[Federal Register: March 23, 1995 (Volume 60, Number 56)]

[Rules and Regulations ] 

[Page 15365-15425]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23mr95-15]

 

[[Page 15365]]

_______________________________________________________________________

Part III

Environmental Protection Agency

_______________________________________________________________________

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

Final Water Quality Guidance for the Great Lakes System;

Final Rule

[[Page 15366]] 

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.

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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 

long-lasting 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 multimedia 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 

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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

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 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 [[Page 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 

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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 

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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 

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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 x 

10<SUP>-\3\ (Lake Superior) (1.8 in one thousand) to 3.7 x 

10<SUP>-\2\ (Lake Michigan) (3.7 in 100). Estimated risks to low income 

minority sport anglers range from 2.5 x 10<SUP>-\3\ (2.5 in one 

thousand) (Lake Superior) to 1.2 x 10<SUP>-\2\ (1.2 in 100) (Lake 

Michigan). Estimated risks for other sport anglers range from 9.7 x 

10<SUP>-\4\ (9.7 in ten thousand) (Lake Superior) to 4.5 x 

10<SUP>-\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 x 

10<SUP>-\4\ (one in ten thousand) to 1 x 10<SUP>-\6\ (one in 1 

million) is an appropriate range of risk to protect human health. 

[[Page 15368]] 

 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

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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 Lakes-specific 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 

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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 

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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. [[Page 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,

multi-media 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 

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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 phase-out 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. 

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Issuance of the final Guidance alone will not solve the existing longterm 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 longlasting 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 <greek-m>g/L 

to 15.0 <greek-m>g/L for cadmium, and from 0.21 <greek-m>g/L to 1.33 

<greek-m>g/L for dieldrin. Other examples of variations in acute 

aquatic life criteria include nickel, which ranges from 290.30 

<greek-m>g/L to 852.669 <greek-m>g/L; lindane, [[Page 15370]] with a 

range of no criteria in place to 1.32 <greek-m>g/L; and mercury, 

ranging from 0.5 <greek-m>g/L to 2.4 <greek-m>g/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 

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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 site-specific 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 

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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 Sec. 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 

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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 [[Page 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 

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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-to-Know 

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 

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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 

[[Page 15372]] 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 

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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 media-specific 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 

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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.

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 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. 

[[Page 15373]] 

A. Water Quality Criteria and Methodologies

1. Protection of Aquatic Life

 (Secs. 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 

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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 

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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

 (Secs. 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 [[Page 15374]] 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 

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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 field-measured 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<SUP>-\4\ (one in one thousand) and 10<SUP>-\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 x 10<SUP>-\2\ (1.2 in 100). The 

proposed and final Guidance establishes 10<SUP>-\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<SUP>-\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 Lakes-specific 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<SUP>-4 to 

10<SUP>-6 as adequately protective of public health. As discussed 

above, the human health criteria methodology is based on a risk level 

of 10<SUP>-5. Therefore, if fish are contaminated at the level 

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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<SUP>-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 subpopulations. 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<SUP>-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 [[Page 15375]] BCCs, there may 

be other sources of exposures for noncarcinogens.

3. Protection of Wildlife

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 (Secs. 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 two-tiered 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-SABEPEC-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 crossreferenced 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.

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4. Bioaccumulation Methodology

(Sec. 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 fieldmeasured 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 laboratory-measured BCF by a 

food-chain multiplier; and BAFs predicted by multiplying a BCF 

calculated from the log K<INF>ow 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

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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 

[[Page 15376]] 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 field-measured BSAF (for non-metals) or from a fieldmeasured BAF or a laboratory-measured BCF (for metals). Field-measured 

BAFs and BSAFs, unlike BAFs based only on laboratory analyses or 

calculations, account for the effects of metabolism.

B. Implementation Procedures

(Secs. 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 

site-specific 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 

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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 site-specific 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 basin-wide 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 

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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 bi-national 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 [[Page 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 

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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<SUP>-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-p-Dioxins 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 

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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. [[Page 15378]] 

6. Intake Pollutants

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(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 

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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 

non-attainment provided limitations require the discharge to meet a 

WQBEL for the pollutant equal to the pollutant's water quality 

criterion. Because inter-waterbody 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 flow-weighted 

combination of these approaches when the facility has co-mingled 

sources of intake water from the same and different bodies of water.

 EPA maintains that the preferred approach to deal with nonattainment 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 

non-existing 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 

TU<INF>a at the point of discharge (i.e., no acute mixing zones) and 

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1.0 TU<INF>c 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 TU<INF>a and 1.0 TU<INF>c 

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. [[Page 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 bio-uptake 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)

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 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

(Sec. 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 

non-BCCs.

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 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 quality-based (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 [[Page 15380]] 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 Sec. 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 

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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, Sec. 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, Sec. 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, Sec. 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

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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 

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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. [[Page 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 ``low-end'' 

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 

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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-of-pipe'' 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 high-end 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 end-ofpipe 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-of-pipe 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 

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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 cost-effectiveness (cost per pound removed) is derived by 

dividing the annualized costs of implementing the final 

[[Page 15382]] Guidance by the toxicity-weighted pounds (poundequivalents) 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 costeffectiveness of regulating point and nonpoint sources of mercury and 

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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 benefitcost 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 toxicsoriented 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 

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$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 river-based 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., basinwide 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

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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 [[Page 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 Guidance-based 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 

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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 

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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, antibacksliding, 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 [[Page 15384]] 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 end-of-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.

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 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 

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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 site-specific 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 [[Page 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.

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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 

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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

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 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: 

[[Page 15386]] 

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''.

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 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:

Sec. 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 

 Water Quality Standards Regulation 

131.1................................................. 2040-0180 

131.5................................................. 2040-0180 

 

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 * * * * * 

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:

Sec. 122.44 Establishing limitations, standards, and other permit 

conditions (applicable to State NPDES programs, see Sec. 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.

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 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:

Sec. 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:

Sec. 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:

Sec. 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:

Sec. 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]

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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:

Sec. 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 

[[Page 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:

Sec. 131.5 EPA Authority.

 (a) * * *

 (5) Whether the State submission meets the requirements included in 

Sec. 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:

Sec. 131.21 EPA review and approval of water quality standards.

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* * * * *

 (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 Secs. 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.

Sec. 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

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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.

Sec. 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 

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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 non-harmful 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 

[[Page 15388]] 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 carbonnormalized 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 

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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.

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 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 waterrelated 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 [[Page 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 

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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 

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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 life-cycle 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). 

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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, [[Page 15390]] 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.

Sec. 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 

Sec. 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.

Sec. 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 Sec. 132.2;

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 (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

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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 Sec. 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 

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procedures more [[Page 15391]] stringent than those set forth in 

appendixes E and F of this part.

Sec. 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 

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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 site-specific 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 

Sec. 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 

Sec. 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 

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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.

Sec. 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)

------------------------------------------------------------------------

 Conversion

 Chemical CMC(<greek-m>g/ factor 

 L) (CF) 

------------------------------------------------------------------------

Arsenic (III).............................. <SUP>a,b339.8 1.000 

Chromium (VI).............................. <SUP>a,b16.02 0.982 

Cyanide.................................... <SUP>c22 n/a 

Dieldrin................................... <SUP>d0.24 n/a 

Endrin..................................... <SUP>d0.086 n/a 

Lindane.................................... <SUP>d0.95 n/a 

Mercury (II)............................... <SUP>a,b1.694 0.85 

Parathion.................................. <SUP>d0.065 n/a 

Selenium................................... <SUP>a,b19.34 0.922 

------------------------------------------------------------------------

<SUP>aCMC=CMC<SUP>tr. 

<SUP>bCMC<SUP>d=(CMC<SUP>tr) CF. The CMC<SUP>d shall be

rounded to two significant digits. 

<SUP>[[Pa<SUP>ge 153<SUP>92]] 

 

<SUP>cCMC should be considered free cyanide as CN. 

<SUP>dCMC=CMC<SUP>t. 

Notes: 

The term ``n/a'' means not applicable. 

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CMC is Criterion Maximum Concentration. 

CMC<SUP>tr is the CMC expressed as total recoverable. 

CMC<SUP>d is the CMC expressed as a dissolved concentration. 

CMC<SUP>t is the CMC expressed as a total concentration. 

 (b)

------------------------------------------------------------------------

 Conversion

 Chemical m<INF>A b<INF>A factor 

 (CF) 

------------------------------------------------------------------------

Cadmium<SUP>a,b............................ 1.128 -3.6867 0.85 

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

Copper<SUP>a,b............................. 0.9422 -1.700 0.960 

Nickel<SUP>a,b............................. 0.846 +2.255 0.998 

Pentachlorophenol<SUP>c.................... 1.005 -4.869 n/a 

Zinc<SUP>a,b............................... 0.8473 +0.884 0.978 

------------------------------------------------------------------------

<SUP>aCMC<SUP>tr=exp { m<INF>A [ln (hardness)]+b<INF>A}. 

 

<SUP>bCMC<SUP>d=(CMC<SUP>tr) CF. The CMC<SUP>d shall be

rounded to two significant digits. 

<SUP>cCMC<SUP>t=exp m<INF>A { [pH]+b<INF>A}. The

CMC<SUP>t 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. 

CMC<SUP>tr is the CMC expressed as total recoverable. 

CMC<SUP>d is the CMC expressed as a dissolved concentration. 

CMC<SUP>t 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)

------------------------------------------------------------------------

 Conversion

 Chemical CCC(<greek-m>g/ factor 

 L) (CF) 

------------------------------------------------------------------------

Arsenic (III).............................. <SUP>a,b147.9 1.000 

Chromium (VI).............................. <SUP>a,b10.98 0.962 

Cyanide.................................... <SUP>c5.2 n/a 

Dieldrin................................... <SUP>d0.056 n/a 

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Endrin..................................... <SUP>d0.036 n/a 

Mercury (II)............................... <SUP>a,b0.9081 0.85 

Parathion.................................. <SUP>d0.013 n/a 

Selenium................................... <SUP>a,b5 0.922 

------------------------------------------------------------------------

<SUP>aCCC=CCC<SUP>tr. 

<SUP>bCCC<SUP>d=(CCC<SUP>tr) CF. The CCC<SUP>d shall be

rounded to two significant digits. 

<SUP>cCCC should be considered free cyanide as CN. 

<SUP>dCCC=CCC<SUP>t. 

 

Notes: 

The term ``n/a'' means not applicable. 

CCC is Criterion Continuous Concentration. 

CCC<SUP>tr is the CCC expressed as total recoverable. 

CCC<SUP>d is the CCC expressed as a dissolved concentration. 

CCC<SUP>t is the CCC expressed as a total concentration. 

 (b)

------------------------------------------------------------------------

 Conversion

 Chemical m<INF>c b<INF>c factor(CF)

------------------------------------------------------------------------

Cadmium<SUP>a,b................................ 0.7852 -2.715 0.850 

Chromium (III)<SUP>a,b......................... 0.819 +0.6848 0.860 

Copper<SUP>a,b................................. 0.8545 -1.702 0.960 

Nickel<SUP>a,b................................. 0.846 +0.0584 0.997 

Pentachlorophenol<SUP>c........................ 1.005 -5.134 n/a 

Zinc<SUP>a,b................................... 0.8473 +0.884 0.986 

------------------------------------------------------------------------

<SUP>aCCC<SUP>tr=exp {m<INF>c[ln (hardness)]+b<INF>c}. 

 

<SUP>bCCC<INF>d=(CCC<SUP>tr) (CF). The CCC<SUP>d shall be

rounded to two significant digits.

<SUP>cCMC<SUP>t=exp {m<INF>A[pH]+b<INF>A}. The

CMC<SUP>t 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. 

CCC<SUP>tr is the CCC expressed as total recoverable. 

CCC<SUP>d is the CCC expressed as a dissolved concentration. 

CCC<SUP>t is the CCC expressed as a total concentration. 

 Table 3.--Water Quality Criteria for Protection of Human H

-----------------------------------------------------------------------------------

 HNV (<greek-m>g/L) 

(<greek-m>g/L) 

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 Chemical ------------------------------

 Drinking Nondrinking 

-----------------------------------------------------------------------------------

Benzene............................................. 1.9E1 5.1E2 

Chlordane........................................... 1.4E-3 1.4E-3 

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

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

DDT................................................. 2.0E-3 2.0E-3 

Dieldrin............................................ 4.1E-4 4.1E-4 

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

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

Hexachlorobenzene................................... 4.6E-2 4.6E-2 

Hexachloroethane.................................... 6.0 7.6 

Lindane............................................. 4.7E-1 5.0E-1 

Mercury<SUP>1............................................ 1.8E-3 1.8E-3 

Methylene chloride.................................. 1.6E3 9.0E4 

PCBs (class)........................................ 

2,3,7,8-TCDD........................................ 6.7E-8 6.7E-8 

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

Toxaphene........................................... 

[[Page 15393]] 

 

Trichloroethylene................................... 

-----------------------------------------------------------------------------------

\1\Includes methylmercury. 

 Table 4.--Water Quality Criteria for Protection of Wildlife 

------------------------------------------------------------------------

 Criteria 

 Chemical (<greek-m>g/

 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

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 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

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 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

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 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-n-propylamine

 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

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consistent 

with (as protective as) this appendix. [[Page 15394]] 

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 nonionizable 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 

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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, 

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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 constant-volume 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 nonresident 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.

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 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: [[Page 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 

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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 

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.)

 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 

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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 

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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 

[[Page 15396]] 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

[GRAPHIC][TIFF OMITTED]TR23MR95.104

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 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 

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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 [[Page 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=e<SUP>Y

 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 

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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<SUP>(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 Acute-Chronic 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 

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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 

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predictions of results of life-cycle and partial life-cycle tests 

with the same species. Therefore, when results of a life-cycle or 

partial life-cycle test are available, results of an early lifestage 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 [[Page 15398]] 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 life-cycle 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.

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 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<divide>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 

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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, 

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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. [[Page 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 

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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=e<SUP>Q

 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<SUP>(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 welldeveloped, 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. 

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Concentrations of EDTA above 200 <greek-m>g/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 

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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) <greek-m>g/L more than once every three years on 

the average and if the one-hour average concentration does not 

exceed (3) <greek-m>g/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 

once-in-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 welldesigned 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 

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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 [[Page 15400]] 

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

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 Calculate the Secondary Chronic Value (SCV) using one of the 

following:

[GRAPHIC][TIFF OMITTED]TR23MR95.099

 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) 

<greek-m>g/L more than once every three years on the average and if 

the one-hour average concentration does not exceed (3) <greek-m>g/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).

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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 

------------------------------------------------------------------------

 Adjustment

 Number of minimum data requirements satisfied 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 

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aquatic organisms to chemicals.

 C. For organic chemicals, baseline BAFs can be derived using 

four methods. Measured baseline BAFs are derived from field-measured 

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 [[Page 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.

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 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 (K<INF>OW). The ration of 

the concentration of a substance in the n-octanol phase to its 

concentration in the aqueous phase in an equilibrated two-phase 

octanol-water system. For log K<INF>OW, 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 K<INF>ow 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 

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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 K<INF>ows 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 laboratory-measured 

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 flowthrough 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 K<INF>ow 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 

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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). [[Page 15402]] 

 E. Predicted BCFs. The following procedural and quality 

assurance requirements shall be met for predicted BCFs:

 1. The K<INF>ow 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 = K<INF>ow

 where:

 K<INF>ow = octanol-water partition coefficient.

 F. Octanol-Water Partition Coefficient (K<INF>ow). 1. The value 

of K<INF>ow used for an organic chemical shall be determined by 

giving priority to the experimental and computational techniques 

used as follows:

 Log K<INF>ow < 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 K<INF>ow > 4:

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------------------------------------------------------------------------

 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 K<INF>ow that seems to be different from the 

others should be considered an outlier and not used. The value of 

K<INF>ow used for an organic chemical shall be the geometric mean of 

the available K<INF>ows with highest priority or can be calculated 

from the arithmetic mean of the available log K<INF>ow with the 

highest priority. Because it is an intermediate value in the 

derivation of a BAF, the value used for the K<INF>ow of a chemical 

should not be rounded to fewer than three significant digits and a 

value for log K<INF>ow 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 K<INF>ow. 

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 

K<INF>ow 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 K<INF>ow 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.

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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, C<INF>l, of a chemical in 

tissue is defined using the following equation:

[GRAPHIC][TIFF OMITTED]TR23MR95.100

Where:

C<INF>B=concentration of the organic chemical in the tissue of 

aquatic biota (either whole organism or specified tissue) 

(<greek-m>g/g).

f<INF>l=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:

[GRAPHIC][TIFF OMITTED]TR23MR95.101

Where:

C<SUP>fd<INF>w=freely dissolved concentration of the organic 

chemical in the ambient water;

C<SUP>t<INF>w=total concentration of the organic chemical in the 

ambient water;

f<INF>fd=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 

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freely dissolved, f<INF>fd, shall be calculated using the following 

equation:

[GRAPHIC][TIFF OMITTED]TR23MR95.102

Where:

DOC=concentration of dissolved organic carbon, kg of dissolved 

organic carbon/L of water.

K<INF>OW=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 

K<INF>OW and linear interpolation. A FCM greater than 1.0 applies to 

most organic chemicals with a log K<INF>OW 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:

[[Page 15403]]

[GRAPHIC][TIFF OMITTED]TR23MR95.103

Where:

BAF<SUP>t<INF>T=BAF based on total concentration in tissue and 

water.

f<INF>l=fraction of the tissue that is lipid.

f<INF>fd=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. 

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A baseline BAF for organic chemical ``i'' shall be calculated from a 

field-measured BSAF of acceptable quality using the following 

equation:

[GRAPHIC][TIFF OMITTED]TR23MR95.105

Where:

(BSAF)<INF>i=BSAF for chemical ``i''.

(BSAF)<INF>r=BSAF for the reference chemical ``r''.

(K<INF>OW)<INF>i=octanol-water partition coefficient for chemical 

``i''.

(K<INF>OW)<INF>r=octanol-water partition coefficient for the 

reference chemical ``r''.

 2. A BSAF shall be calculated using the following equation:

[GRAPHIC][TIFF OMITTED]TR23MR95.106

Where:

C<INF>t=the lipid-normalized concentration of the chemical in 

tissue.

C<INF>SOC=the organic carbon-normalized concentration of the 

chemical in sediment.

 3. The organic carbon-normalized concentration of a chemical in 

sediment, C<INF>SOC, shall be calculated using the following 

equation:

[GRAPHIC][TIFF OMITTED]TR23MR95.107

Where:

C<INF>S=concentration of chemical in sediment (<greek-m>g/g 

sediment).

f<INF>OC=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 

BAF<INF>l<SUP>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 

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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:

[GRAPHIC][TIFF OMITTED]TR23MR95.108

Where:

BCF<SUP>t<INF>T=BCF based on total concentration in tissue and 

water.

f<INF>l=fraction of the tissue that is lipid.

f<INF>fd=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 laboratory-measured 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 K<INF>OW of 

acceptable quality and a FCM using the following equation:

 Baseline BAF=(FCM) (predicted baseline BCF)=(FCM) (K<INF>OW)

Where:

FCM=the food-chain multiplier obtained from Table B-1 by linear 

interpolation for trophic level 3 or 4, as necessary.

K<INF>OW=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 K<INF>OW of the [[Page 15404]] 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:

[GRAPHIC][TIFF OMITTED]TR23MR95.109

 B. The human health BAFs for an organic chemical shall be 

calculated using the following equations:

 For trophic level 3:

[GRAPHIC][TIFF OMITTED]TR23MR95.110

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 For trophic level 4:

[GRAPHIC][TIFF OMITTED]TR23MR95.111

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:

[GRAPHIC][TIFF OMITTED]TR23MR95.112

 For trophic level 4:

[GRAPHIC][TIFF OMITTED]TR23MR95.113

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 

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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 chemicalspecific 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.

[[Page 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 chemicalspecific 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 

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------------------------------------------------------------------------

 Trophic Trophic\1\ Trophic 

 Log K<INF>ow level 2 level 3 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

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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

[[Page 15406]] 

 

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

------------------------------------------------------------------------

\1\The 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 wateroriented 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 

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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 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). 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 water-related 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 dose-response 

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 

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incremental cancer risk equal to one in 100,000.

 Slope factor. Also known as q<INF>1*, 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- 

[[Page 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 

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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 wellconducted 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 

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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-by-case 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 

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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 [[Page 15408]] 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 

well-conducted 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: 

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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 field-measured 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 chemical-specific 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 

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Howe, Crump and Van Landingham (1986), which EPA uses to determine 

cancer potencies. The upper-bound 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 caseby-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:

[GRAPHIC][TIFF OMITTED]TR23MR95.114

Where:

RAD=risk associated dose in milligrams of toxicant per kilogram body 

weight per day (mg/kg/day).

0.00001 (1 x 10<SUP>-5)=incremental risk of developing cancer equal 

to one in 100,000.

q<INF>1*=slope factor (mg/kg/day)<SUP>-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 

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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. [[Page 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 

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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).

 WC<INF>d = per capita water consumption (both drinking and 

incidental exposure) for surface waters classified as public water 

supplies = two liters/day.

 --or--

 WC<INF>r = 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).

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 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:

[GRAPHIC][TIFF OMITTED]TR23MR95.115

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).

WC<INF>d=per capita water consumption (both drinking and incidental 

exposure) for surface waters classified as public water supplies=two 

liters/day.

 or

WC<INF>r=per capita incidental daily water ingestion for surface 

waters not used as human drinking water sources=0.01 liters/day.

FC<INF>TL3=mean consumption of trophic level 3 of regionally caught 

freshwater fish=0.0036 kg/day.

FC<INF>TL4=mean consumption of trophic level 4 of regionally caught 

freshwater fish=0.0114 kg/day.

BAF<SUP>HH<INF>TL3=bioaccumulation factor for trophic level 3 fish, 

as derived using the BAF methodology in appendix B to part 132.

BAF<SUP>HH<INF>TL4=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:

[GRAPHIC][TIFF OMITTED]TR23MR95.116

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).

WC<INF>d=per capita water consumption (both drinking and incidental 

exposure) for surface waters classified as public water supplies=two 

liters/day.

 or

WC<INF>r=per capita incidental daily water ingestion for surface 

waters not used as human drinking water sources=0.01 liters/

day. [[Page 15410]] 

FC<INF>TL3=mean consumption of trophic level 3 fish by regional 

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sport fishers of regionally caught freshwater fish=0.0036 kg/day.

FC<INF>TL4=mean consumption of trophic level 4 fish by regional 

sport fishers of regionally caught freshwater fish=0.0114 kg/day.

BAF<SUP>HH<INF>TL3=human health bioaccumulation factor for edible 

portion of trophic level 3 fish, as derived using the BAF 

methodology in appendix B to part 132.

BAF<SUP>HH<INF>TL4=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 

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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 site-specific 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.

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 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.

[GRAPHIC][TIFF OMITTED]TR23MR95.117

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/kg-d) for the test species. This shall be either a NOAEL or a 

LOAEL.

UF<INF>A=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.

UF<INF>S=UF for extrapolating from subchronic to chronic exposures 

(unitless).

UF<INF>L=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.

F<INF>TLi=Average daily amount of food consumed from trophic level i 

in kilograms per day (kg/d) by the representative species.

BAF<SUP>WL<INF>TLi=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

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 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. 

[[Page 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, chemicalspecific 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.

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 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 

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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 x (Wt)<SUP>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 x (Wt)<SUP>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)<SUP>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 x (Wt)<SUP>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 (UF<INF>L). 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 

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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 UF<INF>L in the equation expressed in Section 

II.A of this appendix. Guidance for selecting an appropriate 

UF<INF>L, based on a review of available wildlife toxicity data, is 

available in the Wildlife TSD.

 G. Subchronic to Chronic Extrapolations (US<INF>S). 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 UF<INF>S 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 

[[Page 15412]] underestimates chronic effects. Guidance for 

selecting an appropriate UF<INF>S, based on a review of available 

wildlife toxicity data, is available in the Wildlife TSD.

 H. Interspecies Extrapolations (UF<INF>A). 1. The selection of 

the UF<INF>A 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 UF<INF>A, 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 UF<INF>A.

 2. For the derivation of Tier I criteria, a UF<INF>A 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 UF<INF>A may differ for 

each of the representative species.

 3. For Tier I wildlife criteria, the UF<INF>A shall be used only 

for extrapolating toxicity data across species within a taxonomic 

class, except as provided below. The Tier I UF<INF>A 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 

UF<INF>A may be used for a given chemical if it can be supported by 

a validated biologically-based 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 

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body weights (Wt), feeding rates (F<INF>Tli), 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 

 

------------------------------------------------------------------------

 Criterion 

 Substance (<greek-m>g/

 L) 

------------------------------------------------------------------------

DDT & Metabolites......................................... 1.1E-5 

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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 Ident

Protection 

-----------------------------------------------------------------------------------

 Water 

 Adult body ingestion Food ingestion rate of prey 

 Species (units) weight rate (L/ in each trophic level (kg/ 

 (kg) day) day) 

-----------------------------------------------------------------------------------

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

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

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

Herring gull................ 1.1 0.063 TL3: 0.192; TL4: 0.0480..... 

20.

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

Bald eagle.................. 4.6 0.160 TL3: 0.371; TL4: 0.0929..... 

20.

 PB: 00283; Other: 0.0121.... 

 

-----------------------------------------------------------------------------------

Note: TL3=trophic level three fish; TL4=trophic level four fish; PB=piscivorous b

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

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 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 [[Page 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 

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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 Bi-National 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 Bi-National 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 

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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 

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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 [[Page 15414]] 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 caseby-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 

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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 

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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 site-specific 

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 sitespecific 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 

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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). [[Page 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 sitespecific 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 

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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 

system-wide 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 

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and occur at the site is different than that used to derive the 

system-wide 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 sitespecific 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 

site-specific 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 sitespecific 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 

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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 [[Page 15416]] 

 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 

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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 

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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 

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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 

Sec. 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 case-specific 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 non-regulatory 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; [[Page 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 case140 of 167 06/15/2001 9:49 AM

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specific 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 

Sec. 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-by-case basis.

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 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 

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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

[[Page 15418]] System beyond the dates specified in sections C.3 and 

C.4 of this procedure, where it can be demonstrated, on a case-bycase 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.

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 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;

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 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 caseby-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 

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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 pollutant-specific 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 biologically-based 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 [[Page 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 

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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.

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 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:

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 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-pdioxins (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:

[GRAPHIC][TIFF OMITTED]TR23MR95.118

where:

(TEC)<INF>tcdd=2,3,7,8-TCDD toxicity equivalence concentration in 

effluent

(C)<INF>x=concentration of total chemical x in effluent

(TEF)<INF>x=TCDD toxicity equivalency factor for x

(BEF)<INF>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.

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 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 

[[Page 15420]] 

 

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

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 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 

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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 lognormal 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 

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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 

[[Page 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 non-cancer 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 

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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 pollutant-by-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 

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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 sitespecific 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 

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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 in-stream.

 c. Upon a finding under section D.3.b of this procedure that a 

pollutant in the [[Page 15422]] 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 

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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.

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 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 chemical-specific, 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 (TU<INF>a). 100/LC<INF>50 where the LC<INF>50 

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 (TU<INF>c). 100/NOEC or 100/IC<INF>25, where 

the NOEC and IC<INF>25 are expressed as a percent effluent in the 

test medium.

 Inhibition concentration 25 (IC<INF>25). the toxicant 

concentration that would cause a 25 percent reduction in a nonquantal biological measurement for the test population. For example, 

the IC<INF>25 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 

life-cycle or partial life-cycle (short-term) test, that causes no 

observable adverse effects on the test organisms (i.e., the highest 

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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 

(TU<INF>a) measured pursuant to test methods in 40 CFR part 136, or 

a numeric interpretation of a narrative criterion establishing that 

0.3 TU<INF>a 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 

(TU<INF>c) measured pursuant to test methods in 40 CFR part 136, or 

a numeric interpretation of a narrative criterion establishing that 

one TU<INF>c 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 [[Page 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 

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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 

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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 acute-chronic 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 effluent-specific information 

demonstrates that:

(TU<INF>a effluent) (B) (effluent flow/(Qad+effluent flow))>AC

Where TU<INF>a 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 TU<INF>a, 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 

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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 effluent-specific 

information demonstrates that:

(TU<INF>c effluent) (B) (effluent flow/Qad+effluent flow))>CC

Where TU<INF>c 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 TU<INF>c, 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.

 

[[Page 15424]] 

 Table F6-1.--Reasonable Potential Mul

Confidence Level and 95% Probability Basis 

-----------------------------------------------------------------------------------

--------------------------------------------------------------------------

 

 

 Number of Samples 

-----------------------------------------------------------------------------------

---------------------

 0.1 0.2 0.3 0.4 

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 

 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 

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 

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 

5.0 5.5 6.0 6.4 6.9 7.4 7.8 8.3 8.8

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5................................................... 1.2 1.4 1.6 1.8 

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 

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 

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 

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 

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 

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 

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 

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 

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 

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 

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 

1.9 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 

1.9 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 

1.8 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 

1.8 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 

1.7 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 

1.4 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 

1.2 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 

1.1 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

70.................................................. 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

80.................................................. 1.0 1.0 1.0 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 

0.8 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 

0.8 0.8 0.8 0.8 0.8 0.8 0.7 0.7 0.7

-----------------------------------------------------------------------------------

--------------------------------------------------------------------------

Procedure 7: Loading Limits

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 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 

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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 [[Page 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 

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(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 less-stringent 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 

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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

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