attorney

General or other appropriate legal

authority pursuant to 40 CFR 123.62

and 40 CFR 131.6(e) as appropriate;

(3) All other information required for

submission of National Pollutant

Discharge Elimination System (NPDES)

program modifications under 40 CFR

123.62; and

(4) General information which will

aid EPA in determining whether the

criteria, methodologies, policies and

procedures are consistent with the

requirements of the Clean Water Act

and this part, as well as information on

general policies which may affect their

application and implementation.

(c) The Regional Administrator may

extend the deadline for the submission

required in paragraph (a) of this section

if the Regional Administrator believes

that the submission will be consistent

with the requirements of this part and

can be reviewed and approved pursuant

to this section no later than March 23,

1997.

(d) If a Great Lakes State or Tribe

makes no submission pursuant to this

part to EPA for review, the requirements

of this part shall apply to discharges to

waters of the Great Lakes System

located within the State or Federal

Indian reservation upon EPA’s

publication of a final rule indicating the

effective date of the part 132

requirements in the identified

jurisdictions.

(e) If a Great Lakes State or Tribe

submits criteria, methodologies,

policies, and procedures pursuant to

this part to EPA for review that contain

substantial modifications of the State or

Tribal NPDES program, EPA shall issue

public notice and provide a minimum of

30 days for public comment on such

modifications. The public notice shall

conform with the requirements of 40

CFR 123.62.

(f) After review of State or Tribal

submissions under this section, and

following the public comment period in

subparagraph (e) of this section, if any,

EPA shall either:

(1) Publish notice of approval of the

submission in the Federal Register

within 90 days of such submission; or

(2) Notify the State or Tribe within 90

days of such submission that EPA has

determined that all or part of the

submission is inconsistent with the

requirements of the Clean Water Act or

this part and identify any necessary

changes to obtain EPA approval. If the

State or Tribe fails to adopt such

changes within 90 days after the

notification, EPA shall publish a notice

in the Federal Register identifying the

approved and disapproved elements of

the submission and a final rule in the

Federal Register identifying the

provisions of part 132 that shall apply

to discharges within the State or Federal

Indian reservation.

(g) EPA’s approval or disapproval of

a State or Tribal submission shall be

based on the requirements of this part

and of the Clean Water Act. EPA’s

determination whether the criteria,

methodologies, policies, and procedures

in a State or Tribal submission are

consistent with the requirements of this

part will be based on whether:

(1) For pollutants listed in Tables 1,

2, 3, and 4 of this part. The Great Lakes

State or Tribe has adopted numeric

water quality criteria as protective as

each of the numeric criteria in Tables 1,

2, 3, and 4 of this part, taking into

account any site-specific criteria

modifications in accordance with

procedure 1 of appendix F of this part;

(2) For pollutants other than those

listed in Tables 1, 2, 3, 4, and 5 of this

part. The Great Lakes State or Tribe

demonstrates that either:

(i) It has adopted numeric criteria in

its water quality standards that were

derived, or are as protective as or more

protective than could be derived, using

the methodologies in appendixes A, B,

C, and D of this part, and the sitespecific criteria modification procedures

in accordance with procedure 1 of

appendix F of this part; or

(ii) It has adopted a procedure by

which water quality-based effluent

limits and total maximum daily loads

are developed using the more protective

of:

(A) Numeric criteria adopted by the

State into State water quality standards

and approved by EPA prior to March 23,

1997; or

(B) Water quality criteria and values

derived pursuant to § 132.4(c); and

(3) For methodologies, policies, and

procedures. The Great Lakes State or

Tribe has adopted methodologies,

policies, and procedures as protective as

the corresponding methodology, policy,

or procedure in § 132.4. The Great Lakes

State or Tribe may adopt provisions that

are more protective than those

contained in this part. Adoption of a

more protective element in one

provision may be used to offset a less

protective element in the same

provision as long as the adopted

provision is as protective as the

corresponding provision in this part;

adoption of a more protective element

in one provision, however, is not

justification for adoption of a less

protective element in another provision

of this part.

(h) A submission by a Great Lakes

State or Tribe will need to include any

provisions that EPA determines, based

on EPA’s authorities under the Clean

Water Act and the results of

consultation under section 7 of the

Endangered Species Act, are necessary

to ensure that water quality is not likely

to jeopardize the continued existence of

any endangered or threatened species

listed under section 4 of the Endangered

Species Act or result in the destruction

or adverse modification of such species’

critical habitat.

(i) EPA’s approval of the elements of

a State’s or Tribe’s submission will

constitute approval under section 118 of

the Clean Water Act, approval of the

submitted water quality standards

pursuant to section 303 of the Clean

Water Act, and approval of the

submitted modifications to the State’s or

Tribe’s NPDES program pursuant to

section 402 of the Clean Water Act.

§ 132.6 Application of part 132

requirements in Great Lakes States and

Tribes. [Reserved]

Tables to Part 132

TABLE 1.—ACUTE WATER QUALITY

CRITERIA FOR PROTECTION OF AQUATIC

LIFE IN AMBIENT WATER

EPA recommends that metals criteria be

expressed as dissolved concentrations (see

appendix A, I.A.4 for more information

regarding metals criteria).

(a)

Chemical CMC

(μg/L)

Conversion

factor

(CF)

Arsenic (III) ................. a,b 339.8 1.000

Chromium (VI) ............ a,b 16.02 0.982

Cyanide ....................... c 22 n/a

Dieldrin ........................ d 0.24 n/a

Endrin .......................... d 0.086 n/a

Lindane ....................... d 0.95 n/a

Mercury (II) ................. a,b 1.694 0.85

Parathion ..................... d 0.065 n/a

Selenium ..................... a,b 19.34 0.922

a CMC=CMCtr. b CMCd=(CMCtr) CF. The CMCd shall be

rounded to two significant digits.
15392 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

c CMC should be considered free cyanide as

CN. d CMC=CMCt

.

Notes:

The term ‘‘n/a’’ means not applicable.

CMC is Criterion Maximum Concentration.

CMCtr is the CMC expressed as total recoverable.

CMCd is the CMC expressed as a dissolved

concentration.

CMCt is the CMC expressed as a total concentration.

(b)

Chemical mA bA

Conversion factor (CF)

Cadmium a,b ............................................................................................................................................................ 1.128 ¥3.6867 0.85

Chromium (III) a,b .................................................................................................................................................... 0.819 +3.7256 0.316

Copper a,b ................................................................................................................................................................ 0.9422 ¥1.700 0.960

Nickel a,b .................................................................................................................................................................. 0.846 +2.255 0.998

Pentachlorophenol c ............................................................................................................................................... 1.005 ¥4.869 n/a

Zinc a,b ..................................................................................................................................................................... 0.8473 +0.884 0.978

a CMCtr=exp { mA [ln (hardness)]+bA}. b CMCd=(CMCtr) CF. The CMCd shall be rounded to two significant digits. c CMCt

=exp mA { [pH]+bA}. The CMCt shall be rounded to two significant digits.

Notes:

The term ‘‘exp’’ represents the base e exponential function.

The term ‘‘n/a’’ means not applicable.

CMC is Criterion Maximum Concentration.

CMCtr is the CMC expressed as total recoverable.

CMCd is the CMC expressed as a dissolved concentration.

CMCt is the CMC expressed as a total concentration.

TABLE 2.—CHRONIC WATER QUALITY

CRITERIA FOR PROTECTION OF AQUATIC

LIFE IN AMBIENT WATER

EPA recommends that metals criteria be

expressed as dissolved concentrations (see

appendix A, I.A.4 for more information

regarding metals criteria).

(a)

Chemical CCC

(μg/L)

Conversion

factor

(CF)

Arsenic (III) ............... a,b 147.9 1.000

Chromium (VI) .......... a,b 10.98 0.962

Cyanide ..................... c 5.2 n/a

Dieldrin ...................... d 0.056 n/a

Endrin ........................ d 0.036 n/a

Mercury (II) ............... a,b 0.9081 0.85

Parathion ................... d 0.013 n/a

Selenium ................... a,b 5 0.922

a CCC=CCCtr.

b CCCd=(CCCtr) CF. The CCCd shall be

rounded to two significant digits. c CCC should be considered free cyanide as

CN. d CCC=CCCt

.

Notes:

The term ‘‘n/a’’ means not applicable.

CCC is Criterion Continuous Concentration.

CCCtr is the CCC expressed as total recoverable.

CCCd is the CCC expressed as a dissolved

concentration.

CCCt is the CCC expressed as a total concentration.

(b)

Chemical mc bc

Conversion

factor

(CF)

Cadmiuma,b ... 0.7852 ¥2.715 0.850

Chromium

(III)a,b .......... 0.819 +0.6848 0.860

Coppera,b ....... 0.8545 ¥1.702 0.960

Chemical mc bc

Conversion

factor

(CF)

Nickela,b ......... 0.846 +0.0584 0.997

Pentachlorophenolc ......... 1.005 ¥5.134 n/a

Zinca,b ............ 0.8473 +0.884 0.986

aCCCtr=exp {mc[ln (hardness)]+bc}. bCCCd=(CCCtr) (CF). The CCCd shall be

rounded to two significant digits. cCMCt

=exp {mA[pH]+bA}. The CMCt shall

be rounded to two significant digits.

Notes:

The term ‘‘exp’’ represents the base e exponential function.

The term ‘‘n/a’’ means not applicable.

CCC is Criterion Continuous Concentration.

CCCtr is the CCC expressed as total recoverable.

CCCd is the CCC expressed as a dissolved

concentration.

CCCt is the CCC expressed as a total concentration.

TABLE 3.—WATER QUALITY CRITERIA FOR PROTECTION OF HUMAN HEALTH

Chemical

HNV (μg/L) HCV (μg/L)

Drinking Nondrinking Drinking Nondrinking

Benzene ............................................................................................................................... 1.9E1 5.1E2 1.2E1 3.1E2

Chlordane ............................................................................................................................. 1.4E–3 1.4E–3 2.5E–4 2.5E–4

Chlorobenzene ..................................................................................................................... 4.7E2 3.2E3

Cyanides .............................................................................................................................. 6.0E2 4.8E4

DDT ...................................................................................................................................... 2.0E–3 2.0E–3 1.5E–4 1.5E–4

Dieldrin ................................................................................................................................. 4.1E–4 4.1E–4 6.5E–6 6.5E–6

2,4-Dimethylphenol .............................................................................................................. 4.5E2 8.7E3

2,4-Dinitrophenol .................................................................................................................. 5.5E1 2.8E3

Hexachlorobenzene ............................................................................................................. 4.6E–2 4.6E–2 4.5E–4 4.5E–4

Hexachloroethane ................................................................................................................ 6.0 7.6 5.3 6.7

Lindane ................................................................................................................................. 4.7E–1 5.0E–1

Mercury 1 .............................................................................................................................. 1.8E–3 1.8E–3

Methylene chloride ............................................................................................................... 1.6E3 9.0E4 4.7E1 2.6E3

PCBs (class) ........................................................................................................................ 3.9E–6 3.9E–6

2,3,7,8-TCDD ....................................................................................................................... 6.7E–8 6.7E–8 8.6E–9 8.6E–9

Toluene ................................................................................................................................ 5.6E3 5.1E4

Toxaphene ........................................................................................................................... 6.8E–5 6.8E–5
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15393

TABLE 3.—WATER QUALITY CRITERIA FOR PROTECTION OF HUMAN HEALTH—Continued

Chemical

HNV (μg/L) HCV (μg/L)

Drinking Nondrinking Drinking Nondrinking

Trichloroethylene .................................................................................................................. 2.9E1 3.7E2

1 Includes methylmercury.

TABLE 4.—WATER QUALITY CRITERIA

FOR PROTECTION OF WILDLIFE

Chemical Criteria

(μg/L)

DDT and metabolites ................... 1.1E–5

Mercury (including

methylmercury).

1.3E–3

PCBs (class) ................................ 7.4E–5

2,3,7,8-TCDD ............................... 3.1E–9

TABLE 5.—POLLUTANTS SUBJECT TO

FEDERAL, STATE, AND TRIBAL

REQUIREMENTS

Alkalinity

Ammonia

Bacteria

Biochemical oxygen demand (BOD)

Chlorine

Color

Dissolved oxygen

Dissolved solids

pH

Phosphorus

Salinity

Temperature

Total and suspended solids

Turbidity

TABLE 6.—POLLUTANTS OF INITIAL FOCUS

IN THE GREAT LAKES WATER QUALITY

INITIATIVE

A. Pollutants that are bioaccumulative

chemicals of concern (BCCs):

Chlordane

4,4′-DDD; p,p′-DDD; 4,4′-TDE; p,p′-TDE

4,4′-DDE; p,p′-DDE

4,4′-DDT; p,p′-DDT

Dieldrin

Hexachlorobenzene

Hexachlorobutadiene; hexachloro-1, 3-

butadiene

Hexachlorocyclohexanes; BHCs

alpha-Hexachlorocyclohexane; alpha-BHC

beta-Hexachlorocyclohexane; beta-BHC

delta-Hexachlorocyclohexane; delta-BHC

Lindane; gamma-hexachlorocyclohexane;

gamma-BHC

Mercury

Mirex

Octachlorostyrene

PCBs; polychlorinated biphenyls

Pentachlorobenzene

Photomirex

2,3,7,8-TCDD; dioxin

1,2,3,4-Tetrachlorobenzene

1,2,4,5-Tetrachlorobenzene Toxaphene

B. Pollutants that are not bioaccumulative

chemicals of concern:

Acenaphthene

Acenaphthylene

Acrolein; 2-propenal

Acrylonitrile

Aldrin

Aluminum

Anthracene

Antimony

Arsenic

Asbestos

1,2-Benzanthracene; benz[a]anthracene

Benzene

Benzidine

Benzo[a]pyrene; 3,4-benzopyrene

3,4-Benzofluoranthene;

benzo[b]fluoranthene

11,12-Benzofluoranthene;

benzo[k]fluoranthene

1,12-Benzoperylene; benzo[ghi]perylene

Beryllium

Bis(2-chloroethoxy) methane

Bis(2-chloroethyl) ether

Bis(2-chloroisopropyl) ether

Bromoform; tribomomethane

4-Bromophenyl phenyl ether

Butyl benzyl phthalate

Cadmium

Carbon tetrachloride; tetrachloromethane

Chlorobenzene

p-Chloro-m-cresol; 4-chloro-3-

methylphenol

Chlorodibromomethane

Chlorethane

2-Chloroethyl vinyl ether

Chloroform; trichloromethane

2-Chloronaphthalene

2-Chlorophenol

4-Chlorophenyl phenyl ether

Chlorpyrifos

Chromium

Chrysene

Copper

Cyanide

2,4-D; 2,4-Dichlorophenoxyacetic acid

DEHP; di(2-ethylhexyl) phthalate

Diazinon

1,2:5,6-Dibenzanthracene;

dibenz[a,h]anthracene

Dibutyl phthalate; di-n-butyl phthalate

1,2-Dichlorobenzene

1,3-Dichlorobenzene

1,4-Dichlorobenzene

3,3′-Dichlorobenzidine

Dichlorobromomethane;

bromodichloromethane

1,1-Dichloroethane

1,2-Dichloroethane

1,1-Dichloroethylene; vinylidene chloride

1,2-trans-Dichloroethylene

2,4-Dichlorophenol

1,2-Dichloropropane

1,3-Dichloropropene; 1,3-

dichloropropylene

Diethyl phthalate

2,4-Dimethylphenol; 2,4-xylenol

Dimethyl phthalate

4,6-Dinitro-o-cresol; 2-methyl-4,6-

dinitrophenol

2,4-Dinitrophenol

2,4-Dinitrotoluene

2,6-Dinitrotoluene

Dioctyl phthalate; di-n-octyl phthalate

1,2-Diphenylhydrazine

Endosulfan; thiodan

alpha-Endosulfan

beta-Endosulfan

Endosulfan sulfate

Endrin

Endrin aldehyde

Ethylbenzene

Fluoranthene

Fluorene; 9H-fluorene

Fluoride

Guthion

Heptachlor

Heptachlor epoxide

Hexachlorocyclopentadiene

Hexachloroethane

Indeno[1,2,3-cd]pyrene; 2,3-o-phenylene

pyrene

Isophorone

Lead

Malathion

Methoxychlor

Methyl bromide; bromomethane

Methyl chloride; chloromethane

Methylene chloride; dichloromethane

Napthalene

Nickel

Nitrobenzene

2-Nitrophenol

4-Nitrophenol

N-Nitrosodimethylamine

N-Nitrosodiphenylamine

N-Nitrosodipropylamine; N-nitrosodi-npropylamine

Parathion

Pentachlorophenol

Phenanthrene

Phenol

Iron

Pyrene

Selenium

Silver

1,1,2,2-Tetrachloroethane

Tetrachloroethylene

Thallium

Toluene; methylbenzene

1,2,4-Trichlorobenzene

1,1,1-Trichloroethane

1,1,2-Trichloroethane

Trichloroethylene; trichloroethene

2,4,6-Trichlorophenol

Vinyl chloride; chloroethylene;

chloroethene

Zinc

Appendix A to part 132—Great Lakes Water

Quality Initiative Methodologies for

Developments of Aquatic Life Criteria and

Values

Methodology for Deriving Aquatic Life

Criteria: Tier I

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

this appendix.
15394 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

I. Definitions

A. Material of Concern. When defining the

material of concern the following should be

considered:

1. Each separate chemical that does not

ionize substantially in most natural bodies of

water should usually be considered a

separate material, except possibly for

structurally similar organic compounds that

only exist in large quantities as commercial

mixtures of the various compounds and

apparently have similar biological, chemical,

physical, and toxicological properties.

2. For chemicals that ionize substantially

in most natural bodies of water (e.g., some

phenols and organic acids, some salts of

phenols and organic acids, and most

inorganic salts and coordination complexes

of metals and metalloid), all forms that

would be in chemical equilibrium should

usually be considered one material. Each

different oxidation state of a metal and each

different non-ionizable covalently bonded

organometallic compound should usually be

considered a separate material.

3. The definition of the material of concern

should include an operational analytical

component. Identification of a material

simply as ‘‘sodium,’’ for example, implies

‘‘total sodium,’’ but leaves room for doubt. If

‘‘total’’ is meant, it must be explicitly stated.

Even ‘‘total’’ has different operational

definitions, some of which do not necessarily

measure ‘‘all that is there’’ in all samples.

Thus, it is also necessary to reference or

describe the analytical method that is

intended. The selection of the operational

analytical component should take into

account the analytical and environmental

chemistry of the material and various

practical considerations, such as labor and

equipment requirements, and whether the

method would require measurement in the

field or would allow measurement after

samples are transported to a laboratory.

a. The primary requirements of the

operational analytical component are that it

be appropriate for use on samples of

receiving water, that it be compatible with

the available toxicity and bioaccumulation

data without making extrapolations that are

too hypothetical, and that it rarely result in

underprotection or overprotection of aquatic

organisms and their uses. Toxicity is the

property of a material, or combination of

materials, to adversely affect organisms.

b. Because an ideal analytical measurement

will rarely be available, an appropriate

compromise measurement will usually have

to be used. This compromise measurement

must fit with the general approach that if an

ambient concentration is lower than the

criterion, unacceptable effects will probably

not occur, i.e., the compromise measure must

not err on the side of underprotection when

measurements are made on a surface water.

What is an appropriate measurement in one

situation might not be appropriate for

another. For example, because the chemical

and physical properties of an effluent are

usually quite different from those of the

receiving water, an analytical method that is

appropriate for analyzing an effluent might

not be appropriate for expressing a criterion,

and vice versa. A criterion should be based

on an appropriate analytical measurement,

but the criterion is not rendered useless if an

ideal measurement either is not available or

is not feasible.

Note: The analytical chemistry of the

material might have to be taken into account

when defining the material or when judging

the acceptability of some toxicity tests, but a

criterion must not be based on the sensitivity

of an analytical method. When aquatic

organisms are more sensitive than routine

analytical methods, the proper solution is to

develop better analytical methods.

4. It is now the policy of EPA that the use

of dissolved metal to set and measure

compliance with water quality standards is

the recommended approach, because

dissolved metal more closely approximates

the bioavailable fraction of metal in the water

column that does total recoverable metal.

One reason is that a primary mechanism for

water column toxicity is adsorption at the gill

surface which requires metals to be in the

dissolved form. Reasons for the consideration

of total recoverable metals criteria include

risk management considerations not covered

by evaluation of water column toxicity. A

risk manager may consider sediments and

food chain effects and may decide to take a

conservative approach for metals,

considering that metals are very persistent

chemicals. This approach could include the

use of total recoverable metal in water quality

standards. A range of different risk

management decisions can be justified. EPA

recommends that State water quality

standards be based on dissolved metal. EPA

will also approve a State risk management

decision to adopt standards based on total

recoverable metal, if those standards are

otherwise approvable under this program.

B. Acute Toxicity. Concurrent and delayed

adverse effect(s) that results from an acute

exposure and occurs within any short

observation period which begins when the

exposure begins, may extend beyond the

exposure period, and usually does not

constitute a substantial portion of the life

span of the organism. (Concurrent toxicity is

an adverse effect to an organism that results

from, and occurs during, its exposure to one

or more test materials.) Exposure constitutes

contact with a chemical or physical agent.

Acute exposure, however, is exposure of an

organism for any short period which usually

does not constitute a substantial portion of its

life span.

C. Chronic Toxicity. Concurrent and

delayed adverse effect(s) that occurs only as

a result of a chronic exposure. Chronic

exposure is exposure of an organism for any

long period or for a substantial portion of its

life span.

II. Collection of Data

A. Collect all data available on the material

concerning toxicity to aquatic animals and

plants.

B. All data that are used should be

available in typed, dated, and signed hard

copy (e.g., publication, manuscript, letter,

memorandum, etc.) with enough supporting

information to indicate that acceptable test

procedures were used and that the results are

reliable. In some cases, it might be

appropriate to obtain written information

from the investigator, if possible. Information

that is not available for distribution shall not

be used.

C. Questionable data, whether published or

unpublished, must not be used. For example,

data must be rejected if they are from tests

that did not contain a control treatment, tests

in which too many organisms in the control

treatment died or showed signs of stress or

disease, and tests in which distilled or

deionized water was used as the dilution

water without the addition of appropriate

salts.

D. Data on technical grade materials may

be used if appropriate, but data on

formulated mixtures and emulsifiable

concentrates of the material must not be

used.

E. For some highly volatile, hydrolyzable,

or degradable materials, it might be

appropriate to use only results of flowthrough tests in which the concentrations of

test material in test solutions were measured

using acceptable analytical methods. A flowthrough test is a test with aquatic organisms

in which test solutions flow into constantvolume test chambers either intermittently

(e.g., every few minutes) or continuously,

with the excess flowing out.

F. Data must be rejected if obtained using:

1. Brine shrimp, because they usually only

occur naturally in water with salinity greater

than 35 g/kg.

2. Species that do not have reproducing

wild populations in North America.

3. Organisms that were previously exposed

to substantial concentrations of the test

material or other contaminants.

4. Saltwater species except for use in

deriving acute-chronic ratios. An ACR is a

standard measure of the acute toxicity of a

material divided by an appropriate measure

of the chronic toxicity of the same material

under comparable conditions.

G. Questionable data, data on formulated

mixtures and emulsifiable concentrates, and

data obtained with species non-resident to

North America or previously exposed

organisms may be used to provide auxiliary

information but must not be used in the

derivation of criteria.

III. Required Data

A. Certain data should be available to help

ensure that each of the major kinds of

possible adverse effects receives adequate

consideration. An adverse effect is a change

in an organism that is harmful to the

organism. Exposure means contact with a

chemical or physical agent. Results of acute

and chronic toxicity tests with representative

species of aquatic animals are necessary so

that data available for tested species can be

considered a useful indication of the

sensitivities of appropriate untested species.

Fewer data concerning toxicity to aquatic

plants are usually available because

procedures for conducting tests with plants

and interpreting the results of such tests are

not as well developed.

B. To derive a Great Lakes Tier I criterion

for aquatic organisms and their uses, the

following must be available:

1. Results of acceptable acute (or chronic)

tests (see section IV or VI of this appendix)

with at least one species of freshwater animal

in at least eight different families such that

all of the following are included:
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15395

a. The family Salmonidae in the class

Osteichthyes;

b. One other family (preferably a

commercially or recreationally important,

warmwater species) in the class Osteichthyes

(e.g., bluegill, channel catfish);

c. A third family in the phylum Chordata

(e.g., fish, amphibian);

d. A planktonic crustacean (e.g., a

cladoceran, copepod);

e. A benthic crustacean (e.g., ostracod,

isopod, amphipod, crayfish);

f. An insect (e.g., mayfly, dragonfly,

damselfly, stonefly, caddisfly, mosquito,

midge);

g. A family in a phylum other than

Arthropoda or Chordata (e.g., Rotifera,

Annelida, Mollusca);

h. A family in any order of insect or any

phylum not already represented.

2. Acute-chronic ratios (see section VI of

this appendix) with at least one species of

aquatic animal in at least three different

families provided that of the three species:

a. At least one is a fish;

b. At least one is an invertebrate; and

c. At least one species is an acutely

sensitive freshwater species (the other two

may be saltwater species).

3. Results of at least one acceptable test

with a freshwater algae or vascular plant is

desirable but not required for criterion

derivation (see section VIII of this appendix).

If plants are among the aquatic organisms

most sensitive to the material, results of a test

with a plant in another phylum (division)

should also be available.

C. If all required data are available, a

numerical criterion can usually be derived

except in special cases. For example,

derivation of a chronic criterion might not be

possible if the available ACRs vary by more

than a factor of ten with no apparent pattern.

Also, if a criterion is to be related to a water

quality characteristic (see sections V and VII

of this appendix), more data will be required.

D. Confidence in a criterion usually

increases as the amount of available pertinent

information increases. Thus, additional data

are usually desirable.

IV. Final Acute Value

A. Appropriate measures of the acute

(short-term) toxicity of the material to a

variety of species of aquatic animals are used

to calculate the Final Acute Value (FAV). The

calculated Final Acute Value is a calculated

estimate of the concentration of a test

material such that 95 percent of the genera

(with which acceptable acute toxicity tests

have been conducted on the material) have

higher Genus Mean Acute Values (GMAVs).

An acute test is a comparative study in which

organisms, that are subjected to different

treatments, are observed for a short period

usually not constituting a substantial portion

of their life span. However, in some cases,

the Species Mean Acute Value (SMAV) of a

commercially or recreationally important

species of the Great Lakes System is lower

than the calculated FAV, then the SMAV

replaces the calculated FAV in order to

provide protection for that important species.

B. Acute toxicity tests shall be conducted

using acceptable procedures. For good

examples of acceptable procedures see

American Society for Testing and Materials

(ASTM) Standard E 729, Guide for

Conducting Acute Toxicity Tests with Fishes,

Macroinvertebrates, and Amphibians.

C. Except for results with saltwater

annelids and mysids, results of acute tests

during which the test organisms were fed

should not be used, unless data indicate that

the food did not affect the toxicity of the test

material. (Note: If the minimum acutechronic ratio data requirements (as described

in section III.B.2 of this appendix) are not

met with freshwater data alone, saltwater

data may be used.)

D. Results of acute tests conducted in

unusual dilution water, e.g., dilution water in

which total organic carbon or particulate

matter exceeded five mg/L, should not be

used, unless a relationship is developed

between acute toxicity and organic carbon or

particulate matter, or unless data show that

organic carbon or particulate matter, etc., do

not affect toxicity.

E. Acute values must be based upon

endpoints which reflect the total severe

adverse impact of the test material on the

organisms used in the test. Therefore, only

the following kinds of data on acute toxicity

to aquatic animals shall be used:

1. Tests with daphnids and other

cladocerans must be started with organisms

less than 24 hours old and tests with midges

must be started with second or third instar

larvae. It is preferred that the results should

be the 48-hour EC50 based on the total

percentage of organisms killed and

immobilized. If such an EC50 is not available

for a test, the 48-hour LC50 should be used

in place of the desired 48-hour EC50. An

EC50 or LC50 of longer than 48 hours can be

used as long as the animals were not fed and

the control animals were acceptable at the

end of the test. An EC50 is a statistically or

graphically estimated concentration that is

expected to cause one or more specified

effects in 50% of a group of organisms under

specified conditions. An LC50 is a

statistically or graphically estimated

concentration that is expected to be lethal to

50% of a group of organisms under specified

conditions.

2. It is preferred that the results of a test

with embryos and larvae of barnacles, bivalve

molluscs (clams, mussels, oysters and

scallops), sea urchins, lobsters, crabs, shrimp

and abalones be the 96-hour EC50 based on

the percentage of organisms with

incompletely developed shells plus the

percentage of organisms killed. If such an

EC50 is not available from a test, of the

values that are available from the test, the

lowest of the following should be used in

place of the desired 96-hour EC50: 48- to 96-

hour EC50s based on percentage of organisms

with incompletely developed shells plus

percentage of organisms killed, 48- to 96-

hour EC50s based upon percentage of

organisms with incompletely developed

shells, and 48-hour to 96-hour LC50s. (Note:

If the minimum acute-chronic ratio data

requirements (as described in section III.B.2

of this appendix) are not met with freshwater

data alone, saltwater data may be used.)

3. It is preferred that the result of tests with

all other aquatic animal species and older life

stages of barnacles, bivalve molluscs (clams,

mussels, oysters and scallops), sea urchins,

lobsters, crabs, shrimp and abalones be the

96-hour EC50 based on percentage of

organisms exhibiting loss of equilibrium plus

percentage of organisms immobilized plus

percentage of organisms killed. If such an

EC50 is not available from a test, of the

values that are available from a test the lower

of the following should be used in place of

the desired 96-hour EC50: the 96-hour EC50

based on percentage of organisms exhibiting

loss of equilibrium plus percentage of

organisms immobilized and the 96-hour

LC50.

4. Tests whose results take into account the

number of young produced, such as most

tests with protozoans, are not considered

acute tests, even if the duration was 96 hours

or less.

5. If the tests were conducted properly,

acute values reported as ‘‘greater than’’

values and those which are above the

solubility of the test material should be used,

because rejection of such acute values would

bias the Final Acute Value by eliminating

acute values for resistant species.

F. If the acute toxicity of the material to

aquatic animals has been shown to be related

to a water quality characteristic such as

hardness or particulate matter for freshwater

animals, refer to section V of this appendix.

G. The agreement of the data within and

between species must be considered. Acute

values that appear to be questionable in

comparison with other acute and chronic

data for the same species and for other

species in the same genus must not be used.

For example, if the acute values available for

a species or genus differ by more than a

factor of 10, rejection of some or all of the

values would be appropriate, absent

countervailing circumstances.

H. If the available data indicate that one or

more life stages are at least a factor of two

more resistant than one or more other life

stages of the same species, the data for the

more resistant life stages must not be used in

the calculation of the SMAV because a

species cannot be considered protected from

acute toxicity if all of the life stages are not

protected.

I. For each species for which at least one

acute value is available, the SMAV shall be

calculated as the geometric mean of the

results of all acceptable flow-through acute

toxicity tests in which the concentrations of

test material were measured with the most

sensitive tested life stage of the species. For

a species for which no such result is

available, the SMAV shall be calculated as

the geometric mean of all acceptable acute

toxicity tests with the most sensitive tested

life stage, i.e., results of flow-through tests in

which the concentrations were not measured

and results of static and renewal tests based

on initial concentrations (nominal

concentrations are acceptable for most test

materials if measured concentrations are not

available) of test material. A renewal test is

a test with aquatic organisms in which either

the test solution in a test chamber is removed

and replaced at least once during the test or

the test organisms are transferred into a new

test solution of the same composition at least

once during the test. A static test is a test

with aquatic organisms in which the solution
15396 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

and organisms that are in a test chamber at

the beginning of the test remain in the

chamber until the end of the test, except for

removal of dead test organisms.

Note 1: Data reported by original

investigators must not be rounded off.

Results of all intermediate calculations must

not be rounded off to fewer than four

significant digits.

Note 2: The geometric mean of N numbers

is the Nth root of the product of the N

numbers. Alternatively, the geometric mean

can be calculated by adding the logarithms of

the N numbers, dividing the sum by N, and

taking the antilog of the quotient. The

geometric mean of two numbers is the square

root of the product of the two numbers, and

the geometric mean of one number is that

number. Either natural (base e) or common

(base 10) logarithms can be used to calculate

geometric means as long as they are used

consistently within each set of data, i.e., the

antilog used must match the logarithms used.

Note 3: Geometric means, rather than

arithmetic means, are used here because the

distributions of sensitivities of individual

organisms in toxicity tests on most materials

and the distributions of sensitivities of

species within a genus are more likely to be

lognormal than normal. Similarly, geometric

means are used for ACRs because quotients

are likely to be closer to lognormal than

normal distributions. In addition, division of

the geometric mean of a set of numerators by

the geometric mean of the set of

denominators will result in the geometric

mean of the set of corresponding quotients.

J. For each genus for which one or more

SMAVs are available, the GMAV shall be

calculated as the geometric mean of the

SMAVs available for the genus.

K. Order the GMAVs from high to low.

L. Assign ranks, R, to the GMAVs from ‘‘1’’

for the lowest to ‘‘N’’ for the highest. If two

or more GMAVs are identical, assign them

successive ranks.

M. Calculate the cumulative probability, P,

for each GMAV as R/(N+1).

N. Select the four GMAVs which have

cumulative probabilities closest to 0.05 (if

there are fewer than 59 GMAVs, these will

always be the four lowest GMAVs).

O. Using the four selected GMAVs, and Ps,

calculate

S

GMAV

GMAV

P

P

L

GMAV S P

A S L

FAV eA

2

2

2

2

4

4

4

0 05

=

( ) ( ) − ( ) ( )

( ) − ( ) ( )

= ( ) − ( ) ( )

= ( ) +

=

∑ ∑

∑ ∑

∑ ∑

ln

ln

ln

.

Note: Natural logarithms (logarithms to

base e, denoted as ln) are used herein merely

because they are easier to use on some hand

calculators and computers than common

(base 10) logarithms. Consistent use of either

will produce the same result.

P. If for a commercially or recreationally

important species of the Great Lakes System

the geometric mean of the acute values from

flow-through tests in which the

concentrations of test material were

measured is lower than the calculated Final

Acute Value (FAV), then that geometric mean

must be used as the FAV instead of the

calculated FAV.

Q. See section VI of this appendix.

V. Final Acute Equation

A. When enough data are available to show

that acute toxicity to two or more species is

similarly related to a water quality

characteristic, the relationship shall be taken

into account as described in sections V.B

through V.G of this appendix or using

analysis of covariance. The two methods are

equivalent and produce identical results. The

manual method described below provides an

understanding of this application of

covariance analysis, but computerized

versions of covariance analysis are much

more convenient for analyzing large data sets.

If two or more factors affect toxicity, multiple

regression analysis shall be used.

B. For each species for which comparable

acute toxicity values are available at two or

more different values of the water quality

characteristic, perform a least squares

regression of the acute toxicity values on the

corresponding values of the water quality

characteristic to obtain the slope and its 95

percent confidence limits for each species.

Note: Because the best documented

relationship is that between hardness and

acute toxicity of metals in fresh water and a

log-log relationship fits these data, geometric

means and natural logarithms of both toxicity

and water quality are used in the rest of this

section. For relationships based on other

water quality characteristics, such as Ph,

temperature, no transformation or a different

transformation might fit the data better, and

appropriate changes will be necessary

throughout this section.

C. Decide whether the data for each species

are relevant, taking into account the range

and number of the tested values of the water

quality characteristic and the degree of

agreement within and between species. For

example, a slope based on six data points

might be of limited value if it is based only

on data for a very narrow range of values of

the water quality characteristic. A slope

based on only two data points, however,

might be useful if it is consistent with other

information and if the two points cover a

broad enough range of the water quality

characteristic. In addition, acute values that

appear to be questionable in comparison with

other acute and chronic data available for the

same species and for other species in the

same genus should not be used. For example,

if after adjustment for the water quality

characteristic, the acute values available for

a species or genus differ by more than a

factor of 10, rejection of some or all of the

values would be appropriate, absent

countervailing justification. If useful slopes

are not available for at least one fish and one

invertebrate or if the available slopes are too

dissimilar or if too few data are available to

adequately define the relationship between

acute toxicity and the water quality

characteristic, return to section IV.G of this

appendix, using the results of tests

conducted under conditions and in waters

similar to those commonly used for toxicity

tests with the species.

D. For each species, calculate the geometric

mean of the available acute values and then

divide each of the acute values for the

species by the geometric mean for the

species. This normalizes the acute values so

that the geometric mean of the normalized

values for each species individually and for

any combination of species is 1.0.

E. Similarly normalize the values of the

water quality characteristic for each species

individually using the same procedure as

above.

F. Individually for each species perform a

least squares regression of the normalized
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15397

acute values of the water quality

characteristic. The resulting slopes and 95

percent confidence limits will be identical to

those obtained in section V.B. of this

appendix. If, however, the data are actually

plotted, the line of best fit for each individual

species will go through the point 1,1 in the

center of the graph.

G. Treat all of the normalized data as if

they were all for the same species and

perform a least squares regression of all of the

normalized acute values on the

corresponding normalized values of the

water quality characteristic to obtain the

pooled acute slope, V, and its 95 percent

confidence limits. If all of the normalized

data are actually plotted, the line of best fit

will go through the point 1,1 in the center of

the graph.

H. For each species calculate the geometric

mean, W, of the acute toxicity values and the

geometric mean, X, of the values of the water

quality characteristic. (These were calculated

in sections V.D and V.E of this appendix).

I. For each species, calculate the logarithm,

Y, of the SMAV at a selected value, Z, of the

water quality characteristic using the

equation:

Y=ln W¥V(ln X¥ln Z)

J. For each species calculate the SMAV at

X using the equation:

SMAV=eY

Note: Alternatively, the SMAVs at Z can be

obtained by skipping step H above, using the

equations in steps I and J to adjust each acute

value individually to Z, and then calculating

the geometric mean of the adjusted values for

each species individually. This alternative

procedure allows an examination of the range

of the adjusted acute values for each species.

K. Obtain the FAV at Z by using the

procedure described in sections IV.J through

IV.O of this appendix.

L. If, for a commercially or recreationally

important species of the Great Lakes System

the geometric mean of the acute values at Z

from flow-through tests in which the

concentrations of the test material were

measured is lower than the FAV at Z, then

the geometric mean must be used as the FAV

instead of the FAV.

M. The Final Acute Equation is written as:

FAV=e(V[ln(water quality characteristic)]∂A¥V[ln Z])

,

where:

V=pooled acute slope, and A=ln(FAV at Z).

Because V, A, and Z are known, the FAV

can be calculated for any selected value of

the water quality characteristic.

VI. Final Chronic Value

A. Depending on the data that are available

concerning chronic toxicity to aquatic

animals, the Final Chronic Value (FCV) can

be calculated in the same manner as the FAV

or by dividing the FAV by the Final AcuteChronic Ratio (FACR). In some cases, it might

not be possible to calculate a FCV. The FCV

is (a) a calculated estimate of the

concentration of a test material such that 95

percent of the genera (with which acceptable

chronic toxicity tests have been conducted

on the material) have higher GMCVs, or (b)

the quotient of an FAV divided by an

appropriate ACR, or (c) the SMCV of an

important and/or critical species, if the

SMCV is lower than the calculated estimate

or the quotient, whichever is applicable.

Note: As the name implies, the ACR is a

way of relating acute and chronic toxicities.

B. Chronic values shall be based on results

of flow-through (except renewal is acceptable

for daphnids) chronic tests in which the

concentrations of test material in the test

solutions were properly measured at

appropriate times during the test. A chronic

test is a comparative study in which

organisms, that are subjected to different

treatments, are observed for a long period or

a substantial portion of their life span.

C. Results of chronic tests in which

survival, growth, or reproduction in the

control treatment was unacceptably low shall

not be used. The limits of acceptability will

depend on the species.

D. Results of chronic tests conducted in

unusual dilution water, e.g., dilution water in

which total organic carbon or particulate

matter exceeded five mg/L, should not be

used, unless a relationship is developed

between chronic toxicity and organic carbon

or particulate matter, or unless data show

that organic carbon, particulate matter, etc.,

do not affect toxicity.

E. Chronic values must be based on

endpoints and lengths of exposure

appropriate to the species. Therefore, only

results of the following kinds of chronic

toxicity tests shall be used:

1. Life-cycle toxicity tests consisting of

exposures of each of two or more groups of

individuals of a species to a different

concentration of the test material throughout

a life cycle. To ensure that all life stages and

life processes are exposed, tests with fish

should begin with embryos or newly hatched

young less than 48 hours old, continue

through maturation and reproduction, and

should end not less than 24 days (90 days for

salmonids) after the hatching of the next

generation. Tests with daphnids should begin

with young less than 24 hours old and last

for not less than 21 days, and for

ceriodaphnids not less than seven days. For

good examples of acceptable procedures see

American Society for Testing and Materials

(ASTM) Standard E 1193 Guide for

conducting renewal life-cycle toxicity tests

with Daphnia magna and ASTM Standard E

1295 Guide for conducting three-brood,

renewal toxicity tests with Ceriodaphnia

dubia. Tests with mysids should begin with

young less than 24 hours old and continue

until seven days past the median time of first

brood release in the controls. For fish, data

should be obtained and analyzed on survival

and growth of adults and young, maturation

of males and females, eggs spawned per

female, embryo viability (salmonids only),

and hatchability. For daphnids, data should

be obtained and analyzed on survival and

young per female. For mysids, data should be

obtained and analyzed on survival, growth,

and young per female.

2. Partial life-cycle toxicity tests consist of

exposures of each of two more groups of

individuals of a species of fish to a different

concentration of the test material through

most portions of a life cycle. Partial life-cycle

tests are allowed with fish species that

require more than a year to reach sexual

maturity, so that all major life stages can be

exposed to the test material in less than 15

months. A life-cycle test is a comparative

study in which organisms, that are subjected

to different treatments, are observed at least

from a life stage in one generation to the

same life-stage in the next generation.

Exposure to the test material should begin

with immature juveniles at least two months

prior to active gonad development, continue

through maturation and reproduction, and

end not less than 24 days (90 days for

salmonids) after the hatching of the next

generation. Data should be obtained and

analyzed on survival and growth of adults

and young, maturation of males and females,

eggs spawned per female, embryo viability

(salmonids only), and hatchability.

3. Early life-stage toxicity tests consisting

of 28- to 32-day (60 days post hatch for

salmonids) exposures of the early life stages

of a species of fish from shortly after

fertilization through embryonic, larval, and

early juvenile development. Data should be

obtained and analyzed on survival and

growth.

Note: Results of an early life-stage test are

used as predictions of results of life-cycle

and partial life-cycle tests with the same

species. Therefore, when results of a lifecycle or partial life-cycle test are available,

results of an early life-stage test with the

same species should not be used. Also,

results of early life-stage tests in which the

incidence of mortalities or abnormalities

increased substantially near the end of the

test shall not be used because the results of

such tests are possibly not good predictions

of comparable life-cycle or partial life-cycle

tests.

F. A chronic value may be obtained by

calculating the geometric mean of the lower

and upper chronic limits from a chronic test

or by analyzing chronic data using regression

analysis.

1. A lower chronic limit is the highest

tested concentration:

a. In an acceptable chronic test;

b. Which did not cause an unacceptable

amount of adverse effect on any of the

specified biological measurements; and

c. Below which no tested concentration

caused an unacceptable effect.

2. An upper chronic limit is the lowest

tested concentration:

a. In an acceptable chronic test;

b. Which did cause an unacceptable

amount of adverse effect on one or more of

the specified biological measurements; and,

c. Above which all tested concentrations

also caused such an effect.

Note: Because various authors have used a

variety of terms and definitions to interpret

and report results of chronic tests, reported

results should be reviewed carefully. The

amount of effect that is considered

unacceptable is often based on a statistical

hypothesis test, but might also be defined in

terms of a specified percent reduction from

the controls. A small percent reduction (e.g.,

three percent) might be considered

acceptable even if it is statistically

significantly different from the control,

whereas a large percent reduction (e.g., 30

percent) might be considered unacceptable

even if it is not statistically significant.

G. If the chronic toxicity of the material to

aquatic animals has been shown to be related
15398 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

to a water quality characteristic such as

hardness or particulate matter for freshwater

animals, refer to section VII of this appendix.

H. If chronic values are available for

species in eight families as described in

section III.B.1 of this appendix, a SMCV shall

be calculated for each species for which at

least one chronic value is available by

calculating the geometric mean of the results

of all acceptable life-cycle and partial lifecycle toxicity tests with the species; for a

species of fish for which no such result is

available, the SMCV is the geometric mean of

all acceptable early life-stage tests.

Appropriate GMCVs shall also be calculated.

A GMCV is the geometric mean of the SMCVs

for the genus. The FCV shall be obtained

using the procedure described in sections

IV.J through IV.O of this appendix,

substituting SMCV and GMCV for SMAV and

GMAV respectively. See section VI.M of this

appendix.

Note: Section VI.I through VI.L are for use

when chronic values are not available for

species in eight taxonomic families as

described in section III.B.1 of this appendix.

I. For each chronic value for which at least

one corresponding appropriate acute value is

available, calculate an ACR, using for the

numerator the geometric mean of the results

of all acceptable flow-through (except static

is acceptable for daphnids and midges) acute

tests in the same dilution water in which the

concentrations are measured. For fish, the

acute test(s) should be conducted with

juveniles. The acute test(s) should be part of

the same study as the chronic test. If acute

tests were not conducted as part of the same

study, but were conducted as part of a

different study in the same laboratory and

dilution water, then they may be used. If no

such acute tests are available, results of acute

tests conducted in the same dilution water in

a different laboratory may be used. If no such

acute tests are available, an ACR shall not be

calculated.

J. For each species, calculate the SMACR

as the geometric mean of all ACRs available

for that species. If the minimum ACR data

requirements (as described in section III.B.2

of this appendix) are not met with freshwater

data alone, saltwater data may be used along

with the freshwater data.

K. For some materials, the ACR seems to

be the same for all species, but for other

materials the ratio seems to increase or

decrease as the SMAV increases. Thus the

FACR can be obtained in three ways,

depending on the data available:

1. If the species mean ACR seems to

increase or decrease as the SMAVs increase,

the FACR shall be calculated as the geometric

mean of the ACRs for species whose SMAVs

are close to the FAV.

2. If no major trend is apparent and the

ACRs for all species are within a factor of ten,

the FACR shall be calculated as the geometric

mean of all of the SMACRs.

3. If the most appropriate SMACRs are less

than 2.0, and especially if they are less than

1.0, acclimation has probably occurred

during the chronic test. In this situation,

because continuous exposure and

acclimation cannot be assured to provide

adequate protection in field situations, the

FACR should be assumed to be two, so that

the FCV is equal to the Criterion Maximum

Concentration (CMC). (See section X.B of this

appendix.)

If the available SMACRs do not fit one of

these cases, a FACR may not be obtained and

a Tier I FCV probably cannot be calculated.

L. Calculate the FCV by dividing the FAV

by the FACR.

FCV=FAV÷FACR

If there is a Final Acute Equation rather than

a FAV, see also section V of this appendix.

M. If the SMCV of a commercially or

recreationally important species of the Great

Lakes System is lower than the calculated

FCV, then that SMCV must be used as the

FCV instead of the calculated FCV.

N. See section VIII of this appendix.

VII. Final Chronic Equation

A. A Final Chronic Equation can be

derived in two ways. The procedure

described in section VII.A of this appendix

will result in the chronic slope being the

same as the acute slope. The procedure

described in sections VII.B through N of this

appendix will usually result in the chronic

slope being different from the acute slope.

1. If ACRs are available for enough species

at enough values of the water quality

characteristic to indicate that the ACR

appears to be the same for all species and

appears to be independent of the water

quality characteristic, calculate the FACR as

the geometric mean of the available SMACRs.

2. Calculate the FCV at the selected value

Z of the water quality characteristic by

dividing the FAV at Z (see section V.M of

this appendix) by the FACR.

3. Use V=pooled acute slope (see section

V.M of this appendix), and

L=pooled chronic slope.

4. See section VII.M of this appendix.

B. When enough data are available to show

that chronic toxicity to at least one species

is related to a water quality characteristic, the

relationship should be taken into account as

described in sections C through G below or

using analysis of covariance. The two

methods are equivalent and produce

identical results. The manual method

described below provides an understanding

of this application of covariance analysis, but

computerized versions of covariance analysis

are much more convenient for analyzing

large data sets. If two or more factors affect

toxicity, multiple regression analysis shall be

used.

C. For each species for which comparable

chronic toxicity values are available at two or

more different values of the water quality

characteristic, perform a least squares

regression of the chronic toxicity values on

the corresponding values of the water quality

characteristic to obtain the slope and its 95

percent confidence limits for each species.

Note: Because the best documented

relationship is that between hardness and

acute toxicity of metals in fresh water and a

log-log relationship fits these data, geometric

means and natural logarithms of both toxicity

and water quality are used in the rest of this

section. For relationships based on other

water quality characteristics, such as Ph,

temperature, no transformation or a different

transformation might fit the data better, and

appropriate changes will be necessary

throughout this section. It is probably

preferable, but not necessary, to use the same

transformation that was used with the acute

values in section V of this appendix.

D. Decide whether the data for each species

are relevant, taking into account the range

and number of the tested values of the water

quality characteristic and the degree of

agreement within and between species. For

example, a slope based on six data points

might be of limited value if it is based only

on data for a very narrow range of values of

the water quality characteristic. A slope

based on only two data points, however,

might be more useful if it is consistent with

other information and if the two points cover

a broad range of the water quality

characteristic. In addition, chronic values

that appear to be questionable in comparison

with other acute and chronic data available

for the same species and for other species in

the same genus in most cases should not be

used. For example, if after adjustment for the

water quality characteristic, the chronic

values available for a species or genus differ

by more than a factor of 10, rejection of some

or all of the values is, in most cases, absent

countervailing circumstances, appropriate. If

a useful chronic slope is not available for at

least one species or if the available slopes are

too dissimilar or if too few data are available

to adequately define the relationship between

chronic toxicity and the water quality

characteristic, it might be appropriate to

assume that the chronic slope is the same as

the acute slope, which is equivalent to

assuming that the ACR is independent of the

water quality characteristic. Alternatively,

return to section VI.H of this appendix, using

the results of tests conducted under

conditions and in waters similar to those

commonly used for toxicity tests with the

species.

E. Individually for each species, calculate

the geometric mean of the available chronic

values and then divide each chronic value for

a species by the mean for the species. This

normalizes the chronic values so that the

geometric mean of the normalized values for

each species individually, and for any

combination of species, is 1.0.

F. Similarly, normalize the values of the

water quality characteristic for each species

individually.

G. Individually for each species, perform a

least squares regression of the normalized

chronic toxicity values on the corresponding

normalized values of the water quality

characteristic. The resulting slopes and the

95 percent confidence limits will be identical

to those obtained in section VII.B of this

appendix. Now, however, if the data are

actually plotted, the line of best fit for each

individual species will go through the point

1,1 in the center of the graph.

H. Treat all of the normalized data as if

they were all the same species and perform

a least squares regression of all of the

normalized chronic values on the

corresponding normalized values of the

water quality characteristic to obtain the

pooled chronic slope, L, and its 95 percent

confidence limits.

If all normalized data are actually plotted,

the line of best fit will go through the point

1,1 in the center of the graph.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15399

I. For each species, calculate the geometric

mean, M, of the toxicity values and the

geometric mean, P, of the values of the water

quality characteristic. (These are calculated

in sections VII.E and F of this appendix.)

J. For each species, calculate the logarithm,

Q, of the SMCV at a selected value, Z, of the

water quality characteristic using the

equation:

Q=ln M—L(ln P¥ln Z)

Note: Although it is not necessary, it is

recommended that the same value of the

water quality characteristic be used here as

was used in section V of this appendix.

K. For each species, calculate a SMCV at

Z using the equation:

SMCV=eQ

Note: Alternatively, the SMCV at Z can be

obtained by skipping section VII.J of this

appendix, using the equations in sections

VII.J and K of this appendix to adjust each

chronic value individually to Z, and then

calculating the geometric means of the

adjusted values for each species individually.

This alternative procedure allows an

examination of the range of the adjusted

chronic values for each species.

L. Obtain the FCV at Z by using the

procedure described in sections IV.J through

O of this appendix.

M. If the SMCV at Z of a commercially or

recreationally important species of the Great

Lakes System is lower than the calculated

FCV at Z, then that SMCV shall be used as

the FCV at Z instead of the calculated FCV.

N. The Final Chronic Equation is written

as:

FCV=e(L[ln(water quality characteristic)]∂lnS¥L[lnZ])

Where:

L=pooled chronic slope and S = FCV at Z.

Because L, S, and Z are known, the FCV

can be calculated for any selected value of

the water quality characteristic.

VIII. Final Plant Value

A. A Final Plant Value (FPV) is the lowest

plant value that was obtained with an

important aquatic plant species in an

acceptable toxicity test for which the

concentrations of the test material were

measured and the adverse effect was

biologically important. Appropriate measures

of the toxicity of the material to aquatic

plants are used to compare the relative

sensitivities of aquatic plants and animals.

Although procedures for conducting and

interpreting the results of toxicity tests with

plants are not well-developed, results of tests

with plants usually indicate that criteria

which adequately protect aquatic animals

and their uses will, in most cases, also

protect aquatic plants and their uses.

B. A plant value is the result of a 96-hour

test conducted with an alga or a chronic test

conducted with an aquatic vascular plant.

Note: A test of the toxicity of a metal to a

plant shall not be used if the medium

contained an excessive amount of a

complexing agent, such as EDTA, that might

affect the toxicity of the metal.

Concentrations of EDTA above 200 μg/L

should be considered excessive.

C. The FPV shall be obtained by selecting

the lowest result from a test with an

important aquatic plant species in which the

concentrations of test material are measured

and the endpoint is biologically important.

IX. Other Data

Pertinent information that could not be

used in earlier sections might be available

concerning adverse effects on aquatic

organisms. The most important of these are

data on cumulative and delayed toxicity,

reduction in survival, growth, or

reproduction, or any other adverse effect that

has been shown to be biologically important.

Delayed toxicity is an adverse effect to an

organism that results from, and occurs after

the end of, its exposure to one or more test

materials. Especially important are data for

species for which no other data are available.

Data from behavioral, biochemical,

physiological, microcosm, and field studies

might also be available. Data might be

available from tests conducted in unusual

dilution water (see sections IV.D and VI.D of

this appendix), from chronic tests in which

the concentrations were not measured (see

section VI.B of this appendix), from tests

with previously exposed organisms (see

section II.F.3 of this appendix), and from

tests on formulated mixtures or emulsifiable

concentrates (see section II.D of this

appendix). Such data might affect a criterion

if the data were obtained with an important

species, the test concentrations were

measured, and the endpoint was biologically

important.

X. Criterion

A. A criterion consists of two

concentrations: the CMC and the Criterion

Continuous Concentration (CCC).

B. The CMC is equal to one-half the FAV.

The CMC is an estimate of the highest

concentration of a material in the water

column to which an aquatic community can

be exposed briefly without resulting in an

unacceptable effect.

C. The CCC is equal to the lowest of the

FCV or the FPV (if available) unless other

data (see section IX of this appendix) show

that a lower value should be used. The CCC

is an estimate of the highest concentration of

a material in the water column to which an

aquatic community can be exposed

indefinitely without resulting in an

unacceptable effect. If toxicity is related to a

water quality characteristic, the CCC is

obtained from the Final Chronic Equation or

FPV (if available) that results in the lowest

concentrations in the usual range of the water

quality characteristic, unless other data (see

section IX) show that a lower value should

be used.

D. Round both the CMC and the CCC to

two significant digits.

E. The criterion is stated as:

The procedures described in the Tier I

methodology indicate that, except possibly

where a commercially or recreationally

important species is very sensitive, aquatic

organisms should not be affected

unacceptably if the four-day average

concentration of (1) does not exceed (2) μg/

L more than once every three years on the

average and if the one-hour average

concentration does not exceed (3) μg/L more

than once every three years on the average.

Where:

(1) = insert name of material

(2) = insert the CCC

(3) = insert the CMC

If the CMC averaging period of one hour or

the CCC averaging period of four days is

inappropriate for the pollutant, or if the oncein-three-year allowable excursion frequency

is inappropriate for the pollutant or for the

sites to which a criterion is applied, then the

State may specify alternative averaging

periods or frequencies. The choice of an

alternative averaging period or frequency

shall be justified by a scientifically defensible

analysis demonstrating that the alternative

values will protect the aquatic life uses of the

water. Appropriate laboratory data and/or

well-designed field biological surveys shall

be submitted to EPA as justification for

differing averaging periods and/or

frequencies of exceedance.

XI. Final Review

A. The derivation of the criterion should be

carefully reviewed by rechecking each step of

the Guidance in this part. Items that should

be especially checked are:

1. If unpublished data are used, are they

well documented?

2. Are all required data available?

3. Is the range of acute values for any

species greater than a factor of 10?

4. Is the range of SMAVs for any genus

greater than a factor of 10?

5. Is there more than a factor of 10

difference between the four lowest GMAVs?

6. Are any of the lowest GMAVs

questionable?

7. Is the FAV reasonable in comparison

with the SMAVs and GMAVs?

8. For any commercially or recreationally

important species of the Great Lakes System,

is the geometric mean of the acute values

from flow-through tests in which the

concentrations of test material were

measured lower than the FAV?

9. Are any of the chronic values used

questionable?

10. Are any chronic values available for

acutely sensitive species?

11. Is the range of acute-chronic ratios

greater than a factor of 10?

12. Is the FCV reasonable in comparison

with the available acute and chronic data?

13. Is the measured or predicted chronic

value for any commercially or recreationally

important species of the Great Lakes System

below the FCV?

14. Are any of the other data important?

15. Do any data look like they might be

outliers?

16. Are there any deviations from the

Guidance in this part? Are they acceptable?

B. On the basis of all available pertinent

laboratory and field information, determine if

the criterion is consistent with sound

scientific evidence. If it is not, another

criterion, either higher or lower, shall be

derived consistent with the Guidance in this

part.

Methodology for Deriving Aquatic Life

Values: Tier II
15400 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

XII. Secondary Acute Value

If all eight minimum data requirements for

calculating an FAV using Tier I are not met,

a Secondary Acute Value (SAV) for the

waters of the Great Lakes System shall be

calculated for a chemical as follows:

To calculate a SAV, the lowest GMAV in

the database is divided by the Secondary

Acute Factor (SAF) (Table A–1 of this

appendix) corresponding to the number of

satisfied minimum data requirements listed

in the Tier I methodology (section III.B.1 of

this appendix). (Requirements for definitions,

data collection and data review, contained in

sections I, II, and IV shall be applied to

calculation of a SAV.) If all eight minimum

data requirements are satisfied, a Tier I

criterion calculation may be possible. In

order to calculate a SAV, the database must

contain, at a minimum, a genus mean acute

value (GMAV) for one of the following three

genera in the family Daphnidae—

Ceriodaphnia sp., Daphnia sp., or

Simocephalus sp.

If appropriate, the SAV shall be made a

function of a water quality characteristic in

a manner similar to that described in Tier I.

XIII. Secondary Acute-Chronic Ratio

If three or more experimentally determined

ACRs, meeting the data collection and review

requirements of Section VI of this appendix,

are available for the chemical, determine the

FACR using the procedure described in

Section VI. If fewer than three acceptable

experimentally determined ACRs are

available, use enough assumed ACRs of 18 so

that the total number of ACRs equals three.

Calculate the Secondary Acute-Chronic Ratio

(SACR) as the geometric mean of the three

ACRs. Thus, if no experimentally determined

ACRs are available, the SACR is 18.

XIV. Secondary Chronic Value

Calculate the Secondary Chronic Value

(SCV) using one of the following:

A. SCV =

FAV

SACR

use FAV from Tier I

 SCV =

SAV

FACR

 SCV =

SAV

SACR

( )

B

C

.

.

If appropriate, the SCV will be made a

function of a water quality characteristic in

a manner similar to that described in Tier I.

XV. Commercially or Recreationally

Important Species

If for a commercially or recreationally

important species of the Great Lakes System

the geometric mean of the acute values or

chronic values from flow-through tests in

which the concentrations of the test materials

were measured is lower than the calculated

SAV or SCV, then that geometric mean must

be used as the SAV or SCV instead of the

calculated SAV or SCV.

XVI. Tier II Value

A. A Tier II value shall consist of two

concentrations: the Secondary Maximum

Concentration (SMC) and the Secondary

Continuous Concentration (SCC).

B. The SMC is equal to one-half of the

SAV.

C. The SCC is equal to the lowest of the

SCV or the Final Plant Value, if available,

unless other data (see section IX of this

appendix) show that a lower value should be

used.

If toxicity is related to a water quality

characteristic, the SCC is obtained from the

Secondary Chronic Equation or FPV, if

available, that results in the lowest

concentrations in the usual range of the water

quality characteristic, unless other data (See

section IX of this appendix) show that a

lower value should be used.

D. Round both the SMC and the SCC to two

significant digits.

E. The Tier II value is stated as:

The procedures described in the Tier II

methodology indicate that, except possibly

where a locally important species is very

sensitive, aquatic organisms should not be

affected unacceptably if the four-day average

concentration of (1) does not exceed (2) μg/

L more than once every three years on the

average and if the one-hour average

concentration does not exceed (3) μg/L more

than once every three years on the average.

Where:

(1) = insert name of material

(2) = insert the SCC

(3) = insert the SMC

As discussed above, States and Tribes have

the discretion to specify alternative averaging

periods or frequencies (see section X.E. of

this appendix).

XVII. Appropriate Modifications

On the basis of all available pertinent

laboratory and field information, determine if

the Tier II value is consistent with sound

scientific evidence. If it is not, another value,

either higher or lower, shall be derived

consistent with the Guidance in this part.

TABLE A–1.— SECONDARY ACUTE

FACTORS

Number of minimum data requirements satisfiedAdjustment

factor

1 .................................................. 21.9

2 .................................................. 13.0

3 .................................................. 8.0

4 .................................................. 7.0

5 .................................................. 6.1

6 .................................................. 5.2

7 .................................................. 4.3

Appendix B to Part 132—Great Lakes Water

Quality Initiative

Methodology for Deriving Bioaccumulation

Factors

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

this appendix.

I. Introduction

A. The purpose of this methodology is to

describe procedures for deriving

bioaccumulation factors (BAFs) to be used in

the calculation of Great Lakes Water Quality

Guidance (Guidance) human health Tier I

criteria and Tier II values and wildlife Tier

I criteria. A subset of the human health BAFs

are also used to identify the chemicals that

are considered bioaccumulative chemicals of

concern (BCCs).

B. Bioaccumulation reflects uptake of a

substance by aquatic organisms exposed to

the substance through all routes (i.e., ambient

water and food), as would occur in nature.

Bioconcentration reflects uptake of a

substance by aquatic organisms exposed to

the substance only through the ambient

water. Both BAFs and bioconcentration

factors (BCFs) are proportionality constants

that describe the relationship between the

concentration of a substance in aquatic

organisms and its concentration in the

ambient water. For the Guidance in this part,

BAFs, rather than BCFs, are used to calculate

Tier I criteria for human health and wildlife

and Tier II values for human health because

they better account for the total exposure of

aquatic organisms to chemicals.

C. For organic chemicals, baseline BAFs

can be derived using four methods. Measured

baseline BAFs are derived from fieldmeasured BAFs; predicted baseline BAFs are

derived using biota-sediment accumulation

factors (BSAFs) or are derived by multiplying

a laboratory-measured or predicted BCF by a

food-chain multiplier (FCM). The lipid

content of the aquatic organisms is used to

account for partitioning of organic chemicals

within organisms so that data from different
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15401

tissues and species can be integrated. In

addition, the baseline BAF is based on the

concentration of freely dissolved organic

chemicals in the ambient water to facilitate

extrapolation from one water to another.

D. For inorganic chemicals, baseline BAFs

can be derived using two of the four

methods. Baseline BAFs are derived using

either field-measured BAFs or by multiplying

laboratory-measured BCFs by a FCM. For

inorganic chemicals, BAFs are assumed to

equal BCFs (i.e., the FCM is 1.0), unless

chemical-specific biomagnification data

support using a FCM other than 1.0.

E. Because both humans and wildlife

consume fish from both trophic levels 3 and

4, two baseline BAFs are needed to calculate

either a human health criterion or value or

a wildlife criterion for a chemical. When

appropriate, ingestion through consumption

of invertebrates, plants, mammals, and birds

in the diet of wildlife species to be protected

may be taken into account.

II. Definitions

Baseline BAF. For organic chemicals, a

BAF that is based on the concentration of

freely dissolved chemical in the ambient

water and takes into account the partitioning

of the chemical within the organism; for

inorganic chemicals, a BAF that is based on

the wet weight of the tissue.

Baseline BCF. For organic chemicals, a BCF

that is based on the concentration of freely

dissolved chemical in the ambient water and

takes into account the partitioning of the

chemical within the organism; for inorganic

chemicals, a BCF that is based on the wet

weight of the tissue.

Bioaccumulation. The net accumulation of

a substance by an organism as a result of

uptake from all environmental sources.

Bioaccumulation factor (BAF). The ratio

(in L/kg) of a substance’s concentration in

tissue of an aquatic organism to its

concentration in the ambient water, in

situations where both the organism and its

food are exposed to and the ratio does not

change substantially over time.

Bioconcentration. The net accumulation of

a substance by an aquatic organism as a

result of uptake directly from the ambient

water through gill membranes or other

external body surfaces.

Bioconcentration factor (BCF). The ratio (in

L/kg) of a substance’s concentration in tissue

of an aquatic organism to its concentration in

the ambient water, in situations where the

organism is exposed through the water only

and the ratio does not change substantially

over time.

Biota-sediment accumulation factor

(BSAF). The ratio (in kg of organic carbon/

kg of lipid) of a substance’s lipid-normalized

concentration in tissue of an aquatic

organism to its organic carbon-normalized

concentration in surface sediment, in

situations where the ratio does not change

substantially over time, both the organism

and its food are exposed, and the surface

sediment is representative of average surface

sediment in the vicinity of the organism.

Depuration. The loss of a substance from

an organism as a result of any active or

passive process.

Food-chain multiplier (FCM). The ratio of

a BAF to an appropriate BCF.

Octanol-water partition coefficient (KOW).

The ration of the concentration of a substance

in the n-octanol phase to its concentration in

the aqueous phase in an equilibrated twophase octanol-water system. For log KOW, the

log of the octanol-water partition coefficient

is a base 10 logarithm.

Uptake. Acquisition of a substance from

the environment by an organism as a result

of any active or passive process.

III. Review and Selection of Data

A. Data Sources. Measured BAFs, BSAFs

and BCFs are assembled from available

sources including the following:

1. EPA Ambient Water Quality Criteria

documents issued after January 1, 1980.

2. Published scientific literature.

3. Reports issued by EPA or other reliable

sources.

4. Unpublished data.

One useful source of references is the

Aquatic Toxicity Information Retrieval

(AQUIRE) database.

B. Field-Measured BAFs. The following

procedural and quality assurance

requirements shall be met for field-measured

BAFs:

1. The field studies used shall be limited

to those conducted in the Great Lakes System

with fish at or near the top of the aquatic

food chain (i.e., in trophic levels 3 and/or 4).

2. The trophic level of the fish species shall

be determined.

3. The site of the field study should not be

so unique that the BAF cannot be

extrapolated to other locations where the

criteria and values will apply.

4. For organic chemicals, the percent lipid

shall be either measured or reliably estimated

for the tissue used in the determination of the

BAF.

5. The concentration of the chemical in the

water shall be measured in a way that can be

related to particulate organic carbon (POC)

and/or dissolved organic carbon (DOC) and

should be relatively constant during the

steady-state time period.

6. For organic chemicals with log Kow

greater than four, the concentrations of POC

and DOC in the ambient water shall be either

measured or reliably estimated.

7. For inorganic and organic chemicals,

BAFs shall be used only if they are expressed

on a wet weight basis; BAFs reported on a

dry weight basis cannot be converted to wet

weight unless a conversion factor is

measured or reliably estimated for the tissue

used in the determination of the BAF.

C. Field-Measured BSAFs. The following

procedural and quality assurance

requirements shall be met for field-measured

BSAFs:

1. The field studies used shall be limited

to those conducted in the Great Lakes System

with fish at or near the top of the aquatic

food chain (i.e., in trophic levels 3 and/or 4).

2. Samples of surface sediments (0–1 cm is

ideal) shall be from locations in which there

is net deposition of fine sediment and is

representative of average surface sediment in

the vicinity of the organism.

3. The Kows used shall be acceptable

quality as described in section III.F below.

4. The site of the field study should not be

so unique that the resulting BAF cannot be

extrapolated to other locations where the

criteria and values will apply.

5. The tropic level of the fish species shall

be determined.

6. The percent lipid shall be either

measured or reliably estimated for the tissue

used in the determination of the BAF.

D. Laboratory-Measured BCFs. The

following procedural and quality assurance

requirements shall be met for laboratorymeasured BCFs:

1. The test organism shall not be diseased,

unhealthy, or adversely affected by the

concentration of the chemical.

2. The total concentration of the chemical

in the water shall be measured and should

be relatively constant during the steady-state

time period.

3. The organisms shall be exposed to the

chemical using a flow-through or renewal

procedure.

4. For organic chemicals, the percent lipid

shall be either measured or reliably estimated

for the tissue used in the determination of the

BCF.

5. For organic chemicals with log Kow

greater than four, the concentrations of POC

and DOC in the test solution shall be either

measured or reliably estimated.

6. Laboratory-measured BCFs should be

determined using fish species, but BCFs

determined with molluscs and other

invertebrates may be used with caution. For

example, because invertebrates metabolize

some chemicals less efficiently than

vertebrates, a baseline BCF determined for

such a chemical using invertebrates is

expected to be higher than a comparable

baseline BCF determined using fish.

7. If laboratory-measured BCFs increase or

decrease as the concentration of the chemical

increases in the test solutions in a

bioconcentration test, the BCF measured at

the lowest test concentration that is above

concentrations existing in the control water

shall be used (i.e., a BCF should be

calculated from a control treatment). The

concentrations of an inorganic chemical in a

bioconcentration test should be greater than

normal background levels and greater than

levels required for normal nutrition of the

test species if the chemical is a

micronutrient, but below levels that

adversely affect the species.

Bioaccummulation of an inorganic chemical

might be overestimated if concentrations are

at or below normal background levels due to,

for example, nutritional requirements of the

test organisms.

8. For inorganic and organic chemicals,

BCFs shall be used only if they are expressed

on a wet weight basis. BCFs reported on a dry

weight basis cannot be converted to wet

weight unless a conversion factor is

measured or reliably estimated for the tissue

used in the determination of the BAF.

9. BCFs for organic chemicals may be

based on measurement or radioactivity only

when the BCF is intended to include

metabolites or when there is confidence that

there is no interference due to metabolites.

10. The calculation of the BCF must

appropriately address growth dilution.

11. Other aspects of the methodology used

should be similar to those described by

ASTM (1990).
15402 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

E. Predicted BCFs. The following

procedural and quality assurance

requirements shall be met for predicted

BCFs:

1. The Kow used shall be of acceptable

quality as described in section III.F below.

2. The predicted baseline BCF shall be

calculated using the equation: predicted

baseline BCF = Kow

where:

Kow = octanol-water partition coefficient.

F. Octanol-Water Partition Coefficient

(Kow). 1. The value of Kow used for an organic

chemical shall be determined by giving

priority to the experimental and

computational techniques used as follows:

Log Kow < 4:

Priority Technique

1 ............................ Slow-stir.

1 ............................ Generator-column.

1 ............................ Shake-flask.

2 ............................ Reverse-phase liquid

chromatography on

C18 chromatography

packing with extrapolation to zero percent

solvent.

3 ............................ Reverse-phase liquid

chromatography on

C18 chromatography

packing without extrapolation to zero

percent solvent.

4 ............................ Calculated by the

CLOGP program.

Log Kow > 4:

Priority Technique

1 ............... Slow Stir.

1 ............... Generator-column.

2 ............... Reverse-phase liquid chromatography on C18 chromatography packing with extrapolation to zero percent solvent.

3 ............... Reverse-phase liquid chromatography on C18 chromatography packing without extrapolation to zero percent solvent.

4 ............... Shake-flask.

5 ............... Calculated by the CLOGP program.

2. The CLOGP program is a computer

program available from Pomona College. A

value of Kow that seems to be different from

the others should be considered an outlier

and not used. The value of Kow used for an

organic chemical shall be the geometric mean

of the available Kows with highest priority or

can be calculated from the arithmetic mean

of the available log Kow with the highest

priority. Because it is an intermediate value

in the derivation of a BAF, the value used for

the Kow of a chemical should not be rounded

to fewer than three significant digits and a

value for log Kow should not be rounded to

fewer than three significant digits after the

decimal point.

G. This methodology provides overall

guidance for the derivation of BAFs, but it

cannot cover all the decisions that must be

made in the review and selection of

acceptable data. Professional judgment is

required throughout the process. A degree of

uncertainty is associated with the

determination of any BAF, BSAF, BCF or

Kow. The amount of uncertainty in a baseline

BAF depends on both the quality of data

available and the method used to derive the

BAF.

H. Hereinafter in this methodology, the

terms BAF, BSAF, BCF and Kow refer to ones

that are consistent with the procedural and

quality assurance requirements given above.

IV. Four Methods for Deriving Baseline BAFs

Baseline BAFs shall be derived using the

following four methods, which are listed

from most preferred to least preferred:

A. A measured baseline BAF for an organic

or inorganic chemical derived from a field

study of acceptable quality.

B. A predicted baseline BAF for an organic

chemical derived using field-measured

BSAFs of acceptable quality.

C. A predicted baseline BAF for an organic

or inorganic chemical derived from a BCF

measured in a laboratory study of acceptable

quality and a FCM.

D. A predicted baseline BAF for an organic

chemical derived from a Kow of acceptable

quality and a FCM.

For comparative purposes, baseline BAFs

should be derived for each chemical by as

many of the four methods as available data

allow.

V. Calculation of Baseline BAFs for Organic

Chemicals

A. Lipid Normalization. 1. It is assumed

that BAFs and BCFs for organic chemicals

can be extrapolated on the basis of percent

lipid from one tissue to another and from one

aquatic species to another in most cases.

2. Because BAFs and BCFs for organic

chemicals are related to the percent lipid, it

does not make any difference whether the

tissue sample is whole body or edible

portion, but both the BAF (or BCF) and the

percent lipid must be determined for the

same tissue. The percent lipid of the tissue

should be measured during the BAF or BCF

study, but in some cases it can be reliably

estimated from measurements on tissue from

other organisms. If percent lipid is not

reported for the test organisms in the original

study, it may be obtained from the author; or,

in the case of a laboratory study, lipid data

for the same or a comparable laboratory

population of test organisms that were used

in the original study may be used.

3. The lipid-normalized concentration, Cl,

of a chemical in tissue is defined using the

following equation:

C

C

f l

B

l

=

Where:

CB=concentration of the organic chemical in

the tissue of aquatic biota (either whole

organism or specified tissue) (μg/g).

fl=fraction of the tissue that is lipid.

B. Bioavailability. By definition, baseline

BAFs and BCFs for organic chemicals,

whether measured or predicted are based on

the concentration of the chemical that is

freely dissolved in the ambient water in order

to account for bioavailability. For the

purposes of this Guidance in this part, the

relationship between the total concentration

of the chemical in the water (i.e., that which

is freely dissolved plus that which is sorbed

to particulate organic carbon or to dissolved

organic carbon) to the freely dissolved

concentration of the chemical in the ambient

water shall be calculated using the following

equation:

C f C w

fd

fd w

t = ( )( )

Where:

Cfdw=freely dissolved concentration of the

organic chemical in the ambient water;

Ct

w=total concentration of the organic

chemical in the ambient water;

ffd=fraction of the total chemical in the

ambient water that is freely dissolved.

The fraction of the total chemical in the

ambient water that is freely dissolved, ffd,

shall be calculated using the following

equation:

f DOC K

POC K

fd ow ow

=

+ +

1

1

10

( )( ) ( )( )

Where:

DOC=concentration of dissolved organic

carbon, kg of dissolved organic carbon/

L of water.

KOW=octanol-water partition coefficient of

the chemical.

POC=concentration of particulate organic

carbon, kg of particulate organic carbon/

L of water.

C. Food-Chain Multiplier. In the absence of

a field-measured BAF or a predicted BAF

derived from a BSAF, a FCM shall be used

to calculate the baseline BAF for trophic

levels 3 and 4 from a laboratory-measured or

predicted BCF. For an organic chemical, the

FCM used shall be derived from Table B–1

using the chemical’s log KOW and linear

interpolation. A FCM greater than 1.0 applies

to most organic chemicals with a log KOW of

four or more. The trophic level used shall

take into account the age or size of the fish

species consumed by the human, avian or

mammalian predator because, for some

species of fish, the young are in trophic level

3 whereas the adults are in trophic level 4.

D. Calculation of a Baseline BAF from a

Field-Measured BAF. A baseline BAF shall be

calculated from a field-measured BAF of

acceptable quality using the following

equation:
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15403

Baseline BAF =

Measured BAFT

t

f f fd l

− 































1

1

Where:

BAFt

T=BAF based on total concentration in

tissue and water.

fl=fraction of the tissue that is lipid.

ffd=fraction of the total chemical that is freely

dissolved in the ambient water.

The trophic level to which the baseline BAF

applies is the same as the trophic level of the

organisms used in the determination of the

field-measured BAF. For each trophic level,

a species mean measured baseline BAF shall

be calculated as the geometric mean if more

than one measured baseline BAF is available

for a given species. For each trophic level,

the geometric mean of the species mean

measured baseline BAFs shall be calculated.

If a baseline BAF based on a measured BAF

is available for either trophic level 3 or 4, but

not both, a measured baseline BAF for the

other trophic level shall be calculated using

the ratio of the FCMs that are obtained by

linear interpolation from Table B–1 for the

chemical.

E. Calculation of a Baseline BAF from a

Field-Measured BSAF. 1. A baseline BAF for

organic chemical ‘‘i’’ shall be calculated from

a field-measured BSAF of acceptable quality

using the following equation:

Baseline BAF Baseline BAF

BSAF i r

i i

r r

( ) = ( ) ⋅ ( ) ⋅ ( )

( ) ⋅ ( ) BSAF K

 K

ow

ow

Where:

(BSAF)i=BSAF for chemical ‘‘i’’.

(BSAF)r=BSAF for the reference chemical

‘‘r’’.

(KOW)i=octanol-water partition coefficient for

chemical ‘‘i’’.

(KOW)r=octanol-water partition coefficient for

the reference chemical ‘‘r’’.

2. A BSAF shall be calculated using the

following equation:

BSAF

C

C

l

SOC

=

Where:

Ct=the lipid-normalized concentration of the

chemical in tissue.

CSOC=the organic carbon-normalized

concentration of the chemical in

sediment.

3. The organic carbon-normalized

concentration of a chemical in sediment,

CSOC, shall be calculated using the following

equation:

C

C

f SOC

S

OC

=

Where:

CS=concentration of chemical in sediment

(μg/g sediment).

fOC=fraction of the sediment that is organic

carbon.

4. Predicting BAFs from BSAFs requires

data from a steady-state (or near steady-state)

condition between sediment and ambient

water for both a reference chemical ‘‘r’’ with

a field-measured BAFl

fd and other chemicals

‘‘n=i’’ for which BSAFs are to be determined.

5. The trophic level to which the baseline

BAF applies is the same as the trophic level

of the organisms used in the determination

of the BSAF. For each trophic level, a species

mean baseline BAF shall be calculated as the

geometric mean if more than one baseline

BAF is predicted from BSAFs for a given

species. For each trophic level, the geometric

mean of the species mean baseline BAFs

derived using BSAFs shall be calculated.

6. If a baseline BAF based on a measured

BSAF is available for either trophic level 3

or 4, but not both, a baseline BAF for the

other trophic level shall be calculated using

the ratio of the FCMs that are obtained by

linear interpolation from Table B–1 for the

chemical.

F. Calculation of a Baseline BAF from a

Laboratory-Measured BCF. A baseline BAF

for trophic level 3 and a baseline BAF for

trophic level 4 shall be calculated from a

laboratory-measured BCF of acceptable

quality and a FCM using the following

equation:

Baseline BAF = FCM T

t

( ) − 































Measured BCF

f f fd l

1

1

Where:

BCFt

T=BCF based on total concentration in

tissue and water.

fl=fraction of the tissue that is lipid.

ffd=fraction of the total chemical in the test

water that is freely dissolved.

FCM=the food-chain multiplier obtained

from Table B–1 by linear interpolation

for trophic level 3 or 4, as necessary.

For each trophic level, a species mean

baseline BAF shall be calculated as the

geometric mean if more than one baseline

BAF is predicted from laboratory-measured

BCFs for a given species. For each trophic

level, the geometric mean of the species

mean baseline BAFs based on laboratorymeasured BCFs shall be calculated.

G. Calculation of a Baseline BAF from an

Octanol-Water Partition Coefficient. A

baseline BAF for trophic level 3 and a

baseline BAF for trophic level 4 shall be

calculated from a KOW of acceptable quality

and a FCM using the following equation:

Baseline BAF=(FCM) (predicted baseline

BCF)=(FCM) (KOW)

Where:

FCM=the food-chain multiplier obtained

from Table B–1 by linear interpolation

for trophic level 3 or 4, as necessary.

KOW=octanol-water partition coefficient.

VI. Human Health and Wildlife BAFs for

Organic Chemicals

A. To calculate human health and wildlife

BAFs for an organic chemical, the KOW of the
15404 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

chemical shall be used with a POC

concentration of 0.00000004 kg/L and a DOC

concentration of 0.000002 kg/L to yield the

fraction freely dissolved:

f DOC K

POC K

kg L K kg L K

kg L K

fd ow ow

ow ow

ow

=

+ +

=

+ +

= +

1

1

10

1

1

0 000002

10

0 00000004

1

1 0 00000024

( )( ) ( )( )

( . / )( ) ( . / )( )

( . / )( )

B. The human health BAFs for an organic

chemical shall be calculated using the

following equations:

For trophic level 3:

Human Health BAF )(0.0182) +1](f TL3

HH

fd = [( ) baseline BAF

For trophic level 4:

Human Health BAF )(0.0310) +1](f TL4

HH

fd = [( ) baseline BAF

Where:

0.0182 and 0.0310 are the standardized

fraction lipid values for trophic levels 3 and

4, respectively, that are used to derive human

health criteria and values for the GLI.

C. The wildlife BAFs for an organic

chemical shall be calculated using the

following equations:

For trophic level 3:

Wildlife BAF baseline BAF TL3

WL

fd = [( ) )(0.0646) +1](f

For trophic level 4:

Wildlife BAF baseline BAF TL4

WL

fd = [( ) )(0.1031) +1](f

Where:

0.0646 and 0.1031 are the standardized

fraction lipid values for trophic levels 3 and

4, respectively, that are used to derive

wildlife criteria for the GLI.

VII. Human Health and Wildlife BAFs for

Inorganic Chemicals

A. For inorganic chemicals, the baseline

BAFs for trophic levels 3 and 4 are both

assumed to equal the BCF determined for the

chemical with fish, i.e., the FCM is assumed

to be 1 for both trophic levels 3 and 4.

However, a FCM greater than 1 might be

applicable to some metals, such as mercury,

if, for example, an organometallic form of the

metal biomagnifies.

B. BAFs for Human Health Criteria and

Values.

1. Measured BAFs and BCFs used to

determine human health BAFs for inorganic

chemicals shall be based on edible tissue

(e.g., muscle) of freshwater fish unless it is

demonstrated that whole-body BAFs or BCFs

are similar to edible-tissue BAFs or BCFs.

BCFs and BAFs based on measurements of

aquatic plants and invertebrates should not

be used in the derivation of human health

criteria and values.

2. If one or more field-measured baseline

BAFs for an inorganic chemical are available

from studies conducted in the Great Lakes

System with the muscle of fish:

a. For each trophic level, a species mean

measured baseline BAF shall be calculated as

the geometric mean if more than one

measured BAF is available for a given

species; and

b. For each trophic level, the geometric

mean of the species mean measured baseline

BAFs shall be used as the human health BAF

for that chemical.

3. If an acceptable measured baseline BAF

is not available for an inorganic chemical and

one or more acceptable edible-portion

laboratory-measured BCFs are available for

the chemical, a predicted baseline BAF shall

be calculated by multiplying the geometric

mean of the BCFs times a FCM. The FCM

will be 1.0 unless chemical-specific

biomagnification data support using a

multiplier other than 1.0. The predicted

baseline BAF shall be used as the human

health BAF for that chemical.

C. BAFs for Wildlife Criteria.

1. Measured BAFs and BCFs used to

determine wildlife BAFs for inorganic

chemicals shall be based on whole-body

freshwater fish and invertebrate data unless

it is demonstrated that edible-tissue BAFs or

BCFs are similar to whole-body BAFs or

BCFs.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15405

2. If one or more field-measured baseline

BAFs for an inorganic chemical are available

from studies conducted in the Great Lakes

System with whole body of fish or

invertebrates:

2. For each trophic level, a species mean

measured baseline BAF shall be calculated as

the geometric mean if more than one

measured BAF is available for a given

species.

b. For each trophic level, the geometric

mean of the species mean measured baseline

BAFs shall be used as the wildlife BAF for

that chemical.

3. If an acceptable measured baseline BAF

is not available for an inorganic chemical and

one or more acceptable whole-body

laboratory-measured BCFs are available for

the chemical, a predicted baseline BAF shall

be calculated by multiplying the geometric

mean of the BCFs times a FCM. The FCM

will be 1.0 unless chemical-specific

biomagnification data support using a

multiplier other than 1.0. The predicted

baseline BAF shall be used as the wildlife

BAF for that chemical.

VIII. Final Review

For both organic and inorganic chemicals,

human health and wildlife BAFs for both

trophic levels shall be reviewed for

consistency with all available data

concerning the bioaccumulation,

bioconcentration, and metabolism of the

chemical. For example, information

concerning octanol-water partitioning,

molecular size, or other physicochemical

properties that might enhance or inhibit

bioaccumulation should be considered for

organic chemicals. BAFs derived in

accordance with this methodology should be

modified if changes are justified by available

data.

IX. Literature Cited

ASTM. 1990. Standard Practice for

Conducting Bioconcentration Tests with

Fishes and Saltwater Bivalve Molluscs.

Standard E 1022. American Society for

Testing and Materials, Philadelphia, PA.

TABLE B–1.—FOOD-CHAIN MULTIPLIERS FOR TROPHIC LEVELS 2, 3 & 4

Log Kow Trophic

level 2

Trophic1

level 3

Trophic

level 4

2.0 ............................................................................................................................................................ 1.000 1.005 1.000

2.5 ............................................................................................................................................................ 1.000 1.010 1.002

3.0 ............................................................................................................................................................ 1.000 1.028 1.007

3.1 ............................................................................................................................................................ 1.000 1.034 1.007

3.2 ............................................................................................................................................................ 1.000 1.042 1.009

3.3 ............................................................................................................................................................ 1.000 1.053 1.012

3.4 ............................................................................................................................................................ 1.000 1.067 1.014

3.5 ............................................................................................................................................................ 1.000 1.083 1.019

3.6 ............................................................................................................................................................ 1.000 1.103 1.023

3.7 ............................................................................................................................................................ 1.000 1.128 1.033

3.8 ............................................................................................................................................................ 1.000 1.161 1.042

3.9 ............................................................................................................................................................ 1.000 1.202 1.054

4.0 ............................................................................................................................................................ 1.000 1.253 1.072

4.1 ............................................................................................................................................................ 1.000 1.315 1.096

4.2 ............................................................................................................................................................ 1.000 1.380 1.130

4.3 ............................................................................................................................................................ 1.000 1.491 1.178

4.4 ............................................................................................................................................................ 1.000 1.614 1.242

4.5 ............................................................................................................................................................ 1.000 1.766 1.334

4.6 ............................................................................................................................................................ 1.000 1.950 1.459

4.7 ............................................................................................................................................................ 1.000 2.175 1.633

4.8 ............................................................................................................................................................ 1.000 2.452 1.871

4.9 ............................................................................................................................................................ 1.000 2.780 2.193

5.0 ............................................................................................................................................................ 1.000 3.181 2.612

5.1 ............................................................................................................................................................ 1.000 3.643 3.162

5.2 ............................................................................................................................................................ 1.000 4.188 3.873

5.3 ............................................................................................................................................................ 1.000 4.803 4.742

5.4 ............................................................................................................................................................ 1.000 5.502 5.821

5.5 ............................................................................................................................................................ 1.000 6.266 7.079

5.6 ............................................................................................................................................................ 1.000 7.096 8.551

5.7 ............................................................................................................................................................ 1.000 7.962 10.209

5.8 ............................................................................................................................................................ 1.000 8.841 12.050

5.9 ............................................................................................................................................................ 1.000 9.716 13.964

6.0 ............................................................................................................................................................ 1.000 10.556 15.996

6.1 ............................................................................................................................................................ 1.000 11.337 17.783

6.2 ............................................................................................................................................................ 1.000 12.064 19.907

6.3 ............................................................................................................................................................ 1.000 12.691 21.677

6.4 ............................................................................................................................................................ 1.000 13.228 23.281

6.5 ............................................................................................................................................................ 1.000 13.662 24.604

6.6 ............................................................................................................................................................ 1.000 13.980 25.645

6.7 ............................................................................................................................................................ 1.000 14.223 26.363

6.8 ............................................................................................................................................................ 1.000 14.355 26.669

6.9 ............................................................................................................................................................ 1.000 14.388 26.669

7.0 ............................................................................................................................................................ 1.000 14.305 26.242

7.1 ............................................................................................................................................................ 1.000 14.142 25.468

7.2 ............................................................................................................................................................ 1.000 13.852 24.322

7.3 ............................................................................................................................................................ 1.000 13.474 22.856

7.4 ............................................................................................................................................................ 1.000 12.987 21.038

7.5 ............................................................................................................................................................ 1.000 12.517 18.967

7.6 ............................................................................................................................................................ 1.000 11.708 16.749

7.7 ............................................................................................................................................................ 1.000 10.914 14.388

7.8 ............................................................................................................................................................ 1.000 10.069 12.050

7.9 ............................................................................................................................................................ 1.000 9.162 9.840

8.0 ............................................................................................................................................................ 1.000 8.222 7.798

8.1 ............................................................................................................................................................ 1.000 7.278 6.012
15406 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

TABLE B–1.—FOOD-CHAIN MULTIPLIERS FOR TROPHIC LEVELS 2, 3 & 4—Continued

Log Kow Trophic

level 2

Trophic1

level 3

Trophic

level 4

8.2 ............................................................................................................................................................ 1.000 6.361 4.519

8.3 ............................................................................................................................................................ 1.000 5.489 3.311

8.4 ............................................................................................................................................................ 1.000 4.683 2.371

8.5 ............................................................................................................................................................ 1.000 3.949 1.663

8.6 ............................................................................................................................................................ 1.000 3.296 1.146

8.7 ............................................................................................................................................................ 1.000 2.732 0.778

8.8 ............................................................................................................................................................ 1.000 2.246 0.521

8.9 ............................................................................................................................................................ 1.000 1.837 0.345

9.0 ............................................................................................................................................................ 1.000 1.493 0.226

1The FCMs for trophic level 3 are the geometric mean of the FCMs for sculpin and alewife.

Appendix C to Part 132—Great Lakes Water

Quality Initiative Methodologies for

Development of Human Health Criteria and

Values

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

this appendix.

I. Introduction

Great Lakes States and Tribes shall adopt

provisions consistent with this appendix C to

ensure protection of human health.

A. Goal. The goal of the human health

criteria for the Great Lakes System is the

protection of humans from unacceptable

exposure to toxicants via consumption of

contaminated fish and drinking water and

from ingesting water as a result of

participation in water-oriented recreational

activities.

B. Definitions.

Acceptable daily exposure (ADE). An

estimate of the maximum daily dose of a

substance which is not expected to result in

adverse noncancer effects to the general

human population, including sensitive

subgroups.

Adverse effect. Any deleterious effect to

organisms due to exposure to a substance.

This includes effects which are or may

become debilitating, harmful or toxic to the

normal functions of the organism, but does

not include non-harmful effects such as

tissue discoloration alone or the induction of

enzymes involved in the metabolism of the

substance.

Carcinogen. A substance which causes an

increased incidence of benign or malignant

neoplasms, or substantially decreases the

time to develop neoplasms, in animals or

humans. The classification of carcinogens is

discussed in section II.A of appendix C to

part 132.

Human cancer criterion (HCC). A Human

Cancer Value (HCV) for a pollutant that

meets the minimum data requirements for

Tier I specified in appendix C.

Human cancer value (HCV). The maximum

ambient water concentration of a substance at

which a lifetime of exposure from either:

drinking the water, consuming fish from the

water, and water-related recreation activities;

or consuming fish from the water, and waterrelated recreation activities, will represent a

plausible upper-bound risk of contracting

cancer of one in 100,000 using the exposure

assumptions specified in the Methodologies

for the Development of Human Health

Criteria and Values in appendix C of this

part.

Human noncancer criterion (HNC). A

Human Noncancer Value (HNV) for a

pollutant that meets the minimum data

requirements for Tier I specified in appendix

C of this part.

Human noncancer value (HNV). The

maximum ambient water concentration of a

substance at which adverse noncancer effects

are not likely to occur in the human

population from lifetime exposure via either:

drinking the water, consuming fish from the

water, and water-related recreation activities;

or consuming fish from the water, and waterrelated recreation activities using the

Methodologies for the Development of

Human Health criteria and Values in

appendix C of this part.

Linearized multi-stage model. A

conservative mathematical model for cancer

risk assessment. This model fits linear doseresponse curves to low doses. It is consistent

with a no-threshold model of carcinogenesis,

i.e., exposure to even a very small amount of

the substance is assumed to produce a finite

increased risk of cancer.

Lowest observed adverse effect level

(LOAEL). The lowest tested dose or

concentration of a substance which resulted

in an observed adverse effect in exposed test

organisms when all higher doses or

concentrations resulted in the same or more

severe effects.

No observed adverse effect level (NOAEL).

The highest tested dose or concentration of

a substance which resulted in no observed

adverse effect in exposed test organisms

where higher doses or concentrations

resulted in an adverse effect.

Quantitative structure activity relationship

(OSAR) or structure activity relationship

(SAR). A mathematical relationship between

a property (activity) of a chemical and a

number of descriptors of the chemical. These

descriptors are chemical or physical

characteristics obtained experimentally or

predicted from the structure of the chemical.

Relative source contribution (RSC). The

factor (percentage) used in calculating an

HNV or HNC to account for all sources of

exposure to a contaminant. The RSC reflects

the percent of total exposure which can be

attributed to surface water through water

intake and fish consumption.

Risk associated dose (RAD). A dose of a

known or presumed carcinogenic substance

in (mg/kg/day) which, over a lifetime of

exposure, is estimated to be associated with

a plausible upper bound incremental cancer

risk equal to one in 100,000.

Slope factor. Also known as q1*, slope

factor is the incremental rate of cancer

development calculated through use of a

linearized multistage model or other

appropriate model. It is expressed in (mg/kg/

day) of exposure to the chemical in question.

Threshold effect. An effect of a substance

for which there is a theoretical or empirically

established dose or concentration below

which the effect does not occur.

Uncertainty factor (UF). One of several

numeric factors used in operationally

deriving criteria from experimental data to

account for the quality or quantity of the

available data.

C. Level of Protection. The criteria

developed shall provide a level of protection

likely to be without appreciable risk of

carcinogenic and/or noncarcinogenic effects.

Criteria are a function of the level of

designated risk or no adverse effect

estimation, selection of data and exposure

assumptions. Ambient criteria for single

carcinogens shall not be set at a level

representing a lifetime upper-bound

incremental risk greater than one in 100,000

of developing cancer using the hazard

assessment techniques and exposure

assumptions described herein. Criteria

affording protection from noncarcinogenic

effects shall be established at levels that,

taking into account uncertainties, are

considered likely to be without an

appreciable risk of adverse human health

effects (i.e., acute, subchronic and chronic

toxicity including reproductive and

developmental effects) during a lifetime of

exposure, using the risk assessment

techniques and exposure assumptions

described herein.

D. Two-tiered Classification. Chemical

concentration levels in surface water

protective of human health shall be derived

based on either a Tier I or Tier II

classification. The two Tiers are primarily

distinguished by the amount of toxicity data

available for deriving the concentration

levels and the quantity and quality of data on

bioaccumulation.

II. Minimum Data Requirements

The best available toxicity data on the

adverse health effects of a chemical and the

best data on bioaccumulation factors shall be

used when developing human health Tier I

criteria or Tier II values. The best available

toxicity data shall include data from well-
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15407

conducted epidemiologic and/or animal

studies which provide, in the case of

carcinogens, an adequate weight of evidence

of potential human carcinogenicity and, in

the case of noncarcinogens, a dose-response

relationship involving critical effects

biologically relevant to humans. Such

information should be obtained from the EPA

Integrated Risk Information System (IRIS)

database, the scientific literature, and other

informational databases, studies and/or

reports containing adverse health effects data

of adequate quality for use in this procedure.

Strong consideration shall be given to the

most currently available guidance provided

by IRIS in deriving criteria or values,

supplemented with any recent data not

incorporated into IRIS. When deviations from

IRIS are anticipated or considered necessary,

it is strongly recommended that such actions

be communicated to the EPA Reference Dose

(RfD) and/or the Cancer Risk Assessment

Verification Endeavor (CRAVE) workgroup

immediately. The best available

bioaccumulation data shall include data from

field studies and well-conducted laboratory

studies.

A. Carcinogens. Tier I criteria and Tier II

values shall be derived using the

methodologies described in section III.A of

this appendix when there is adequate

evidence of potential human carcinogenic

effects for a chemical. It is strongly

recommended that the EPA classification

system for chemical carcinogens, which is

described in the 1986 EPA Guidelines for

Carcinogenic Risk Assessment (U.S. EPA,

1986), or future modifications thereto, be

used in determining whether adequate

evidence of potential carcinogenic effects

exists. Carcinogens are classified, depending

on the weight of evidence, as either human

carcinogens, probable human carcinogens, or

possible human carcinogens. The human

evidence is considered inadequate and

therefore the chemical cannot be classified as

a human carcinogen, if one of two conditions

exists: (a) there are few pertinent data, or (b)

the available studies, while showing

evidence of association, do not exclude

chance, bias, or confounding and therefore a

casual interpretation is not credible. The

animal evidence is considered inadequate,

and therefore the chemical cannot be

classified as a probable or possible human

carcinogen, when, because of major

qualitative or quantitative limitations, the

evidence cannot be interpreted as showing

either the presence or absence of a

carcinogenic effect.

Chemicals are described as ‘‘human

carcinogens’’ when there is sufficient

evidence from epidemiological studies to

support a causal association between

exposure to the chemicals and cancer.

Chemicals described as ‘‘probable human

carcinogens’’ include chemicals for which

the weight of evidence of human

carcinogenicity based on epidemiological

studies is limited. Limited human evidence

is that which indicates that a causal

interpretation is credible, but that alternative

explanations, such as chance, bias, or

confounding, cannot adequately be excluded.

Probable human carcinogens are also agents

for which there is sufficient evidence from

animal studies and for which there is

inadequate evidence or no data from

epidemiologic studies. Sufficient animal

evidence is data which indicates that there is

an increased incidence of malignant tumors

or combined malignant and benign tumors:

(a) in multiple species or strains; (b) in

multiple experiments (e.g., with different

routes of administration or using different

dose levels); or (c) to an unusual degree in

a single experiment with regard to high

incidence, unusual site or type of tumor, or

early age at onset. Additional evidence may

be provided by data on dose-response effects,

as well as information from short-term tests

(such as mutagenicity/genotoxicity tests

which help determine whether the chemical

interacts directly with DNA) or on chemical

structure, metabolism or mode of action.

‘‘Possible human carcinogens’’ are

chemicals with limited evidence of

carcinogenicity in animals in the absence of

human data. Limited animal evidence is

defined as data which suggests a

carcinogenic effect but are limited because:

(a) The studies involve a single species,

strain, or experiment and do not meet criteria

for sufficient evidence (see preceding

paragraph); or (b) the experiments are

restricted by inadequate dosage levels,

inadequate duration of exposure to the agent,

inadequate period of follow-up, poor

survival, too few animals, or inadequate

reporting; or (c) the studies indicate an

increase in the incidence of benign tumors

only. More specifically, this group can

include a wide variety of evidence, e.g., (a)

a malignant tumor response in a single wellconducted experiment that does not meet

conditions for sufficient evidence, (b) tumor

response of marginal statistical significance

in studies having inadequate design or

reporting, (c) benign but not malignant

tumors with an agent showing no response in

a variety of short-term tests for mutagenicity,

and (d) response of marginal statistical

significance in a tissue known to have a high

or variable background rate.

1. Tier I: Weight of evidence of potential

human carcinogenic effects sufficient to

derive a Tier I HCC shall generally include

human carcinogens, probable human

carcinogens and can include, on a case-bycase basis, possible human carcinogens if

studies have been well-conducted albeit

based on limited evidence, when compared

to studies used in classifying human and

probable human carcinogens. The decision to

use data on a possible human carcinogen for

deriving Tier I criteria shall be a case-by-case

determination. In determining whether to

derive a Tier I HCC, additional evidence that

shall be considered includes but is not

limited to available information on mode of

action, such as mutagenicity/genotoxicity

(determinations of whether the chemical

interacts directly with DNA), structure

activity, and metabolism.

2. Tier II: Weight of evidence of possible

human carcinogenic effects sufficient to

derive a Tier II human cancer value shall

include those possible human carcinogens

for which there are at a minimum, data

sufficient for quantitative risk assessment,

but for which data are inadequate for Tier I

criterion development due to a tumor

response of marginal statistical significance

or inability to derive a strong dose-response

relationship. In determining whether to

derive Tier II human cancer values,

additional evidence that shall be considered

includes but is not limited to available

information on mode of action such as

mutagenicity/genotoxicity (determinations of

whether the chemical interacts directly with

DNA), structure activity and metabolism. As

with the use of data on possible human

carcinogens in developing Tier I criteria, the

decision to use data on possible human

carcinogens to derive Tier II values shall be

made on a case-by-case basis.

B. Noncarcinogens. All available toxicity

data shall be evaluated considering the full

range of possible health effects of a chemical,

i.e., acute/subacute, chronic/subchronic and

reproductive/developmental effects, in order

to best describe the dose-response

relationship of the chemical, and to calculate

human noncancer criteria and values which

will protect against the most sensitive

endpoint(s) of toxicity. Although it is

desirable to have an extensive database

which considers a wide range of possible

adverse effects, this type of data exists for a

very limited number of chemicals. For many

others, there is a range in quality and

quantity of data available. To assure

minimum reliability of criteria and values, it

is necessary to establish a minimum database

with which to develop Tier I criteria or Tier

II values. The following represent the

minimum data sets necessary for this

procedure.

1. Tier I: The minimum data set sufficient

to derive a Tier I human HNC shall include

at least one well-conducted epidemiologic

study or animal study. A well-conducted

epidemiologic study for a Tier I HNC must

quantify exposure level(s) and demonstrate

positive association between exposure to a

chemical and adverse effect(s) in humans. A

well-conducted study in animals must

demonstrate a dose response relationship

involving one or more critical effect(s)

biologically relevant to humans. (For

example, study results from an animal whose

pharmacokinetics and toxicokinetics match

those of a human would be considered most

biologically relevant.) Ideally, the duration of

a study should span multiple generations of

exposed test species or at least a major

portion of the lifespan of one generation.

This type of data is currently very limited. By

the use of uncertainty adjustments, shorter

term studies (such as 90-day subchronic

studies) with evaluation of more limited

effect(s) may be used to extrapolate to longer

exposures or to account for a variety of

adverse effects. For Tier I criteria developed

pursuant to this procedure, such a limited

study must be conducted for at least 90 days

in rodents or 10 percent of the lifespan of

other appropriate test species and

demonstrate a no observable adverse effect

level (NOAEL). Chronic studies of one year

or longer in rodents or 50 percent of the

lifespan or greater in other appropriate test

species that demonstrate a lowest observable

adverse effect level (LOAEL) may be

sufficient for use in Tier I criterion derivation

if the effects observed at the LOAEL were

relatively mild and reversible as compared to
15408 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

effects at higher doses. This does not

preclude the use of a LOAEL from a study

(of chronic duration) with only one or two

doses if the effects observed appear minimal

when compared to effect levels observed at

higher doses in other studies.

2. Tier II: When the minimum data for

deriving Tier I criteria are not available to

meet the Tier I data requirements, a more

limited database may be considered for

deriving Tier II values. As with Tier I criteria,

all available data shall be considered and

ideally should address a range of adverse

health effects with exposure over a

substantial portion of the lifespan (or

multiple generations) of the test species.

When such data are lacking it may be

necessary to rely on less extensive data in

order to establish a Tier II value. With the use

of appropriate uncertainty factors to account

for a less extensive database, the minimum

data sufficient to derive a Tier II value shall

include a NOAEL from at least one wellconducted short-term repeated dose study.

This study shall be of at least 28 days

duration, in animals demonstrating a doseresponse, and involving effects biologically

relevant to humans. Data from studies of

longer duration (greater than 28 days) and

LOAELs from such studies (greater than 28

days) may be more appropriate in some cases

for derivation of Tier II values. Use of a

LOAEL should be based on consideration of

the following information: severity of effect,

quality of the study and duration of the

study.

C. Bioaccumulation factors (BAFs).

1. Tier I for Carcinogens and

Noncarcinogens: To be considered a Tier I

cancer or noncancer human health criterion,

along with satisfying the minimum toxicity

data requirements of sections II.A.1 and II.B.1

of this appendix, a chemical must have the

following minimum bioaccumulation data.

For all organic chemicals either: (a) a fieldmeasured BAF; (b) a BAF derived using the

BSAF methodology; or (c) a chemical with a

BAF less than 125 regardless of how the BAF

was derived. For all inorganic chemicals,

including organometals such as mercury,

either: (a) a field-measured BAF or (b) a

laboratory-measured BCF.

2. Tier II for Carcinogens and

Noncarcinogens: A chemical is considered a

Tier II cancer or noncancer human health

value if it does not meet either the minimum

toxicity data requirements of sections II.A.1

and II.B.1 of this appendix or the minimum

bioaccumulation data requirements of section

II.C.1 of this appendix.

III. Principles for Development of Tier I

Criteria or Tier II Values

The fundamental components of the

procedure to calculate Tier I criteria or Tier

II values are the same. However, certain of

the aspects of the procedure designed to

account for short-duration studies or other

limitations in data are more likely to be

relevant in deriving Tier II values than Tier

I criteria.

A. Carcinogens.

1. A non-threshold mechanism of

carcinogenesis shall be assumed unless

biological data adequately demonstrate the

existence of a threshold on a chemicalspecific basis.

2. All appropriate human epidemiologic

data and animal cancer bioassay data shall be

considered. Data specific to an

environmentally appropriate route of

exposure shall be used. Oral exposure should

be used preferentially over dermal and

inhalation since, in most cases, the exposure

routes of greatest concern are fish

consumption and drinking water/incidental

ingestion. The risk associated dose shall be

set at a level corresponding to an incremental

cancer risk of one in 100,000. If acceptable

human epidemiologic data are available for a

chemical, it shall be used to derive the risk

associated dose. If acceptable human

epidemiologic data are not available, the risk

associated dose shall be derived from

available animal bioassay data. Data from a

species that is considered most biologically

relevant to humans (i.e., responds most like

humans) is preferred where all other

considerations regarding quality of data are

equal. In the absence of data to distinguish

the most relevant species, data from the most

sensitive species tested, i.e., the species

showing a carcinogenic effect at the lowest

administered dose, shall generally be used.

3. When animal bioassay data are used and

a non-threshold mechanism of

carcinogenicity is assumed, the data are fitted

to a linearized multistage computer model

(e.g., Global ’86 or equivalent model). Global

’86 is the linearized multistage model,

derived by Howe, Crump and Van

Landingham (1986), which EPA uses to

determine cancer potencies. The upperbound 95 percent confidence limit on risk

(or, the lower 95 percent confidence limit on

dose) at the one in 100,000 risk level shall

be used to calculate a risk associated dose

(RAD). Other models, including

modifications or variations of the linear

multistage model which are more appropriate

to the available data may be used where

scientifically justified.

4. If the duration of the study is

significantly less than the natural lifespan of

the test animal, the slope may be adjusted on

a case-by-case basis to compensate for latent

tumors which were not expressed (e.g., U.S.

EPA, 1980) In the absence of alternative

approaches which compensate for study

durations significantly less than lifetime, the

permitting authority may use the process

described in the 1980 National Guidelines

(see 45 FR 79352).

5. A species scaling factor shall be used to

account for differences between test species

and humans. It shall be assumed that

milligrams per surface area per day is an

equivalent dose between species (U.S. EPA,

1986). All doses presented in mg/kg

bodyweight will be converted to an

equivalent surface area dose by raising the

mg/kg dose to the 2/3 power. However, if

adequate pharmacokinetic and metabolism

studies are available, these data may be

factored into the adjustment for species

differences on a case-by-case basis.

6. Additional data selection and

adjustment decisions must also be made in

the process of quantifying risk. Consideration

must be given to tumor selection for

modeling, e.g., pooling estimates for multiple

tumor types and identifying and combining

benign and malignant tumors. All doses shall

be adjusted to give an average daily dose over

the study duration. Adjustments in the rate

of tumor response must be made for early

mortality in test species. The goodness-of-fit

of the model to the data must also be

assessed.

7. When a linear, non-threshold dose

response relationship is assumed, the RAD

shall be calculated using the following

equation:

RAD

q = 0 00001

1

.

*

Where:

RAD=risk associated dose in milligrams of

toxicant per kilogram body weight per

day (mg/kg/day).

0.00001 (1×10¥5)=incremental risk of

developing cancer equal to one in

100,000.

q1*=slope factor (mg/kg/day)¥1.

8. If human epidemiologic data and/or

other biological data (animal) indicate that a

chemical causes cancer via a threshold

mechanism, the risk associated dose may, on

a case-by-case basis, be calculated using a

method which assumes a threshold

mechanism is operative.

B. Noncarcinogens.

1. Noncarcinogens shall generally be

assumed to have a threshold dose or

concentration below which no adverse effects

should be observed. Therefore, the Tier I

criterion or Tier II value is the maximum

water concentration of a substance at or

below which a lifetime exposure from

drinking the water, consuming fish caught in

the water, and ingesting water as a result of

participating in water-related recreation

activities is likely to be without appreciable

risk of deleterious effects.

For some noncarcinogens, there may not be

a threshold dose below which no adverse

effects should be observed. Chemicals acting

as genotoxic teratogens and germline

mutagens are thought to possibly produce

reproductive and/or developmental effects

via a genetically linked mechanism which

may have no threshold. Other chemicals also

may not demonstrate a threshold. Criteria for

these types of chemicals will be established

on a case-by-case basis using appropriate

assumptions reflecting the likelihood that no

threshold exists.

2. All appropriate human and animal

toxicologic data shall be reviewed and

evaluated. To the maximum extent possible,

data most specific to the environmentally

relevant route of exposure shall be used. Oral

exposure data should be used preferentially

over dermal and inhalation since, in most

cases, the exposure routes of greatest concern

are fish consumption and drinking water/

incidental ingestion. When acceptable

human data are not available (e.g., wellconducted epidemiologic studies), animal

data from species most biologically relevant

to humans shall be used. In the absence of

data to distinguish the most relevant species,

data from the most sensitive animal species

tested, i.e., the species showing a toxic effect

at the lowest administered dose (given a

relevant route of exposure), should generally

be used.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15409

3. Minimum data requirements are

specified in section II.B of this appendix. The

experimental exposure level representing the

highest level tested at which no adverse

effects were demonstrated (NOAEL) from

studies satisfying the provisions of section

II.B of this appendix shall be used for criteria

calculations. In the absence of a NOAEL, the

LOAEL from studies satisfying the provisions

of section II.B of this appendix may be used

if it is based on relatively mild and reversible

effects.

4. Uncertainty factors shall be used to

account for the uncertainties in predicting

acceptable dose levels for the general human

population based upon experimental animal

data or limited human data.

a. An uncertainty factor of 10 shall

generally be used when extrapolating from

valid experimental results from studies on

prolonged exposure to average healthy

humans. This 10-fold factor is used to protect

sensitive members of the human population.

b. An uncertainty factor of 100 shall

generally be used when extrapolating from

valid results of long-term studies on

experimental animals when results of studies

of human exposure are not available or are

inadequate. In comparison to a, above, this

represents an additional 10-fold uncertainty

factor in extrapolating data from the average

animal to the average human.

c. An uncertainty factor of up to 1000 shall

generally be used when extrapolating from

animal studies for which the exposure

duration is less than chronic, but greater than

subchronic (e.g., 90 days or more in length),

or when other significant deficiencies in

study quality are present, and when useful

long-term human data are not available. In

comparison to b, above, this represents an

additional UF of up to 10-fold for less than

chronic, but greater than subchronic, studies.

d. An UF of up to 3000 shall generally be

used when extrapolating from animal studies

for which the exposure duration is less than

subchronic (e.g., 28 days). In comparison to

b above, this represents an additional UF of

up to 30-fold for less than subchronic studies

(e.g., 28-day). The level of additional

uncertainty applied for less than chronic

exposures depends on the duration of the

study used relative to the lifetime of the

experimental animal.

e. An additional UF of between one and

ten may be used when deriving a criterion

from a LOAEL. This UF accounts for the lack

of an identifiable NOAEL. The level of

additional uncertainty applied may depend

upon the severity and the incidence of the

observed adverse effect.

f. An additional UF of between one and ten

may be applied when there are limited effects

data or incomplete sub-acute or chronic

toxicity data (e.g., reproductive/

developmental data). The level of quality and

quantity of the experimental data available as

well as structure-activity relationships may

be used to determine the factor selected.

g. When deriving an UF in developing a

Tier I criterion or Tier II value, the total

uncertainty, as calculated following the

guidance of sections 4.a through f, cited

above, shall not exceed 10,000 for Tier I

criteria and 30,000 for Tier II values.

5. All study results shall be converted, as

necessary, to the standard unit for acceptable

daily exposure of milligrams of toxicant per

kilogram of body weight per day (mg/kg/day).

Doses shall be adjusted for continuous

exposure (i.e., seven days/week, 24 hours/

day, etc.).

C. Criteria and Value Derivation.

1. Standard Exposure Assumptions. The

following represent the standard exposure

assumptions used to calculate Tier I criteria

and Tier II values for carcinogens and

noncarcinogens. Higher levels of exposure

may be assumed by States and Tribes

pursuant to Clean Water Act (CWA) section

510, or where appropriate in deriving sitespecific criteria pursuant to procedure 1 in

appendix F to part 132.

BW = body weight of an average human

(BW = 70kg).

WCd = per capita water consumption (both

drinking and incidental exposure) for surface

waters classified as public water supplies =

two liters/day.

—or—

WCr = per capita incidental daily water

ingestion for surface waters not used as

human drinking water sources = 0.01 liters/

day.

FC = per capita daily consumption of

regionally caught freshwater fish = 0.015kg/

day (0.0036 kg/day for trophic level 3 and

0.0114 kg/day for trophic level 4).

BAF = bioaccumulation factor for trophic

level 3 and trophic level 4, as derived using

the BAF methodology in appendix B to part

132.

2. Carcinogens. The Tier I human cancer

criteria or Tier II values shall be calculated

as follows:

HCV

RAD BW

WC FC BAF FC BAF TL TL

HH

TL TL

HH = ×

+ × [ ] ( ) 3 3 4 4 + × ( )

Where:

HCV=Human Cancer Value in milligrams per

liter (mg/L).

RAD=Risk associated dose in milligrams

toxicant per kilogram body weight per

day (mg/kg/day) that is associated with

a lifetime incremental cancer risk equal

to one in 100,000.

BW=weight of an average human (BW=70

kg).

WCd=per capita water consumption (both

drinking and incidental exposure) for

surface waters classified as public water

supplies=two liters/day.

or

WCr=per capita incidental daily water

ingestion for surface waters not used as

human drinking water sources=0.01

liters/day.

FCTL3=mean consumption of trophic level 3

of regionally caught freshwater

fish=0.0036 kg/day.

FCTL4=mean consumption of trophic level 4

of regionally caught freshwater

fish=0.0114 kg/day.

BAFHHTL3=bioaccumulation factor for trophic

level 3 fish, as derived using the BAF

methodology in appendix B to part 132.

BAFHHTL4=bioaccumulation factor for trophic

level 4 fish, as derived using the BAF

methodology in appendix B to part 132.

3. Noncarcinogens. The Tier I human

noncancer criteria or Tier II values shall be

calculated as follows:

HNV

ADE BW RSC

WC FC BAF FC BAF TL TL

HH

TL TL

HH = × ×

+ × [ ] ( ) 3 3 4 4 + × ( )

Where:

HNV=Human noncancer value in milligrams

per liter (mg/L).

ADE=Acceptable daily exposure in

milligrams toxicant per kilogram body

weight per day (mg/kg/day).

RSC=Relative source contribution factor of

0.8. An RSC derived from actual

exposure data may be developed using

the methodology outlined by the 1980

National Guidelines (see 45 FR 79354).

BW=weight of an average human (BW=70

kg).

WCd=per capita water consumption (both

drinking and incidental exposure) for

surface waters classified as public water

supplies=two liters/day.

or

WCr=per capita incidental daily water

ingestion for surface waters not used as

human drinking water sources=0.01

liters/day.
15410 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

FCTL3=mean consumption of trophic level 3

fish by regional sport fishers of

regionally caught freshwater fish=0.0036

kg/day.

FCTL4=mean consumption of trophic level 4

fish by regional sport fishers of

regionally caught freshwater fish=0.0114

kg/day.

BAFHHTL3=human health bioaccumulation

factor for edible portion of trophic level

3 fish, as derived using the BAF

methodology in appendix B to part 132.

BAFHHTL4=human health bioaccumulation

factor for edible portion of trophic level

4 fish, as derived using the BAF

methodology in appendix B to part 132.

IV. References

A. Howe, R.B., K.S. Crump and C. Van

Landingham. 1986. Computer Program to

Extrapolate Quantitative Animal Toxicity

Data to Low Doses. Prepared for EPA under

subcontract #2–251U–2745 to Research

Triangle Institute.

B. U.S. Environmental Protection Agency.

1980. Water Quality Criteria Availability,

Appendix C Guidelines and Methodology

Used in the Preparation of Health Effects

Assessment Chapters of the Consent Decree

Water Quality Criteria Documents. Available

from U.S. Environmental Protection Agency,

Office of Water Resource Center (WH–550A),

401 M St., SW., Washington, DC 20460.

C. U.S. Environmental Protection Agency.

1986. Guidelines for Carcinogen Risk

Assessment. Available from U.S.

Environmental Protection Agency, Office of

Water Resource Center (WH–550A), 401 M

St., SW., Washington, DC 20460.

Appendix D to Part 132—Great Lakes Water

Quality Initiative Methodology for the

Development of Wildlife Criteria

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

this appendix.

I. Introduction

A. A Great Lakes Water Quality Wildlife

Criterion (GLWC) is the concentration of a

substance which is likely to, if not exceeded,

protect avian and mammalian wildlife

populations inhabiting the Great Lakes basin

from adverse effects resulting from the

ingestion of water and aquatic prey taken

from surface waters of the Great Lakes

System. These criteria are based on existing

toxicological studies of the substance of

concern and quantitative information about

the exposure of wildlife species to the

substance (i.e., food and water consumption

rates). Since toxicological and exposure data

for individual wildlife species are limited, a

GLWC is derived using a methodology

similar to that used to derive noncancer

human health criteria (Barnes and Dourson,

1988; NAS, 1977; NAS, 1980; U.S. EPA,

1980). Separate avian and mammalian values

are developed using taxonomic class-specific

toxicity data and exposure data for five

representative Great Lakes basin wildlife

species. The wildlife species selected are

representative of avian and mammalian

species resident in the Great Lakes basin

which are likely to experience the highest

exposures to bioaccumulative contaminants

through the aquatic food web; they are the

bald eagle, herring gull, belted kingfisher,

mink, and river otter.

B. This appendix establishes a

methodology which is required when

developing Tier I wildlife criteria for

bioaccumulative chemicals of concern

(BCCs). The use of the equation provided in

the methodology is encouraged, but not

required, for the development of Tier I

criteria or Tier II values for pollutants other

than those identified in Table 6–A for which

Tier I criteria or Tier II values are determined

to be necessary for the protection of wildlife

in the Great Lakes basin. A discussion of the

methodology for deriving Tier II values can

be found in the Great Lakes Water Quality

Initiative Technical Support Document for

Wildlife Criteria (Wildlife TSD).

C. In the event that this methodology is

used to develop criteria for pollutants other

than BCCs, or in the event that the Tier II

methodology described in the Wildlife TSD

is used to derive Tier II values, the

methodology for deriving bioaccumulation

factors under appendix B to part 132 must be

used in either derivation. For chemicals

which do not biomagnify to the extent of

BCCs, it may be appropriate to select

different representative species which are

better examples of species with the highest

exposures for the given chemical. The

equation presented in this methodology,

however, is still encouraged. In addition,

procedure 1 of appendix F of this part

describes the procedures for calculating sitespecific wildlife criteria.

D. The term ‘‘wildlife value’’ (WV) is used

to denote the value for each representative

species which results from using the

equation presented below, the value obtained

from averaging species values within a class,

or any value derived from application of the

site-specific procedure provided in

procedure 1 of appendix F of this part. The

WVs calculated for the representative species

are used to calculate taxonomic class-specific

WVs. The WV is the concentration of a

substance which, if not exceeded, should

better protect the taxon in question.

E. ‘‘Tier I wildlife criterion,’’ or ‘‘Tier I

criterion’’ is used to denote the number

derived from data meeting the Tier I

minimum database requirements, and which

will be protective of the two classes of

wildlife. It is synonymous with the term

‘‘GLWC,’’ and the two are used

interchangeably.

II. Calculation of Wildlife Values for Tier I

Criteria

Table 4 of Part 132 and Table D–1 of this

appendix contain criteria calculated by EPA

using the methodology provided below.

A. Equation for Avian and Mammalian

Wildlife Values. Tier I wildlife values for the

pollutants designated BCCs pursuant to part

132 are to be calculated using the equation

presented below.

WV

TD

UF UF UF

Wt

W F BAF

A S L

TLi TLi

WL = × ×

×

+ × ∑( )

Where:

WV=Wildlife Value in milligrams of

substance per liter (mg/L).

TD=Test Dose (TD) in milligrams of

substance per kilograms per day (mg/kgd) for the test species. This shall be

either a NOAEL or a LOAEL.

UFA=Uncertainty Factor (UF) for

extrapolating toxicity data across species

(unitless). A species-specific UF shall be

selected and applied to each

representative species, consistent with

the equation.

UFS=UF for extrapolating from subchronic to

chronic exposures (unitless).

UFL=UF for LOAEL to NOAEL extrapolations

(unitless).

Wt=Average weight in kilograms (kg) for the

representative species.

W=Average daily volume of water consumed

in liters per day (L/d) by the

representative species.

FTLi=Average daily amount of food consumed

from trophic level i in kilograms per day

(kg/d) by the representative species.

BAFWLTLi=Bioaccumulation factor (BAF) for

wildlife food in trophic level i in liters

per kilogram (L/kg), developed using the

BAF methodology in appendix B to part

132, Methodology for Development of

Bioaccumulation Factors. For

consumption of piscivorous birds by

other birds (e.g., herring gull by eagles),

the BAF is derived by multiplying the

trophic level 3 BAF for fish by a

biomagnification factor to account for the

biomagnification from fish to the

consumed birds.

B. Identification of Representative Species

for Protection. For bioaccumulative

chemicals, piscivorous species are identified

as the focus of concern for wildlife criteria

development in the Great Lakes. An analysis

of known or estimated exposure components

for avian and mammalian wildlife species is

presented in the Wildlife TSD. This analysis

identifies three avian species (eagle,

kingfisher and herring gull) and two

mammalian species (mink and otter) as

representative species for protection. The TD

obtained from toxicity data for each

taxonomic class is used to calculate WVs for

each of the five representative species.

C. Calculation of Avian and Mammalian

Wildlife Values and GLWC Derivation. The

avian WV is the geometric mean of the WVs

calculated for the three representative avian

species. The mammalian WV is the geometric

mean of the WVs calculated for the two

representative mammalian species. The

lower of the mammalian and avian WVs must

be selected as the GLWC.

III. Parameters of the Effect Component of

the Wildlife Criteria Methodology

A. Definitions. The following definitions

provide additional specificity and guidance

in the evaluation of toxicity data and the

application of this methodology.

Acceptable endpoints. For the purpose of

wildlife criteria derivation, acceptable

subchronic and chronic endpoints are those

which affect reproductive or developmental

success, organismal viability or growth, or

any other endpoint which is, or is directly

related to, parameters that influence

population dynamics.
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15411

Chronic effect. An adverse effect that is

measured by assessing an acceptable

endpoint, and results from continual

exposure over several generations, or at least

over a significant part of the test species’

projected life span or life stage.

Lowest-observed-adverse-effect-level

(LOAEL). The lowest tested dose or

concentration of a substance which resulted

in an observed adverse effect in exposed test

organisms when all higher doses or

concentrations resulted in the same or more

severe effects.

No-observed-adverse-effect-level (NOAEL).

The highest tested dose or concentration of

a substance which resulted in no observed

adverse effect in exposed test organisms

where higher doses or concentrations

resulted in an adverse effect.

Subchronic effect. An adverse effect,

measured by assessing an acceptable

endpoint, resulting from continual exposure

for a period of time less than that deemed

necessary for a chronic test.

B. Minimum Toxicity Database for Tier I

Criteria Development. A TD value is required

for criterion calculation. To derive a Tier I

criterion for wildlife, the data set shall

provide enough data to generate a subchronic

or chronic dose-response curve for any given

substance for both mammalian and avian

species. In reviewing the toxicity data

available which meet the minimum data

requirements for each taxonomic class, the

following order of preference shall be applied

to select the appropriate TD to be used for

calculation of individual WVs. Data from

peer-reviewed field studies of wildlife

species take precedence over other types of

studies, where such studies are of adequate

quality. An acceptable field study must be of

subchronic or chronic duration, provide a

defensible, chemical-specific dose-response

curve in which cause and effect are clearly

established, and assess acceptable endpoints

as defined in this document. When

acceptable wildlife field studies are not

available, or determined to be of inadequate

quality, the needed toxicity information may

come from peer-reviewed laboratory studies.

When laboratory studies are used, preference

shall be given to laboratory studies with

wildlife species over traditional laboratory

animals to reduce uncertainties in making

interspecies extrapolations. All available

laboratory data and field studies shall be

reviewed to corroborate the final GLWC, to

assess the reasonableness of the toxicity

value used, and to assess the appropriateness

of any UFs which are applied. When

evaluating the studies from which a test dose

is derived in general, the following

requirements must be met:

1. The mammalian data must come from at

least one well-conducted study of 90 days or

greater designed to observe subchronic or

chronic effects as defined in this document.

2. The avian data must come from at least

one well-conducted study of 70 days or

greater designed to observe subchronic or

chronic effects as defined in this document.

3. In reviewing the studies from which a

TD is derived for use in calculating a WV,

studies involving exposure routes other than

oral may be considered only when an

equivalent oral daily dose can be estimated

and technically justified because the criteria

calculations are based on an oral route of

exposure.

4. In assessing the studies which meet the

minimum data requirements, preference

should be given to studies which assess

effects on developmental or reproductive

endpoints because, in general, these are more

important endpoints in ensuring that a

population’s productivity is maintained. The

Wildlife TSD provides additional discussion

on the selection of an appropriate toxicity

study.

C. Selection of TD Data. In selecting data

to be used in the derivation of WVs, the

evaluation of acceptable endpoints, as

defined in Section III.A of this appendix, will

be the primary selection criterion. All data

not part of the selected subset may be used

to assess the reasonableness of the toxicity

value and the appropriateness of the Ufs

which are applied.

1. If more than one TD value is available

within a taxonomic class, based on different

endpoints of toxicity, that TD, which is likely

to reflect best potential impacts to wildlife

populations through resultant changes in

mortality or fecundity rates, shall be used for

the calculation of WVs.

2. If more than one TD is available within

a taxonomic class, based on the same

endpoint of toxicity, the TD from the most

sensitive species shall be used.

3. If more than one TD based on the same

endpoint of toxicity is available for a given

species, the TD for that species shall be

calculated using the geometric mean of those

TDs.

D. Exposure Assumptions in the

Determination of the TD. 1. In those cases in

which a TD is available in units other than

milligrams of substance per kilograms per

day (mg/kg/d), the following procedures shall

be used to convert the TD to the appropriate

units prior to calculating a WV.

2. If the TD is given in milligrams of

toxicant per liter of water consumed by the

test animals (mg/L), the TD shall be

multiplied by the daily average volume of

water consumed by the test animals in liters

per day (L/d) and divided by the average

weight of the test animals in kilograms (kg).

3. If the TD is given in milligrams of

toxicant per kilogram of food consumed by

the test animals (mg/kg), the TD shall be

multiplied by the average amount of food in

kilograms consumed daily by the test animals

(kg/d) and divided by the average weight of

the test animals in kilograms (kg).

E. Drinking and Feeding Rates. 1. When

drinking and feeding rates and body weight

are needed to express the TD in milligrams

of substance per kilograms per day (mg/kg/

d), they are obtained from the study from

which the TD was derived. If not already

determined, body weight, and drinking and

feeding rates are to be converted to a wet

weight basis.

2. If the study does not provide the needed

values, the values shall be determined from

appropriate scientific literature. For studies

done with domestic laboratory animals,

either the Registry of Toxic Effects of

Chemical Substances (National Institute for

Occupational Safety and Health, the latest

edition, Cincinnati, OH), or

Recommendations for and Documentation of

Biological Values for Use in Risk Assessment

(U.S. EPA, 1988) should be consulted. When

these references do not contain exposure

information for the species used in a given

study, either the allometric equations from

Calder and Braun (1983) and Nagy (1987),

which are presented below, or the exposure

estimation methods presented in Chapter 4 of

the Wildlife Exposure Factors Handbook

(U.S. EPA, 1993), should be applied to

approximate the needed feeding or drinking

rates. Additional discussion and

recommendations are provided in the

Wildlife TSD. The choice of the methods

described above is at the discretion of the

State or Tribe.

3. For mammalian species, the general

allometric equations are:

a. F = 0.0687 × (Wt)0.82

Where:

F = Feeding rate of mammalian species in

kilograms per day (kg/d) dry weight.

Wt = Average weight in kilograms (kg) of the

test animals.

b. W = 0.099 × (Wt)0.90

Where:

W = Drinking rate of mammalian species in

liters per day (L/d).

Wt = Average weight in kilograms (kg) of the

test animals.

4. For avian species, the general allometric

equations are:

a. F = 0.0582 (Wt)0.65

Where:

F = Feeding rate of avian species in kilograms

per day (kg/d) dry weight.

Wt = Average weight in kilograms (kg) of the

test animals.

b. W = 0.059 × (Wt)0.67

Where:

W = Drinking rate of avian species in liters

per day (L/d).

Wt = Average weight in kilograms (kg) of the

test animals.

F. LOAEL to NOAEL Extrapolations (UFL).

In those cases in which a NOAEL is

unavailable as the TD and a LOAEL is

available, the LOAEL may be used to

estimate the NOAEL. If used, the LOAEL

shall be divided by an UF to estimate a

NOAEL for use in deriving WVs. The value

of the UF shall not be less than one and

should not exceed 10, depending on the

dose-response curve and any other available

data, and is represented by UFL in the

equation expressed in Section II.A of this

appendix. Guidance for selecting an

appropriate UFL, based on a review of

available wildlife toxicity data, is available in

the Wildlife TSD.

G. Subchronic to Chronic Extrapolations

(USS). In instances where only subchronic

data are available, the TD may be derived

from subchronic data. In such cases, the TD

shall be divided by an UF to extrapolate from

subchronic to chronic levels. The value of the

UF shall not be less than one and should not

exceed 10, and is represented by UFS in the

equation expressed in Section II.A of this

appendix. This factor is to be used when

assessing highly bioaccumulative substances

where toxicokinetic considerations suggest

that a bioassay of limited length
15412 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

underestimates chronic effects. Guidance for

selecting an appropriate UFS, based on a

review of available wildlife toxicity data, is

available in the Wildlife TSD.

H. Interspecies Extrapolations (UFA). 1.

The selection of the UFA shall be based on

the available toxicological data and on

available data concerning the

physicochemical, toxicokinetic, and

toxicodynamic properties of the substance in

question and the amount and quality of

available data. This value is an UF that is

intended to account for differences in

toxicological sensitivity among species.

Guidance for selecting an appropriate UFA,

based on a review of available wildlife

toxicity data, is available in the Wildlife TSD.

Additional discussion of an interspecies UF

located in appendix A to the Great Lakes

Water Quality Initiative Technical Support

Document for Human Health Criteria may be

useful in determining the appropriate value

for UFA.

2. For the derivation of Tier I criteria, a

UFA shall not be less than one and should

not exceed 100, and shall be applied to each

of the five representative species, based on

existing data and best professional judgment.

The value of UFA may differ for each of the

representative species.

3. For Tier I wildlife criteria, the UFA shall

be used only for extrapolating toxicity data

across species within a taxonomic class,

except as provided below. The Tier I UFA is

not intended for interclass extrapolations

because of the poorly defined comparative

toxicokinetic and toxicodynamic parameters

between mammals and birds. However, an

interclass extrapolation employing a UFA

may be used for a given chemical if it can

be supported by a validated biologicallybased dose-response model or by an analysis

of interclass toxicological data, considering

acceptable endpoints, for a chemical analog

that acts under the same mode of toxic

action.

IV. Parameters of the Exposure Component

of the Wildlife Criteria Methodology

A. Drinking and Feeding Rates of

Representative Species. The body weights

(Wt), feeding rates (FTli), drinking rates (W),

and trophic level dietary composition (as

food ingestion rate and percent in diet) for

each of the five representative species are

presented in Table D–2 of this appendix.

Guidance on incorporating the non-aquatic

portion of the bald eagle and mink diets in

the criteria calculations is available in the

Wildlife TSD.

B. BAFs. The Methodology for

Development of Bioaccumulation Factors is

presented in appendix B to part 132. Trophic

level 3 and 4 BAFs are used to derive Wvs

because these are the trophic levels at which

the representative species feed.

V. References

A. Barnes, D.G. and M. Dourson. 1988.

Reference Dose (RfD): Description and Use in

Health Risk Assessments. Regul. Toxicol.

Pharmacol. 8:471–486.

B. Calder III, W.A. and E.J. Braun. 1983.

Scaling of Osmotic Regulation in Mammals

and Birds. American Journal of Physiology.

244:601–606.

C. Nagy, K.A. 1987. Field Metabolic Rate

and Food Requirement Scaling in Mammals

and Birds. Ecological Monographs.

57(2):111–128.

D. National Academy of Sciences. 1977.

Chemical Contaminants: Safety and Risk

Assessment, in Drinking Water and Health,

Volume 1. National Academy Press.

E. National Academy of Sciences. 1980.

Problems of Risk Estimation, in Drinking

Water and Health, Volume 3. National

Academy Press.

F. National Institute for Occupational

Safety and Health. Latest edition. Registry of

Toxic Effects of Chemical Substances.

Division of Standards Development and

Technology Transfer. (Available only on

microfiche or as an electronic database.)

G. U.S. EPA. 1980. Appendix C. Guidelines

and Methodology Used in the Preparation of

Health Effect Assessment Chapters of the

Consent Decree Water Criteria Documents,

pp. 79347–79357 in Water Quality Criteria

Documents; Availability. Available from U.S.

Environmental Protection Agency, Office of

Water Resource Center (WH–550A), 401 M

St. SW, Washington, DC 20460.

H. U.S. EPA. 1988. Recommendations for,

and documentation of, biological values for

use in risk assessment. NTIS–PB88–179874.

I. U.S. EPA. 1993. Wildlife Exposure

Factors Handbook, Volumes I and II. EPA/

600/R–93/187a and b.

Tables to Appendix D to Part 132

TABLE D–1.—TIER I GREAT LAKES

WILDLIFE CRITERIA

Substance Criterion

(μg/L)

DDT & Metabolites ........................ 1.1E–5

Mercury .......................................... 1.3E–3

PCBs (total) ................................... 7.4E–5

2,3,7,8-TCDD ................................. 3.1E–9

TABLE D–2.—EXPOSURE PARAMETERS FOR THE FIVE REPRESENTATIVE SPECIES IDENTIFIED FOR PROTECTION

Species (units) Adult body

weight (kg)

Water ingestion rate

(L/day)

Food ingestion rate of prey in each

trophic level (kg/day) Trophic level of prey (percent of diet)

Mink ....................................... 0.80 0.081 TL3: 0.159; Other: 0.0177 ................. TL3: 90; Other: 10.

Otter ....................................... 7.4 0.600 TL3: 0.977; TL4: 0.244 ...................... TL3: 80; TL4: 20.

Kingfisher ............................... 0.15 0.017 TL3: 0.0672 ....................................... TL3: 100.

Herring gull ............................ 1.1 0.063 TL3: 0.192; TL4: 0.0480 .................... Fish: 90—TL3: 80; TL4: 20.

Other: 0.0267 .................................... Other: 10.

Bald eagle .............................. 4.6 0.160 TL3: 0.371; TL4: 0.0929 .................... Fish: 92—TL3: 80; TL4: 20.

PB: 00283; Other: 0.0121 ................. Birds: 8—PB: 70; non-aquatic: 30.

NOTE: TL3=trophic level three fish; TL4=trophic level four fish; PB=piscivorous birds; Other=non-aquatic birds and mammals.

Appendix E to Part 132—Great Lakes Water

Quality Initiative Antidegradation Policy

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

appendix E to part 132.

The State or Tribe shall adopt an

antidegradation standard applicable to all

waters of the Great Lakes System and identify

the methods for implementing such a

standard. Consistent with 40 CFR 131.12, an

acceptable antidegradation standard and

implementation procedure are required

elements of a State’s or Tribe’s water quality

standards program. Consistent with 40 CFR

131.6, a complete water quality standards

submission needs to include both an

antidegradation standard and antidegradation

implementation procedures. At a minimum,

States and Tribes shall adopt provisions in

their antidegradation standard and

implementation methods consistent with

sections I, II, III and IV of this appendix,

applicable to pollutants identified as

bioaccumulative chemicals of concern

(BCCs).

I. Antidegradation Standard

This antidegradation standard shall be

applicable to any action or activity by any

source, point or nonpoint, of pollutants that

is anticipated to result in an increased

loading of BCCs to surface waters of the Great

Lakes System and for which independent

regulatory authority exists requiring

compliance with water quality standards.

Pursuant to this standard:

A. Existing instream water uses, as defined

pursuant to 40 CFR 131, and the level of

water quality necessary to protect existing

uses shall be maintained and protected.

Where designated uses of the waterbody are

impaired, there shall be no lowering of the

water quality with respect to the pollutant or

pollutants which are causing the impairment;

B. Where, for any parameter, the quality of

the waters exceed levels necessary to support

the propagation of fish, shellfish, and

wildlife and recreation in and on the waters,

that water shall be considered high quality

for that parameter consistent with the

definition of high quality water found at

section II.A of this appendix and that quality
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15413

shall be maintained and protected unless the

State or Tribe finds, after full satisfaction of

intergovernmental coordination and public

participation provisions of the State’s or

Tribe’s continuing planning process, that

allowing lower water quality is necessary to

accommodate important economic or social

development in the area in which the waters

are located. In allowing such degradation, the

State or Tribe shall assure water quality

adequate to protect existing uses fully.

Further, the State or Tribe shall assure that

there shall be achieved the highest statutory

and regulatory requirements for all new and

existing point sources and all cost-effective

and reasonable best management practices

for nonpoint source control. The State or

Tribe shall utilize the Antidegradation

Implementation Procedures adopted

pursuant to the requirements of this

regulation in determining if any lowering of

water quality will be allowed;

C. Where high quality waters constitute an

outstanding national resource, such as waters

of national and State parks and wildlife

refuges and waters of exceptional

recreational or ecological significance, that

water quality shall be maintained and

protected; and

D. In those cases where the potential

lowering of water quality is associated with

a thermal discharge, the decision to allow

such degradation shall be consistent with

section 316 of the Clean Water Act (CWA).

II. Antidegradation Implementation

Procedures

A. Definitions.

Control Document. Any authorization

issued by a State, Tribal or Federal agency to

any source of pollutants to waters under its

jurisdiction that specifies conditions under

which the source is allowed to operate.

High quality waters. High quality waters

are water bodies in which, on a parameter by

parameter basis, the quality of the waters

exceeds levels necessary to support

propagation of fish, shellfish, and wildlife

and recreation in and on the water.

Lake Superior Basin—Outstanding

International Resource Waters. Those waters

designated as such by a Tribe or State

consistent with the September 1991 BiNational Program to Restore and Protect the

Lake Superior Basin. The purpose of such

designations shall be to ensure that any new

or increased discharges of Lake Superior

bioaccumulative substances of immediate

concern are subject to best technology in

process and treatment requirements.

Lake Superior Basin—Outstanding

National Resource Waters. Those waters

designated as such by a Tribe or State

consistent with the September 1991 BiNational Program to Restore and Protect the

Lake Superior Basin. The purpose of such

designations shall be to prohibit new or

increased discharges of Lake Superior

bioaccumulative substances of immediate

concern from point sources in these areas.

Lake Superior bioaccumulative substances

of immediate concern. A list of substances

identified in the September 1991 Bi-National

Program to Restore and Protect the Lake

Superior Basin. They include: 2, 3, 7, 8-

TCDD; octachlorostyrene;

hexachlorobenzene; chlordane; DDT, DDE,

and other metabolites; toxaphene; PCBs; and

mercury. Other chemicals may be added to

the list following States’ or Tribes’

assessments of environmental effects and

impacts and after public review and

comment.

Outstanding National Resource Waters.

Those waters designated as such by a Tribe

or State. The State or Tribal designation shall

describe the quality of such waters to serve

as the benchmark of the water quality that

shall be maintained and protected. Waters

that may be considered for designation as

Outstanding National Resource Waters

include, but are not limited to, water bodies

that are recognized as:

Important because of protection through

official action, such as Federal or State law,

Presidential or secretarial action,

international treaty, or interstate compact;

Having exceptional recreational

significance;

Having exceptional ecological significance;

Having other special environmental,

recreational, or ecological attributes; or

waters whose designation as Outstanding

National Resource Waters is reasonably

necessary for the protection of other waters

so designated.

Significant Lowering of Water Quality. A

significant lowering of water quality occurs

when there is a new or increased loading of

any BCC from any regulated existing or new

facility, either point source or nonpoint

source for which there is a control document

or reviewable action, as a result of any

activity including, but not limited to:

(1) Construction of a new regulated facility

or modification of an existing regulated

facility such that a new or modified control

document is required;

(2) Modification of an existing regulated

facility operating under a current control

document such that the production capacity

of the facility is increased;

(3) Addition of a new source of untreated

or pretreated effluent containing or expected

to contain any BCC to an existing wastewater

treatment works, whether public or private;

(4) A request for an increased limit in an

applicable control document;

(5) Other deliberate activities that, based

on the information available, could be

reasonably expected to result in an increased

loading of any BCC to any waters of the Great

Lakes System.

b. Notwithstanding the above, changes in

loadings of any BCC within the existing

capacity and processes, and that are covered

by the existing applicable control document,

are not subject to an antidegradation review.

These changes include, but are not limited to:

(1) Normal operational variability;

(2) Changes in intake water pollutants;

(3) Increasing the production hours of the

facility, (e.g., adding a second shift); or

(4) Increasing the rate of production.

C. Also, excluded from an antidegradation

review are new effluent limits based on

improved monitoring data or new water

quality criteria or values that are not a result

of changes in pollutant loading.

B. For all waters, the Director shall ensure

that the level of water quality necessary to

protect existing uses is maintained. In order

to achieve this requirement, and consistent

with 40 CFR 131.10, water quality standards

use designations must include all existing

uses. Controls shall be established as

necessary on point and nonpoint sources of

pollutants to ensure that the criteria

applicable to the designated use are achieved

in the water and that any designated use of

a downstream water is protected. Where

water quality does not support the designated

uses of a waterbody or ambient pollutant

concentrations exceed water quality criteria

applicable to that waterbody, the Director

shall not allow a lowering of water quality for

the pollutant or pollutants preventing the

attainment of such uses or exceeding such

criteria.

C. For Outstanding National Resource

Waters:

1. The Director shall ensure, through the

application of appropriate controls on

pollutant sources, that water quality is

maintained and protected.

2. Exception. A short-term, temporary (i.e.,

weeks or months) lowering of water quality

may be permitted by the Director.

D. For high quality waters, the Director

shall ensure that no action resulting in a

lowering of water quality occurs unless an

antidegradation demonstration has been

completed pursuant to section III of this

appendix and the information thus provided

is determined by the Director pursuant to

section IV of this appendix to adequately

support the lowering of water quality.

1. The Director shall establish conditions

in the control document applicable to the

regulated facility that prohibit the regulated

facility from undertaking any deliberate

action, such that there would be an increase

in the rate of mass loading of any BCC, unless

an antidegradation demonstration is

provided to the Director and approved

pursuant to section IV of this appendix prior

to commencement of the action. Imposition

of limits due to improved monitoring data or

new water quality criteria or values, or

changes in loadings of any BCC within the

existing capacity and processes, and that are

covered by the existing applicable control

document, are not subject to an

antidegradation review.

2. For BCCs known or believed to be

present in a discharge, from a point or

nonpoint source, a monitoring requirement

shall be included in the control document.

The control document shall also include a

provision requiring the source to notify the

Director or any increased loadings. Upon

notification, the Director shall require actions

as necessary to reduce or eliminate the

increased loading.

3. Fact Sheets prepared pursuant to 40 CFR

124.8 and 124.56 shall reflect any conditions

developed under sections II.D.1 or II.D.2 of

this appendix and included in a permit.

E. Special Provisions for Lake Superior.The

following conditions apply in addition to

those specified in section II.B through II.C of

this appendix for waters of Lake Superior so

designated.

1. A State or Tribe may designate certain

specified areas of the Lake Superior Basin as

Lake Superior Basin—Outstanding National

Resource Waters for the purpose of

prohibiting the new or increased discharge of
15414 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

Lake Superior bioaccumulative substances of

immediate concern from point sources in

these areas.

2. States and Tribes may designate all

waters of the Lake Superior Basin as

Outstanding International Resource Waters

for the purpose of restricting the increased

discharge of Lake Superior bioaccumulative

substances of immediate concern from point

sources consistent with the requirements of

sections III.C and IV.B of this appendix.

F. Exemptions. Except as the Director may

determine on a case-by-case basis that the

application of these procedures is required to

adequately protect water quality, or as the

affected waterbody is an Outstanding

National Resource Water as defined in

section II.A of this appendix, the procedures

in this part do not apply to:

1. Short-term, temporary (i.e., weeks or

months) lowering of water quality;

2. Bypasses that are not prohibited at 40

CFR 122.41(m); and

3. Response actions pursuant to the

Comprehensive Environmental Response,

Compensation and Liability Act (CERCLA),

as amended, or similar Federal, State or

Tribal authorities, undertaken to alleviate a

release into the environment of hazardous

substances, pollutants or contaminants

which may pose an imminent and substantial

danger to public health or welfare.

III. Antidegradation Demonstration

Any entity seeking to lower water quality

in a high quality water or create a new or

increased discharge of Lake Superior

bioaccumulative substances of immediate

concern in a Lake Superior Outstanding

International Resource Water must first, as

required by sections II.D or II.E.2 of this

appendix, submit an antidegradation

demonstration for consideration by the

Director. States and Tribes should tailor the

level of detail and documentation in

antidegradation reviews, to the specific

circumstances encountered. The

antidegradation demonstration shall include

the following:

A. Pollution Prevention Alternatives

Analysis. Identify any cost-effective pollution

prevention alternatives and techniques that

are available to the entity, that would

eliminate or significantly reduce the extent to

which the increased loading results in a

lowering of water quality.

B. Alternative or Enhanced Treatment

Analysis. Identify alternative or enhanced

treatment techniques that are available to the

entity that would eliminate the lowering of

water quality and their costs relative to the

cost of treatment necessary to achieve

applicable effluent limitations.

C. Lake Superior. If the States or Tribes

designate the waters of Lake Superior as

Outstanding International Resource Waters

pursuant to section II.E.2 of this appendix,

then any entity proposing a new or increased

discharge of any Lake Superior

bioaccumulative substance of immediate

concern to the Lake Superior Basin shall

identify the best technology in process and

treatment to eliminate or reduce the extent of

the lowering of water quality. In this case, the

requirements in section III.B of this appendix

do not apply.

D. Important Social or Economic

Development Analysis. Identify the social or

economic development and the benefits to

the area in which the waters are located that

will be foregone if the lowering of water

quality is not allowed.

E. Special Provision for Remedial Actions.

Entities proposing remedial actions pursuant

to the CERCLA, as amended, corrective

actions pursuant to the Resource

Conservation and Recovery Act, as amended,

or similar actions pursuant to other Federal

or State environmental statutes may submit

information to the Director that demonstrates

that the action utilizes the most cost effective

pollution prevention and treatment

techniques available, and minimizes the

necessary lowering of water quality, in lieu

of the information required by sections III.B

through III.D of this appendix.

IV. Antidegradation Decision

A. Once the Director determines that the

information provided by the entity proposing

to increase loadings is administratively

complete, the Director shall use that

information to determine whether or not the

lowering of water quality is necessary, and,

if it is necessary, whether or not the lowering

of water quality will support important social

and economic development in the area. If the

proposed lowering of water quality is either

not necessary, or will not support important

social and economic development, the

Director shall deny the request to lower water

quality. If the lowering of water quality is

necessary, and will support important social

and economic development, the Director may

allow all or part of the proposed lowering to

occur as necessary to accommodate the

important social and economic development.

In no event may the decision reached under

this section allow water quality to be lowered

below the minimum level required to fully

support existing and designated uses. The

decision of the Director shall be subject to the

public participation requirements of 40 CFR

25.

B. If States designate the waters of Lake

Superior as Outstanding International

Resource Waters pursuant to section II.E.2 of

this appendix, any entity requesting to lower

water quality in the Lake Superior Basin as

a result of the new or increased discharge of

any Lake Superior bioaccumulative

substance of immediate concern shall be

required to install and utilize the best

technology in process and treatment as

identified by the Director.

Appendix F to Part 132—Great Lakes Water

Quality Initiative Implementation

Procedures

Procedure 1: Site-specific Modifications to

Criteria and Values

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

this procedure.

A. Requirements for Site-specific

Modifications to Criteria and Values. Criteria

and values may be modified on a site-specific

basis to reflect local environmental

conditions as restricted by the following

provisions. Any such modifications must be

protective of designated uses and aquatic life,

wildlife or human health and be submitted

to EPA for approval. In addition, any sitespecific modifications that result in less

stringent criteria must be based on a sound

scientific rationale and shall not be likely to

jeopardize the continued existence of

endangered or threatened species listed or

proposed under section 4 of the Endangered

Species Act (ESA) or result in the destruction

or adverse modification of such species’

critical habitat. More stringent modifications

shall be developed to protect endangered or

threatened species listed or proposed under

section 4 of the ESA, where such

modifications are necessary to ensure that

water quality is not likely to jeopardize the

continued existence of such species or result

in the destruction or adverse modification of

such species’ critical habitat. More stringent

modifications may also be developed to

protect candidate (C1) species being

considered by the U.S. Fish and Wildlife

Service (FWS) for listing under section 4 of

the ESA, where such modifications are

necessary to protect such species.

1. Aquatic Life.

a. Aquatic life criteria or values may be

modified on a site-specific basis to provide

an additional level of protection, pursuant to

authority reserved to the States and Tribes

under Clean Water Act (CWA) section 510.

Guidance on developing site-specific

criteria in these instances is provided in

Chapter 3 of the U.S. EPA Water Quality

Standards Handbook, Second Edition—

Revised (1994).

b. Less stringent site-specific modifications

to chronic or acute aquatic life criteria or

values may be developed when:

i. The local water quality characteristics

such as Ph, hardness, temperature, color, etc.,

alter the biological availability or toxicity of

a pollutant; or

ii. The sensitivity of the aquatic organisms

species that ‘‘occur at the site’’ differs from

the species actually tested in developing the

criteria. The phrase ‘‘occur at the site’’

includes the species, genera, families, orders,

classes, and phyla that: are usually present at

the site; are present at the site only

seasonally due to migration; are present

intermittently because they periodically

return to or extend their ranges into the site;

were present at the site in the past, are not

currently present at the site due to degraded

conditions, and are expected to return to the

site when conditions improve; are present in

nearby bodies of water, are not currently

present at the site due to degraded

conditions, and are expected to be present at

the site when conditions improve. The taxa

that ‘‘occur at the site’’ cannot be determined

merely by sampling downstream and/or

upstream of the site at one point in time.

‘‘Occur at the site’’ does not include taxa that

were once present at the site but cannot exist

at the site now due to permanent physical

alteration of the habitat at the site resulting,

for example, from dams, etc.

c. Less stringent modifications also may be

developed to acute and chronic aquatic life

criteria or values to reflect local physical and

hydrological conditions.

Guidance on developing site-specific

criteria is provided in Chapter 3 of the U.S.

EPA Water Quality Standards Handbook,

Second Edition—Revised (1994).
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15415

d. Any modifications to protect threatened

or endangered aquatic species required by

procedure 1.A of this appendix may be

accomplished using either of the two

following procedures:

i. If the Species Mean Acute Value (SMAV)

for a listed or proposed species, or for a

surrogate of such species, is lower than the

calculated Final Acute Value (FAV), such

lower SMAV may be used instead of the

calculated FAV in developing site-specific

modified criteria; or,

ii. The site-specific criteria may be

calculated using the recalculation procedure

for site-specific modifications described in

Chapter 3 of the U.S. EPA Water Quality

Standards Handbook, Second Edition—

Revised (1994).

2. Wildlife.

a. Wildlife water quality criteria may be

modified on a site-specific basis to provide

an additional level of protection, pursuant to

authority reserved to the States and Tribes

under CWA section 510.

b. Less stringent site-specific modifications

to wildlife water quality criteria may be

developed when a site-specific

bioaccumulation factor (BAF) is derived

which is lower than the system-wide BAF

derived under appendix B of this part. The

modification must consider both the mobility

of prey organisms and wildlife populations

in defining the site for which criteria are

developed. In addition, there must be a

showing that:

i. Any increased uptake of the toxicant by

prey species utilizing the site will not cause

adverse effects in wildlife populations; and

ii. Wildlife populations utilizing the site or

downstream waters will continue to be fully

protected.

c. Any modification to protect endangered

or threatened wildlife species required by

procedure 1.A of this appendix must

consider both the mobility of prey organisms

and wildlife populations in defining the site

for which criteria are developed, and may be

accomplished by using the following

recommended method.

i. The methodology presented in appendix

D to part 132 is used, substituting

appropriate species-specific toxicological,

epidemiological, or exposure information,

including changes to the BAF;

ii. An interspecies uncertainty factor of 1

should be used where epidemiological data

are available for the species in question. If

necessary, species-specific exposure

parameters can be derived as presented in

Appendix D of this part;

iii. An intraspecies uncertainty factor (to

account for protection of individuals within

a wildlife population) should be applied in

the denominator of the effect part of the

wildlife equation in appendix D of this part

in a manner consistent with the other

uncertainty factors described in appendix D

of this part; and

iv. The resulting wildlife value for the

species in question should be compared to

the two class-specific wildlife values which

were previously calculated, and the lowest of

the three shall be selected as the site-specific

modification.

Note: Further discussion on the use of this

methodology may be found in the Great

Lakes Water Quality Initiative Technical

Support Document for Wildlife Criteria.

3. BAFs.

a. BAFs may be modified on a site-specific

basis to larger values, pursuant to the

authority reserved to the States and Tribes

under CWA section 510, where reliable data

show that local bioaccumulation is greater

than the system-wide value.

b. BAFs may be modified on a site-specific

basis to lower values, where scientifically

defensible, if:

i. The fraction of the total chemical that is

freely dissolved in the ambient water is

different than that used to derive the systemwide BAFs (i.e., the concentrations of

particulate organic carbon and the dissolved

organic carbon are different than those used

to derive the system-wide BAFs);

ii. Input parameters of the Gobas model,

such as the structure of the aquatic food web

and the disequilibrium constant, are different

at the site than those used to derive the

system-wide BAFs;

iii. The percent lipid of aquatic organisms

that are consumed and occur at the site is

different than that used to derive the systemwide BAFs; or

iv. Site-specific field-measured BAFs or

biota-sediment accumulation factor (BSAFs)

are determined.

If site-specific BAFs are derived, they shall

be derived using the methodology in

appendix B of this part.

c. Any more stringent modifications to

protect threatened or endangered species

required by procedure 1.A of this appendix

shall be derived using procedures set forth in

the methodology in appendix B of this part.

4. Human Health.

a. Human health criteria or values may be

modified on a site-specific basis to provide

an additional level of protection, pursuant to

authority reserved to the States and Tribes

under CWA section 510. Human health

criteria or values shall be modified on a sitespecific basis to provide additional

protection appropriate for highly exposed

subpopulations.

b. Less stringent site-specific modifications

to human health criteria or values may be

developed when:

i. local fish consumption rates are lower

than the rate used in deriving human health

criteria or values under appendix C of this

part; and/or

ii. a site-specific BAF is derived which is

lower than that used in deriving human

health criteria or values under appendix C of

this part.

B. Notification Requirements. When a State

proposes a site-specific modification to a

criterion or value as allowed in section 4.A

above, the State should notify the other Great

Lakes States of such a proposal and, for less

stringent criteria, supply appropriate

justification.

C. References.

U.S. EPA. 1984. Water Quality Standards

Handbook—Revised. Chapter 3 and

Appendices. U.S. Environmental Protection

Agency, Office of Water Resource Center

(RC–4100), 401 M Street, SW., Washington,

DC 20960.

Procedure 2: Variances from Water Quality

Standards for Point Sources

The Great Lakes States or Tribes may adopt

water quality standards (WQS) variance

procedures and may grant WQS variances for

point sources pursuant to such procedures.

Variance procedures shall be consistent with

(as protective as) the provisions in this

procedure.

A. Applicability. A State or Tribe may grant

a variance to a WQS which is the basis of a

water quality-based effluent limitation

included in a National Pollutant Discharge

Elimination System (NPDES) permit. A WQS

variance applies only to the permittee

requesting the variance and only to the

pollutant or pollutants specified in the

variance. A variance does not affect, or

require the State or Tribe to modify, the

corresponding water quality standard for the

waterbody as a whole.

1. This provision shall not apply to new

Great Lakes dischargers or recommencing

dischargers.

2. A variance to a water quality standard

shall not be granted that would likely

jeopardize the continued existence of any

endangered or threatened species listed

under Section 4 of the Endangered Species

Act (ESA) or result in the destruction or

adverse modification of such species’ critical

habitat.

3. A WQS variance shall not be granted if

standards will be attained by implementing

effluent limits required under sections 301(b)

and 306 of the Clean Water Act (CWA) and

by the permittee implementing cost-effective

and reasonable best management practices

for nonpoint source control.

B. Maximum Timeframe for Variances. A

WQS variance shall not exceed five years or

the term of the NPDES permit, whichever is

less. A State or Tribe shall review, and

modify as necessary, WQS variances as part

of each water quality standards review

pursuant to section 303(c) of the CWA.

C. Conditions to Grant a Variance. A

variance may be granted if:

1. The permittee demonstrates to the State

or Tribe that attaining the WQS is not

feasible because:

a. Naturally occurring pollutant

concentrations prevent the attainment of the

WQS;

b. Natural, ephemeral, intermittent or low

flow conditions or water levels prevent the

attainment of the WQS, unless these

conditions may be compensated for by the

discharge of sufficient volume of effluent to

enable WQS to be met without violating State

or Tribal water conservation requirements;

c. Human-caused conditions or sources of

pollution prevent the attainment of the WQS

and cannot be remedied, or would cause

more environmental damage to correct than

to leave in place;

d. Dams, diversions or other types of

hydrologic modifications preclude the

attainment of the WQS, and it is not feasible

to restore the waterbody to its original

condition or to operate such modification in

a way that would result in the attainment of

the WQS;

e. Physical conditions related to the natural

features of the waterbody, such as the lack of

a proper substrate cover, flow, depth, pools,

riffles, and the like, unrelated to chemical

water quality, preclude attainment of WQS;

or
15416 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

f. Controls more stringent than those

required by sections 301(b) and 306 of the

CWA would result in substantial and

widespread economic and social impact.

2. In addition to the requirements of C.1,

above, the permittee shall also:

a. Show that the variance requested

conforms to the requirements of the State’s or

Tribe’s antidegradation procedures; and

b. Characterize the extent of any increased

risk to human health and the environment

associated with granting the variance

compared with compliance with WQS absent

the variance, such that the State or Tribe is

able to conclude that any such increased risk

is consistent with the protection of the public

health, safety and welfare.

D. Submittal of Variance Application. The

permittee shall submit an application for a

variance to the regulatory authority issuing

the permit. The application shall include:

1. All relevant information demonstrating

that attaining the WQS is not feasible based

on one or more of the conditions in section

C.1 of this procedure; and,

2. All relevant information demonstrating

compliance with the conditions in section

C.2 of this procedure.

E. Public Notice of Preliminary Decision.

Upon receipt of a complete application for a

variance, and upon making a preliminary

decision regarding the variance, the State or

Tribe shall public notice the request and

preliminary decision for public comment

pursuant to the regulatory authority’s

Administrative Procedures Act and shall

notify the other Great Lakes States and Tribes

of the preliminary decision. This public

notice requirement may be satisfied by

including the supporting information for the

variance and the preliminary decision in the

public notice of a draft NPDES permit.

F. Final Decision on Variance Request. The

State or Tribe shall issue a final decision on

the variance request within 90 days of the

expiration of the public comment period

required in section E of this procedure. If all

or part of the variance is approved by the

State or Tribe, the decision shall include all

permit conditions needed to implement those

parts of the variance so approved. Such

permit conditions shall, at a minimum,

require:

1. Compliance with an initial effluent

limitation which, at the time the variance is

granted, represents the level currently

achievable by the permittee, and which is no

less stringent than that achieved under the

previous permit;

2. That reasonable progress be made

toward attaining the water quality standards

for the waterbody as a whole through

appropriate conditions;

3. When the duration of a variance is

shorter than the duration of a permit,

compliance with an effluent limitation

sufficient to meet the underlying water

quality standard, upon the expiration of said

variance; and

4. A provision that allows the permitting

authority to reopen and modify the permit

based on any State or Tribal triennial water

quality standards revisions to the variance.

The State shall deny a variance request if

the permittee fails to make the

demonstrations required under section C of

this procedure.

G. Incorporating Variance into Permit. The

State or Tribe shall establish and incorporate

into the permittee’s NPDES permit all

conditions needed to implement the variance

as determined in section F of this procedure.

H. Renewal of Variance. A variance may be

renewed, subject to the requirements of

sections A through G of this procedure. As

part of any renewal application, the

permittee shall again demonstrate that

attaining WQS is not feasible based on the

requirements of section C of this procedure.

The permittee’s application shall also contain

information concerning its compliance with

the conditions incorporated into its permit as

part of the original variance pursuant to

sections F and G of this procedure. Renewal

of a variance may be denied if the permittee

did not comply with the conditions of the

original variance.

I. EPA Approval. All variances and

supporting information shall be submitted by

the State or Tribe to the appropriate EPA

regional office and shall include:

1. Relevant permittee applications

pursuant to section D of this procedure;

2. Public comments and records of any

public hearings pursuant to section E of this

procedure;

3. The final decision pursuant to section F

of this procedure; and,

4. NPDES permits issued pursuant to

section G of this procedure.

5. Items required by sections I.1 through

I.3. of this procedure shall be submitted by

the State within 30 days of the date of the

final variance decision. The item required by

section I.4 of this procedure shall be

submitted in accordance with the State or

Tribe Memorandum of Agreement with the

Regional Administrator pursuant to 40 CFR

123.24.

6. EPA shall review the State or Tribe

submittal for compliance with the CWA

pursuant to 40 CFR 123.44, and 40 CFR

131.21.

J. State WQS Revisions. All variances shall

be appended to the State or Tribe WQS rules.

Procedure 3: Total Maximum Daily Loads,

Wasteload Allocations for Point Sources,

Load Allocations for Nonpoint Sources,

Wasteload Allocations in the Absence of a

TMDL, and Preliminary Wasteload

Allocations for Purposes of Determining the

Need for Water Quality Based Effluent

Limits

The Great Lakes States and Tribes shall

adopt provisions consistent with (as

protective as) this procedure 3 for the

purpose of developing Total Maximum Daily

Loads (TMDLs), Wasteload Allocations

(WLAs) in the Absence of TMDLs, and

Preliminary Wasteload Allocations for

Purposes of Determining the Need for Water

Quality Based Effluent Limits (WQBELs),

except as specifically provided.

A. Where a State or Tribe develops an

assessment and remediation plan that the

State or Tribe certifies meets the

requirements of sections B through F of this

procedure and public participation

requirements applicable to TMDLs, and that

has been approved by EPA as meeting those

requirements under 40 CFR 130.6, the

assessment and remediation plan may be

used in lieu of a TMDL for purposes of

appendix F to part 132. Assessment and

remediation plans under this procedure may

include, but are not limited to, Lakewide

Management Plans, Remedial Action Plans,

and State Water Quality Management Plans.

Also, any part of an assessment and

remediation plan that also satisfies one or

more requirements under Clean Water Act

(CWA) section 303(d) or implementing

regulations may be incorporated by reference

into a TMDL as appropriate. Assessment and

remediation plans under this section should

be tailored to the level of detail and

magnitude for the watershed and pollutant

being assessed.

B. General Conditions of Application.

Except as provided in § 132.4, the following

are conditions applicable to establishing

TMDLs for all pollutants and pollutant

parameters in the Great Lakes System, with

the exception of whole effluent toxicity,

unless otherwise provided in procedure 6 of

appendix F. Where specified, these

conditions also apply to wasteload

allocations (WLAs) calculated in the absence

of TMDLs and to preliminary WLAs for

purposes of determining the needs for

WQBELs under procedure 5 of appendix F.

1. TMDLs Required. TMDLs shall, at a

minimum, be established in accordance with

the listing and priority setting process

established in section 303(d) of the CWA and

at 40 CFR 130.7. Where water quality

standards cannot be attained immediately,

TMDLs must reflect reasonable assurances

that water quality standards will be attained

in a reasonable period of time. Some TMDLs

may be based on attaining water quality

standards over a period of time, with specific

controls on individual sources being

implemented in stages. Determining the

reasonable period of time in which water

quality standards will be met is a casespecific determination considering a number

of factors including, but not limited to:

receiving water characteristics; persistence,

behavior and ubiquity of pollutants of

concern; type of remediation activities

necessary; available regulatory and nonregulatory controls; and individual State or

Tribal requirements for attainment of water

quality standards.

2. Attainment of Water Quality Standards.

A TMDL must ensure attainment of

applicable water quality standards, including

all numeric and narrative criteria, Tier I

criteria, and Tier II values for each pollutant

or pollutants for which a TMDL is

established.

3. TMDL Allocations.

a. TMDLs shall include WLAs for point

sources and load allocations (LAs) for

nonpoint sources, including natural

background, such that the sum of these

allocations is not greater than the loading

capacity of the water for the pollutant(s)

addressed by the TMDL, minus the sum of

a specified margin of safety (MOS) and any

capacity reserved for future growth.

b. Nonpoint source LAs shall be based on:

i. Existing pollutant loadings if changes in

loadings are not reasonably anticipated to

occur;

ii. Increases in pollutant loadings that are

reasonably anticipated to occur;
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15417

iii. Anticipated decreases in pollutant

loadings if such decreased loadings are

technically feasible and are reasonably

anticipated to occur within a reasonable time

period as a result of implementation of best

management practices or other load

reduction measures. In determining whether

anticipated decreases in pollutant loadings

are technically feasible and can reasonably be

expected to occur within a reasonable period

of time, technical and institutional factors

shall be considered. These decisions are casespecific and should reflect the particular

TMDL under consideration.

c. WLAs. The portion of the loading

capacity not assigned to nonpoint sources

including background, or to an MOS, or

reserved for future growth is allocated to

point sources. Upon reissuance, NPDES

permits for these point sources must include

effluent limitations consistent with WLAs in

EPA-approved or EPA-established TMDLs.

d. Monitoring. For LAs established on the

basis of subsection b.iii above, monitoring

data shall be collected and analyzed in order

to validate the TMDL’s assumptions, to varify

anticipated load reductions, to evaluate the

effectiveness of controls being used to

implement the TMDL, and to revise the

WLAs and LAs as necessary to ensure that

water quality standards will be achieved

within the time-period established in the

TMDL.

4. WLA Values. If separate EPA-approved

or EPA-established TMDLs are prepared for

different segments of the same watershed,

and the separate TMDLs each include WLAs

for the same pollutant for one or more of the

same point sources, then WQBELs for that

pollutant for the point source(s) shall be

consistent with the most stringent of those

WLAs in order to ensure attainment of all

applicable water quality standards.

5. Margin of Safety (MOS). Each TMDL

shall include a MOS sufficient to account for

technical uncertainties in establishing the

TMDL and shall describe the manner in

which the MOS is determined and

incorporated into the TMDL. The MOS may

be provided by leaving a portion of the

loading capacity unallocated or by using

conservative modeling assumptions to

establish WLAs and LAs. If a portion of the

loading capacity is left unallocated to

provide a MOS, the amount left unallocated

shall be described. If conservative modeling

assumptions are relied on to provide a MOS,

the specific assumptions providing the MOS

shall be identified.

6. More Stringent Requirements. States and

Tribes may exercise authority reserved to

them under section 510 of the CWA to

develop more stringent TMDLs (including

WLAs and LAs) than are required herein,

provided that all LAs in such TMDLs reflect

actual nonpoint source loads or those loads

that can reasonably be expected to occur

within a reasonable time-period as a result of

implementing nonpoint source controls.

7. Accumulation in Sediments. TMDLs

shall reflect, where appropriate and where

sufficient data are available, contributions to

the water column from sediments inside and

outside of any applicable mixing zones.

TMDLs shall be sufficiently stringent so as to

prevent accumulation of the pollutant of

concern in sediments to levels injurious to

designated or existing uses, human health,

wildlife and aquatic life.

8. Wet Weather Events. Notwithstanding

the exception provided for the establishment

of controls on wet weather point sources in

§ 132.4(e)(1), TMDLs shall reflect, where

appropriate and where sufficient data are

available, discharges resulting from wet

weather events. This procedure does not

provide specific procedures for considering

discharges resulting from wet weather events.

However, some of the provisions of

procedure 3 may be deemed appropriate for

considering wet weather events on a case-bycase basis.

9. Background Concentration of Pollutants.

The representative background concentration

of pollutants shall be established in

accordance with this subsection to develop

TMDLs, WLAs calculated in the absence of

a TMDL, or preliminary WLAs for purposes

of determining the need for WQBELs under

procedure 5 of appendix F. Background

loadings may be accounted for in a TMDL

through an allocation to a single

‘‘background’’ category or through individual

allocations to the various background

sources.

a. Definition of Background. ‘‘Background’’

represents all loadings that: (1) flow from

upstream waters into the specified

watershed, waterbody or waterbody segment

for which a TMDL, WLA in the absence of

a TMDL or preliminary WLA for the purpose

of determining the need for a WQBEL is

being developed; (2) enter the specified

watershed, waterbody or waterbody segment

through atmospheric deposition or sediment

release or resuspension; or (3) occur within

the watershed, waterbody or waterbody

segment as a result of chemical reactions.

b. Data considerations. When determining

what available data are acceptable for use in

calculating background, the State or Tribe

should use best professional judgment,

including consideration of the sampling

location and the reliability of the data

through comparison to reported analytical

detection levels and quantification levels.

When data in more than one of the data sets

or categories described in section B.9.c.i

through B.9.c.iii below exist, best

professional judgment should be used to

select the one data set that most accurately

reflects or estimates background

concentrations. Pollutant degradation and

transport information may be considered

when utilizing pollutant loading data.

c. Calculation requirements. Except as

provided below, the representative

background concentration for a pollutant in

the specified watershed, waterbody or

waterbody segment shall be established on a

case-by-case basis as the geometric mean of:

i. Acceptable available water column data;

or

ii. Water column concentrations estimated

through use of acceptable available caged or

resident fish tissue data; or

iii. Water column concentrations estimated

through use of acceptable available or

projected pollutant loading data.

d. Detection considerations.

i. Commonly accepted statistical

techniques shall be used to evaluate data sets

consisting of values both above and below

the detection level.

ii. When all of the acceptable available data

in a data set or category, such as water

column, caged or resident fish tissue or

pollutant loading data, are below the level of

detection for a pollutant, then all the data for

that pollutant in that data set shall be

assumed to be zero.

10. Effluent Flow. If WLAs are expressed as

concentrations of pollutants, the TMDL shall

also indicate the point source effluent flows

assumed in the analyses. Mass loading

limitations established in NPDES permits

must be consistent with both the WLA and

assumed effluent flows used in establishing

the TMDL.

11. Reserved Allocations. TMDLs may

include reserved allocations of loading

capacity to accommodate future growth and

additional sources. Where such reserved

allocations are not included in a TMDL, any

increased loadings of the pollutant for which

the TMDL was developed that are due to a

new or expanded discharge shall not be

allowed unless the TMDL is revised in

accordance with these proceudres to include

an allocation for the new or expanded

discharge.

C. Mixing Zones for Bioaccumulative

Chemicals of Concern (BCCs). The following

requirements shall be applied in establishing

TMDLs, WLAs in the absence of TMDLs, and

preliminary WLAs for purposes of

determining the need for WQBELs under

procedure 5 of appendix F, for BCCs:

1. Beginning on March 23, 1997, there shall

be no mixing available for new discharges of

BCCs to the Great Lakes System. WLAs

established through TMDLs, WLAs in the

absence of TMDLs, and preliminary WLAs

for purposes of determining the need for

WQBELs for new discharges of BCCs shall be

set equal to the most stringent applicable

water quality criteria or values for the BCCs

in question.

2. For purposes of section C of procedure

3 of appendix F, new discharges are defined

as: (1) discharges from new Great Lakes

dischargers; or (2) new or expanded

discharges from an existing Great Lakes

discharger. All other discharges of BCCs are

defined as existing discharges.

3. Up until March 23, 2007, mixing zones

for BCCs may be allowed for existing

discharges to the Great Lakes System

pursuant to the procedures specified in

sections D and E of this procedure.

4. Except as provided in sections C.5 and

C.6 of this procedure, permits issued on or

after March 23, 1997 shall not authorize

mixing zones for existing discharges of BCCs

to the Great Lakes System after March 23,

2007. After March 23, 2007, WLAs

established through TMDLs, WLAs

established in the absence of TMDLs and

preliminary WLAs for purposes of

determining the need for WQBELs under

procedure 5 of appendix F for existing

dischrges of BCCs to the Great Lakes System

shall be set equal to the most stringent

applicable water quality criteria or values for

the BCCs in question.

5. Exception for Water Conservation. States

and Tribes may grant mixing zones for any

existing discharge of BCCs to the Great Lakes
15418 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

System beyond the dates specified in

sections C.3 and C.4 of this procedure, where

it can be demonstrated, on a case-by-case

basis, that failure to grant a mixing zone

would preclude water conservation measures

that would lead to overall load reductions in

BCCs, even though higher concentrations of

BCCs occur in the effluent. Such mixing

zones must also be consistent with sections

D and E of this procedure.

6. Exception for Technical and Economic

Considerations. States and Tribes may grant

mixing zones beyond the dates specified in

sections C.3 and C.4 of this procedure for any

existing discharges of a BCC to the Great

Lakes System upon the request of a

discharger subject to the limited

circumstances specified in sections C.6.a

through C.6.d below. Such mixing zones

shall also be consistent with sections D and

E of this procedure.

a. The permitting authority must determine

that:

i. The discharger is in compliance with and

will continue to implement all applicable

technology-based treatment and pretreatment

requirements of CWA sections 301, 302, 304,

306, 307, 401, and 402, and is in compliance

with its existing NPDES water quality-based

effluent limitations, including those based on

a mixing zone; and

ii. The discharger has reduced and will

continue to reduce the loading of the BCC for

which a mixing zone is requested to the

maximum extent possible.

b. In making the determination in section

C.6.a above, the State or Tribal authority

should consider:

i. The availability and feasibility, including

cost effectiveness, of additional controls or

pollution prevention measures for reducing

and ultimately eliminating BCCs for that

discharger, including those used by similar

dischargers;

ii. Whether the discharger or affected

communities will suffer unreasonable

economic effects if the mixing zone is

eliminated;

iii. The extent to which the discharger will

implement an ambient monitoring plan to

ensure compliance with water quality criteria

at the edge of any authorized mixing zone or

to ensure consistency with any applicable

TMDL or such other strategy consistent with

section A of this procedure; and,

iv. Other information the State or Tribe

deems appropriate.

c. Any exceptions to the mixing zone

elimination provision for existing discharges

of BCCs granted pursuant to this section

shall:

i. Not result in any less stringent

limitations than those existing March 23,

1997;

ii. Not likely jeopardize the continued

existence of any endangered or threatened

species listed under section 4 of the ESA or

result in the destruction or adverse

modification of such species’ critical habitat;

iii. Be limited to one permit term unless

the permitting authority makes a new

determination in accordance with this

section for each successive permit

application in which a mixing zone for the

BCC(s) is sought;

iv. Reflect all information relevant to the

size of the mixing zone considered by the

State or Tribe under subsection b above;

v. Protect all designated and existing uses

of the receiving water;

vi. Meet all applicable aquatic life, wildlife

and human health criteria and values at the

edge of the mixing zone and, as appropriate,

within the mixing zone or be consistent with

any appropriate TMDL or such other strategy

consistent with section A of this procedure;

vii. Ensure the discharger has developed

and conducted a pollutant minimization

program for the BCC(s) if required to do so

under regulations adopted consistent with

procedure 8 of appendix F; and

viii. Ensure that alternative means for

reducing BCCs elsewhere in the watershed

are evaluated.

d. For each draft NPDES permit that would

allow a mixing zone for one or more BCCs

after March 23, 2007, the fact sheet or

statement of basis for the draft permit,

required to be made available through public

notice under 40 CFR 124.6(e), shall:

i. Specify the mixing provisions used in

calculating the permit limits; and

ii. Identify each BCC for which a mixing

zone is proposed.

D. Deriving TMDLs, WLAs, and LAs for

Point and Nonpoint Sources: WLAs in the

Absence of a TMDL; and Preliminary WLAs

for Purposes of Determining the Need for

WQBELs for OWGL. This section addresses

conditions for deriving TMDLs for Open

Waters of the Great Lakes (OWGL), inland

lakes and other waters of the Great Lakes

System with no appreciable flow relative to

their volumes. State and Tribal procedures to

derive TMDLs under this section must be

consistent with (as protective as) the general

conditions in section B of this procedure,

CWA section 303(d), existing regulations (40

CFR 130.7), section C of this procedure, and

sections D.1. through D.4 below. State and

Tribal procedures to derive WLAs calculated

in the absence of a TMDL and preliminary

WLAs for purposes of determining the need

for WQBELs under procedure 5 of appendix

F must be consistent with sections B.9, C.1,

C3 through C.6, and D. 1 through D.4 of this

procedure.

1. Individual point source WLAs and

preliminary WLAs for purposes of

determining the need for WQBELs under

procedure 5 of appendix F shall assume no

greater dilution than one part effluent to 10

parts receiving water for implementation of

numeric and narrative chronic criteria and

values (including, but not limited to human

cancer criteria, human cancer values, human

noncancer values, human noncancer criteria,

wildlife criteria, and chronic aquatic life

criteria and values) unless an alternative

mixing zone is demonstrated as appropriate

in a mixing zone demonstration conducted

pursuant to section F of this procedure. In no

case shall a mixing zone be granted that

exceeds the area where discharge-induced

mixing occurs.

2. Appropriate mixing zone assumptions to

be used in calculating load allocations for

nonpoint sources shall be determined,

consistent with applicable State or Tribal

requirements, on a case-by-case basis.

3. WLAs and preliminary WLAs based on

acute aquatic life criteria or values shall not

exceed the Final Acute Value (FAV), unless

a mixing zone demonstration is conducted

and approved pursuant to section F of this

procedure. If mixing zones from two or more

proximate sources interact or overlap, the

combined effect must be evaluated to ensure

that applicable criteria and values will be

met in the area where acute mixing zones

overlap.

4. In no case shall a mixing zone be granted

that would likely jeopardize the continued

existence of any endangered or threatened

species listed under section 4 of the ESA or

result in the destruction or adverse

modification of such species’ critical habitat.

E. Deriving TMDLs, WLAs, and LAs for

Point and Nonpoint Sources; WLAs in the

Absence of a TMDL; and Preliminary WLAs

for the Purposes of Determining the Need for

WQBELs for Great Lakes Systems Tributaries

and Connecting Channels. This section

describes conditions for deriving TMDLs for

tributaries and connecting channels of the

Great Lakes System that exhibit appreciable

flows relative to their volumes. State and

Tribal procedures to derive TMDLs must be

consistent with the general conditions listed

in section B of this procedure, section C of

this procedure, existing TMDL regulations

(40 CFR 130.7) and specific conditions E.1

through E.5. State and Tribal procedures to

derive WLAs calculated in the absence of a

TMDL, and preliminary WLAs for purposes

of determining reasonable potential under

procedure 5 of this appendix for discharges

to tributaries and connecting channels must

be consistent with sections B.9, C.1, C.3

through C.6, and E.1 through E.5 of this

procedure.

1. Stream Design. These design flows must

be used unless data exist to demonstrate that

an alternative stream design flow is

appropriate for stream-specific and pollutantspecific conditions. For purposes of

calculating a TMDL, WLAs in the absence of

a TMDL, or preliminary WLAs for the

purposes of determining reasonable potential

under procedure 5 of this appendix, using a

steady-state model, the stream design flows

shall be:

a. The 7-day, 10-year stream design flow

(7Q10), or the 4-day, 3-year biologicallybased stream design flow for chronic aquatic

life criteria or values;

b. The 1-day, 10-year stream design flow

(1Q10), for acute aquatic life criteria or

values;

c. The harmonic mean flow for human

health criteria or values;

d. The 90-day, 10-year flow (90Q10) for

wildlife criteria.

e. TMDLs, WLAs in the absence of TMDLs,

and preliminary WLAs for the purpose of

determining the need for WQBELs calculated

using dynamic modelling do not need to

incorporate the stream design flows specified

in sections E.1.a through E.1.d of this

procedure.

2. Loading Capacity. The loading capacity

is the greatest amount of loading that a water

can receive without violating water quality

standards. The loading capacity is initially

calculated at the farthest downstream

location in the watershed drainage basin. The

maximum allowable loading consistent with

the attainment of each applicable numeric
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15419

criterion or value for a given pollutant is

determined by multiplying the applicable

criterion or value by the flow at the farthest

downstream location in the tributary basin at

the design flow condition described above.

This loading is then compared to the

loadings at sites within the basin to assure

that applicable numeric criteria or values for

a given pollutant are not exceeded at all

applicable sites. The lowest load is then

selected as the loading capacity.

3. Polluant Degradation. TMDLs, WLAs in

the absence of a TMDL and preliminary

WLAs for purposes of determining the need

for WQBELs under procedure 5 of appendix

F shall be based on the assumption that a

pollutant does not degrade. However, the

regulatory authority may take into account

degradation of the pollutant if each of the

following conditions are met.

a. Scientifically valid field studies or other

relevant information demonstrate that

degradation of the pollutant is expected to

occur under the full range of environmental

conditions expected to be encountered;

b. Scientifically valid field studies or other

relevant information address other factors

that affect the level of pollutants in the water

column including, but not limited to,

resuspension of sediments, chemical

speciation, and biological and chemical

transformation.

4. Acute Aquatic Life Criteria and Values.

WLAs and LAs established in a TMDL, WLAs

in the absence of a TMDL, and preliminary

WLAs for the purpose of determining the

need for WQBELs based on acute aquatic life

criteria or values shall not exceed the FAV,

unless a mixing zone demonstration is

completed and approved pursuant to section

F of this procedure. If mixing zones from two

or more proximate sources interact or

overlap, the combined effect must be

evaluated to ensure that applicable criteria

and values will be met in the area where any

applicable acute mixing zones overlap. This

acute WLA review shall include, but not be

limited to, consideration of:

a. The expected dilution under all effluent

flow and concentration conditions at stream

design flow;

b. Maintenance of a zone of passage for

aquatic organisms; and

c. Protection of critical aquatic habitat.

In no case shall a permitting authority

grant a mixing zone that would likely

jeopardize the continued existence of any

endangered or threatened species listed

under section 4 of the ESA or result in the

destruction or adverse modification of such

species’ critical habitat.

5. Chronic Mixing Zones. WLAs and LAs

established in a TMDL, WLAs in the absence

of a TMDL, and preliminary WLAs for the

purposes of determining the need for

WQBELs for protection of aquatic life,

wildlife and human health from chronic

effects shall be calculated using a dilution

fraction no greater than 25 percent of the

stream design flow unless a mixing zone

demonstration pursuant to section F of this

procedure is conducted and approved. A

demonstration for a larger mixing zone may

be provided, if approved and implemented in

accordance with section F of this procedure.

In no case shall a permitting authority grant

a mixing zone that would likely jeopardize

the continued existence of any endangered or

threatened species listed under section 4 of

the ESA or result in the destruction or

adverse modification of such species’ critical

habitat.

F. Mixing Zone Demonstration

Requirements.

1. For purposes of establishing a mixing

zone other than as specified in sections D

and E above, a mixing zone demonstration

must:

a. Describe the amount of dilution

occurring at the boundaries of the proposed

mixing zone and the size, shape, and location

of the area of mixing, including the manner

in which diffusion and dispersion occur;

b. For sources discharging to the open

waters of the Great Lakes (OWGLs), define

the location at which discharge-induced

mixing ceases;

c. Document the substrate character and

geomorphology within the mixing zone;

d. Show that the mixing zone does not

interfere with or block passage of fish or

aquatic life;

e. Show that the mixing zone will be

allowed only to the extent that the level of

the pollutant permitted in the waterbody

would not likely jeopardize the continued

existence of any endangered or threatened

species listed under section 4 of the ESA or

result in the destruction or adverse

modification of such species’ critical habitat;

f. Show that the mixing zone does not

extend to drinking water intakes;

g. Show that the mixing zone would not

otherwise interfere with the designated or

existing uses of the receiving water or

downstream waters;

h. Document background water quality

concentrations;

i. Show that the mixing zone does not

promote undesirable aquatic life or result in

a dominance of nuisance species; and

j. Provide that by allowing additional

mixing/dilution:

i. Substances will not settle to form

objectionable deposits;

ii. Floating debris, oil, scum, and other

matter in concentrations that form nuisances

will not be produced; and

iii. Objectionable color, odor, taste or

turbidity will not be produced.

2. In addition, the mixing zone

demonstration shall address the following

factors:

a. Whether or not adjacent mixing zones

overlap;

b. Whether organisms would be attracted to

the area of mixing as a result of the effluent

character; and

c. Whether the habitat supports endemic or

naturally occurring species.

3. The mixing zone demonstration must be

submitted to EPA for approval. Following

approval of a mixing zone demonstration

consistent with sections F.1 and F.2,

adjustment to the dilution ratio specified in

section D.1 of this procedure shall be limited

to the dilution available in the area where

discharger-induced mixing occurs.

4. The mixing zone demonstration shall be

based on the assumption that a pollutant

does not degrade within the proposed mixing

zone, unless:

a. Scientifically valid field studies or other

relevant information demonstrate that

degradation of the pollutant is expected to

occur under the full range of environmental

conditions expected to be encountered; and

b. Scientifically valid field studies or other

relevant information address other factors

that affect the level of pollutants in the water

column including, but not limited to,

resuspension of sediments, chemical

speciation, and biological and chemical

transformation.

Procedure 4: Additivity

The Great Lakes States and Tribes shall

adopt additivity provisions consistent with

(as protective as) this procedure.

A. The Great Lakes States and Tribes shall

adopt provisions to protect human health

from the potential adverse additive effects

from both the noncarcinogenic and

carcinogenic components of chemical

mixtures in effluents. For the chlorinated

dibenzo-p-dioxins (CDDs) and chlorinated

dibenzofurans (CDFs) listed in Table 1,

potential adverse additive effects in effluents

shall be accounted for in accordance with

section B of this procedure.

B. Toxicity Equivalency Factors (TEFs)/

Bioaccumulation Equivalency Factors (BEFs).

1. The TEFs in Table 1 and BEFs in Table

2 shall be used when calculating a 2,3,7,8-

TCDD toxicity equivalence concentration in

effluent to be used when implementing both

human health noncancer and cancer criteria.

The chemical concentration of each CDDs

and CDFs in effluent shall be converted to a

2,3,7,8-TCDD toxicity equivalence

concentration in effluent by (a) multiplying

the chemical concentration of each CDDs and

CDFs in the effluent by the appropriate TEF

in Table 1 below, (b) multiplying each

product from step (a) by the BEF for each

CDDs and CDFs in Table 2 below, and (c)

adding all final products from step (b). The

equation for calculating the 2,3,7,8-TCDD

toxicity equivalence concentration in effluent

is:

( ) ( ) ( ) ( ) TEC C TEF BEF tcdd x x x = ∑

where:

(TEC)tcdd=2,3,7,8-TCDD toxicity equivalence

concentration in effluent

(C)x=concentration of total chemical x in

effluent

(TEF)x=TCDD toxicity equivalency factor for

x

(BEF)x=TCDD bioaccumulation equivalency

factor for x

2. The 2,3,7,8-TCDD toxicity equivalence

concentration in effluent shall be used when

developing waste load allocations under

procedure 3, preliminary waste load

allocations for purposes of determining

reasonable potential under procedure 5, and

for purposes of establishing effluent quality

limits under procedure 5.

TABLE 1.—TOXICITY EQUIVALENCY

FACTORS FOR CDDS AND CDFS

Congener TEF

2,3,7,8-TCDD ............................ 1.0

1,2,3,7,8-PeCDD ...................... 0.5
15420 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

TABLE 1.—TOXICITY EQUIVALENCY

FACTORS FOR CDDS AND CDFS—

Continued

Congener TEF

1,2,3,4,7,8-HxCDD ................... 0.1

1,2,3,6,7,8-HxCDD ................... 0.1

1,2,3,7,8,9-HxCDD ................... 0.1

1,2,3,4,6,7,8-HpCDD ................ 0.01

OCDD ....................................... 0.001

2,3,7,8-TCDF ............................ 0.1

1,2,3,7,8-PeCDF ....................... 0.05

2,3,4,7,8-PeCDF ....................... 0.5

1,2,3,4,7,8-HxCDF .................... 0.1

1,2,3,6,7,8-HxCDF .................... 0.1

2,3,4,6,7,8-HxCDF .................... 0.1

1,2,3,7,8,9-HxCDF .................... 0.1

1,2,3,4,6,7,8-HpCDF ................. 0.01

1,2,3,4,7,8,9-HpCDF ................. 0.01

OCDF ........................................ 0.001

TABLE 2.—BIOACCUMULATION EQUIVALENCY FACTORS FOR CDDS AND

CDFS

Congener BEF

2,3,7,8-TCDD ............................ 1.0

1,2,3,7,8-PeCDD ...................... 0.9

1,2,3,4,7,8-HxCDD ................... 0.3

1,2,3,6,7,8-HxCDD ................... 0.1

1,2,3,7,8,9-HxCDD ................... 0.1

1,2,3,4,6,7,8-HpCDD ................ 0.05

OCDD ....................................... 0.01

2,3,7,8-TCDF ............................ 0.8

1,2,3,7,8-PeCDF ....................... 0.2

2,3,4,7,8-PeCDF ....................... 1.6

1,2,3,4,7,8-HxCDF .................... 0.08

1,2,3,6,7,8-HxCDF .................... 0.2

2,3,4,6,7,8-HxCDF .................... 0.7

1,2,3,7,8,9-HxCDF .................... 0.6

1,2,3,4,6,7,8-HpCDF ................. 0.01

1,2,3,4,7,8,9-HpCDF ................. 0.4

OCDF ........................................ 0.02

Procedure 5: Reasonable Potential To Exceed

Water Quality Standards

Great Lakes States and Tribes shall adopt

provisions consistent with (as protective as)

this procedure. If a permitting authority

determines that a pollutant is or may be

discharged into the Great Lakes System at a

level which will cause, have the reasonable

potential to cause, or contribute to an

excursion above any Tier I criterion or Tier

II value, the permitting authority shall

incorporate a water quality-based effluent

limitation (WQBEL) in an NPDES permit for

the discharge of that pollutant. When facilityspecific effluent monitoring data are

available, the permitting authority shall make

this determination by developing preliminary

effluent limitations (PEL) and comparing

those effluent limitations to the projected

effluent quality (PEQ) of the discharge in

accordance with the following procedures. In

all cases, the permitting authority shall use

any valid, relevant, representative

information that indicates a reasonable

potential to exceed any Tier I criterion or

Tier II value.

A. Developing Preliminary Effluent

Limitations on the Discharge of a Pollutant

From a Point Source.

1. The permitting authority shall develop

preliminary wasteload allocations (WLAs) for

the discharge of the pollutant from the point

source to protect human health, wildlife,

acute aquatic life, and chronic aquatic life,

based upon any existing Tier I criteria. Where

there is no Tier I criterion nor sufficient data

to calculate a Tier I criterion, the permitting

authority shall calculate a Tier II value for

such pollutant for the protection of human

health, and aquatic life and the preliminary

WLAs shall be based upon such values.

Where there is insufficient data to calculate

a Tier II value, the permitting authority shall

apply the procedure set forth in section C of

this procedure to determine whether data

must be generated to calculate a Tier II value.

2. The following provisions in procedure 3

of appendix F shall be used as the basis for

determining preliminary WLAs in

accordance with section 1 of this procedure:

procedure 3.B.9, Background Concentrations

of Pollutants; procedure 3.C, Mixing Zones

for Bioaccumulative Chemicals of Concern

(BCCs), procedures 3.C.1, and 3.C.3 through

3.C.6; procedure 3.D, Deriving TMDLs for

Discharges to Lakes (when the receiving

water is an open water of the Great Lakes

(OWGL), an inland lake or other water of the

Great Lakes System with no appreciable flow

relative to its volume); procedure 3.E,

Deriving TMDLs, WLAs and Preliminary

WLAs, and load allocations (LAs) for

Discharges to Great Lakes System Tributaries

(when the receiving water is a tributary or

connecting channel of the Great Lakes that

exhibits appreciable flow relative to its

volume); and procedure 3.F, Mixing Zone

Demonstration Requirements.

3. The permitting authority shall develop

PELs consistent with the preliminary WLAs

developed pursuant to sections A.1 and A.2

of this procedure, and in accordance with

existing State or Tribal procedures for

converting WLAs into WQBELs. At a

minimum:

a. The PELs based upon criteria and values

for the protection of human health and

wildlife shall be expressed as monthly

limitations;

b. The PELs based upon criteria and values

for the protection of aquatic life from chronic

effects shall be expressed as either monthly

limitations or weekly limitations; and

c. The PELs based upon the criteria and

values for the protection of aquatic life from

acute effects shall be expressed as daily

limitations.

B. Determining Reasonable Potential Using

Effluent Pollutant Concentration Data.

If representative, facility-specific effluent

monitoring data samples are available for a

pollutant discharged from a point source to

the waters of the Great Lakes System, the

permitting authority shall apply the

following procedures:

1. The permitting authority shall specify

the PEQ as the 95 percent confidence level

of the 95th percentile based on a log-normal

distribution of the effluent concentration; or

the maximum observed effluent

concentration, whichever is greater. In

calculating the PEQ, the permitting authority

shall identify the number of effluent samples

and the coefficient of variation of the effluent

data, obtain the appropriate multiplying

factor from Table 1 of procedure 6 of

appendix F, and multiply the maximum

effluent concentration by that factor. The

coefficient of variation of the effluent data

shall be calculated as the ratio of the

standard deviation of the effluent data

divided by the arithmetic average of the

effluent data, except that where there are

fewer than ten effluent concentration data

points the coefficient of variation shall be

specified as 0.6. If the PEQ exceeds any of

the PELs developed in accordance with

section A.3 of this procedure, the permitting

authority shall establish a WQBEL in a

NPDES permit for such pollutant.

2. In lieu of following the procedures

under section B.1 of this procedure, the

permitting authority may apply procedures

consistent with the following:

a. The permitting authority shall specify

the PEQ as the 95th percentile of the

distribution of the projected population of

daily values of the facility-specific effluent

monitoring data projected using a

scientifically defensible statistical method

that accounts for and captures the long-term

daily variability of the effluent quality,

accounts for limitations associated with

sparse data sets and, unless otherwise shown

by the effluent data set, assumes a lognormal

distribution of the facility-specific effluent

data. If the PEQ exceeds the PEL based on the

criteria and values for the protection of

aquatic life from acute effects developed in

accordance with section A.3 of this

procedure, the permitting authority shall

establish a WQBEL in an NPDES permit for

such pollutant;

b. The permitting authority shall calculate

the PEQ as the 95th percentile of the

distribution of the projected population of

monthly averages of the facility-specific

effluent monitoring data using a scientifically

defensible statistical method that accounts

for and captures the long-term variability of

the monthly average effluent quality,

accounts for limitations associated with

sparse data sets and, unless otherwise shown

by the effluent data set, assumes a lognormal

distribution of the facility-specific effluent

data. If the PEQ exceeds the PEL based on

criteria and values for the protection of

aquatic life from chronic effects, human

health or wildlife developed in accordance

with section A.3 of this procedure, the

permitting authority shall establish a WQBEL

in an NPDES permit for such pollutant; and

c. The permitting authority shall calculate

the PEQ as the 95th percentile of the

distribution of the projected population of

weekly averages of the facility-specific

effluent monitoring data using a scientifically

defensible statistical method that accounts

for and captures the long-term variability of

the weekly average effluent quality, accounts

for limitations associated with sparse data

sets and, unless otherwise shown by the

effluent data set, assumes a lognormal

distribution of the facility-specific effluent

data. If the PEQ exceeds the PEL based on

criteria and values to protect aquatic life from

chronic effects developed in accordance with

section A.3 of this procedure, the permitting
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15421

authority shall establish a WQBEL in an

NPDES permit for such pollutant.

C. Developing Necessary Data to Calculate

Tier II Values Where Such Data Does Not

Currently Exist.

1. Except as provided in sections C.2, C.4,

or D of this procedure, for each pollutant

listed in Table 6 of part 132 that a permittee

reports as known or believed to be present in

its effluent, and for which pollutant data

sufficient to calculate Tier II values for noncancer human health, acute aquatic life and

chronic aquatic life do not exist, the

permitting authority shall take the following

actions:

a. The permitting authority shall use all

available, relevant information, including

Quantitative Structure Activity Relationship

information and other relevant toxicity

information, to estimate ambient screening

values for such pollutant which will protect

humans from health effects other than

cancer, and aquatic life from acute and

chronic effects.

b. Using the procedures specified in

sections A.1 and A.2 of this procedure, the

permitting authority shall develop

preliminary WLAs for the discharge of the

pollutant from the point source to protect

human health, acute aquatic life, and chronic

aquatic life, based upon the estimated

ambient screening values.

c. The permitting authority shall develop

PELs in accordance with section A.3 of this

procedure, which are consistent with the

preliminary WLAs developed in accordance

with section C.1.b of this procedure.

d. The permitting authority shall compare

the PEQ developed according to the

procedures set forth in section B of this

procedure to the PELs developed in

accordance with section C.1.c of this

procedure. If the PEQ exceeds any of the

PELs, the permitting authority shall generate

or require the permittee to generate the data

necessary to derive Tier II values for

noncancer human health, acute aquatic life

and chronic aquatic life.

e. The data generated in accordance with

section C.1.d of this procedure shall be used

in calculating Tier II values as required under

section A.1 of this procedure. The calculated

Tier II value shall be used in calculating the

preliminary WLA and PEL under section A

of this procedure, for purposes of

determining whether a WQBEL must be

included in the permit. If the permitting

authority finds that the PEQ exceeds the

calculated PEL, a WQBEL for the pollutant or

a permit limit on an indicator parameter

consistent with 40 CFR 122.44(d)(1)(vi)(C)

must be included in the permit.

2. With the exception of bioaccumulative

chemicals of concern (BCCs), a permitting

authority is not required to apply the

procedures set forth in section C.1 of this

procedure or include WQBELs to protect

aquatic life for any pollutant listed in Table

6 of part 132 discharged by an existing point

source into the Great Lakes System, if:

a. There is insufficient data to calculate a

Tier I criterion or Tier II value for aquatic life

for such pollutant;

b. The permittee has demonstrated through

a biological assessment that there are no

acute or chronic effects on aquatic life in the

receiving water; and

c. The permittee has demonstrated in

accordance with procedure 6 of this

appendix that the whole effluent does not

exhibit acute or chronic toxicity.

3. Nothing in sections C.1 or C.2 of this

procedure shall preclude or deny the right of

a permitting authority to:

a. Determine, in the absence of the data

necessary to derive a Tier II value, that the

discharge of the pollutant will cause, have

the reasonable potential to cause, or

contribute to an excursion above a narrative

criterion for water quality; and

b. Incorporate a WQBEL for the pollutant

into an NPDES permit.

4. If the permitting authority develops a

WQBEL consistent with section C.3 of this

procedure, and the permitting authority

demonstrates that the WQBEL developed

under section C.3 of this procedure is at least

as stringent as a WQBEL that would have

been based upon the Tier II value or values

for that pollutant, the permitting authority

shall not be obligated to generate or require

the permittee to generate the data necessary

to derive a Tier II value or values for that

pollutant.

D. Consideration of Intake Pollutants in

Determining Reasonable Potential.

1. General.

a. Any procedures adopted by a State or

Tribe for considering intake pollutants in

water quality-based permitting shall be

consistent with this section and section E.

b. The determinations under this section

and section E shall be made on a pollutantby-pollutant, outfall-by-outfall, basis.

c. This section and section E apply only in

the absence of a TMDL applicable to the

discharge prepared by the State or Tribe and

approved by EPA, or prepared by EPA

pursuant to 40 CFR 130.7(d), or in the

absence of an assessment and remediation

plan submitted and approved in accordance

with procedure 3.A. of appendix F. This

section and section E do not alter the

permitting authority’s obligation under 40

CFR 122.44(d)(vii)(B) to develop effluent

limitations consistent with the assumptions

and requirements of any available WLA for

the discharge, which is part of a TMDL

prepared by the State or Tribe and approved

by EPA pursuant to 40 CFR 130.7, or

prepared by EPA pursuant to 40 CFR

130.7(d).

2. Definition of Same Body of Water.

a. This definition applies to this section

and section E of this procedure.

b. An intake pollutant is considered to be

from the same body of water as the discharge

if the permitting authority finds that the

intake pollutant would have reached the

vicinity of the outfall point in the receiving

water within a reasonable period had it not

been removed by the permittee. This finding

may be deemed established if:

i. The background concentration of the

pollutant in the receiving water (excluding

any amount of the pollutant in the facility’s

discharge) is similar to that in the intake

water;

ii. There is a direct hydrological

connection between the intake and discharge

points; and

iii. Water quality characteristics (e.g.,

temperature, Ph, hardness) are similar in the

intake and receiving waters.

c. The permitting authority may also

consider other site-specific factors relevant to

the transport and fate of the pollutant to

make the finding in a particular case that a

pollutant would or would not have reached

the vicinity of the outfall point in the

receiving water within a reasonable period

had it not been removed by the permittee.

d. An intake pollutant from groundwater

may be considered to be from the same body

of water if the permitting authority

determines that the pollutant would have

reached the vicinity of the outfall point in the

receiving water within a reasonable period

had it not been removed by the permittee,

except that such a pollutant is not from the

same body of water if the groundwater

contains the pollutant partially or entirely

due to human activity, such as industrial,

commercial, or municipal operations,

disposed actions, or treatment processes.

e. An intake pollutant is the amount of a

pollutant that is present in waters of the

United States (including groundwater as

provided in section D.2.d of this procedure)

at the time it is withdrawn from such waters

by the discharger or other facility (e.g., public

water supply) supplying the discharger with

intake water.

3. Reasonable Potential Determination.

a. The permitting authority may use the

procedure described in this section of

procedure 5 in lieu of procedures 5.A

through C provided the conditions specified

below are met.

b. The permitting authority may determine

that there is no reasonable potential for the

discharge of an identified intake pollutant or

pollutant parameter to cause or contribute to

an excursion above a narrative or numeric

water quality criterion within an applicable

water quality standard where a discharger

demonstrates to the satisfaction of the

permitting authority (based upon information

provided in the permit application or other

information deemed necessary by the

permitting authority) that:

i. The facility withdraws 100 percent of the

intake water containing the pollutant from

the same body of water into which the

discharge is made;

ii. The facility does not contribute any

additional mass of the identified intake

pollutant to its wastewater;

iii. The facility does not alter the identified

intake pollutant chemically or physically in

a manner that would cause adverse water

quality impacts to occur that would not occur

if the pollutants were left in-stream;

iv. The facility does not increase the

identified intake pollutant concentration, as

defined by the permitting authority, at the

edge of the mixing zone, or at the point of

discharge if a mixing zone is not allowed, as

compared to the pollutant concentration in

the intake water, unless the increased

concentration does not cause or contribute to

an excursion above an applicable water

quality standard; and

v. The timing and location of the discharge

would not cause adverse water quality

impacts to occur that would not occur if the

identified intake pollutant were left instream.

c. Upon a finding under section D.3.b of

this procedure that a pollutant in the
15422 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

discharge does not cause, have the reasonable

potential to cause, or contribute to an

excursion above an applicable water quality

standard, the permitting authority is not

required to include a WQBEL for the

identified intake pollutant in the facility’s

permit, provided:

i. The NPDES permit fact sheet or

statement of basis includes a specific

determination that there is no reasonable

potential for the discharge of an identified

intake pollutant to cause or contribute to an

excursion above an applicable narrative or

numeric water quality criterion and

references appropriate supporting

documentation included in the

administrative record;

ii. The permit requires all influent,

effluent, and ambient monitoring necessary

to demonstrate that the conditions in section

D.3.b of this procedure are maintained during

the permit term; and

iii. The permit contains a reopener clause

authorizing modification or revocation and

reissuance of the permit if new information

indicates changes in the conditions in section

D.3.b of this procedure.

d. Absent a finding under section D.3.b of

this procedure that a pollutant in the

discharge does not cause, have the reasonable

potential to cause, or contribute to an

excursion above an applicable water quality

standard, the permitting authority shall use

the procedures under sections 5.A through C

of this procedure to determine whether a

discharge causes, has the reasonable

potential to cause, or contribute to an

excursion above an applicable narrative or

numeric water quality criterion.

E. Consideration of Intake Pollutants in

Establishing WQBELs.

1. General. This section applies only when

the concentration of the pollutant of concern

upstream of the discharge (as determined

using the provisions in procedure 3.B.9 of

appendix F) exceeds the most stringent

applicable water quality criterion for that

pollutant.

2. The requirements of sections D.1–D.2 of

this procedure shall also apply to this

section.

3. Intake Pollutants from the Same Body of

Water.

a. In cases where a facility meets the

conditions in sections D.3.b.i and D.3.b.iii

through D.3.b.v of this procedure, the

permitting authority may establish effluent

limitations allowing the facility to discharge

a mass and concentration of the pollutant

that are no greater than the mass and

concentration of the pollutant identified in

the facility’s intake water (‘‘no net addition

limitations’’). The permit shall specify how

compliance with mass and concentration

limitations shall be assessed. No permit may

authorize ‘‘no net addition limitations’’

which are effective after March 23, 2007.

After that date, WQBELs shall be established

in accordance with procedure 5.F.2 of

appendix F.

b. Where proper operation and

maintenance of a facility’s treatment system

results in removal of a pollutant, the

permitting authority may establish

limitations that reflect the lower mass and/

or concentration of the pollutant achieved by

such treatment, taking into account the

feasibility of establishing such limits.

c. For pollutants contained in intake water

provided by a water system, the

concentration of the intake pollutant shall be

determined at the point where the raw water

supply is removed from the same body of

water, except that it shall be the point where

the water enters the water supplier’s

distribution system where the water

treatment system removes any of the

identified pollutants from the raw water

supply. Mass shall be determined by

multiplying the concentration of the

pollutant determined in accordance with this

paragraph by the volume of the facility’s

intake flow received from the water system.

4. Intake Pollutants from a Different Body

of Water. Where the pollutant in a facility’s

discharge originates from a water of the

United States that is not the same body of

water as the receiving water (as determined

in accordance with section D.2 of this

procedure), WQBELs shall be established

based upon the most stringent applicable

water quality criterion for that pollutant.

5. Multiple Sources of Intake Pollutants.

Where a facility discharges intake pollutants

that originate in part from the same body of

water, and in part from a different body of

water, the permitting authority may apply the

procedures of sections E.3 and E.4 of this

procedure to derive an effluent limitation

reflecting the flow-weighted average of each

source of the pollutant, provided that

adequate monitoring to determine

compliance can be established and is

included in the permit.

F. Other Applicable Conditions.

1. In addition to the above procedures,

effluent limitations shall be established to

comply with all other applicable State, Tribal

and Federal laws and regulations, including

technology-based requirements and

antidegradation policies.

2. Once the permitting authority has

determined in accordance with this

procedure that a WQBEL must be included

in an NPDES permit, the permitting authority

shall:

a. Rely upon the WLA established for the

point source either as part of any TMDL

prepared under procedure 3 of this appendix

and approved by EPA pursuant to 40 CFR

130.7, or as part of an assessment and

remediation plan developed and approved in

accordance with procedure 3.A of this

appendix, or, in the absence of such TMDL

or plan, calculate WLAs for the protection of

acute and chronic aquatic life, wildlife and

human health consistent with the provisions

referenced in section A.1 of this procedure

for developing preliminary wasteload

allocations, and

b. Develop effluent limitations consistent

with these WLAs in accordance with existing

State or Tribal procedures for converting

WLAs into WQBELs.

3. When determining whether WQBELs are

necessary, information from chemicalspecific, whole effluent toxicity and

biological assessments shall be considered

independently.

4. If the geometric mean of a pollutant in

fish tissue samples collected from a

waterbody exceeds the tissue basis of a Tier

I criterion or Tier II value, after consideration

of the variability of the pollutant’s

bioconcentration and bioaccumulation in

fish, each facility that discharges detectable

levels of such pollutant to that water has the

reasonable potential to cause or contribute to

an excursion above a Tier I criteria or a Tier

II value and the permitting authority shall

establish a WQBEL for such pollutant in the

NPDES permit for such facility.

Procedure 6: Whole Effluent Toxicity

Requirements

The Great Lakes States and Tribes shall

adopt provisions consistent with (as

protective as) procedure 6 of appendix F of

part 132.

The following definitions apply to this

part:

Acute toxic unit (TUa). 100/LC50 where the

LC50 is expressed as a percent effluent in the

test medium of an acute whole effluent

toxicity (WET) test that is statistically or

graphically estimated to be lethal to 50

percent of the test organisms.

Chronic toxic unit (TUc). 100/NOEC or

100/IC25, where the NOEC and IC25 are

expressed as a percent effluent in the test

medium.

Inhibition concentration 25 (IC25). the

toxicant concentration that would cause a 25

percent reduction in a non-quantal biological

measurement for the test population. For

example, the IC25 is the concentration of

toxicant that would cause a 25 percent

reduction in mean young per female or in

growth for the test population.

No observed effect concentration (NOEC).

The highest concentration of toxicant to

which organisms are exposed in a full lifecycle or partial life-cycle (short-term) test,

that causes no observable adverse effects on

the test organisms (i.e., the highest

concentration of toxicant in which the values

for the observed responses are not

statistically significantly different from the

controls).

A. Whole Effluent Toxicity Requirements.

The Great Lakes States and Tribes shall adopt

whole effluent toxicity provisions consistent

with the following:

1. A numeric acute WET criterion of 0.3

acute toxic units (TUa) measured pursuant to

test methods in 40 CFR part 136, or a

numeric interpretation of a narrative criterion

establishing that 0.3 TUa measured pursuant

to test methods in 40 CFR part 136 is

necessary to protect aquatic life from acute

effects of WET. At the discretion of the

permitting authority, the foregoing

requirement shall not apply in an acute

mixing zone that is sized in accordance with

EPA-approved State and Tribal methods.

2. A numeric chronic WET criterion of one

chronic toxicity unit (TUc) measured

pursuant to test methods in 40 CFR part 136,

or a numeric interpretation of a narrative

criterion establishing that one TUc measured

pursuant to test methods in 40 CFR part 136

is necessary to protect aquatic life from the

chronic effects of WET. At the discretion of

the permitting authority, the foregoing

requirements shall not apply within a

chronic mixing zone consistent with: (a)

procedures 3.D.1 and 3.D.4, for discharges to

the open of the Great Lakes (OWGL), inland
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15423

lakes and other waters of the Great Lakes

System with no appreciable flow relative to

their volume, or (b) procedure 3.E.5 for

discharges to tributaries and connecting

channels of the Great Lakes System.

B. WET Test Methods. All WET tests

performed to implement or ascertain

compliance with this procedure shall be

performed in accordance with methods

established in 40 CFR part 136.

C. Permit Conditions.

1. Where a permitting authority determines

pursuant to section D of this procedure that

the WET of an effluent is or may be

discharged at a level that will cause, have the

reasonable potential to cause, or contribute to

an excursion above any numeric WET

criterion or narrative criterion within a

State’s or Tribe’s water quality standards, the

permitting authority:

a. Shall (except as provided in section

C.1.e of this procedure) establish a water

quality-based effluent limitation (WQBEL) or

WQBELs for WET consistent with section

C.1.b of this procedure;

b. Shall calculate WQBELs pursuant to

section C.1.a. of this procedure to ensure

attainment of the State’s or Tribe’s chronic

WET criteria under receiving water flow

conditions described in procedures 3.E.1.a

(or where applicable, with procedure 3.E.1.e)

for Great Lakes System tributaries and

connecting channels, and with mixing zones

no larger than allowed pursuant to section

A.2. of this procedure. Shall calculate

WQBELs to ensure attainment of the State’s

or Tribe’s acute WET criteria under receiving

water flow conditions described in procedure

3.E.1.b (or where applicable, with procedure

3.E.1.e) for Great Lakes System tributaries

and connecting channels, with an allowance

for mixing zones no greater than specified

pursuant to section A.1 of this procedure.

c. May specify in the NPDES permit the

conditions under which a permittee would

be required to perform a toxicity reduction

evaluation.

d. May allow with respect to any WQBEL

established pursuant to section C.1.a of this

procedure an appropriate schedule of

compliance consistent with procedure 9 of

appendix F; and

e. May decide on a case-by-case basis that

a WQBEL for WET is not necessary if the

State’s or Tribe’s water quality standards do

not contain a numeric criterion for WET, and

the permitting authority demonstrates in

accordance with 40 CFR 122.44(d)(1)(v) that

chemical-specific effluent limits are

sufficient to ensure compliance with

applicable criteria.

2. Where a permitting authority lacks

sufficient information to determine pursuant

to section D of this procedure whether the

WET of an effluent is or may be discharged

at levels that will cause, have the reasonable

potential to cause, or contribute to an

excursion above any numeric WET criterion

or narrative criterion within a State’s or

Tribe’s water quality standards, then the

permitting authority should consider

including in the NPDES permit appropriate

conditions to require generation of additional

data and to control toxicity if found, such as:

a. WET testing requirements to generate the

data needed to adequately characterize the

toxicity of the effluent to aquatic life;

b. Language requiring a permit reopener

clause to establish WET limits if any toxicity

testing data required pursuant to section

C.2.a of this procedure indicate that the WET

of an effluent is or may be discharged at

levels that will cause, have the reasonable

potential to cause, or contribute to an

excursion above any numeric WET criterion

or narrative criterion within a State’s or

Tribe’s water quality standards.

3. Where sufficient data are available for a

permitting authority to determine pursuant to

section D of this procedure that the WET of

an effluent neither is nor may be discharged

at a level that will cause, have the reasonable

potential to cause, or contribute to an

excursion above any numeric WET criterion

or narrative criterion within a State’s or

Tribe’s water quality standards, the

permitting authority may include conditions

and limitations described in section C.2 of

this procedure at its discretion.

D. Reasonable Potential Determinations.

The permitting authority shall take into

account the factors described in 40 CFR

122.44(d)(1)(ii) and, where representative

facility-specific WET effluent data are

available, apply the following requirements

in determining whether the WET of an

effluent is or may be discharged at a level

that will cause, have the reasonable potential

to cause, or contribute to an excursion above

any numeric WET criterion or narrative

criterion within a State’s or Tribe’s water

quality standards.

1. The permitting authority shall

characterize the toxicity of the discharge by:

a. Either averaging or using the maximum

of acute toxicity values collected within the

same day for each species to represent one

daily value. The maximum of all daily values

for the most sensitive species tested is used

for reasonable potential determinations;

b. Either averaging or using the maximum

of chronic toxicity values collected within

the same calendar month for each species to

represent one monthly value. The maximum

of such values, for the most sensitive species

tested, is used for reasonable potential

determinations:

c. Estimating the toxicity values for the

missing endpoint using a default acutechronic ratio (ACR) of 10, when data exist for

either acute WET or chronic WET, but not for

both endpoints.

2. The WET of an effluent is or may be

discharged at a level that will cause, have the

reasonable potential to cause, or contribute to

an excursion above any numeric acute WET

criterion or numeric interpretation of a

narrative criterion within a State’s or Tribe’s

water quality standards, when effluentspecific information demonstrates that:

(TUa effluent) (B) (effluent flow/

(Qad+effluent flow))>AC

Where TUa effluent is the maximum

measured acute toxicity of 100 percent

effluent determined pursuant to section

D.1.a. of this procedure, B is the multiplying

factor taken from Table F6–1 of this

procedure to convert the highest measured

effluent toxicity value to the estimated 95th

percentile toxicity value for the discharge,

effluent flow is the same effluent flow used

to calculate the preliminary wasteload

allocations (WLAs) for individual pollutants

to meet the acute criteria and values for those

pollutants, AC is the numeric acute WET

criterion or numeric interpretation of a

narrative criterion established pursuant to

section A.1 of this procedure and expressed

in TUa, and Qad is the amount of the

receiving water available for dilution

calculated using: (i) the specified design

flow(s) for tributaries and connecting

channels in section C.1.b of this procedure,

or where appropriate procedure 3.E.1.e of

appendix F, and using EPA-approved State

and Tribal procedures for establishing acute

mixing zones in tributaries and connecting

channels, or (ii) the EPA-approved State and

Tribal procedures for establishing acute

mixing zones in OWGLs. Where there are less

than 10 individual WET tests, the

multiplying factor taken from Table F6–1 of

this procedure shall be based on a coefficient

of variation (CV) or 0.6. Where there are 10

or more individual WET tests, the

multiplying factor taken from Table F6–1

shall be based on a CV calculated as the

standard deviation of the acute toxicity

values found in the WET tests divided by the

arithmetic mean of those toxicity values.

3. The WET of an effluent is or may be

discharged at a level that will cause, have the

reasonable potential to cause, or contribute to

an excursion above any numeric chronic

WET criterion or numeric interpretation of a

narrative criterion within a State’s or Tribe’s

water quality standards, when effluentspecific information demonstrates that:

(TUc effluent) (B) (effluent flow/Qad+effluent

flow))>CC

Where TUc effluent is the maximum

measured chronic toxicity value of 100

percent effluent determined in accordance

with section D.1.b. of this procedure, B is the

multiplying factor taken from Table F6–1 of

this procedure, effluent flow is the same

effluent flow used to calculate the

preliminary WLAs for individual pollutants

to meet the chronic criteria and values for

those pollutants, CC is the numeric chronic

WET criterion or numeric interpretation of a

narrative criterion established pursuant to

section A.2 of this procedure and expressed

in TUc, and Qad is the amount of the

receiving water available for dilution

calculated using: (i) the design flow(s) for

tributaries and connecting channels specified

in procedure 3.E.1.a of appendix F, and

where appropriate procedure 3.E.1.e of

appendix F, and in accordance with the

provisions of procedure 3.E.5 for chronic

mixing zones, or (ii) procedures 3.D.1 and

3.D.4 for discharges to the OWGLs. Where

there are less than 10 individual WET tests,

the multiplying factor taken from Table F6–

1 of this procedure shall be based on a CV

of 0.6. Where there are 10 more individual

WET tests, the multiplying factor taken from

Table F6–1 of this procedure shall be based

on a CV calculated as the standard deviation

of the WET tests divided by the arithmetic

mean of the WET tests.
15424 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations

TABLE F6–1.—REASONABLE POTENTIAL MULTIPLYING FACTORS: 95% CONFIDENCE LEVEL AND 95% PROBABILITY BASIS

Number of Samples

Coefficient of variation

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2.0

1 ............................................... 1.4 1.9 2.6 3.6 4.7 6.2 8.0 10.1 12.6 15.5 18.7 22.3 26.4 30.8 35.6 40.7 46.2 52.1 58.4 64.9

2 ............................................... 1.3 1.6 2.0 2.5 3.1 3.8 4.6 5.4 6.4 7.4 8.5 9.7 10.9 12.2 13.6 15.0 16.4 17.9 19.5 21.1

3 ............................................... 1.2 1.5 1.8 2.1 2.5 3.0 3.5 4.0 4.6 5.2 5.8 6.5 7.2 7.9 8.6 9.3 10.0 10.8 11.5 12.3

4 ............................................... 1.2 1.4 1.7 1.9 2.2 2.6 2.9 3.3 3.7 4.2 4.6 5.0 5.5 6.0 6.4 6.9 7.4 7.8 8.3 8.8

5 ............................................... 1.2 1.4 1.6 1.8 2.1 2.3 2.6 2.9 3.2 3.6 3.9 4.2 4.5 4.9 5.2 5.6 5.9 6.2 6.6 6.9

6 ............................................... 1.1 1.3 1.5 1.7 1.9 2.1 2.4 2.6 2.9 3.1 3.4 3.7 3.9 4.2 4.5 4.7 5.0 5.2 5.5 5.7

7 ............................................... 1.1 1.3 1.4 1.6 1.8 2.0 2.2 2.4 2.6 2.8 3.1 3.3 3.5 3.7 3.9 4.1 4.3 4.5 4.7 4.9

8 ............................................... 1.1 1.3 1.4 1.6 1.7 1.9 2.1 2.3 2.4 2.6 2.8 3.0 3.2 3.3 3.5 3.7 3.9 4.0 4.2 4.3

9 ............................................... 1.1 1.2 1.4 1.5 1.7 1.8 2.0 2.1 2.3 2.4 2.6 2.8 2.9 3.1 3.2 3.4 3.5 3.6 3.8 3.9

10 ............................................. 1.1 1.2 1.3 1.5 1.6 1.7 1.9 2.0 2.2 2.3 2.4 2.6 2.7 2.8 3.0 3.1 3.2 3.3 3.4 3.6

11 ............................................. 1.1 1.2 1.3 1.4 1.6 1.7 1.8 1.9 2.1 2.2 2.3 2.4 2.5 2.7 2.8 2.9 3.0 3.1 3.2 3.3

12 ............................................. 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.0

13 ............................................. 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.5 2.6 2.7 2.8 2.9

14 ............................................. 1.1 1.2 1.3 1.4 1.4 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.2 2.3 2.3 2.4 2.5 2.6 2.6 2.7

15 ............................................. 1.1 1.2 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.8 1.9 2.0 2.1 2.2 2.2 2.3 2.4 2.4 2.5 2.5

16 ............................................. 1.1 1.1 1.2 1.3 1.4 1.5 1.6 1.6 1.7 1.8 1.9 1.9 2.0 2.1 2.1 2.2 2.3 2.3 2.4 2.4

17 ............................................. 1.1 1.1 1.2 1.3 1.4 1.4 1.5 1.6 1.7 1.7 1.8 1.9 1.9 2.0 2.0 2.1 2.2 2.2 2.3 2.3

18 ............................................. 1.1 1.1 1.2 1.3 1.3 1.4 1.5 1.6 1.6 1.7 1.7 1.8 1.9 1.9 2.0 2.0 2.1 2.1 2.2 2.2

19 ............................................. 1.1 1.1 1.2 1.3 1.3 1.4 1.5 1.5 1.6 1.6 1.7 1.8 1.8 1.9 1.9 2.0 2.0 2.0 2.1 2.1

20 ............................................. 1.1 1.1 1.2 1.2 1.3 1.4 1.4 1.5 1.5 1.6 1.6 1.7 1.7 1.8 1.8 1.9 1.9 2.0 2.0 2.0

30 ............................................. 1.0 1.1 1.1 1.1 1.2 1.2 1.2 1.3 1.3 1.3 1.3 1.4 1.4 1.4 1.4 1.5 1.5 1.5 1.5 1.5

40 ............................................. 1.0 1.0 1.1 1.1 1.1 1.1 1.1 1.1 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.3 1.3

50 ............................................. 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1 1.1

60 ............................................. 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0

70 ............................................. 1.0 1.0 1.0 1.0 1.0 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9

80 ............................................. 1.0 1.0 1.0 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.8 0.8 0.8 0.8 0.8 0.8

90 ............................................. 1.0 1.0 0.9 0.9 0.9 0.9 0.9 0.9 0.9 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8

100 ........................................... 1.0 1.0 0.9 0.9 0.9 0.9 0.9 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.7 0.7 0.7

Procedure 7: Loading Limits

The Great Lakes States and Tribes shall

adopt provisions consistent with (as

protective as) this procedure.

Whenever a water quality-based effluent

limitation (WQBEL) is developed, the

WQBEL shall be expressed as both a

concentration value and a corresponding

mass loading rate.

A. Both mass and concentration limits

shall be based on the same permit averaging

periods such as daily, weekly, or monthly

averages, or in other appropriate permit

averaging periods.

B. The mass loading rates shall be

calculated using effluent flow rates that are

consistent with those used in establishing the

WQBELs expressed in concentration.

Procedure 8: Water Quality-based Effluent

Limitations Below the Quantification Level

The Great Lakes States and Tribes shall

adopt provisions consistent with (as

protective as) this procedure.

When a water quality-based effluent

limitation (WQBEL) for a pollutant is

calculated to be less than the quantification

level:

A. Permit Limits. The permitting authority

shall designate as the limit in the NPDES

permit the WQBEL exactly as calculated.

B. Analytical Method and Quantification

Level.

1. The permitting authority shall specify in

the permit the most sensitive, applicable,

analytical method, specified in or approved

under 40 CFR part 136, or other appropriate

method if one is not available under 40 CFR

part 136, to be used to monitor for the

presence and amount in an effluent of the

pollutant for which the WQBEL is

established; and shall specify in accordance

with section B.2 of this procedure, the

quantification level that can be achieved by

use of the specified analytical method.

2. The quantification level shall be the

minimum level (ML) specified in or

approved under 40 CFR part 136 for the

method for that pollutant. If no such ML

exists, or if the method is not specified or

approved under 40 CFR part 136, the

quantification level shall be the lowest

quantifiable level practicable. The permitting

authority may specify a higher quantification

level if the permittee demonstrates that a

higher quantification level is appropriate

because of effluent-specific matrix

interference.

3. The permit shall state that, for the

purpose of compliance assessment, the

analytical method specified in the permit

shall be used to monitor the amount of

pollutant in an effluent down to the

quantification level, provided that the analyst

has complied with the specified quality

assurance/quality control procedures in the

relevant method.

4. The permitting authority shall use

applicable State and Tribal procedures to

average and account for monitoring data. The

permitting authority may specify in the

permit the value to be used to interpret

sample values below the quantification level.

C. Special Conditions. The permit shall

contain a reopener clause authorizing

modification or revocation and reissuance of

the permit if new information generated as a

result of special conditions included in the

permit indicates that presence of the

pollutant in the discharge at levels above the

WQBEL. Special conditions that may be

included in the permit include, but are not

limited to, fish tissue sampling, whole

effluent toxicity (WET) tests, limits and/or

monitoring requirements on internal waste

streams, and monitoring for surrogate

parameters. Data generated as a result of

special conditions can be used to reopen the

permit to establish more stringent effluent

limits or conditions, if necessary.

D. Pollutant Minimization Program. The

permitting authority shall include a

condition in the permit requiring the

permittee to develop and conduct a pollutant

minimization program for each pollutant

with a WQBEL below the quantification

level. The goal of the pollutant minimization

program shall be to reduce all potential

sources of the pollutant to maintain the

effluent at or below the WQBEL. In addition,

States and Tribes may consider costeffectiveness when establishing the

requirements of a PMP. The pollutant

minimization program shall include, but is

not limited to, the following:

1. An annual review and semi-annual

monitoring of potential sources of the

pollutant, which may include fish tissue

monitoring and other bio-uptake sampling;

2. Quarterly monitoring for the pollutant in

the influent to the wastewater treatment

system;

3. Submittal of a control strategy designed

to proceed toward the goal of maintaining all

sources of the pollutant to the wastewater

collection system below the WQBEL;

4. When the sources of the pollutant are

discovered, appropriate cost-effective control
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15425

measures shall be implemented, consistent

with the control strategy; and

5. An annual status report that shall be sent

to the permitting authority including:

a. All minimization program monitoring

results for the previous year;

b. A list of potential sources of the

pollutant; and

c. A summary of all action taken to reduce

or eliminate the identified sources of the

pollutant.

6. Any information generated as a result of

procedure 8.D can be used to support a

request for subsequent permit modifications,

including revisions to (e.g., more or less

frequent monitoring), or removal of the

requirements of procedure 8.D, consistent

with 40 CFR 122.44, 122.62 and 122.63.

Procedure 9: Compliance Schedules

The Great Lakes States and Tribes shall

adopt provisions consistent with (as

protective as) procedure 9 of appendix F of

part 132.

A. Limitations for New Great Lakes

Dischargers. When a permit issued on or after

March 23, 1997 to a new Great Lakes

discharger (defined in Part 132.2) contains a

water quality-based effluent limitation

(WQBEL), the permittee shall comply with

such a limitation upon the commencement of

the discharge.

B. Limitations for Existing Great Lakes

Dischargers.

1. Any existing permit that is reissued or

modified on or after March 23, 1997 to

contain a new or more restrictive WQBEL

may allow a reasonable period of time, up to

five years from the date of permit issuance

or modification, for the permittee to comply

with that limit, provided that the Tier I

criterion or whole effluent toxicity (WET)

criterion was adopted (or, in the case of a

narrative criterion, Tier II value, or Tier I

criterion derived pursuant to the

methodology in appendix A of part 132, was

newly derived) after July 1, 1977.

2. When the compliance schedule

established under paragraph 1 goes beyond

the term of the permit, an interim permit

limit effective upon the expiration date 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 the final limit and its compliance

date.

3. If a permit establishes a schedule of

compliance under paragraph 1 which

exceeds one year from the date of permit

issuance or modification, the schedule shall

set forth interim requirements and dates for

their achievement. The time between such

interim dates may not exceed one year. If the

time necessary for completion of any interim

requirement is more than one year and 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 any interim

requirements.

C. Delayed Effectiveness of Tier II

Limitations for Existing Great Lakes

Discharges.

1. Whenever a limit (calculated in

accordance with Procedure 3) based upon a

Tier II value is included in a reissued or

modified permit for an existing Great Lakes

discharger, the permit may provide a

reasonable period of time, up to two years,

in which to provide additional studies

necessary to develop a Tier I criterion or to

modify the Tier II value. In such cases, the

permit shall require compliance with the Tier

II limitation within a reasonable period of

time, no later than five years after permit

issuance or modification, and contain a

reopener clause.

2. The reopener clause shall authorize

permit modifications if specified studies

have been completed by the permittee or

provided by a third-party during the time

allowed to conduct the specified studies, and

the permittee or a third-party demonstrates,

through such studies, that a revised limit is

appropriate. Such a revised limit shall be

incorporated through a permit modification

and a reasonable time period, up to five

years, shall be allowed for compliance. If

incorporated prior to the compliance date of

the original Tier II limitation, any such

revised limit shall not be considered lessstringent for purposes of the anti-backsliding

provisions of section 402(o) of the Clean

Water Act.

3. If the specified studies have been

completed and do not demonstrate that a

revised limit is appropriate, the permitting

authority may provide a reasonable

additional period of time, not to exceed five

years with which to achieve compliance with

the original effluent limitation.

4. Where a permit is modified to include

new or more stringent limitations, on a date

within five years of the permit expiration

date, such compliance schedules may extend

beyond the term of a permit consistent with

section B.2 of this procedure.

5. If future studies (other than those

conducted under paragraphs 1, 2, or 3 above)

result in a Tier II value being changed to a

less stringent Tier II value or Tier I criterion,

after the effective date of a Tier II-based limit,

the existing Tier II-based limit may be

revised to be less stringent if:

(a) It complies with sections 402(o) (2) and

(3) of the CWA; or,

(b) In non-attainment waters, where the

existing Tier II limit was based on procedure

3, the cumulative effect of revised effluent

limitation based on procedure 3 of this

appendix will assure compliance with water

quality standards; or,

(c) In attained waters, the revised effluent

limitation complies with the State or Tribes’

antidegradation policy and procedures.

[FR Doc. 95–6671 Filed 3–22–95; 8:45 am]

BILLING CODE 6560–50–P