Thursday
March 23, 1995
Part 111
Environmental
Protection Agency
40 CFR 9, 122, 123, 131, and 132
Final Water Quality Guidance for the
Great Lakes System; Final Rule
-------
-------
15366 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9,122,123,131, and 132
[FRL-5173-7]
RIN 2040-AC08
Final Water Quality Guidance for the
Great Lakes System
AGENCY: U.S. Environmental Protection
Agency.
ACTION: Final rule.
SUMMARY: EPA is publishing Final Water
Quality Guidance for the Great Lakes
System. Great Lakes States and Tribes
will use the water quality criteria,
methodologies, policies, and procedures
in the Guidance to establish consistent,
enforceable, long-term protection for
fish and shellfish in the Great Lakes and
their tributaries, as well as for the
people and wildlife who consume them.
The Guidance was initially developed
by the Great Lakes States, EPA, and
other Federal agencies in open dialogue
with citizens, local governments, and
industries in the Great Lakes ecosystem.
It will affect all types of pollutants, but
will target especially the types of 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 multi-media efforts to
protect and restore the Great Lakes
ecosystem.
EFFECTIVE DATE: April 24,1995.
ADDRESSES: The public docket for this
rulemaking, including applicable
Federal Register documents, public
comments in response to these
documents, the Final Water Quality
Guidance for the Great Lakes System,
Response to Comments Document, other
major supporting documents, and the
index to the docket are available for
inspection and copying at U.S. EPA
Region 5, 77 West Jackson Blvd.,
Chicago, IL 60604 by appointment only.
Appointments may be made by calling
Wendy Schumacher (telephone 312-
886-0142).
Information concerning the Great
Lakes Initiative (GLI) Clearinghouse is
available from Ken Fenner, Water
Quality Branch Chief, (WQS-16J), U.S.
EPA Region 5, 77 W. Jackson Blvd.,
Chicago, IL 60604 (312-353-2079).
Copies of the Information Collection
Request for the Guidance are available
by writing or calling Sandy Farmer,
Information Policy Branch, EPA, 401 M
St., S.W. (Mail Code 2136), Washington,
DC 20460 (202-260-2740).
Selected documents supporting the
Guidance are also available for viewing
by the public at locations listed in
section XI of the preamble.
Selected documents supporting the
Guidance are available by mail upon
request for a fee. Selected documents
are also available in electronic format at
no incremental cost to users of the
Internet. See section XI of the preamble
for additional information.
FOR FURTHER INFORMATION CONTACT:
Kenneth A. Fenner, Water Quality
Branch Chief (WQS-16J), U.S. EPA
Region 5, 77 W. Jackson Blvd., Chicago,
IL 60604 (312-353-2079).
SUPPLEMENTARY INFORMATION
Preamble Outline
I. Introduction
II. Background
III. Purpose of the Guidence
A. Use the Best Available Science to
Protect Human Health, Aquatic Life, and
Wildlife
B. Recognize the Unique Nature of the
Great Lakes Basin Ecosystem
C. Promote Consistency in Standards and
Implementation Procedures While
Allowing Appropriate Flexibility to
States and Tribes
D. Establish Equitable Strategies to Control
Pollution Sources
E. Promote Pollution Prevention Practices
F. Provide Accurate Assessment of Costs
and Benefits
IV. Sumarry of the Final Guidance
A. Water Quality Criteria and
Methodologies
1. Protection of Aquatic Life
2. Protection of Human Health
3. Protection of Wildlife
4. Bioaccumulation Methodology
B. Implementation Procedures
1. Site-Specific Modifications
2. Variances from Water Quality Standards
for Point Sources
3. TMDLs and Mixing Zones
4. Additivity
5. Deteimining 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. Judica.il Review of Provisions not
Amended
XI. Supporting Documents
I. Introduction
Section i:L8(c)(2) of the Clean Water
Act (CV/A) (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
Guidan.ee for the Great Lakes System
(proposed Guidance) in the Federal
Register on April 16,1993 (58 FR
20802),, EPA also published four
subsequent documents in the Federal
Register identifying corrections and
requesting comments on additional
related materials (April 16,1993, 58 FR
21046; August 9,1993, 58 FR 42266;
September 13,1993, 58 FR 47845; and
August 30,1994, 59 FR 44678). EPA
received over 26,500 pages of
comments, data, and information from
over 6,000 commenters in response to
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15367
those documents and from meetings
with members of the public.
After reviewing and analyzing the
information in the proposal and these
comments, EPA has developed the Final
Water Quality Guidance for the Great
Lakes System (final Guidance),
published in this document and
codified in 40 CFR part 132, which
includes six appendixes of detailed
methodologies, policies, and
procedures. This preamble describes the
background and purpose of the final
Guidance, and briefly summarizes the
major provisions. Detailed discussion of
EPA's reasons for issuing the final
Guidance, analysis of comments and
issues, description of specific changes
made to the proposed Guidance, and
further description of the final
Guidance, are provided in "Final Water
Quality Guidance for the Great Lakes
System: Supplementary Information
Document" (SID), (EPA, 1995, 820-B-
95-001) and in additional technical and
supporting documents which are
available in the docket for this
rulemaking. Copies of the SID and other
supporting documents are also available
from EPA in electronic format, or in
printed form for a fee upon request; see
section XI of this preamble.
II. Background
The Great Lakes are one of the
outstanding natural resources of the
world. They have played a vital role in
the history and development of the
United States and Canada, and have
physical, chemical, and biological
characteristics that make them a unique
ecosystem. The Great Lakes
themselves—Lakes Superior, Huron,
Michigan, Erie and Ontario and then-
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
spedes of aquatic life, wildlife and
plants along more than 4,500 miles of
coastline which boast six National Parks
and Lakeshores, six National Forests,
seven National Wildlife Refuges, and
hundreds of State parks, forests and
sanctuaries.
.Because of their unique features, the
Great Lakes are viewed as important to
the residents of the region, and to the
Nation as a whole. The natural
resources of the region have contributed
to the development of its economy. The
Lakes' natural beauty and aquatic
resources form the basis for heavy
recreational activity. The Great Lakes
Basin Ecosystem—the interacting
components of air, land, water and
living organisms, including humans,
that live within the Great Lakes drainage
basin—is a remarkably diverse and
unique ecosystem important in the
global ecology.
In the past few decades, the presence
of environmental contaminants in the
Great Lakes has been of significant
concern. In spite of the fact that the
Great Lakes contain 5,500 cubic miles of
water that cover a total surface area of
94,000 square miles, they have proved
to be sensitive to the effects of
pollutants that accumulate in them. The
internal responses and processes that
operate in the Great Lakes because of
their depth and long hydraulic
residence times cause pollutants to
recycle between biota, sediments and
the water column.
The first major basin-wide
environmental problem in the Great
Lakes emerged in the late 1960s, when
increased nutrients had dramatically
stimulated the growth of green plants
and algae, reduced dissolved oxygen
levels, and accelerated the process of
eutrophication. As oxygen levels
continued to drop, certain species of
insects and fish were displaced from
affected areas of the Great Lakes Basin
Ecosystem. Environmental managers
determined that a lakewide approach
was necessary to adequately control
accelerated eutrophication. From the
late 1960s through the late 1970s,
United States and Canadian regulatory
agencies agreed on measures to limit the
loadings of phosphorus, including
effluent limits on all major municipal
sewage treatment facilities, limitations
on the phosphorus content in household
detergents, and reductions in nonpoint
source runoff loadings. As a result of all
of these efforts, open lake phosphorus
concentrations have declined, and
phosphorus loadings from municipal
sewage treatment facilities have been
reduced by an estimated 80 to 90
percent. These reductions have resulted
in dramatic improvements in nearshore
water quality and measurable
improvements in open lake conditions.
More recently, scientists and public
leaders have reached a general
consensus that the presence of
environmentally persistent,
bioaccumulative contaminants is a
serious environmental threat to the
Great Lakes Basin Ecosystem. Beginning
in 1963, adverse environmental impacts
in the form of poor reproductive success
and high levels of the pesticide DDT
were observed in herring gulls in Lake
Michigan. Through ongoing research,
scientists have detected 362
contaminants in the Great Lakes System.
Of these, approximately one third have
lexicological 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. i
Potential adverse human health
effects by these pollutants resulting
from the consumption of fish include
both the increased risk of cancer and the
potential for systemic or noncancer risks
such as kidney damage. EPA has
calculated health risks to populations in
the Great Lakes basin from consumption
of contaminated fish based on exposure
to eight bioaccumulative pollutants:
chlordane, DDT, diejdrin,
hexachlorobenzene, mercury, PCBs,
2,3,7,8-TCDD, and tbxaphene. 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
10-3 (L^e Superior) (1.8 in one
thousand) to 3.7 x 10~2 (Lake Michigan)
(3.7 in 100). Estimated risks to low
income minority sport anglers range
from 2.5 x 10~3 (2.5 in one thousand)
(Lake Superior) to 1.2 x 10~2 (1.2 in
100) (Lake Michigan). Estimated risks
for other sport anglers range from 9.7 x
10-* (9.7 in ten thousand) (Lake
Superior) to 4.5 x 10 r3 (4.5 in one
thousand) (Lake Michigan). (See section
I.B.2.a of the SID.) hi comparison, EPA
has long maintained |that 1 x 10~4 (one
in ten thousand) to 1-x 10~6 (one in 1
million) is an appropriate range of risk
to protect human health.
-------
15368 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
EPA also estimates a high potential
risk of systemic (noncancer) injury to
populations in the Great Lakes basin
due to ingestion of fish contaminated
with these pollutants at current
concentrations. The systemic adverse
health effects associated with the
assessed contaminants are described in
section I.B of the SID.
Although the Great Lakes States and
EPA have moved forward to deal with
these problems, control of persistent,
bioaccumulative pollutants proved to be
more complex and difficult than dealing
with nutrients. As a result,
inconsistencies began to be apparent in
the ways various States developed and
implemented controls for the pollutants.
By the mid-1980s, such inconsistencies
became of increasing concern to EPA
and State environmental managers.
EPA began the Great Lakes Water
Quality Initiative ("Initiative") in
cooperation with the Great Lakes States
to establish a consistent level of
environmental protection for the Great
Lakes ecosystem, particularly in the area
of State water quality standards and the
National Pollutant Discharge
Elimination System (NPDES) programs.
In the spring of 1989, the Council of
Great Lakes Governors unanimously
agreed to participate in the Initiative
with EPA, because the Initiative
supported the principles and goals of
the Great Lakes Toxic Substances
Control Agreement (Governors'
Agreement). Signed in 1986 by the
Governors of all eight Great Lakes
States, the Governors' Agreement
affirmed the Governors' intention to
manage and protect the resources of the
Great Lakes basin through the joint
pursuit of unified and cooperative
principles, policies and programs
enacted and adhered to by each Great
Lakes State.
The Initiative provided a forum for a
regional dialogue to establish minimum
requirements that would reduce
disparities between State water quality
controls in the Great Lakes basin. The
scope of the Initiative included
development of proposed Great Lakes
water quality guidance—Great 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 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 m the 30 years of effort
described above on the part of the Great
Lakes stakeholders to define and apply
innovative, comprehensive
environmental programs in protecting
and restoring the Great Lakes. In
particular, this publication of the final
Guidance culminates six years of
intensive, cooperative effort that
included participation by the eight
Great Lakes States, the environmental
commtinity, academia, industry,
municipalities and EPA Regional and
National offices.
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15369
The final Guidance will help establish
consistent, enforceable, long-term
protection with respect to all types of
pollutants, but will place short-term
emphasis on the types of long-lasting
pollutants that accumulate in the food
web and pose a threat to the Great Lakes
System. The final Guidance will
establish goals and minimum
requirements that will further the next
phase of Great Lakes programs,
including the Great Lakes Toxic
Reduction Effort's integrated, 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 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 jvould have been
dramatically less costly than clean-up.
Issuance of the final Guidance alone
will not solve the existing long-term
problems in the Great Lakes System
from these contaminants. Full
implementation of provisions consistent
with the final Guidance will, however,
provide a coordinated ecosystem
approach for addressing possible
pollutant problems before they produce
adverse and long-lasting basin-wide
impacts, rather than waiting to see what
the future impacts of the pollutants
might be before acting to control them.
The comprehensive approach used in
the development of the final Guidance
provides regulatory authorities with
both remedial and preventive ways of
gauging the-actions and potential effects
of chemical stressors upon the Great
Lakes Basin Ecosystem. The
methodologies, policies and procedures
contained in the final Guidance provide
mechanisms for appropriately
addressing both pollutants that have
been or may in the future be
documented as chemicals of concern.
i
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 develbpment 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 ng/L to 15.0 ug/L for
cadmium, and from (3.21 ug/L to 1.33
Ug/L for dieldrin. Other examples of
variations in acute aquatic life criteria
include nickel, which ranges from
290.30 ug/L to 852.669 ug/L; lindane,
-------
Federal Rerister / Vol. 60. No. 56 / Thursday. March 23. 1995 / Rules and Regulations
with a range of no criteria in place to
1.32 |ig/L; and mercury, ranging from
0.5 |ig/L to 2.4 jig/L. Similar ranges and
disparities exist for chronic aquatic life
criteria, and for water quality criteria to
protect human health.
Disparities also exist among State
procedures to translate water quality
criteria into individual discharge
permits. Wide variations exist, for
example, in procedures for the granting
of mixing zones, interpretation of
background levels of pollutants,
consideration of pollutants present in
intake waters, controls for pollutants
present in concentrations below the
level of detection, and determination of
appropriate levels for pollutants
discharged in mixtures with other
pollutants. Additionally, when
addressing the accumulation of
chemicals by fish that will be consumed
by humans and wildlife, some States
consider accumulation through multiple
steps in the food chain
(bioaccumulation) while others consider
only the single step of concentration
from the water column
(bioconcentration). Further disparities
exist in different translator
methodologies in deriving numeric
values for implementing narrative water
quality criteria; different assumptions
when calculating total maximum daily
loads (TMDLs) and wasteload
allocations (WLAs), including different
assumptions about background
concentrations, mixing zones, receiving
water flows, or environmental fate; and
different practices in deciding what
pollutants need to be regulated in a
discharge, what effect detection limits
have on compliance determinations,
and how to develop whole effluent
toxicity limitations.
These inconsistencies in State
standards and implementation
procedures have resulted in the
disparate regulation of point source
discharges. In the Governors'
Agreement, the Governors recognized
that the water resources of the basin
transcend political boundaries and
committed to taking steps to manage the
Great Lakes as an integrated ecosystem.
The Great Lakes States, as participants
in the Initiative Committees,
recommended provisions, based on
their extensive experience in
administering State water programs and
knowledge of the significant differences
in these programs within the basin, that
were ultimately included in the
proposed Guidance. The final Guidance
incorporates the work begun by the
Initiative Committees to identify these
disparities and improve consistency in
water quality standards and permit
procedures in the Great Lakes System.
Although unproved 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 have
flexibility in adopting antidegradation
provisions regarding non-BCCs.
—TMDLs: Great Lakes States and Tribes
may use assessment and remediation
plans for the purposes of appendix F
to part 132 if the State or Tribe
certifies that the assessment and
remediation plan meets certain
TMDL-related provisions in the final
Guidance and public participation
requirements applicable to TMDLs,
and if EPA approves such plan. Thus,
States have the flexibility in many
cases to use LAMPs, RAPs and State
Water Quality Management Plans in
lieu of TMDLs.
—Intake Credits: Great Lakes States and
Tribes may consider the presence of
intake water pollutants in establishing
water quality-based effluent limits
(WQBELs) in accordance with
procedure 5 of appendix F.
—Site-Specific Modifications: Great
Lakes States and Tribes may adopt
either more or less stringent
modifications to human health,
wildlife, and aquatic life criteria and
bioaccumulation factors (BAFs) based
on site-specific circumstances
specified in procedure 1 of appendix
F. All criteria, however, must be
sufficient not to cause jeopardy to
threatened or endangered species
listed or proposed to be listed under
the Federal Endangered Species Act.
Variances: Great Lakes States and
Tribes may grant variances from water
quality standards based on the factors
identified in procedure 2 of appendix
p.
—Compliance Schedules: Great Lakes
States and Tribes may allow existing
Great Lakes dischargers additional
time to comply with permit limits in
order to collect data to derive new or
revised Tier I criteria and Tier II
values in accordance with procedure
9 of appendix F.
—Mixing Zones: Great Lakes States and
Tribes may authorize mixing zones for
existing discharges of BCCs after the
10-year phase-out period in
accordance with procedure 3.B of
appendix F, if the permitting
authority determines, among other
things, that the discharger has
reduced its discharge of the BCC for
which a mixing zone is sought to the
maximum extent possible. Water
conservation efforts that result in
overall reductions of BCCs are also
allowed even if they result in higher
effluent concentrations.
—Scientific Defensibility Exclusion:
Great Lakes States and Tribes may
apply alternate procedures consistent
with Federal, State, and Tribal
requirements upon demonstration
that a provision in the final Guidance
would not be scientifically defensible
if applied to a particular pollutant in
one or more sites. This provision is in
§ 132.4(h) of the final Guidance.
—Reduced Detail: In many instances,
EPA has revised the proposed
Guidance to reduce the amount of
detail in the provisions without
sacrificing the objectives of the
provisions. Examples of such
revisions include simplification of
procedures for developing TMDLs in
procedure 3 of appendix F, and
simplification of procedures for
determining reasonable potential to
exceed water quality standards in
S c "O nt nvtnAnrllV f?
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
hiamaia health and wildlife criteria
methodologies; selection of data sets
for establishing water quality criteria;
identifying reasonable and prudent
-------
Thursday, March 23, 1995 / Rules and Regulations
15371
measures in antidegradation
provisions; and specifying
appropriate margins of safety when
developing TMDLs. In all cases, of
course, State and Tribal provisions
would need to be scientifically
defensible and consistent with all
applicable regulatory requirements.
D. Establish Equitable Strategies to
Control Pollution Sources
Many commenters argued that the
proposed Guidance unfairly focused on
point source discharges. They asserted
that nonpoint sources or diffuse sources
of pollution, such as air emissions, are
responsible for most of the loadings of
some pollutants of concern in the Great
Lalces, 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 Lalces. In
addition to discharges from point
sources, toxic pollutants are also
contributed to the Great Lakes from
industrial and municipal emissions to
the air, resuspension of pollutants from
contaminated sediments, urban and
agricultural runoff, hazardous waste and
Superfund sites, and spills. Restoration
and maintenance of a healthy ecosystem
will require significant efforts in all of
these areas. EPA, Canada and the Great
Lakes States and Tribes are currently
implementing or developing many
voluntary and regulatory programs to
address these and other nonpoint
sources of environmental contaminants
in the Great Lakes.
Additionally, EPA intends to use the
scientific data developed in the final
Guidance and new or revised water
quality criteria subsequently adopted by
Great Lakes States and Tribes in
evaluating and determining appropriate
levels of control in other environmental
programs. For example, EPA's future
biennial reports under section 112(m) of
the Clean Air Act will consider the
extent to which air discharges cause or
contribute to exceedances of water
quality criteria in assessing whether
additional air emission standards or
control measures are necessary to
prevent serious adverse effects.
Similarly, once provisions consistent
with the final Guidance are adopted by
the Great Lakes States or Tribes, they
will serve as applicable or relevant and
appropriate requirements (ARARs) for
on-site responses under the
Comprehensive Environmental
Response, Compensation and Liability
Act (CERCLA). EPA will also consider
the data and criteria developed for the
final Guidance, including the
information on BCCs, in developing or
evaluating LaMPs and RAPs under
section 118 of the CWA and Article VI,
Annex 2 of the GLWQA; determination
of corrective action requirements under
sections 3004(u), 3008(h), or 7003 of the
Solid Waste Disposal Act; new or
existing chemical reviews under the
Toxic Substances Control Act (TSCA);
pesticide reviews under the Federal
Insecticide, Fungicide and Rodenticide
Act (FIFRA); and reporting requirements
for toxic releases under the Emergency
Planning and Community Right-to-
KnowAct(EPCRA).
The final Guidance also includes
provisions to address the contribution of
pollutants by nonpoint sources. First,
the water quality criteria to protect
human health, wildlife and aquatic life,
and the antidegradation provisions
apply to the waters in the Great Lakes
System regardless of whether discharges
to the water are from point or nonpoint
sources. Accordingly, any regulatory
programs for nonpoint sources that
require compliance with water quality
standards would also be subject to the
criteria and antidegradation provisions
of the final Guidance once they are
adopted into State or Tribal standards.
Second, several elements of the final
Guidance would, after State, Tribal or
Federal promulgation, require or allow
permitting authorities to consider the
presence of pollutants in ambient
waters—including pollutants from
nonpoint source dischargers—in
establishing WQBELs for point sources.
For example, permit authorities may
consider the presence of other point or
nonpoint source discharges when
evaluating whether to grant a variance
from water quality criteria.
Additionally, the provisions for TMDLs
address nonpoint sources by specifying
that the loading capacity of a receiving
water that does not meet water quality
standards for a particular pollutant be
allocated, where appropriate, among
nonpoint as well as point sources of the
pollutant, including, at a minimum, a
margin of safety to account for technical
uncertainties in establishing the TMDL.
The development of TMDLs is the
preferred mechanism for addressing
equitable division of the loading
capacities of these nonattained waters.
Because TMDLs have not been
completed for most nonattained waters,
however, the final Guidance promotes
the development of TMDLs through a
phased approach, where appropriate,
and provides for short-term regulatory
relief to point source dischargers in the
absence of TMDLs through intake
credits, variances, and other water
quality permitting procedures.
EPA received numerous comments on
the problem posed in controlling
mercury in particular. Many
commenters stated that since the
primary source of mercury is now
atmospheric deposition, point sources
contribute only a minor portion of the
total loading of mercury to the Great
Lakes System and further restriction of
point source discharges would have no
apparent effect in improving water
quality. Although EPA believes that
there is sufficient flexibility in the
Guidance to handle the unique
problems posed by mercury (e.g., water
quality variances, phased TMDLs,
intake credits), EPA is committed to
developing a mercury permitting
strategy to provide a holistic,
comprehensive approach for dealing
with this pollutant. EPA will publish
this strategy no later than two years
following publication of this Guidance.
There are also many ongoing
voluntary and regulatory activities that
address nonpoint sources of toxic
pollutants to the Great Lakes System,
including activities taken under the
Clean Air Act Amendments of 1990
(CAAA), the CWA, and State regulatory
and voluntary programs. Some of these
activities are summarized in the
preamble to the proposed Guidance (58
FR 20826-32) and section I.D of the SID.
In addition to the many ongoing
activities, EPA and the Great Lakes
States, Tribes, and other federal
agencies are pursuing a multi-media
program to prevent and to further
reduce toxic loadings from all sources of
pollution to the Great Lakes System,
with an emphasis on nonpoint sources.
This second phase of the Great Lakes
Water Quality Initiativje, called the Great
Lakes Toxic Reduction Effort (GLTRE),
will build on the open,1 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 noripoint source and
wet-weather point source contributions
of toxic pollutants in the Great Lakes
System. A special emphasis will be
placed on BCCs identified in the final
Guidance.
A partial list of ongoing actions that
are being or could be focused on BCCs
includes: implementation of the CAAA
to reduce atmospheric deposition of
toxics; Resource Conservation and
Recovery Act and CERCLA remedial
actions to reduce loadings of toxics from
-------
15372 Federal Register / Vol. 60, No. 56 / Thursday..March 23, 1995 / Rules and Regulations
hazardous waste sites; increased focus
(through the GLTRE) on toxic pollutants
emanating from combined sewer
overflows and stormwater outfalls;
application in the Great Lakes basin of
the National Contaminated Sediment
Management Strategy; implementation
of spill prevention planning practices to
minimize this potential source of
loadings to the Great Lakes; improved
reporting of toxic pollutants under the
Toxic Release Inventory; public
education on the dangers of mercury
and other BCCs; pesticide registration
and re-registration processes;
development of a "mass balance" model
for fate and transport of pollutants in
the Great Lakes; and, development of a
"virtual elimination strategy." These
programs will prevent and further
reduce mass loadings of pollutants and
facilitate equitable division of the costs
of any necessary control measures
between point and nonpoint sources.
In addition to the GLTRE, which is
basin-wide in scope, a primary vehicle
for coordinating Federal and State
programs at the local level for meeting
water quality standards and restoring
beneficial uses for the open waters of
the Great Lakes are LaMPS. LaMPs will
define media specific program actions to
further reduce loadings of toxic
substances, assess whether these
programs will ensure restoration and
attainment of water quality standards
and designated beneficial uses, and
recommend any media-specific program
enhancements as necessary.
Additionally, LaMPs will be
periodically updated and revised to
assess progress in implementing 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 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 o:F 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 rato their water programs.
The following sections provide a brief
summary of the provisions of the final
Guidance. A more complete discussion
of the Enal Guidance, including EPA's
analysis of major comments, issues, and
a description of specific changes made
to the proposed Guidance, are contained
in the SID.
The parenthetical note at the
beginning of each section provides
references to the primary provisions in
the final Guidance being discussed in
the section, and to discussions in the
SID. The final Guidance is codified as
40 CFR132, 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.I of
procedure 1 may be referred to as
procedure I.A.I of appendix F.
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15373
A. Water Quality Criteria and
Methodologies
1. Protection of Aquatic Life
(§§132.3(a), 132.3(10,132.4(a)(2);
Tables 1 and 2 to part 132; appendix A
to part 132; section m, 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
spedes (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 n 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 n 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 H 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)(l)(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 tir Tribe must ensure
that the indicator parameter will attain
the "applicable water quality standard"
(as described in 40 CFR
122.44(d)(l)(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. I
Finally, the aquatic criteria for metals
in the proposed Guidance were
expressed as total recoverable
concentrations. The final Guidance
expresses the criteria for metals in
dissolved form because the dissolved
metal more closely approximates the
bioavailable fraction of metal in the
water column than does the total
recoverable metal. The dissolved criteria
are obtained by multiplying the chronic
and/or acute criterion by appropriate
conversion factors iii 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
lexicological data and exposure data
become available or additional Tier I
numeric criteria and Tier II values are
calculated by EPA, States, or Tribes,
Region 5 will ensure that this
information is disseminated to the Great
Lakes States and Tribes. EPA believes
operation of the GLI Clearinghouse will
help ensure consistency during
implementation of the final Guidance.
2. Protection of Human Health
(§§ 132.3(c), 132.4(a)(4); Table 3 to
part 132; appendix Cito part 132; section
V of the SID)
The final Guidance contains numeric
human health criteria for 18 pollutants,
and includes Tier I and Tier II
methodologies to derive cancer and
-------
15374 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
non-cancer human health criteria for
additional pollutants. The proposed
Guidance contained numeric criteria for
20 pollutants, but two pollutants were
deleted because they do not meet the
more restrictive minimum data
requirements for BAFs used in the final
Guidance.
Tier I human health criteria are
derived to establish ambient
concentrations of chemicals which, if
not exceeded in the Great Lakes System,
will protect individuals from adverse
health impacts from that chemical due
to consumption of aquatic organisms
and water, including incidental water
consumption related to recreational
activities in the Great Lakes System. For
each chemical, chronic criteria are
derived to reflect long-term
consumption of food and water from the
Great Lakes System. Tier II values are
intended to provide a conservative,
interim level of protection in the
establishment of a permit limit, and are
distinguished from the Tier I approach
by the amount and quality of data used
for derivation.
The final Guidance differs from
current National water quality criteria
guidelines when calculating the
assumed human exposure through
consumption of aquatic organisms. The
final Guidance uses BAFs predicted
from biota-sediment accumulation
factors (BSAFs) in addition to 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 ~4 (one in one thousand)
and 10 ~6 (one in one million), hi
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 10~2 (1.2 in
100). The proposed and final Guidance
establishes 10 ~s (one in one hundred
thousand) as the risk level used for
deriving criteria and values for
individual carcinogens. This is within
the range historically used in EPA
actions, and approved for State actions,
designed to protect human health. The
majority of the Great Lakes States use
10 ~5 as a baseline risk level in
establishing their water quality
standards.
The methodology is designed to
protect humans who drink water or
consume fish from the Great Lakes
System. The portion of the methodology
addressing fish consumption includes a
factor describing how much fish
humans consume per day. The final
Guidance includes a Great 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 sub-
populations. In carrying out regulatory
actions under a variety of statutory
authorities, including the CWA, EPA
has generally viewed an upper bound
incremental cancer risk in the range of
10~4 to 10~6 as adequately protective of
public health. As discussed above, the
human health criteria methodology is
based on a risk level of 10 ~5. Therefore,
if fish are contaminated at the level
permitted by criteria derived under the
final Guidance, individuals eating up to
10 times (i.e., 150 grams per day) the
assumed fish consumption rate would
still be protected at the 10 ~4 risk level.
Available data indicate that, even
among low-income minorities who as a
group consume more fish than the
population on average, the
overwhelming majority (approximately
95 percent) consume less than 150
grams per day. The final Guidance
requires, moreover, that States and
Tribes modify the human health criteria
on a site-specific basis to provide
additional protection appropriate for
highly exposed sub-populations. Thus,
where a State or Tribe finds that a
population of high-end consumers
would not be adequately protected by
criteria derived using the 15 gram per
day assumption (e.g., where the risk was
greater than 10 ~4), the State or Tribe
would be required to modify the criteria
to provide appropriate additional
protection. The final Guidance also
requires States and Tribes to adopt
provisions to protect human health from
the potential adverse effects of mixtures
of pollutants in effluents, specifically
including mixtures of carcinogens.
Understood in the larger context of the
human health methodology and the
final Guidance as a whole, therefore,
EPA believes that the 15 gram per day
fish consumption rate provides
adequate health protection for the
public, including highly exposed
populations, and that the final Guidance
is theref ore consistent with Executive
Order 12898.
In developing bioaccumulation
factors, lie 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 arid 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 ma.jor contributors to human
exposure. The final Guidance uses the
more protective 80 percent RSC for all
pollutants in deriving noncancer
criteria. This change was made because
of concern that for non-BCCs as well as
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15375
BCCs, there may be other sources of
exposures for noncarcinogens.
3. Protection of Wildlife
(§§ 132.3{d), 132.4(a)(5); Table 4 to
part 132; appendix D to part 132;
section VI of the SID)
The final Guidance contains numeric
criteria to protect wildlife for four
pollutants and a methodology to derive
Tier I criteria for additional BCCs.
Wildlife criteria are derived to establish
ambient concentrations of chemicals
which, if not exceeded, will protect
mammals and birds from adverse
impacts from that chemical due to
consumption of food and/or water from
the Great Lakes System.
These are EPA's first water quality
criteria specifically for the protection of
wildlife. The methodology is based
largely on the noncancer human health
paradigm. It focuses, however, on
endpoints related to reproduction and
population survival rather than the
survival of individual members of a
species. The methodology incorporates
pollutant-specific effect data for a
variety of mammals and birds and
species-specific exposure parameters for
two mammals and three birds
representative of mammals and birds
resident in the Great Lakes basin which
are likely to experience significant
exposure to bioaccumulative
contaminants through the aquatic food
web.
In the proposal, EPA included a 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 n methodologies
for other pollutants. The wildlife
methodology was limited to the BCCs
because these are the chemicals of
greatest concern to the higher trophic
level wildlife species feeding from the
aquatic food web in the Great Lakes
basin. This decision is consistent with
comments made by the EPA Science
Advisory Board (SAB) who agreed that
the initial focus for wildlife criteria
development should be on persistent,
bioaccumulative organic contaminants
(USEPA, 1994, EPA-SAB-EPEC-ADV-
94-001).
Numerous commenters were
concerned that the mercury criterion for
wildlife was not scientifically
appropriate. After review of all
comments and a revaluation of all the
data, the mercury criterion for wildlife
has been increased from 180 pg/L to
1300 pg/L. EPA believes the 1300 pg/L
is protective of wildlife in the Great
Lakes System.
In developing bioaccumulation
factors, the proposed Guidance used a
7.9 percent lipid value for fish
consumed by wildlife. The final
Guidance uses a 10.31 percent lipid
value for trophic level 4 fish and 6.46
for trophic level 3 fish. These percent
lipid values are based on the actual prey
species consumed by the representative
wildlife species specified in the
methodology, and are used to estimate
the BAFs for the trophic levels which
those species consume. The percent
lipid is based on the preferential
consumption patterns of wildlife and
cross-referenced with fish weight and
size and appropriate percent lipid. This
approach is a more accurate reflection of
the lipid content of the fish consumed
by wildlife species than the approach
used in the proposal.
4. Bioaccumulation Methodology
(§ 132.4(a)(3); appendix B to part 132;
section IV of the SID)
The proposed Guidance incorporated
BAFs in the derivation of criteria and
values to protect human health and
wildlife. Bioaccumulation refers to the
uptake and retention of a substance by
an aquatic organism from its
surrounding medium and from food. For
certain chemicals, uptake through the
aquatic food chain is the most important
route of exposure for wildlife and
humans. The wildlife criteria and the
human health criteria and values
incorporate appropriate BAFs in order
to more accurately account for the total
exposure to a chemical. Current EPA
guidelines for the derivation of human
health water quality criteria use BCFs,
which measure only uptake from water,
when field-measured BAFs are not
available. EPA believes, however, that
the BAF is a better predictor of the
concentration of a chemical within fish
tissues in the Great Lakes System
because it includes consideration of the
uptake of contaminants from all routes
of exposure.
The proposed Guidance included a
hierarchy of three methods for deriving
BAFs for non-polar organic chemicals:
field-measured BAFs; predicted BAFs
derived by multiplying a laboratory-
measured BCF by a food-chain
multiplier; and BAFs predicted by
multiplying a BCF calculated from the
log Kow by a food-chain multiplier. For
inorganic chemicals, the proposal
would have required either a field-
measured BAF or laboratory-measured
BCF. On August 30,1994, EPA
published a document in the Federal
Register (59 FR 44678) requesting
comments on revising the hierarchy of
methods for deriving BAFs for organic
chemicals, and issues pertaining to the
model used to assist in predicting BAFs
when a field-measured BAF is not
available. Based on the comments
received, the final Guidance modifies
the proposed hierarchy by adding a
predicted BAF based' on a BSAF as the
second method in the hierarchy. BSAFs
may be used for predicting BAFs from
concentrations of chemicals in surface
sediments. In addition, the final
Guidance uses a model to assist in
predicting BAFs that'includes both
benthic and pelagic food chains thereby
incorporating exposures of organisms to
chemicals from both the sediment and
the water column. The model used in
the proposal only included the pelagic
food chain, and therefore, did not
account for exposure to aquatic
organisms from sediment.
The proposed Guidance used the total
concentration of a chemical in the
ambient water when 'deriving BAFs for
organic chemicals. In the preamble to
the proposed Guidance and in the
Federal Register document cited above,
EPA requested comments on deriving
BAFs in terms of the|freely dissolved
concentration of the chemical in the
ambient water. Based on comments
received from the proposal and the
document, the final Guidance uses the
freely dissolved concentration of a
chemical instead of the total
concentration in the derivation of BAFs
for organic chemicals. Use of the freely
dissolved concentration will improve
the accuracy of extrapolations between
water bodies.
Finally, as discussed in section II of
this preamble, bioaccumulation of
persistent pollutants is a serious
environmental threat to the Great Lakes
Basin Ecosystem. Because of these
concerns, the proposed Guidance would
have required that pollutants with
human health BAFs greater than 1000
receive increased attention and more
stringent controls within the Great
Lakes System. These pollutants are
termed BCCs. EPA identified 28 BCCs in
the proposed Guidance. The additional
controls for BCCs are specified in
certain of the implementation
procedures and the antidegradation
procedures, and are discussed further in
the SID. The final Guidance continues
to include increased' attention on and
more stringent controls for BCCs within
the Great Lakes System. The final
Guidance identifies 22 BCCs that are
targeted for special controls instead of
the 28 in the proposed Guidance. Six
BCCs were deleted from the proposed
list because of concern that the methods
used to estimate the BAFs may not
-------
15376 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
account for the metabolism or
degradation of the pollutants in the
environment. States and Tribes may
identify more BCCs as additional BAF
data become available. The final
Guidance designates as BCCs only those
chemicals with human health BAFs
greater than 1000 that were derived
from either a field-measured BAF or a
predicted BAF based on a field-
measured BSAF (for non-metals) or from
a field-measured 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
(§§ 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 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 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
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15377
States and Tribes in exercising the
exception provision with special focus
on the technical and economic
feasibility criteria. This guidance will
also consider the notice, public hearing,
monitoring and pollution prevention
demonstration elements of the
exception criteria.
The final Guidance also retains many
of the proposed provisions for
calculating background concentrations
used in TMDLs and WLAs established
in the absence of TMDLs. The procedure
addressing data points below the level
of detection, however, has been
modified so that it no longer specifies
the use of default values (i.e., half of the
level of detection).
The final TMDL procedures do not
require that TMDLs be established for
point sources prior to the issuance/
reissuance of NPDES permits. The final
Guidance defers to the existing National
program for determining when a TMDL
is required. Lastly, the final Guidance
allows assessment and remediation
plans that are approved by EPA under
40 CFR 130.6 to be used in lieu of a
TMDL for purposes of appendix F as
long as they meet the general conditions
of a TMDL as outlined by procedure 3
of appendix F, and the public
participation requirements applicable to
TMDLs.
4. Additivity
(Procedure 4 of appendix F to part 132;
section Vm.D of the SID)
EPA has traditionally developed
numeric water quality criteria on a
single pollutant basis. While some
potential environmental hazards involve
significant exposure to only a single
compound, most instances of
contamination in surface waters involve
mixtures of two or more pollutants. The
individual pollutants in such mixtures
can act or interact in various ways
which may affect the magnitude and
nature of risks or effects on human
health, aquatic life and wildlife. WET
tests are available to generally address
interactive effects of mixtures on aquatic
organisms. EPA's 1986 "Guidelines for
the Health Risk Assessment of Chemical
Mixtures" set forth principles and
procedures for human health risk
assessment of chemical mixtures. There
are currently no technical guidelines on
how to assess effects on wildlife from
chemical mixtures.
The preamble for the proposed
Guidance discussed several possible
approaches to address additive effects
from multiple pollutants. Proposed
regulatory language was provided for
two specific options, each with separate
provisions related to aquatic life,
wildlife and human health. One
approach was developed by the
Initiative Committees, modified to
delete the application of toxicity
equivalency factors (TEFs) for PCBs to
wildlife. The other approach was
developed by EPA. Neither approach
addressed the possible toxicologic
interactions between pollutants in a
mixture (e.g., synergism or antagonism)
because of the limited data available on
these interactive effects. In the absence
of contrary data, both approaches
recommended that the risk to human
health from individual carcinogens in a
mixture be considered additive, and that
a 10 ~5 risk level be adopted as a cap for
the cancer risk associated with
mixtures. Both approaches also
proposed using TEFs to assess the risk
to humans and wildlife from certain
chemical classes. The TEF approach
converts the concentration of individual
components in a mixture of chemicals
to an "equivalent" concentration
expressed in terms of a reference
chemical. Both approaches used the 17
TEFs for dioxins and furans identified
in the 1989 EPA document, "Estimating
Risks Associated with Exposures to
Mixtures of Chlorinated Dibenzo-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 VIHE of the SID)
EPA's existing regulations require
NPDES permits to include WQBELs to
control all pollutants or pollutant
parameters which the permitting
authority determines are or may be
discharged at a level which will cause,
have the reasonable potential to cause or
contribute to an excursion of any
applicable water quality standard. If the
permitting authority determines that a
discharge has the reasonable potential to
cause or contribute to an excursion of an
applicable numeric water quality
criterion, it must include a WQBEL for
the individual pollutant in the permit.
ha 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) pf the CWA,
supplemented with other information
where necessary; or establishing effluent
limitations on an indicator pollutant.
See 40 CFR 122.44(dj(l).
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 ll 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 IL values havfe been derived due
to a lack of lexicological data. EPA
believes that the data necessary to
calculate Tier II values for aquatic life,
wildlife and human health currently
exists for most of the specified
pollutants of concern.
The final Guidance .maintains all the
basic requirements from the proposed
procedure. Some minor changes are that
the procedure no longer includes a
special provision for effluent dominated
streams, and the procedure allows a
broader range of statistical approaches
to be used when evaluating effluent
data, which provides added simplicity
and flexibility to States and Tribes.
Another change from the proposal is
the relationship in the final Guidance
between the reasonable potential and
TMDL procedures. Numerous
commenters pointed out that the
proposed Guidance indicated that
TMDLs would be required for any water
receiving effluent from a discharger
found to exhibit reasonable potential.
Given the fact that there are many
waterbodies in the Great Lakes basin for
which TMDLs have not been developed,
and the obvious need for permitting to
proceed in the interim'until TMDLs are
completed, the final Guidance provides
that the permitting authority can
establish waste load allocations and
WQBELs in the absence of a TMDL or
an assessment and remediation plan
developed and approved in accordance
with procedure 3.A of appendix F. A
more detailed discussion of the
assessment and remediation plan and its
relationship to a TMDL can be found in
section VIII.C.2 of the SID. Procedures
for establishing such WLAs are therefore
addressed in the final Guidance.
-------
15378
Federal Register / Vol. 60, No. 56 / Thursday. March 23, 1995 / Rules and Regulation^
6. Intake Pollutants
(Procedures 5.D and 5.E of appendix F
to part 132; section Vffl.E of the SID)
The proposed Guidance allowed a
permitting authority to determine that
the return of an identified intake water
pollutant to the same body of water
under specified circumstances does not
cause, have the reasonable potential to
cause, or contribute to an excursion
above water quality standards, and
therefore, that a WQBEL would not be
required for that pollutant. Under the
proposal, this "pass through" of intake
water pollutants would be allowed if the
facility returns the intake water
containing the pollutant of concern to
the same waterbody; does not contribute
additional mass of pollutant; does not
increase the concentration of the intake
water pollutant; and does not discharge
at a time or location, or alter the
pollutant in a manner which would
cause adverse impacts to occur that
would not occur if the pollutant were
left in-stream.
EPA received numerous comments on
the proposal. Some commenters argued
that the proposed provision was too
narrow because relief would not be
available if the facility added any
amount of the pollutant to the
discharge, even where the facility was
not contributing any additional mass or
concentration to the waterbody than
was contained in the intake water. After
consideration of public comments, EPA
decided to expand the intake pollutant
provisions to include not only a
reasonable potential procedure like the
one contained in the proposal, but also
a provision that allows the permitting
authority to take into account the
presence of pollutants in intake water in
deriving WQBELs. Specifically, the final
Guidance authorizes the permitting
authority to establish limits based on a
principle of "no net addition" (i.e., the
limit would allow the mass and
concentration of the pollutant in the
discharge up to the mass and
concentration of the pollutant in the
intake water). This provision would be
available where the facility's discharge
is to the same body of water as the
intake water, and could be applied for
up to 12 years after publication of the
final Guidance. After that time, if a
TMDL or comparable plan that meets
the requirements of procedure 3 of
appendix F has not been completed, the
facility's WQBEL must be established in
accordance with the "baseline"
provisions in procedure 5.F.2 of
appendix F. This time limit provides a
period of relief for dischargers that are
not causing increased impacts on the
waterbody by virtue of their discharge
that would not have occurred had the
pollutant remained in-stream, while
maintaining the incentive for
development of a comprehensive
assessment and remediation plan for
achieving attainment of water quality
standards, which EPA believes is a
critical element of the final Guidance for
addressing pollutants for which a large
contributor to non-attainment is
nonpoint source pollution.
The final Guidance allows States and
Tribes to address intake pollutants in a
manner consistent with assessment and
remediation plans that have been
developed through mechanisms other
than TMDLs in order to provide
flexibility where such plans
comprehensively address the point and
non-point sources of non-attainment in
a waterbody and the means for attaining
compliance with standards.
EPA believes that 12 years provides
sufficient time for States to develop and
complete the water quality assessments
that would serve as the basis for
establishing effluent limits (including
"no net addition" limits, where
appropriate) under procedure 3.A of
appendix F. However, EPA also
recognizes that unforeseen events could
delay State completion of these
assessments, and therefore will, at 7
years following promulgation, in
consultation with the States, evaluate
the progress of the assessments. If this
evaluation shows that completion of the
assessments may not be accomplished
by the 12 year date, EPA will revisit
these provisions, and consider
proposing extensions if appropriate.
! final Guidance, the
V£««»*— ~O
Under 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 non-attainment
waters, particularly when multiple
sources contribute a pollutant for which
the receiving water exceeds the
applicable criterion, is development of a
TMDL or comparable assessment and
remediation plan. The above "no net
addition" permitting approach provides
additional flexibility in situations where
a TMDL or comparable plan has not yet
been developed. Other existing relief
mechanisms include variances to water
quality standards, removal of non-
existing uses, and site-specific criteria.
7. WET
(Procedure 6 of appendix F to part 132;
section VIH.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)(l)). The regulations allow
States and Tribes the flexibility to
control for WET with either numeric or
narrative criteria. Current technical
guidelines recommend that no discharge
should exceed 0.3 acute toxic units
(TUa = 100/LC50) at the edge of an
acute mixing zone and 1.0 chronic toxic
units (TUc = 100/NOEC, the No
Observed Effect Concentration) at the
edge of a chronic mixing zone.
The proposed Guidance would have
continued to allow States and Tribes the
flexibility to choose to control WET
with either numeric or narrative criteria,
but specified that no discharge could
exceed 1.0 TUa at the point of discharge
(i.e., no acute mixing zones) and 1.0 TUC
at the edge of a chronic mixing zone
(with some exceptions). In addition, the
proposal contained minimum
requirements for appropriate test
methods to measure WET and for permit
conditions, and procedures for
deteirmining whether or not limits for
WET are necessary.
The final Guidance differs principally
from, the proposal in requiring States
and TribBS to adopt 0.3 TUa and 1.0 TUC
either as numeric criteria or as an
equivalent numeric interpretation of
narrative criteria. The final Guidance
also allows the use of acute mixing
zones for the application of the acute
criterion. This approach will promote
consistency among States and Tribes in
controlling WET, while still permitting
considerable flexibility regarding
implementation measures, consistent
with current National policies and
guidelines.
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15379
8. Loading Limits
(Procedure 9 of appendix F to part 132;
section VHI.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 V1H.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, nowever, 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 Vm.I of the SID)
The final Guidance includes a
procedure that allows Great Lakes States
and Tribes to include schedules of
compliance in permits for existing Great
Lakes dischargers for effluent
limitations based on new water quality
criteria and certain other requirements.
Generally, compliance schedules may
provide for up to five years to comply
with the effluent limitation in question
and may, in specified cases, allow the
compliance schedule to go beyond the
term of the permit. Existing Great Lakes
dischargers are those whose
construction commenced before March
23,1997. Thus the term, existing Great
Lakes discharges, covers expanding
dischargers who were ineligible for
compliance schedules under the
proposal. The final Guidance also
provides the opportunity for States and
Tribes to allow dischargers additional
time to comply with effluent limitations
based on Tier n values while
conducting studies to justify
modifications of those limitations.
C. Antidegradation Provisions
(§ 132.4(a)(6); appendix E to part 132;
section Vn 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 offish, 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 uie
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.
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-BGCs; 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, anti-
degradation policies, and
implementation procedures for waters
within the Great Lakes System which
are consistent with the final Guidance
within two years of this publication. If
a Great Lakes State fails to adopt such
standards, policies, and procedures,
section 118(c)(2)(C) of the CWA requires
EPA to promulgate them not later than
the end of that two-year period.
Additionally, when an Indian Tribe is
authorized to administer the NPDES or
water quality standards program in the
Great Lakes basin, it will also need to
adopt provisions consistent with the
final Guidance into its water program.
Part 132 establishes requirements and
procedures to implement section
118(c)(2)(C). Sections 132.3 and 132.4
-------
15380 Federal Register / Vol. 60, No. 56 / Thursday. March 23, 1995 / Rules and Regulations
require Great Lakes States and Tribes to
adopt criteria, methodologies, policies,
and procedures consistent with the
criteria, methodologies, policies, and
procedures contained in part 132—that
is, the definitions in § 132.2, the
numeric criteria in Tables 1 through 4,
the criteria development methodologies
in appendixes A through D, the
antidegradation policy in appendix E,
and the implementation procedures in
appendix F. Section 132.5 specifies the
procedures for States and Tribes to
make their submissions to EPA, and for
EPA to approve or disapprove the
submissions. The section specifies that
in reviewing submissions, EPA will
consider provisions of State and Tribal
submissions to be "consistent with" the
final Guidance if each provision is as
protective as the corresponding
provision of the final Guidance. If a
State or Tribe fails to make a
submission, or if provisions of the
submission are not consistent with the
final Guidance, § 132.5 provides that
EPA will publish a final rule in the
Federal Register identifying the final
Guidance provisions that will apply to
discharges within the particular State or
Federal Indian Reservation.
Section 132.4 specifies that water
quality criteria adopted by States and
Tribes consistent with the final
Guidance will apply to all waters of the
Great Lakes System, regardless of
designated uses of the waters in most-
cases, with some variations in human
health criteria depending on whether
the waters are designated for drinking
water use. Section 132.4 also contains
certain exceptions in applying the final
Guidance methodologies and
procedures. First, States and Tribes do
not have to adopt and apply the final
Guidance methodologies and
procedures for the 14 pollutants listed
in Table 5 of part 132. EPA believes that
some or all of the methodologies and
procedures are not scientifically
appropriate for these pollutants.
Second, if a State or Tribe demonstrates
that the final Guidance methodologies
or procedures are not scientifically
defensible for a particular pollutant, the
State or Tribe may use alternate
methodologies or procedures so long as
they meet all applicable Federal, State,
and Tribal laws. Third, § 132.4 specifies
that for wet-weather point sources,
States and Tribes generally do not have
to adopt and apply the final Guidance
implementation procedures. The
exception is the TMDL general
condition for wet weather events.
Fourth, pursuant to section 510 of the
CWA, part 132 specifies that nothing in
the final Guidance prohibits States or
Tribes from adopting provisions more
stringent than the final Guidance.
As discussed further in section IX of
this preamble, § 132.4 also provides that
State and Tribal submissions will need
to include any provisions that EPA
determines, based on EPA's authorities
under the CWA and the results of
consultation with the U.S. Fish and
Wildlife Service (FWS) under section 7
of the ESA, are necessary to ensure that
water quality is not likely to cause
jeopardy to any endangered or
threatened species listed under the ESA.
Part 132 extends the requirements of
section 118(c)(2)(C) to Indian Tribes
within the Great Lakes basin for which
EPA has approved water quality
standards under section 303 of the CWA
or which EPA has authorized to
administer an NPDES program under
section 402 of the CWA. EPA believes
that inclusion of Great Lakes Tribes in
this way is necessary and appropriate to
be consistent with section 518 of the
CWA. The reasons for EPA's proposal
are discussed further in the preamble to
the proposed Guidance (58 FR 20834),
and section II.D.3 of the SID. As a
practical matter, no Great Lakes Tribes
currently have approved water quality
standards or authorized NPDES
programs, so the submission
requirements of part 132 do not apply
to any Great Lakes Tribes. Tribes that
are approved or authorized in the
future, however, will need to adopt
provisions consistent with the final
Guidance in their water programs.
V. Costs, Cost-Effectiveness and Benefits
(Section IX of the SID)
Under Executive Order 12866 (58 FR
51735, October 4,1993), EPA must
determine whether the regulatory action
is "significant" and therefore subject to
Office of Management and Budget
(OMB) review and the requirements of
the Executive Order. The Order defines
"significant regulatory action" as one
that is likely to result in a rule that may:
(1) Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
competition, jobs, the environment,
public health or safety, or State, local,
or Tribal governments or communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency;
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs or the rights and
obligations of recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President's priorities, or the principles
set forth in the Executive Order.
Pursuant to the terms of Executive
Order 12866, it has been determined
that this rule is a "significant regulatory
action'' because it raises novel policy
issues arising out of the development of
a comprehensive ecosystem-based
approach for a large geographic area
involving several States, Tribal
governments, local governments, and a
large number of regulated dischargers.
This approach, including the Great
Lakes Water Quality Initiative which
developed the core concepts of the final
Guidance, is a unique and precedential
approiach 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.
Thei following is a summary of major
elements of the "Regulatory Impact
Analysis of the Final Great Lakes Water
Quality Guidance" (RIA) (EPA 820-B-
95-0111) that has been prepared in
compliance with Executive Order
12866. Further discussion is included in
section IX of the SID, and in the full
RIA, which is available in the docket for
this rulemaking.
The provisions of the final Guidance
are not enforceable requirements until
adopted by States or Tribes, or
promulgated by EPA for a particular
State or Tribe. Therefore, this
publication of the final Guidance does
not have an immediate effect on
dischargers. Until actions are taken to
promulgate and implement these
provisions (or equally protective
provisions consistent with the final
Guidance), there will be no economic
effect on any dischargers. For the
purposes of the RIA, EPA's analysis of
costs and benefits assumes that either
State or EPA promulgations occur
consistent with the final Guidance
within the next two years.
Under the CWA, costs cannot be a
basis for adopting water quality criteria
that will not be protective of designated
uses. If a range of scientifically
defensible criteria that are protective
can be identified, however, costs may be
considered in selecting a particular
criterion within that range. Costs may
also be relevant under the
antidegradation standard as applied to
high quality waters.
EPA has assessed compliance costs
for facilities that could be .affected by
provisions adopted by States or Tribes
consistent with the final Guidance. EPA
has also assessed basin-wide risk
reduction benefits to sport anglers and
Native American subsistence anglers in
the basin, and benefits for three case
study sites in the Great Lakes System.
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15381
The methodology used in each
assessment and the results of these
assessments are discussed below.
EPA solicited public comment and
supporting data on the RIA
methodology used to estimate both costs
and benefits for implementation of the
proposed Guidance. EPA evaluated
these comments and supporting data as
well as comments provided by OMB
and revised the RIA methodology prior
to performing these assessments for the
final Guidance.
A. Costs
Based on the information provided by
each State and a review of the permit
files, EPA identified about 3,800 direct
dischargers that could be affected by
State or Tribal adoption or subsequent
EPA promulgation, if necessary, of
requirements consistent with the final
Guidance. Of these, about 590 are major
dischargers and the remaining 3,210 are
minor dischargers. Of the 590 majors,
about 275 are industrial facilities and
315 are publicly owned treatment works
(POTWs). Out of these dischargers, EPA
used a stratified random sampling
procedure to select 59 facilities (50
major and nine minor) that it considered
representative of all types and sizes of
facilities in the basin.
EPA divided the major facilities into
nine industrial categories and a category
for POTWs. The nine industrial
categories are: mining, food and food
products, pulp and paper, inorganic
chemical manufacturing, organic
chemical manufacturing/petroleum
refining, metals manufacturing,
electroplating/metal fabrication, steam
electric power plants, and
miscellaneous facilities.
For each major and minor facility in
the sample, EPA estimated incremental
costs to comply with subsequently
promulgated provisions consistent with
the final Guidance, using a baseline of
compliance with the requirements of
section 303(c)(2)(B) of the CWA. Using
a decision matrix, costs were developed
for two different scenarios—a "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 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-
of-pipe treatment under the high-end
scenario. In addition, it was assumed
that a smaller proportion of indirect
dischargers (10 percent) would be
impacted under the high-end scenario,
since municipalities are adding end-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 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 icosts 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 antidegradatibn 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
-------
15382 Federal Register / Vol. 60, No. 56 / Thursday,
Guidance by the toxicity-weighted
pounds (pound-equivalents) of
pollutants removed. Pound-equivalents
are calculated by multiplying pounds of
each pollutant removed by the toxic
weight (based on the toxicity of copper)
for that pollutant.
It is estimated that implementation of
provisions consistent with the final
Guidance would be responsible for the
reduction of about six to eight million
toxic pounds per year, or 16 to 22
percent of the toxic-weighted baseline
for the low- and high-end scenarios,
respectively. The cost-effectiveness of
the scenarios, over the baseline, is quite
good, ranging from $10 to $50 per
pound-equivalent.
Approximately 80 percent of the
pollutant load reduction from
implementation of the final Guidance,
regardless of the scenario, is attributable
to reducing BCCs as a result of PMPs
and end-of-pipe treatment. The largest
pollutant load reductions occur for
chlordane, dieldrin, heptachlor, lead,
and pentachlorobenzene.
In a separate analysis, EPA also
investigated the cost-effectiveness of
regulating point and nonpoint sources
of mercury and PCBs, two contaminants
associated with fish advisories in the
Great Lakes basin. Although data and
resource constraints limited the findings
from these analyses, the preliminary
results indicate that point sources may
factor cost-effectively into pollutant
reduction scenarios. For both
contaminants, the cost-effectiveness of
point and nonpoint source controls are
likely to be highly site-specific.
C. Benefits
The benefits analysis is intended to
provide insight into both the types and
potential magnitude of the economic
benefits expected to arise as a result of
implementation of provisions adopted
by States and Tribes consistent with the
final Guidance. To the extent feasible,
empirical estimates of the potential
magnitude of the benefits are developed
and then compared to the estimated
costs of implementing provisions
adopted by States and Tribes consistent
with the final Guidance.
The benefits analysis is based on a
case study approach, using benefits
transfer applied to three case studies.
The case study approach was used
because it is more amenable to
meaningful benefit-cost analyses than
are studies of larger aggregate areas.
Although the results obtained for a case
study site may not apply uniformly to
the entire Great Lakes basin, the case
study approach does provide a
how implementation of the final
Guidance can generate benefits^ the
types of benefits anticipated, and how
these benefits compare to costs.
The case studies include: (1) the
lower Fox River drainage, including
Green Bay, located on Lake Michigan in
northeastern Wisconsin; (2) the Saginaw
River and Saginaw Bay, located on Lake
Huron in northeastern Michigan; and (3)
the Black River, located on Lake Erie in
north-central Ohio. The case studies
were selected from a list of candidate
sites (i.e., designated Areas of Concern
(AOCs) in the Great Lakes basin) on the
basis of data availability and the
relevance of the water quality problems
to the final Guidance (i.e., areas in
which problems were more likely to be
associated with on-going point source
discharges rather than historic loadings
from Superfund sites and other sources).
Geographic diversity was also
considered in selecting the sites so that
the analyses might better promote a
broad perspective of the final
Guidance's benefits and costs.
For each of the three case studies,
EPA estimated future toxics-oriented
water quality benefits, and then
attributed a percentage of these benefits
to implementation of the final
Guidance. The attribution of benefits
was based only on the estimated
reduction in loadings from point
sources at the case study sites and
information on the relative contribution
of point sources to total loadings in the
basin. EPA did not attempt to calculate
the longer-term benefits to human
health, wildlife, and aquatic life once
the final Guidance provisions are fully
implemented by nonpoint sources as
well as point sources and the minimum
protection levels are attained in the
ambient water.
In the Fox River and Green Bay case
study, total annual undiscounted
benefits attributable to the final
Guidance range from $0.3 million to
$8.5 million (first quarter 1994 dollars).
Human health benefits account for
between 29 percent and 72 percent of
the estimated benefits, recreational
fishing accounts for between eight
percent and 45 percent, and nonuse/
ecologic benefits account for between
nine percent and 23 percent. Municipal
and industrial dischargers in this case
study are estimated to incur annualized
costs of about $3.6 million.
In the Saginaw River/Bay case study,
total annual undiscounted benefits
range from $0.2 million to $7.7 million.
Recreational fishing benefits account for
between 36 percent and 60 percent of
the estimated benefits, non-use benefits
account for between 18 percent and 30
percent, and human health benefits
account for between eight percent and
36 percent. Total annualized costs to
municipal and industrial dischargers are
estimated to be about $2.6 million.
In the Black River case study, total
annual undiscounted benefits range
from $0.4 million to $1.5 million.
Recreational fishing benefits account for
between 48 percent and 63 percent of
the estimated benefits, and nonuse
benefits account for between 32 percent
and 44 jpercent. 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 nanconsumptive recreation days)
were used an place of total benefits for
this analysis because there is no
estimate of benefits for the entire Great
.Lakes basin. The three case studies
combine to account for nearly 14
percent of the total cost of the final
Guidance, nearly 17 percent of the
loadings reductions, and from four
percent to 10 percent of the benefits
proxies (i.e., basin-wide population,
recreational angling, nonconsumptive
recreation, and commercial fishery
harvest). Thus, the three case studies
may represent a reasonably
proportionate share of costs and
benefits.
In addition to the case study analyses,
a basin-wide risk assessment was
conducted for Great Lakes anglers. EPA
collected data and information on the
consumption of Great Lakes basin fish
to estimate baseline risk levels and
reductions in risks due to
implementation of the final Guidance
for two populations at risk: Great Lakes
sport imglers (including minority and
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15383
low-income anglers) and Native
Americans engaged in subsistence
fishing in the basin. For sport anglers,
EPA estimated that the projected
reduction in loadings from point
sources based on controls consistent
with the final Guidance would result in
a reduction of annual excess lifetime
cancer cases (potential cancer cases
assuming a 70-year lifetime exposure
period) of 2.2 to 4.1 for low-income
minorities in lakeshore counties; 0.4 to
0.8 for other minorities in lakeshore
counties; and 21.9 to 41.9 for all other
sport anglers. For Native American
subsistence anglers, EPA estimated that
reductions from point source loadings
attributable to the final Guidance would
result in a reduction of excess lifetime
cancer cases of between 0.1 and 0.3
using a low fish ingestion scenario and
0.5 to 1.1 using a high fish ingestion
scenario. Note that these estimates do
not include the long-term benefits
(including reduced cancer cases) that
will result once the final Guidance
provisions are fully implemented and
the minimum protection levels are
attained in the ambient water.
In total, using the most conservative
consumption scenario for Native
Americans, these reductions represent
between 0.35 and 0.67 excess cancer
cases per year, and potential basin-wide
benefits of the final Guidance for this
one benefits category of between $0.7
million and §6.7 million per year, based
on the estimated value of a statistical
life of between $2.0 million and $10.0
million. Comparison to case study
results, which were based on a more
comprehensive sample of facilities
within case study areas than was
possible for the entire basin, indicates
these values likely underestimate the
potential risk reduction benefits of the
final Guidance at the basin level. For
example, if the average percentage load
reduction for PCBs for the three case
studies is used to reflect reductions in
PCBs for the basin, the reduction in
excess cancer cases increases to between
three and six cases per year, and
potential benefits increase to between
56.6 and $60 million per year.
The reduction in pollutant loadings
forPGBs 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 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 jthe development
of the final Guidance.
As described in section II above, the
core elements of the final Guidance
were developed by the Great Lakes
States, EPA, and other Federal agencies
in open dialogue with citizens, local
governments, and industries in the
Great Lakes ecosystem over a five-year
period through the Initiative. The
Initiative process marks the first time
that EPA has developed a major
rulemaking effort in the water program
through a regional public forum. The
Initiative process is described further in
the preamble to the proposed Guidance
(58 FR 20820-23) and section II of this
preamble.
In addition to the participation by
State and local governments in the
initial development of the proposed
Guidance and in the public comment
process, several activities have been
carried out since the publication of the
proposed Guidance. These include:
(1) On April 26,1994, EPA held a
public meeting to solicit additional
information from interested parties on
the proposed Guidance. As part of
EPA's outreach efforts to State, Tribal
and local governments, a special
invitation was sent inviting elected
officials and other State, Tribal and
local representatives to participate in
the public meeting. EPA specifically
welcomed Tribal and local officials and
opened the floor to them to hear and
discuss their specific concerns and
views on the final Guidance.
(2) A series of meetings and
teleconferences were held with Great
Lakes States in early 1994 to discuss
their comments on several-issues,
including development of water quality
criteria, State adoption requirements,
WET, BAFs, additivity, compliance
schedules, anti-backsliding, nonpoint
sources, and international concerns.
(3) In October, 1994, EPA met with
each individual State in the Great Lakes
basin to discuss the nature, form, and
scope of the proposed'Guidance, and
State concerns with implementation of
the provisions under consideration. The
following issues were discussed at each
of the meetings: intake credits,
antidegradation and EEQ, wildlife
criteria, excluded pollutants (e.g.,
ammonia and chlorine), elimination of
mixing zones, site-specific
modifications, fish consumption,
appropriate degrees of flexibility for
implementation (e.g., guidance vs.
regulation), and implementation
procedures.
(4) In 1994 and 1995, EPA met with
representatives of the National Wildlife
Federation to discuss EPA's activities in
developing the final Guidance in
-------
15384 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
accordance with the terms of a consent
decree governing the schedule for
development of the final Guidance.
(5) hi 1994, EPA also met with elected
officials and other representatives from
several local communities in the Great
Lakes hasin 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.
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
ofaPOTW.
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.
hi this rulemaking EPA is also
amending the table of currently
approved ICR control numbers issued
by OMB for various regulations into 40
CFR 9.1. This amendment updates the
table to accurately display those
information requirements promulgated
under the CWA. The affected
regulations are codified at 40 CFR parts
122,123,131, and 132. EPA will
continue to present OMB control
numbers in a consolidated table format.
The table will be codified in 40 CFR
part 9 of EPA's regulations and in each
40 CFR volume containing EPA
regulations. The table lists the section
numbers with reporting and
recordkeeping requirements, and the
current OMB control numbers. This
display of the OMB control numbers
and their subsequent codification in the
CFR satisfies the requirements of the
Paperwork Reduction Act (44 U.S.C.
3501 et seq.) and OMB's implementing
regulations at 5 CFR part 1320.
The ICR for this rulemaking was
previously subject to public notice and
comment prior to OMB approval. As a
result, EPA finds that there is "good
cause" under section 553(b)(B) of the
Administrative Procedure Act (5 U.S.C.
553(b)(B)) to amend this table without
prior notice and comment. Due to the
technical nature of the table, further
notice and comment would be
unnecesisary.
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 Ihe 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 Lukes 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 Greiat Lakes basin as part of EPA's
responsibilities under section 303(c) of
the CWA.
During the consultation, two issues
were identified that required formal
consultation, as defined in 40 CFR part
402. These issues were: the absence of
toxicological data concerning effects of
contaminants on three species of
freshwater mussels in the Great Lakes
basin, and the adequacy of the wildlife
criteria methodology to protect three
endangered or threatened wildlife
species in the basin. On February 21,
1995, the FWS provided EPA with a
written Biological Opinion (Opinion) on
these issues. The Opinion is available in
the docket for this rulemaking. On both
issues, the FWS concluded that the
water quality resulting from
implementation of the final Guidance
will not cause jeopardy to the listed
species. To minimize the amount or
extent of any incidental take that might
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15385
occur, the FWS consulted closely with
EPA to develop a coordinated approach.
The final Opinion specified reasonable
and prudent measures that the FWS
considers necessary or appropriate to
minimize such impact. EPA has agreed
to implement the measures, and the
FWS and EPA will continue to work
cooperatively during the
implementation.
X. Judicial Review of Provisions Not
Amended
In some situations, EPA has
renumbered or included other editorial
changes to regulations that have been
promulgated in past rulemakings.
Additionally, to provide for ease in
reading changes to existing regulations,
EPA has in some cases repeated entire
sections, including portions not
changed. The promulgation of this final
rule, however, does not provide another
opportunity to seek judicial review on
the substance of the existing regulations.
XI. Supporting Documents
All documents that are referenced in
this preamble are available for
inspection and photocopying in the
docket for this rulemaking at the
address listed at the beginning of this
preamble. A reasonable fee will be
charged for photocopies.
Selected documents supporting the
final Guidance are also available for
viewing by the public at locations listed
below:
Illinois: Illinois State Library, 300
South 2nd Street, Springfield, EL 62701
(217-785-5600)
Indiana: Indiana Department of
Environmental Management, Office of
Water Management, 100 North Senate
Street, Indianapolis, IN 46204 (317-
232-8671)
Michigan: Library of Michigan,
Government Documents Service, 717
West Allegan, Lansing, MI 48909 (517-
373-1300); Detroit Public Library,
Sociology and Economics Department,
5201 Woodward Avenue, Detroit, MI
48902 (313-833-1440)
Minnesota: Minnesota Pollution
Control Agency, Library, 520 Lafayette,
St. Paul, MN (612-296-7719)
New York: U.S. EPA Region 2 Library,
Room 402,26 Federal Plaza, New York,
NY 10278 (212-264-2881); U.S. EPA
Public Information Office, Carborundum
Center, Suite 530,345 Third Street,
Niagara Falls, NY 14303 (716-285-
8842); New York State Department of
Environmental Conservation (NYSDEC),
Room 310,50 Wolf Road, Albany, NY
12333 (518-457-7463); NYSDEC,
Region 6,7th Floor, State Office
Building, 317 Washington Street,
Watertown, NY 13602 (315-785-2513);
NYSDEC, Region 7, 615 Erie Boulevard
West, Syracuse, NY 13204 (315-426-
7400); NYSDEC, Region 8, 6274 East
Avon-Lima Road, Avon, NY 14414
(716-226-2466); NYSDEC, Region 9,
270 Michigan Avenue, Buffalo, NY
14203 (716-851-7070)
Ohio: Ohio Environmental Protection
Agency Library—Central District Office,
1800 Watermark Road, Columbus, OH
43215 (614-644-3024); U.S. EPA
Eastern District Office, 25809 Central
Ridge Road, Westlake, OH 44145 (216-
522-7260)
Pennsylvania: Pennsylvania
Department of Environmental
Resources, 230 Chestnut Street,
Meadville, PA 16335 (814-332-6945);
U.S. EPA Region 3 Library, 8th Floor,
841 Chestnut Building, Philadelphia,
PA 19107-4431 (215-597-7904)
Wisconsin: Water Resources Center,
University of Wisconsin-Madison, 2nd
Floor, 1975 Willow Drive, Madison, WI
(608-262-3069)
EPA is also making a number of
documents available in electronic
format at no incremental cost to users of
the Internet. These documents include
the contents of this Federal Register
document, the SID, many documents
listed below, and other supporting
materials.
The documents listed below are also
available for a fee upon written request
or telephone call to the National
Technical Information Center (NTIS),
U.S. Department of Commerce, 5285
Port Royal Road, Springfield, VA 22161
(telephone 800-553-6847 or 703-487-
4650). Alternatively, copies may be
obtained for a fee upon written request
or telephone call to the Educational
Resources Information Center/
Clearinghouse for Science, Mathematics,
and Environmental Education (ERIC/
CSMEE), 1200 Chambers Road, Room
310, Columbus, OH 43212 (614-292-
6717). When ordering, please include
the NTIS or ERIC/CSMEE accession
number.
A. Final Water Quality Guidance for
the Great Lakes System: Supplementary
Information Document (SID). NTIS
Number: PB95187266. ERIC Number:
D046.
B. Great Lakes Water Quality
Initiative Criteria Document for the
Protection of Aquatic Life in Ambient
Water. NTIS Number: PB95187282.
ERIC Number: D048.
C. Great Lakes Water Quality
Initiative Technical Support Document
for the Procedure to Determine
Bioaccumulation Factors. NTIS Number:
PB95187290. ERIC Number: D049.
D. Great Lakes Water Quality
Initiative Criteria Document for the
Protection of Human Health. NTIS
Number: PB95187308. ERIC Number:
D050.
E. Great Lakes Water Quality Initiative
Technical Support Document for
Human Health Criteria and Values.
NTIS Number: PB95187316. ERIC
Number: D051. !
F. Great Lakes Water Quality Initiative
Criteria Document for the Protection of
Wildlife: DDT; Mercury; 2,3,7,8-TCDD;
PCBs. NTIS Number: PB95187324. ERIC
Number: D052.
G. Great Lakes Water Quality
Initiative Technical Support Document
for Wildlife Criteria. NTIS Number:
PB95187332. ERIC Number: D053.
H. Assessment of Compliance Costs
Resulting from. Implementation of the
Final Great Lakes Water Quality
Guidance. NTIS Number: PB95187340.
ERIC Number: D054.
I. Regulatory Impact Analysis of the
Final Great Lakes Water Quality
Guidance. NTIS Number: PB95187357.
ERIC Number: D055.:
List of Subjects
40 CFR Part 9
Reporting and recordkeeping
requirements.
40 CFR Part 122
Administrative practice and
procedure, Confidential business
information, Great Lakes, Hazardous
substances, Reporting and
recordkeeping requirements, Water
pollution control.
40 CFR Part 123
Administrative practice and
procedure, Confidential business
information, Great Lakes, Hazardous
substances, Indians-lands,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements, Water pollution control.
40 CFR Part 131 '•
Great Lakes, Reporting and
recordkeeping requirements, Water
pollution control.
40 CFR Part 132
Administrative practice and
procedure, Great Lakes, Indians-lands,
Intergovernmental relations, Reporting
and recordkeeping requirements, Water
pollution control.
Dated: March 13,199?.
Carol M. Browner,
Administrator.
For the reasons set out in the
preamble, title 40, chapter I, parts 9,
122,123, and 131 are amended, and part
132 is added as follows:
-------
15386
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rulesand Regulations
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9
continues to read as follows:
Authority: 7 U.S.C. 155 etseq., 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 etseq., 1311,1313d, 1314,1318,
1321,1326,1330,1342,1344,1345 (d) and
(e), 1361; E.0.11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-1,
300J-2,300J-3, 300J-4, 300J-9,1857 et seq.,
6901-6992k, 7401-7671q,7542, 9601-9657,
11023,11048.
2. Section 9.1 is amended as follows:
a. By adding in numerical order the
entry "122.44(r)" under the heading
"EPA Administered Permit Programs:
The National Pollutant Discharge
Elimination System".
b. By revising the entries under the
heading "State Permit Requirements";
c. By adding in numerical order the
entries "131.1" and "131.5" and by
revising the entries "131.20", "131.21"
and "131.22" under the heading "Water
Quality Standards Regulations"; and
d. By adding in numerical order a
new heading and new entries for "Water
Quality Guidance for the Great Lakes
System" to read as follows:
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
40 CFR citation
OMB control
No.
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-O057,
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
12344 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! 2040-0180
13l!s '.'.'.".""". 2040-0180
*****
131.20 2040-0049
131 21 """ 2040-0049,
2040-0180
131.22 2040-0049
* * * * *
Water Quality Guidance for the Great Lakes
System
132 i 2040-0180
132-2 2040-0180
132 31!'.!'.'.!!!!'.'.'.! 2040-0130
132 4 '".'".'.". 2040-0180
132.5 '".".". 2040-0180
Appendix A 2040-0180
Appendix B 2040-fll80
Appendix C 2040-0180
Appendix D 2040-0180
Appendix E 2040-0180
Appendix F 2040-0180
*****
PART 122—EPA ADMINISTERED
PERMIT PROGRAMS: THE NATIONAL
POLLUTANT DISCHARGE
ELIMINATION SYSTEM
3. The authority citation for part 122
continues to read as follows:
Authority: The Clean Water Act, 33 U.S.C.
1251 et seq.
4. Section 122.44 is amended by
adding a new paragraph (r) to read as
follows:
§122.44 Establishing limitations,
standards, and other permit conditions
(applicable to State NPDES programs, see
§123.25).
(r) Great Lakes. When a permit is
issued to a facility that discharges into
the Great Lakes System (as defined in 40
CFR 132.2), conditions promulgated by
the State, Tribe, or EPA pursuant to 40
CFR part 132.
PART 123-STATE PROGRAM
REQUIREMENTS
5. The authority citation for part 123
continues to read as follows:
Authority: Clean Water Act, 33 U.S.C. 1251
et seq.
6. Section 123.25 is amended by
removing "and" at the end of paragraph
(a)(36), removing the period at the end
of paragraph (a)(37) and adding "; and"
in its place, and adding a new paragraph
(a)(38) to read as follows:
§ 123.25 Requirements for permitting.
jaj * * *
(38) For a Great Lakes State or Tribe
(as denned in 40 CFR 132.2), 40 CFR
part 132 (NPDES permitting
implementation procedures only).
*****
7. Section 123.44 is amended by
adding a new paragraph (c)(9) to read as
follows:
§123.44 EPA review of and objections to
State permits.
* it * * *
(c) * * *
(9) For a. permit issued by a Great
Lakes State or Tribe (as defined in 40
CFR 132.2), the permit does not satisfy
the conditions promulgated by the State,
Tribe, or EPA pursuant to 40 CFR part
132.
*****
8. Section 123.62 is amended by
adding a new paragraph (f) to read as
follows:
§ 123.B2 Procedures for revision of State
programs.
*****
(f) Revision of a State program by a
Great Lakes State or Tribe (as defined in
40 CFR 132.2) to conform to section 118
of the CWA and 40 CFR part 132 shall
be accomplished pursuant to 40 CFR
part 132.
9. Section 123.63 is amended by
adding a new paragraph (a) (6) and
adding and reserving paragraph (b) to
read as follows:
§ 123.63 Criteria for withdrawal of State
programs.
(a) * * *
(6) Where a Great Lakes State or Tribe
(as defined in 40 CFR 132.2) fails to
adequately incorporate the NPDES
permitting implementation procedures
promulgated by the State, Tribe, or EPA
pursuant to 40 CFR part 132 into
individual permits.
(b) [Reserved)
PART 131—WATER QUALITY
STANDARDS
10. The authority citation for part 131
continues to read as follows:
Authority: 33 U.S.C. 1251 et seq.
11. Section 131.1 is revised to read as
follows:
§131.1 Scope.
This part describes the requirements
and. procedures for developing,
reviewing, revising, and approving
water quality standards by the States as
authorized by section 303 (c) of the
Clean Water Act. Additional specific
procedures for developing, reviewing,
revising, and approving water quality
standards for Great Lakes States or Great
Lakes Tribes (as defined in 40 CFR
132.2) to conform to section 118 of the
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
15387
Clean Water Act and 40 CFR part 132,
are provided in 40 CFR part 132.
12. Section 131.5 is amended by
revising paragraph (a)(5), by
redesignating paragraph (b) as paragraph
(c), and by adding a new paragraph (b)
to read as follows:
§131.5 EPA Authority.
(a) * * *
(5) Whether the State submission
meets the requirements included in
§ 131.6 of this part and, for Great Lakes
States or Great Lakes Tribes (as defined
in 40 CFR 132.2) to conform to section
118 of the Act, the requirements of 40
CFR part 132.
(b) If EPA determines that the State's
or Tribe's water quality standards are
consistent with the factors listed in
paragraphs (a)(l) 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)(2KC) of the Act, if State
or Tribal adopted standards are not
consistent with the factors listed in
paragraphs (a)(l) through (a)(5) of this
section. EPA may also promulgate a new
or revised standard when necessary to
meet the requirements of the Act.
13. Section 131.21 is amended by
revising paragraph (b) to read as follows:
§131.21 EPA review and approval of water
quality standards.
« * * * *
(b) The Regional Administrator's
approval or disapproval of a State water
quality standard shall be based on the
requirements of the Act as described in
§§ 131.5 and 131.6, and, with respect to
Great Lakes States or Tribes (as defined
in 40 CFR 132.2), 40 CFR part 132.
* * » * *
14. Part 132 is added as follows:
PART 132—WATER QUALITY
GUIDANCE FOR THE GREAT LAKES
SYSTEM
See.
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.
132.8 Application of part 132 requirements
in Groat Lakes States and Tribes.
[Reserved]
Tables to Part 132
Appendix A to Part 132—Great Lakes Water
Quality Initiative Methodologies for
Development of Aquatic Life Criteria and
Values
Appendix B to Part 132—Great Lakes Water
Quality Initiative Methodology for
Development of Bioaccumulation Factors
Appendix C to Part 132—Great Lakes Water
Quality Initiative Methodology for
Development of Human Health Criteria
and Values
Appendix D to Part 132—Great Lakes Water
Quality Initiative Methodology for the
Development of Wildlife Criteria
Appendix E to Part 132—Great Lakes Water
Quality Initiative Antidegradation Policy
Appendix F to Part 132—Great Lakes Water
Quality Initiative Implementation
Procedures
Authority: 33 U.S.C. 1251 et seq.
§ 132.1 Scope, purpose, and availability of
documents.
(a) This part constitutes the Water
Quality Guidance for the Great Lakes
System (Guidance) required by section
118(c)(2) of the Clean Water Act (33
U.S.C. 1251 et seq.) as amended by the
Great Lakes Critical Programs Act of
1990 (Pub. L. 101-596,104 Stat. 3000 et
seq.). The Guidance in this part
identifies minimum water quality
standards, antidegradation policies, and
implementation procedures for the
Great Lakes System to protect human
health, aquatic life, and wildlife.
(b) The U.S. Environmental Protection
Agency, Great Lakes States, and Great
Lakes Tribes will use the Guidance in
this part to evaluate the water quality
programs of the States and Tribes to
assure that they are protective of water
quality. State and Tribal programs do
not need to be identical to the Guidance
in this part, but must contain provisions
that are consistent with (as protective
as) the Guidance in this part. The
scientific, policy and legal basis for
EPA's development of each section of
the final Guidance in this part is set
forth in the preamble, Supplementary
Information Document, Technical
Support Documents, and other
supporting documents in the public
docket. EPA will follow the guidance set
out in these documents in reviewing the
State and Tribal water quality programs
in the Great Lakes for consistency with
this part.
(c) The Great Lakes States and Tribes
must adopt provisions consistent with
the Guidance in this part applicable to
waters in the Great Lakes System or be
subject to EPA promulgation of its terms
pursuant to this part.
(d) EPA understands that the science
of risk assessment is rapidly improving.
Therefore, to ensure that the scientific
basis for the methodologies in
appendices A through D are always
current and peer reviewed, EPA will
review the methodologies and revise
them, as appropriatejevery 3 years.
(e) Certain documents referenced in
the appendixes to this part with a
designation of NTIS and/or ERIC are
available for a fee upon request to the
National Technical Information Center
(NTIS), U.S. Department of Commerce,
5285 Port Royal Road, Springfield, VA
22161. Alternatively, copies may be
obtained for a fee upon request to the
Educational Resources Information
Center/Clearinghouse for Science,
Mathematics, and Environmental
Education (ERIC/CSMEE), 1200
Chambers Road, Room 310, Columbus,
Ohio 43212. When ordering, please
include the NTIS or ERIC/CSMEE
accession number. '
§132.2 Definitions.
The following definitions apply in
this part. Terms not defined in this
section have the meaning given by the
Clean Water Act and EPA implementing
regulations. ;
Acute-chronic ratio (ACR) is a
standard measure of the acute toxicity of
a material divided by an appropriate
measure of the chronic toxicity of the
same material under comparable
conditions.
Acute toxicity is concurrent and
delayed adverse effect(s) that results
from an acute exposure and occurs
within any short observation period
which begins when the exposure begins,
may extend beyond the exposure
period, and usually does not constitute
a substantial portion of the life span of
the organism. >
Adverse effect is any deleterious effect
to organisms due to exposure to a
substance. This includes effects which
are or may become debilitating, harmful
or toxic to the normal functions of the
organism, but does not include 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
-------
Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
product, accumulates in aquatic
organisms by a human health
hioaccumulation factor greater than
1000, after considering metabolism and
other physicochemical properties that
might enhance or inhibit
bioaccumulation, in accordance with
the methodology in appendix B of this
part. Chemicals with half-lives of less
than eight weeks in the water column,
sediment, and biota are not BCCs. The
minimum BAF information needed to
define an organic chemical as a BCC is
either a field-measured BAF or a BAF
derived using the BSAF methodology.
The minimum BAF information needed
to define an inorganic chemical,
including an organometal, as a BCC is
either a field-measured BAF or a
laboratory-measured BCF. BCCs
include, but are not limited to, the
pollutants identified as BCCs in section
A of Table 6 of this part.
Bioconcentration is the net
accumulation of a substance by an
aquatic organism as a result of uptake
directly from the ambient water through
gill membranes or other external body
surfaces.
Bioconcentration factor (BCF) is the
ratio (in L/kg) of a substance's
concentration in tissue of an aquatic
organism to its concentration in the
ambient water, in situations where the
organism is exposed through the water
only and the ratio does not change
substantially over time.
Biota-sediment accumulation factor
(BSAF) is the ratio (in kg of organic
carbon/kg of lipid) of a substance's
lipid-normalized concentration in tissue
of an aquatic organism to its organic
carbon-normalized concentration in
surface sediment, in situations where
the ratio does not change substantially
over time, both the organism and its
food are exposed, and the surface
sediment is representative of average
surface sediment in the vicinity of the
organism.
Carcinogen is a substance wnicn
causes an increased incidence of benign
or malignant neoplasms, or substantially
decreases the time to develop
neoplasms, in animals or humans. The
classification of carcinogens is
discussed in section II. A of appendix C
to part 132.
Chronic toxicityis concurrent and
delayed adverse effect(s) that occurs
only as a result of a chronic exposure.
Connecting channels of the Great
Lakes are the Saint Mary's River, Saint
Clair River, Detroit River, Niagara River,
and Saint Lawrence River to the
Canadian Border.
Criterion continuous concentration
(CCC) is an estimate of the highest
concentration of a material in the water
column to which an aquatic community
can be exposed indefinitely without
resulting in an unacceptable effect.
Criterion maximum concentration
(CMC) is an estimate of the highest
concentration of a material in the water
column to which an aquatic community
can be exposed briefly without resulting
in an unacceptable effect.
EC50 is a statistically or graphically
estimated concentration that is expected
to cause one or more specified effects in
50 percent of a group of organisms
under specified conditions.
Endangered or threatened species are
those species that are listed as
endangered or threatened under section
4 of the Endangered Species Act.
Existing Great Lakes discharger is any
building, structure, facility, or
installation from which there is or may
be a "discharge of pollutants" (as
defined in 40 CFR 122.2) to the Great
Lakes System, that is not a new Great
Lakes discharger.
Federal Indian reservation, Indian
reservation, or reservation means all
land within the limits of any Indian
reservation under the jurisdiction of the
United States Government,
notwithstanding the issuance of any
patent, and including rights-of-way
running through the reservation.
Final acute value (FAV) is (a) a
calculated estimate of the concentration
of a test material such that 95 percent
of the genera (with which acceptable
acute toxicity tests have been conducted
on the material) have higher GMAVs, or
(b) the SMAV of an important and/or
critical species, if the SMAV is lower
than the calculated estimate.
Final chronic value (FCV) is (a) a
calculated estimate of the concentration
of a test material such that 95 percent
of the genera (with which acceptable
chronic toxicity tests have been
conducted on the material) have higher
GMCVs, (b) the quotient of an FAV
divided by an appropriate acute-chronic
ratio, or (c) the SMCV of an important
and/or critical species, if the SMCV is
lower than the calculated estimate or
the quotient, whichever is applicable.
Final plant value (FPV) is the lowest
plant value that was obtained with an
important aquatic plant species in an
acceptable toxicity test for which the
concentrations of the test material were
measured and the adverse effect was
biologically important.
Genus mean acute value (GMAV) is
the geometric mean of the SMAVs for
the genus.
Genus mean chronic value (GMCV) is
the geometric mean of the SMCVs for
the genus. .
Great Lakes means Lake Ontario, Lake
Erie, Lake Huron (including Lake St..
Clair), Lake Michigan, and Lake
Superior; and the connecting channels
(Saint Mary's River, Saint Clair River,
Detroit River, Niagara River, and Saint
Lawrence River to the Canadian Border).
Great Lakes States and Great Lakes
Tribes, or Great Lakes States and Tribes
means the States of Illinois, Indiana,
Michigan, Minnesota, New York, Ohio,
Pennsylvania, and Wisconsin, and any
Indian Tribe as defined in this part
which is located in whole or in part
within the drainage basin of the Great
Lakes, and for which EPA has approved
water quality standards under section
303 of the Clean Water Act or which
EPA has authorized to administer an
NPDES program under section 402 of
the Clean Water Act.
Great Lakes System means all the
streams, rivers, lakes and other bodies of
water within the drainage basin of the
Great Lakes within the United States.
Human cancer criterion (HCC) is a
Humsin 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
appemdix C of this part.
Human noncancer value (HNV) is the
maximum ambient water concentration
of a isubstance at which adverse
noncancer effects are not likely to occur
in the human population from lifetime
exposure via either: drinking the water,
consuming fish from the water, and
water-related recreation activities; or
consuming fish from the water, and
water-related recreation activities using
the Methodologies for the Development
of Human Health Criteria and Values in
appendix C of this part.
Indian Tribe or Tribe means any
Indian Tribe, band, group, or
community recognized by the Secretary
of the Interior and exercising
governmental authority over a Federal
Indian reservation.
LC50 is a statistically or graphically
estimated concentration that is expected
-------
Federal Register/ Vol. 60. No. 56 / Thursday. March 23, 1995 / Rules and Regulations 15389
to be lethal to 50 percent of a group of
organisms under specified conditions.
Load allocation (LA) is the portion of
a receiving water's loading capacity that
is attributed either to one of its existing
or future nonpoint sources or to natural
background sources, as more fully
defined at 40 CFR 130.2(g). Nonpoint
sources include: in-place contaminants,
direct wet and dry deposition,
groundwater inflow, and overland
runoff.
Loading capacity is the greatest
amount of loading that a water can
receive without violating water quality
standards.
Lowest observed adverse effect level
(LOAEL) is the lowest tested dose or
concentration of a substance which
resulted in an observed adverse effect in
exposed test organisms when all higher
doses or concentrations resulted in the
same or more severe effects.
Method detection level is the
minimum concentration of an analyte
(substance) that can be measured and
reported with a 99 percent confidence
that the analyte concentration is greater
than zero as determined by the
procedure set forth in appendix B of 40
CFR part 136.
Minimum Level (ML) is the
concentration at which the entire
analytical system must give a
recognizable signal and acceptable
calibration point. The ML is the
concentration in a sample that is
equivalent to the concentration of the
lowest calibration standard analyzed by
a specific analytical procedure,
assuming that all the method-specified
sample weights, volumes and
processing steps have been followed.
New Great Lakes discharger is any
building, structure, facility, or
installation from which there is or may
be a "discharge of pollutants" (as
defined in 40 CFR 122.2) to the Great
Lakes System, the construction of which
commenced after March 23,1997.
No observed adverse effect level
(NOAEL) is the highest tested dose or
concentration of a substance which
resulted in no observed adverse effect in
exposed test organisms where higher
doses or concentrations resulted in an
adverse effect.
No observed effect concentration
(NOEC) is the highest concentration of
toxicant to which organisms are
exposed in a full life-cycle or partial
life-cycle (short-term) test, that causes
no observable adverse effects on the test
organisms (i.e., the highest
concentration of toxicant in which the
values for the observed responses are
not statistically significantly different
from the controls).
Open waters of the Great Lakes
(OWGLs) means all of the waters within
Lake Erie, Lake Huron (including Lake
St. Clair), Lake Michigan, Lake Ontario,
and Lake Superior lakeward from a line
drawn across the mouth of tributaries to
the Lakes, including all waters enclosed
by constructed breakwaters, but not
including the connecting channels.
Quantification level is a measurement
of the concentration of a contaminant
obtained by using a specified laboratory
procedure calibrated at a specified
concentration above the method
detection level. It is considered the
lowest concentration at which a
particular contaminant can be
quantitatively measured using a
specified laboratory procedure for
monitoring of the contaminant.
Quantitative structure activity
relationship (QSAR) or structure activity
relationship (SAR) is a mathematical
relationship between a property
(activity) of a chemical and a number of
descriptors of the chemical. These
descriptors are chemical or physical
characteristics obtained experimentally
or predicted from the structure of the
chemical.
Risk associated dose (RAD) is a dose
of a known or presumed carcinogenic
substance in (mg/kg)/day which, over a
lifetime of exposure, is estimated to be
associated with a plausible upper bound
incremental cancer risk equal to one in
100,000.
Species mean acute value (SMAV) is
the geometric mean of the results of all
acceptable flow-through acute toxicity
tests (for which the concentrations of
the test material were measured) with
the most sensitive tested life stage of the
species. For a species for which no such
result is available for the most sensitive
tested life stage, the SMAV is the
geometric mean of the results of all
acceptable acute toxicity tests with the
most sensitive tested life stage.
Species mean chronic value (SMCV)
is the geometric mean of the results of
all acceptable life-cycle and partial 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). In the absence of a TMDL
approved by EPA pursuant to 40 CFR
130.7 or an assessment and remediation
plan developed and approved in
accordance with procedure 3.A of
appendix F of this part, a WLA is the
allocation for an individual point
source, that ensures that the level of
water quality to be achieved by the
point source is derived from and
complies with all applicable water
quality standards. ;
Wet weather point source means any
discernible, confined and discrete
conveyance from which pollutants are,
or may be, discharged as the result of a
wet weather event. Discharges from wet
weather point sources shall include
only: discharges of storm water from a
municipal separate storm sewer as
defined at 40 CFR 122.26(b)(8); storm
water discharge associated with
industrial activity as defined at 40 CFR
122.26(b)(14); discharges of storm water
and sanitary wastewaters (domestic,
-------
15390
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
commercial, and industrial) from a
combined sewer overflow; or any other
stormwater discharge for which a permit
is required under section 402(p) of the
Clean Water Act. A storm water
discharge associated with industrial
activity which is mixed with process
wastewater shall not be considered a
wet weather point source.
§ 132.3 Adoption of criteria.
The Great Lakes States and Tribes
shall adopt numeric water quality
criteria for the purposes of section
303 (c) of the Clean Water Act applicable
to waters of the Great Lakes System in
accordance with § 132.4(d) that are
consistent with:
(a) The acute water quality criteria for
protection of aquatic life in Table 1 of
this part, or a site-specific modification
thereof in accordance with procedure 1
of appendix F of this part;
[b) The chronic water quality criteria
for protection of aquatic life in Table 2
of this part, or a site-specific
modification thereof in accordance with
procedure 1 of appendix F of this part;
(c) The water quality criteria for
protection of human health in Table 3
of this part, or a site-specific
modification thereof in accordance with
procedure 1 of appendix F of this part;
and
(d) The water quality criteria for
protection of wildlife in Table 4 of this
part, or a site-specific modification
thereof in accordance with procedure 1
of appendix F of this part.
§ 132.4 State adoption and application of
methodologies, policies and procedures.
(a) The Great Lakes States and Tribes
shall adopt requirements applicable to
waters of the Great Lakes System for the
purposes of sections 118, 301, 303, and
402 of the Clean Water Act that are
consistent with:
(1) The definitions in § 132.2;
(2) The Methodologies for
Development of Aquatic Life Criteria
and Values in appendix A of this part;
(3) The Methodology for Development
of Bioaccumulation Factors in appendix
B of this part;
(4) The Methodologies for
Development of Human Health Criteria
and Values in appendix C of this part;
(5) The Methodology for Development
of Wildlife Criteria in appendix D of this
part;
(6) The Antidegradation Policy in
appendix E of this part; and
(7) The Implementation Procedures in
appendix F of this part.
(b) Except as provided in paragraphs
(g), 61), 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-Drmking 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 HNV-
Nondrinking shall apply to all waters of
the Great Lakes System other than those
in paragraph (d)[3)(i) of this section.
(4) Criteria for protection of wildlife,
or site-specific modifications thereof,
shall apply to all waters of the Great
Lakes System.
(e) The Great Lakes States and Tribes
shall apply implementation procedures
consistent with the procedures in
appendix F of this part for all applicable
purposes under the Clean Water Act,
including developing total maximum
daily loads for the purposes of section
303(d) and water quality-based effluent
limits for the purposes of section 402, in
establisihing 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 Ei of this part for which the
State or Tribe demonstrates that a
methodology or procedure in this part is
not scientifically defensible, the Great
Laker. States and Tribes shall:
(1) Apply an alternative methodology
or procedure acceptable under 40 CFR
part 131 when developing water quality
criteria; or
(2) Apply an alternative
implementation procedure that is
consistent with all applicable Federal,
State, and Tribal laws.
(i) Nothing in this part shall prohibit
the Great Lakes States and Tribes from
adopting numeric water quality criteria,
narrative criteria, or water quality
values that are more stringent than
criteria or values specified in § 132.3 or
that would be derived from application
of the methodologies set forth in
appendixes A, B, C, and D of this part,
or to adopt antidegradation standards
and implementation procedures more
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
15391
stringent than those set forth in
appendixes E and F of this part.
§ 132.5 Procedures for adoption and EPA
review.
(a) Except as provided in paragraph
(c) of this section, the Great Lakes States
and Tribes shall adopt and submit for
EPA review and approval the criteria,
methodologies, policies, and procedures
developed pursuant to this part no later
than September 23,1996.
(b) The following elements must be
included in each submission to EPA for
review:
(1) The criteria, methodologies,
policies, and procedures developed
pursuant to this part;
(2) Certification by the Attorney
General or other appropriate legal
authority pursuant to 40 CFR 123.62
and 40 CFR 131.6(e) as appropriate;
(3) All other information required for
submission of National Pollutant
Discharge Elimination System (NPDES)
program modifications under 40 CFR
123.62; and
(4) General information which will
aid EPA in determining whether the
criteria, methodologies, policies and
procedures are consistent with the
requirements of the Clean Water Act
and this part, as well as information on
general policies which may affect their
application and implementation.
(c) The Regional Administrator may
extend the deadline for the submission
required in paragraph (a) of this section
if the Regional Administrator believes
that the submission will be consistent
with the requirements of this part and
can be reviewed and approved pursuant
to this section no later than March 23,
1997.
(d) If a Great Lakes State or Tribe
makes no submission pursuant to this
part to EPA for review, the requirements
of this part shall apply to discharges to
waters of the Great Lakes System
located within the State or Federal
Indian reservation upon EPA's
publication of a final rule indicating the
effective date of the part 132
requirements in the identified
jurisdictions.
(e) If a Great Lakes State or Tribe
submits criteria, methodologies,
policies, and procedures pursuant to
this part to EPA for review that contain
substantial modifications of the State or
Tribal NPDES program, EPA shall issue
public notice and provide a minimum of
30 days for public comment on such
modifications. The public notice shall
conform •with the requirements of 40
CFR 123.62.
(f) After review of State or Tribal
submissions under this section, and
following the public comment period in
subparagraph (e) of this section, if any,
EPA shall either:
(1) Publish notice of approval of the
submission in the Federal Register
within 90 days of such submission; or
(2) Notify the State or Tribe within 90
days of such submission that EPA has
determined that all or part of the
submission is inconsistent with the
requirements of the Clean Water Act or
this part and identify any necessary
changes to obtain EPA approval. If the
State or Tribe fails to adopt such
changes within 90 days after the
notification, EPA shall publish a notice
in the Federal Register identifying the
approved and disapproved elements of
the submission and a final rule in the
Federal Register identifying the
provisions of part 132 that shall apply
to discharges within the State or Federal
Indian reservation.
(g) EPA's approval or disapproval of
a State or Tribal submission shall be
based on the requirements of this part
and of the Clean Water Act. EPA's
determination whether the criteria,
methodologies, policies, and procedures
in a State or Tribal submission are
consistent with the requirements of this
part will be based on whether:
(1) For pollutants listed in Tables 1,
2, 3, and 4 of this part. The Great Lakes
State or Tribe has adopted numeric
water quality criteria as protective as
each of the numeric criteria in Tables 1,
2, 3, and 4 of this part, taking into
account any site-specific criteria
modifications in accordance with
procedure 1 of appendix F of this part;
(2) For pollutants other than those
listed in Tables 1, 2, 3, 4, and 5 of this
part. The Great Lakes State or Tribe
demonstrates that either:
(i) It has adopted numeric criteria in
its water quality standards that were
derived, or are as protective as or more
protective than could be derived, using
the methodologies in appendixes A, B,
C, and D of this part, and the 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 § 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 § 132i4. The Great Lakes
State or Tribe may adopt provisions that
are more protective than those
contained in this parti Adoption of a
more protective element in one
provision may be used to offset a less
protective element in |the same
provision as long as the adopted
provision is as protective as the
corresponding provision in this part;
adoption of a more protective element
in one provision, however, is not
justification for adoption of a less
protective element in another provision
of this part.
(h) A submission by a Great Lakes
State or Tribe will need to include any
provisions that EPA determines, based
on EPA's authorities under the Clean
Water Act and the results of
consultation under section .7 of the
Endangered Species Act, are necessary
to ensure that water quality is not likely
to jeopardize the continued existence of
any endangered or threatened species
listed under section 4 of the Endangered
Species Act or result in the destruction
or adverse modification of such species'
critical habitat. |
(i) EPA's approval of the elements of
a State's or Tribe's submission will
constitute approval under section 118 of
the Clean Water Act, approval of the
submitted water quality standards
pursuant to section 303 of the Clean
Water Act, and approval of the
submitted modifications to the State's or
Tribe's NPDES program pursuant to
section 402 of the Clean Water Act.
§132.6 Application of part 132
requirements in Great Lakes States and
Tribes. [Reserved]
Tables to Part 132
TABLE 1.—ACUTE WATER QUALITY
CRITERIA FOR PROTECTION OF AQUATIC
LIFE IN AMBIENT WATER
EPA recommends that metals criteria be
expressed as dissolved concentrations (see
appendix A, I.A.4 for more information
regarding metals criteria).
(a)
Chemical
Arsenic (III)
Chromium (VI)
Cyanide
Dieldrin
Endrin
Lindane
Mercury (II)
Parathion
Selenium
i
CMC
; (iig/U
a.b3398
"•M602
C22
d024
' d 0 086
> d095
a.b-| 694
! d 0 065
"•>> 19.34
Con-
version
factor
(CF)
1 000
n QR9
n/a
n/a
n/a
n fl^
n/a
0.922
CMC=CMC".
"CMCd=(CMC"-) CF. The CMC" shall be
rounded to two significant digits.
-------
15392 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
should be considered free cyanide as gMC i
erable.
CMCd is the CMC expressed as a dissolved
The term "n/a" means not applicable. concentration.
..jag* the CMC expressed as a
tota, .on-
dCMC=CMCl.
Chemical
Cadmium3* :
Chromium (III) »* '
Copper3-6
Nickel ^
Pentachlorophenolc •
Zinc3*
3CMCtr=exp { mA [In (hardness)]+bA>.
bCMCMCMC") CF. The CMC" shall be rounded to two significant digits.
cCMC1=exp mA { [pH]+bA>. The CMC1 shall be rounded to two significant digits.
The term "exp" represents the base e exponential function.
The term "n/a" means not applicable.
CMC is Criterion Maximum Concentration.
CMClr is the CMC expressed as total recoverable.
CMCd is the CMC expressed as a dissolved concentration.
CMC1 is the CMC expressed as a total concentration.
mA
1.128
0.819
0.9422
0.846
1.005
0.8473
bA
-3.6867
+3.7256
-1.700
+2.255
-4.869
+0.884
Conver-
sion fac-
tor (CF)
0.85
0.316
0.960
0.998
n/a
0.978
TABLE 2.—CHRONIC WATER QUALITY
CRITERIA FOR PROTECTION OF AQUATIC
LIFE IN AMBIENT WATER
EPA recommends that metals criteria be
expressed as dissolved concentrations (see
appendix A, I.A.4 for more information
regarding metals criteria).
(a)
Chemical
Arsenic (III)
Chromium (VI)
Cyanide
Dieldrin
Parathion
Selenium
CCC
WU
=-b 147.9
a-b 10.98
'5.2
d 0.056
d 0.036
^ 0.9081
"0.013
a*5
Con-
version
factor
(CF)
1.000
0.962
n/a
n/a
n/a
0.85
n/a
0.922
bCCCd=(CCClr) CF. The CCCd shall be
rounded to two significant digits.
cCCC should be considered free cyanide as
CN.
dCCC=CCC'.
Notes:
The term "n/a" means not applicable.
CCC is Criterion Continuous Concentration.
CCC'r is the CCC expressed as total recov-
erable. ' . , .
CCCd is the CCC expressed as a dissolved
concentration.
CCC1 is the CCC expressed as a total con-
centration.
(b)
Chemical
Nickel3-'1
Pentachlorop-
henolc
Zinc3-"
rtic
0.846
1.005
0.8473
be
+0.0584
-5134
+0.884
Con-
version
factor
(CF)
0.997
n/a
0.986
3CCC=CCClr.
Chemical
Cadmium3* ...
Chromium
(III)3*
Copper3*
rric
0.7852
0.819
0.8545
be
-2715
+0.6848
-1.702
Con-
version
factor
(CF)
0.850
0.860
0.960
3CCC"=exp {rrtctln (hardness)]+bc>.
»CCCd=(CCC") (CF). The CCCd shall be
rounded to two significant digits.
cCMC'=exp {mA[pH]+bA}. The CMC1 shall
be rounded to two significant digits.
Notes;:
The term "exp" represents the base e expo-
nential function.
The term "n/a" means not applicable.
CCC is Criterion Continuous Concentration.
CCO;r is the CCC expressed as total recov-
erable. _,. , .
CCC" is the CCC expressed as a dissolved
concentration.
CCC1 is the CCC expressed as a total con-
centration.
TABLE 3.—WATER QUALITY CRITERIA FOR PROTECTION OF HUMAN HEALTH
Chemical
Benzene •
Chlordane -
Hexachlorobenzene •
Hexachloroethane
2to,f,o- \ oUU
Toxaohene r •
HNV
Drinking
1.9E1
4.7E2
6.0E2
2.0E-3
4.1 E-4
4.5E2
5.5E1
4.6E-2
6.0
4.7E-1
1.8E-3
1.6E3
6.7E-8
5.6E3
(ng/L)
Nondrinking
I3.1E2
•1 AF-.3
3.2E3
4.8E4
2.0E--3
4.1 E--4
B.7E3
2.8E3
4.6E-2
7.6
5.0E-1
1.8E--3
9.0E4
6.7E-8
5.1 E4
HCV(
Drinking
1.2E1
25E-4
1.5E-4
6.5E-6
4.5E-4
5.3
4.7E1
3.9E-6
8.6E-9
6.8E-5
H9/L)
Nondrinking
3.1 E2
2.5E-4
1.5E-4
6.5E-6
4.5E-4
6.7
2.6E3
3.9E-6
8.6E-9
6.8E-5
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15393
TABLES.—WATER QUALITY CRITERIA FOR PROTECTION OF HUMAN HEALTH—Continued
Chemical
Trichloroethytene
1 1ncludes methylmercury.
HNV
Drinking
(WI/L)
Nondrinking
HCV (ng/L)
Drinking | Nondrinking
2.9E1 3.7E2
TABLE 4.—WATER QUALITY CRITERIA
FOR PROTECTION OF WILDLIFE
Chemical
DDT and metabolites
Mercury (including
methylmercury).
PCBs (class)
2,3,7,8-TCDD
Criteria
(H9/L)
1.1 E-5
1.3E-3
74E-5
3.1 E-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
Tempera ture
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):
Chlordano
4,4'-DDD; p,p'-DDD; 4,4'-TDE; p.p'-TDE
4,4'-DDE; p.p'-DDE
4.4MDDT; p.p'-DDT
Dioldrin
Hexachlorobonzene
Hoxachlorobutadiene; hexachloro-l, 3-
butadlono
Hoxachlorocyclohexanes; BHCs
alpha-Hexachlorocyclohexane;alpha-BHC
bota-Hexachlorocyclohexane; beta-BHC
dolta-Hexachlorocyclohexane;delta-BHC
Llndono; gamma-hexachlorocyclohexane;
gamma-BHC
Mercury
Mirox
Octachlorostyrone
PCBs; polychlorinated biphenyls
Pentachlorobenzene
Photomirex
2,3,7,8-TCDD; dioxin
1,2,3,4-Tetrachlorobenzene
1,2,4,5-TetrachlorobenzeneToxaphene
B. Pollutants that are not bioaccumulative
chemicals of concern:
Acenaphthene
Acenaphthylene
Acroloin; 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
l,12-Benzoperylene;benzo[ghi]perylene
Beryllium
Bis(2-chloroethoxy) methane
Bis(2-chloroethyl) ether
Bis(2-chloroisopropyl) ether
Bromoform; tribomomethane
4-Bromophenyl phenyl ether
Butyl benzyl phthalate
Cadmium
Carbon tetrachloride; tetrachloromethane
Chlorobenzene
p-Chloro-m-cresol; 4-chloro-3-
methylphenol
Chlorodibromomethane
Chlore thane
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
l,2:5,6-Dibenzanthracene;
dibenz[a,h]anthracene
Dibutyl phthalate; di-n-butyl phthalate
1,2-Dichlorobenzene
1,3-Dichlorobenzene
1,4-Dichlorobenzene
3,3'-Dichlorobenzidine
Dichlorobromomethane;
bromodichloromethane
1,1-Dichloroethane
1,2-Dichloroethane
1,1-Dichloroethylene; vinylidene chloride
1,2-trans-Dichloroethylene
2,4-Dichlorophenol
1,2-Dichloropropane
1,3-Dichloropropene; 1,3-
dichloropropylene
Diethyl phthalate
2,4-Dimethylphenol; 2,4-xylenol
Dimethyl phthalate
4,6-Dinitro-o-cresol; 2-methyl-4,6-
dinitrophenol
2,4-Dinitrophenol
2,4-Dinitrotoluene
2,6-Dinitrotoluene
Dioctyl phthalate; di-n-octyl phthalate
1,2-Diphenylhydrazine
Endosulfan; thiodan
alpha-Endosulfan '
beta-Endosulfan
Endosulfan sulfate
Endrin :
Endrin aldehyde ,
Ethylbenzene
Fluoranthene
Fluorene; 9H-fluorene
Fluoride
Guthion :
Heptachlor
Heptachlor epoxide
HexachlorocyclopentadieBe
Hexachloroethane
Indeno[l,2,3-cd]pyrehe;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; methylbenzehe
1,2,4-Trichlorobenzene
1,1,1-Trichloroethane !
1,1,2-Trichloroethane
Trichloroethylene;trichloroethene
2,4,6-Trichlorophenol ,
Vinyl chloride; chloroethylene;
chloroethene j
Zinc
Appendix A to part 132—Great Lakes Water
Quality Initiative Methodologies for
Developments of Aquatic Life Criteria and
Values
Methodology for Deriving Aquatic Life
Criteria: Tier I
Great Lakes States and Tribes shall adopt
provisions consistent with (as protective as)
this appendix.
-------
15394 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
I. Definitions
A. Material of Concern. When defining the
material of concern the following should be
considered:
1. Each separate chemical that does not
ionize substantially in most natural bodies of
water should usually be considered a
separate material, except possibly for
structurally similar organic compounds that
only exist in large quantities as commercial
mixtures of the various compounds and
apparently have similar biological, chemical,
physical, and lexicological properties.
2. For chemicals that ionize substantially
in most natural bodies of water (e.g., some
phenols and organic acids, some salts of
phenols and organic acids, and most
inorganic salts and coordination complexes
of metals and metalloid), all forms that
would be in chemical equilibrium should
usually be considered one material. Each
different oxidation state of a metal and each
different non-ionizable covalently bonded
organometallic compound should usually be
considered a separate material.
3. The definition of the material of concern
should include an operational analytical
component. Identification of a material
simply as "sodium," for example, implies
"total sodium," but leaves room for doubt. If
"total" is meant, it must be explicitly stated.
Even "total" has different operational
definitions, some of which do not necessarily
measure "all that is there" in all samples.
Thus, it is also necessary to reference or
describe the analytical method that is
intended. The selection of the operational
analytical component should take into
account the analytical and environmental
chemistry of the material and various
practical considerations, such as labor and
equipment requirements, and whether the
method would require measurement in the
field or would allow measurement after
samples are transported to a laboratory.
a. The primary requirements of the
operational analytical component are that it
be appropriate for use on samples of
receiving water, that it be compatible with
the available toxicity and bioaccumulation
data without making extrapolations that are
too hypothetical, and that it rarely result in
underprotection or overprotection of aquatic
organisms and their uses. Toxicity is the
property of a material, or combination of
materials, to adversely affect organisms.
b. Because an ideal analytical measurement
will rarely be available, an appropriate
compromise measurement will usually have
to be used. This compromise measurement
must fit with the general approach that if an
ambient concentration is lower than the
criterion, unacceptable effects will probably
not occur, i.e., the compromise measure must
not err on the side of underprotection when
measurements are made on a surface water.
What is an appropriate measurement in one
situation might not be appropriate for
another. For example, because the chemical
and physical properties of an effluent are
usually quite different from those of the
receiving water, an analytical method that is
appropriate for analyzing an effluent might
not be appropriate for expressing a criterion,
and vice versa. A criterion should be based
on an appropriate analytical measurement,
but the criterion is not rendered useless if an
ideal measurement either is not available or
is not feasible.
Note: The analytical chemistry of the
material might have to be taken into account
when defining the material or when judging
the acceptability of some toxicity tests, but a
criterion must not be based on the sensitivity
of an analytical method. When aquatic
organisms are more sensitive than routine
analytical methods, the proper solution is to
develop better analytical methods.
4. It is now the policy of EPA that the use
of dissolved metal to set and measure
compliance with water quality standards is
the recommended approach, because
dissolved metal more closely approximates
the bioavailable fraction of metal in the water
column that does total recoverable metal.
One reason is that a primary mechanism for
water column toxicity is adsorption at the gill
surface which requires metals to be in the
dissolved form. Reasons for the consideration
of total recoverable metals criteria include
risk management considerations not covered
by evaluation of water column toxicity. A
risk manager may consider sediments and
food chain effects and may decide to take a
conservative approach for metals,
considering that metals are very persistent
chemicals. This approach could include the
use of total recoverable metal in water quality
standards. A range of different risk
management decisions can be justified. EPA
recommends that State water quality
standards be based on dissolved metal. EPA
will also approve a State risk management
decision to adopt standards based on total
recoverable metal, if those standards are
otherwise approvable under this program.
B. Acute Toxicity. Concurrent and delayed
adverse effect(s) that results from an acute
exposure and occurs within any short
observation period which begins when the
exposure begins, may extend beyond the
exposure period, and usually does not
constitute a substantial portion of the life
span of the organism. (Concurrent toxicity is
an adverse effect to an organism that results
from, and occurs during, its exposure to one
or more test materials.) Exposure constitutes
contact with a chemical or physical agent.
Acute exposure, however, is exposure of an
organism for any short period which usually
does not constitute a substantial portion of its
life span.
C. Chronic Toxicity. Concurrent and
delayed adverse effect(s) that occurs only as
a result of a chronic exposure. Chronic
exposure is exposure of an organism for any
long period or for a substantial portion of its
life span.
//. Collection of Data
A. Collect all data available on the material
concerning toxicity to aquatic animals and
plants.
B. All data that are used should be
available in typed, dated, and signed hard
copy (e.g., publication, manuscript, letter,
memorandum, etc.) with enough supporting
information to indicate that acceptable test
procedures were used and that the results are
reliable. In some cases, it might be
appropriate to obtain written information
from the investigator, if possible. Information
that is not available for distribution shall not
be used.
C. Questionable data, whether published or
unpublished, must not be used. For example,
data must be rejected if they are from tests
that did not contain a control treatment, tests
in which too many organisms in the control
treatment died or showed signs of stress or
disease, and tests in which distilled or
deionized water was used as the dilution
water without the addition of appropriate
salts.
D. Data on technical grade materials may
be used if appropriate, but data on
formulated mixtures and emulsifiable
concentrates of the material must not be
used.
E. For some highly volatile, hydrolyzable,
or degradable materials, it might be
appropriate to use only results of flow-
through tests in which the concentrations of
test material in test solutions were measured
using acceptable analytical methods. A flow-
through, 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 non-resident to
North America or previously exposed
organisms may be used to provide auxiliary
information but must not be used in the
derivation of criteria.
in. Required Data
A. Certain data should be available to help
ensure that each of the major kinds of
possible adverse effects receives adequate
consideration. An adverse effect is a change
in an organism that is harmful to the
organism. Exposure means contact with a
chemical or physical agent. Results of acute
and chronic toxicity tests with representative
species of aquatic animals are necessary so
that data available for tested species can be
considered a useful indication of the
sensitivities of appropriate untested species.
Fewer data concerning toxicity to aquatic
plants are usually available because
procedures for conducting tests with plants
and interpreting the results of such tests are
not as well developed.
B. To derive a Great Lakes Tier I criterion
for aquatic organisms and their uses, the
following must be available:
1. Results of acceptable acute (or chronic)
tests (see section IV or VI of this appendix)
with at least one species of freshwater animal
in at least eight different families such that
all of the following are included:
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15395
a. Tho family Salmonidae in the class
Ostokhthyes;
b. Ono 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
cladocoran, copepod);
o. A benthic crustacean (e.g., ostracod,
isopod, amphipod, crayfish);
f. An insect (e.g., mayfly, dragonfly,
damselfly, stonefly, caddisfly, mosquito,
mldgo);
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 Vm 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
•xcopt 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 Vn
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) toxiciry 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
havo been conducted on the material) have
higher Genus Mean Acute Values (GMAVs).
An acuto 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 thoir life span. However, in some cases,
tho Species Mean Acute Value (SMAV) of a
commercially or recreationally important
species of the Great Lakes System is lower
than tho calculated FAV, then the SMAV
replaces the calculated FAV in order to
provide protection for that important species.
B. Acute toxiciry 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 m.B.2 of this appendix) are not
met with freshwater data alone, saltwater
data may be used.)
D. Results of acute tests conducted in
unusual dilution water, e.g., dilution water in
which total organic carbon or particulate
matter exceeded five mg/L, should not be
used, unless a relationship is developed
between acute toxicity and organic carbon or
particulate matter, or unless data show that
organic carbon or particulate matter, etc., do
not affect toxicity.
E. Acute values must be based upon
endpoints which reflect the total severe
adverse impact of the test material on the
organisms used in the test. Therefore, only
the following kinds of data on acute toxicity
to aquatic animals shall be used:
1. Tests with daphnids and other
cladocerans must be started with organisms
less than 24 hours old and tests with midges
must be started with second or third instar
larvae. It is preferred that the results should
be the 48-hour EC50 based on the total
percentage of organisms killed and
immobilized. If such an EC50 is not available
for a test, the 48-hour LC50 should be used
in place of the desired 48-hour EC50. An
EC50 or LC50 of longer than 48 hours can be
used as long as the animals were not fed and
the control animals were acceptable at the
end of the test. An EC50 is a statistically or
graphically estimated concentration that is
expected to cause one or more specified
effects in 50% of a group of organisms under
specified conditions. An LC50 is a
statistically or graphically estimated
concentration that is expected to be lethal to
50% of a group of organisms under specified
conditions.
2. It is preferred that the results of a test
with embryos and larvae of barnacles, bivalve
molluscs (clams, mussels, oysters and
scallops), sea urchins, lobsters, crabs, shrimp
and abalones be the 96-hour EC50 based on
the percentage of organisms with
incompletely developed shells plus the
percentage of organisms killed. If such an
EC50 is not available from a test, of the
values that are available from the test, the
lowest of the following should be used in
place of the desired 96-hour EC50:48- to 96-
hour ECSOs based on percentage of organisms
with incompletely developed shells plus
percentage of organisms killed, 48- to 96-
hour ECSOs based upon percentage of
organisms with incompletely developed
shells, and 48-hour to 96-hour LCSOs. (Note:
If the minimum acute-chronic ratio data
requirements (as described in section m.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 organisms1 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 ^>e 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 Jjy 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 da1;a 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! accept able acute
toxicity tests with the most sensitive tested
life stage, i.e., results of flow-through tests in
which the concentrations were not measured
and results of static and renewal tests based
on initial concentrations (nominal
concentrations are acceptable for most test
materials if measured concentrations are not
available) of test material. A renewal test is
a test with aquatic organisms in which either
the test solution in a test chamber is removed
and replaced at least once during the test or
the test organisms are transferred into a new
test solution of the same composition at least
once during the test. A static test is a test
with aquatic organisms in which the solution
-------
15396
Federal Register / Vol. 60. No. 56 / Thursday. March 23. 1995 / Rulesjind Regulations
and organisms that are in a test chamber at
the beginning of the test remain in the
chamber until the end of the test, except for
removal of dead test organisms.
Note 1: Data reported by original
investigators must not be rounded off.
Results of all intermediate calculations must
not be rounded off to fewer than four
significant digits.
Note 2: The geometric mean of N numbers
is the Nth root of the product of the N
numbers. Alternatively, the geometric mean
can be calculated by adding the logarithms of
the N numbers, dividing the sum by N, and
taking the antilog of the quotient. The
geometric mean of two numbers is the square
root of the product of the two numbers, and
the geometric mean of one number is that
number. Either natural (base e) or common
(base 10) logarithms can be used to calculate
geometric means as long as they are used
consistently within each set of data, i.e., the
antilog used must match the logarithms used.
Note 3: Geometric means, rather than
arithmetic means, are used here because the
distributions of sensitivities of individual
organisms in toxicity tests on most materials
and the distributions of sensitivities of
species within a genus are more likely to be
lognormal than normal. Similarly, geometric
means are used for ACRs because quotients
are likely to be closer to lognormal than
normal distributions. In addition, division of
the geometric mean of a set of numerators by
the geometric mean of the set of
denominators will result in the geometric
mean of the set of corresponding quotients.
J. For each genus for which one or more
SMAVs are available, the GMAV shall be
calculated as the geometric mean of the
SMAVs available for the genus.
K. Order the GMAVs from high to low.
L. Assign ranks, R, to the GMAVs from "1"
for the lowest to "N" for the highest. If two
or more GMAVs are identical, assign them
successive ranks.
M. Calculate the cumulative probability, P,
for each GMAV as R/(N+1).
N. Select the four GMAVs which have
cumulative probabilities closest to 0.05 (if
there sire fewer than 59 GMAVs, these will
always be the four lowest GMAVs).
O. Using the four selected GMAVs, and Ps,
calculate
S2 _
—
n GMAV
£<>•>-
L =
+ L
FAV = e'
Note: Natural logarithms (logarithms to
base e, denoted as In) are used herein merely
because they are easier to use on some hand
calculators and computers than common
(base 10) logarithms. Consistent use of either
will produce the same result.
P. If for a commercially or recreationally
important species of the Great Lakes System
the geometric mean of the acute values from
flow-through tests in which the
concentrations of test material were
measured is lower than the calculated Final
Acute Value (FAV), then that geometric mean
must be used as the FAV instead of the
calculated FAV.
Q. See section VI of this appendix.
V. Final Acute Equation
A. When enough data are available to show
that acute toxicity to two or more species is
similarly related to a water quality
characteristic, the relationship shall be taken
into account as described in sections V.B
through V.G of this appendix or using
analysis of covariance. The two methods are
equivalent and produce identical results. The
manual method described below provides an
understanding of this application of
covariance analysis, but computerized
versions of covariance analysis are much
more convenient for analyzing large data sets.
If two or more factors affect toxicity, multiple
regression analysis shall be used.
B. For each species for which comparable
acute toxicity values are available at two or
more different values of the water quality
characteristic, perform a least squares
regression of the acute toxicity values on the
corresponding values of the water quality
characteristic to obtain the slope and its 95
percent confidence limits for each species.
Note: Because the best documented
relationship is that between hardness and
acute toxicity of metals in fresh water and a
log-log relationship fits these data, geometric
means and natural logarithms of both toxicity
and water quality are used in the rest of this
section. For relationships based on other
water quality characteristics, such as Ph,
temperature, no transformation or a different
transformation might fit the data better, and
appropriate changes will be necessary
throughout this section.
C. Decide whether the data for each species
are relevant, taking into account the range
and number of the tested values of the water
quality characteristic and the degree of
agreement within and between species. For
example, a slope based on six data points
might be of limited value if it is based only
on data for a very narrow range of values of
the water quality characteristic. A slope
based on only two data points, however,
might be useful if it is consistent with other
information and if the two points cover a
broad enough range of the water quality
characteristic. In addition, acute values that
appear to be questionable in comparison with
other acute and chronic data available for'the
same species and for other species in the
same genus should not be used. For example,
if after adjustment for the water quality
characteristic, the acute values available for
a species or genus differ by more than a
factor of 10, rejection of some or all of the
values would be appropriate, absent
countervailing justification. If useful slopes
are not available for at least one fish and one
invertebrate or if the available slopes are too
dissimilar or if too few data are available to
adequately define the relationship between
acute toxicity and the water quality
characteristic, return to section IV.G of this
appendix, using the results of tests
conducted under conditions and in waters
similar to those commonly used for toxicity
tests: with the species.
D. For each species, calculate the geometric
mean of the available acute values and then
divide each of the acute values for the
species by the geometric mean for the
species. This normalizes the acute values so
that the geometric mean of the normalized
values for each species individually and for
any combination of species is 1.0.
E, Similarly normalize the values of the
water quality characteristic for each species
individually using the same procedure as
above.
F. Individually for each species perform a
leasit squares regression of the normalized
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15397
acute values of the water quality
characteristic. Tho resulting slopes and 95
percent confidence limits will be identical to
those obtained in section V.B. of this
idual
appendix If, however, the data are actual!
plotted, tha line of best fit for each individ,
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«lnW-V(mX-lnZ)
J. For each species calculate the SMAV at
X using the equation:
Note: Alternatively, the SMAVs at Z can be
obtained by skipping step H above, using the
equations In steps I and J to adjust each acute
value individually to Z, and then calculating
the geometric mean of the adjusted values for
each species individually. This alternative
procedure allows an examination of the range
of the adjusted acute values for each species.
K. Obtain the FAV at Z by using the
procedure described in sections IV.J through
IV.O of this appendix. ^
L. If, for a commercially or recreationally
important species of the Great Lakes System
the geometric mean of the acute values at Z
from flow-through tests in which the
concentrations of the test material were
measured is lower than the FAV at Z, then
the geometric mean must be used as the FAV
instead of the FAV.
M. The Final Acute Equation is written as:
where:
V«pooled acute slope, and A=ln(FAV at Z).
Because V, A, and Z are known, the FAV
can bo calculated for any selected value of
the water quality characteristic.
W. Final Chronic Value
A. Depending on the data that are available
concerning chronic toxicity to aquatic
animals, the Final Chronic Value (FCV) can
bo 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 bo possible to calculate a FCV. The FCV
is (a) a calculated estimate of the
concentration of a test material such that 95
percent of the genera (with which acceptable
chronic toxicity tests have been conducted
on the material) have higher GMCVs, or (b)
the quotient of an FAV divided by an
appropriate ACR, or (c) the SMCV of an
important and/or critical species, if the
SMCV is lower than the calculated estimate
or the quotient, whichever is applicable.
Note: As the name implies, the ACR is a
way of relating acute and chronic toxicities.
B. Chronic values shall be based on results
of flow-through (except renewal is acceptable
for daphnids) chronic tests in which the
concentrations of test material in the test
solutions were properly measured at
appropriate times during the test. A chronic
test is a comparative study in which
organisms, that are subjected to different
treatments, are observed for a long period or
a substantial portion of their life span.
C. Results of chronic tests in which
survival, growth, or reproduction in the
control treatment was unacceptably low shall
not be used. The limits of acceptability will
depend on the species.
D. Results of chronic tests conducted in
unusual dilution water, e.g., dilution water in
which total organic carbon or particulate
matter exceeded five mg/L, should not be
used, unless a relationship is developed
between chronic toxicity and organic carbon
or particulate matter, or unless data show
that organic carbon, particulate matter, etc.,
do not affect toxicity.
E. Chronic values must be based on
endpoints and lengths of exposure
appropriate to the species. Therefore, only
results of the following kinds of chronic
toxicity tests shall be used:
1. Life-cycle toxicity tests consisting of
exposures of each of two or more groups of
individuals of a species to a different
concentration of the test material throughout
a life cycle. To ensure that all life stages and
life processes are exposed, tests with fish
should begin with embryos or newly hatched
young less than 48 hours old, continue
through maturation and reproduction, and
should end not less than 24 days (90 days for
salmonids) after the hatching of the next
generation. Tests with daphnids should begin
with young less than 24 hours old and last
for not less than 21 days, and for
ceriodaphnids not less than seven days. For
good examples of acceptable procedures see
American Society for Testing and Materials
(ASTM) Standard E1193 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 offish 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 he obtained and
analyzed on survival andigrowth of adults
and young, maturation of males and females,
eggs spawned per female, embryo viability
(salmonids only), and hatchability.
3. Early life-stage toxicity tests consisting
of 28- to 32-day (60 days post hatch for
salmonids) exposures of the early life stages
of a species of fish from shortly after
fertilization through embryonic, larval, and
early juvenile development. Data should be
obtained and analyzed on, survival and
growth.
Note: Results of an early life-stage test are
used as predictions of results of life-cycle
and partial life-cycle tests with the same
species. Therefore, when results of a life-
cycle or partial life-cycle test are available,
results of an early life-stage test with the
same species should not be used. Also,
results of early life-stage tests in which the
incidence of mortalities or abnormalities
increased substantially near the end of the
test shall not be used because the results of
such tests are possibly not good predictions
of comparable life-cycle or partial life-cycle
tests.
F. A chronic value may be obtained by
calculating the geometric mean of the lower
and upper chronic limits from a chronic test
or by analyzing chronic data using regression
analysis.
1. A lower chronic limit is the highest
tested concentration:
a. In an acceptable chronic test;
b. Which did not cause an unacceptable
amount of adverse effect on any of the
specified biological measurements; and
c. Below which no tested concentration
caused an unacceptable effect.
2. An upper chronic limit is the lowest
tested concentration: i
a. In an acceptable chronic test;
b. Which did cause an unacceptable
amount of adverse effect on one or more of
the specified biological measurements; and,
c. Above which all tested concentrations
also caused such an effect.
Note: Because various authors have used a
variety of terms and definitions to interpret
and report results of chronic tests, reported
results should be reviewed carefully. The
amount of effect that is considered
unacceptable is often based on a statistical
hypothesis test, but might also be defined in
terms of a specified percent reduction from
the controls. A small percent reduction (e.g.,
three percent) might be considered
acceptable even if it is statistically
significantly different from the control,
whereas a large percent reduction (e.g., 30
percent) might be considered unacceptable
even if it is not statistically significant.
G. If the chronic toxicity of the material to
aquatic animals has been shown to be related
-------
15398 Federal Register / Vol. 60. No. 56 / Thursday, March 23, 1995 /Rules and Regulations
to a water quality characteristic such as
hardness or particulate matter for freshwater
animals, refer to section VII of this appendix.
H. If chronic values are available for
species in eight families as described in
section III.B.l 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 offish 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
IVJ 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 ffl.B.l of this appendix.
I. For each chronic value for which at least
one corresponding appropriate acute value is
available, calculate an ACR, using for the
numerator the geometric mean of the results
of all acceptable flow-through (except static
is acceptable for daphnids and midges) acute
tests in the same dilution water in which the
concentrations are measured. For fish, the
acute test(s) should be conducted with
juveniles. The acute test(s) should be part of
the same study as the chronic test. If acute
tests were not conducted as part of the same
study, but were conducted as part of a
different study in the same laboratory and
dilution water, then they may be used. If no
such acute tests are available, results of acute
tests conducted in the same dilution water in
a different laboratory may be .used. If no such
acute tests are available, an ACR shall not be
calculated.
J. For each species, calculate the SMACR
as the geometric mean of all ACRs available
for that species. If the minimum ACR data
requirements (as described in section III.B.2
of this appendix) are not met with freshwater
data alone, saltwater data may be used along
with the freshwater data.
K. For some materials, the ACR seems to
be the same for all species, but for other
materials the ratio seems to increase or
decrease as the SMAV increases. Thus the
FACR can be obtained in three ways,
depending on the data available:
1. If the species mean ACR seems to
increase or decrease as the SMAVs increase,
the FACR shall be calculated as the geometric
mean of the ACRs for species whose SMAVs
are close to the FAV.
2. If no major trend is apparent and the
ACRs for all species are within a factor of ten,
the FACR shall be calculated as the geometric
mean of all of the SMACRs.
3. If the most appropriate SMACRs are less
than 2.0, and especially if they are less than
1.0, acclimation has probably occurred
during the chronic test. In this situation,
because continuous exposure and
acclimation cannot be assured to provide
adequate protection in field situations, the
FACR should be assumed to be two, so that
the FCV is equal to the Criterion Maximum
Concentration (CMC). (See section X.B of this
appendix.)
If the available SMACRs do not fit one of
these cases, a FACR may not be obtained and
a Tier I FCV probably cannot be calculated.
L. Calculate the FCV by dividing the FAV
by the FACR.
FCV=FAV-)-FACR
If there is a Final Acute Equation rather than
a FAV, see also section V of this appendix.
M. If the SMCV of a commercially or
recreationally important species of the Great
Lakes System is lower than the calculated
FCV, then that SMCV must be used as the
FCV instead of the calculated FCV.
N. See section VHI of this appendix.
VU. Final Chronic Equation
A. A Final Chronic Equation can be
derived in two ways. The procedure
described in section VILA of this appendix
will result in the chronic slope being the
same as the acute slope. The procedure
described in sections VII.B through N of this
appendix will usually result in the chronic
slope being different from the acute slope.
1. If ACRs are available for enough species
at enough values of the water quality
characteristic to indicate that the ACR
appears to be the same for all species and
appears to be independent of the water
quality characteristic, calculate the FACR as
the geometric mean of the available SMACRs.
2. Calculate the FCV at the selected value
Z of the water quality characteristic by
dividing the FAV at Z (see section V.M of
this appendix) by the FACR.
3. Use V=pooled acute slope (see section
V.M of this appendix), and
L=pooled chronic slope.
4. See section VII.M of this appendix.
B. When enough data are available to show
that chronic toxicity to at least one species
is related to a water quality characteristic, the
relationship should be taken into account as
described in sections C through G below or
using analysis of covariance. The two
methods are equivalent and produce
identical results. The manual method
described below provides an understanding
of this application of covariance analysis, but
computerized versions of covariance analysis
are much more convenient for analyzing
large data sets. If two or more factors affect
toxicity, multiple regression analysis shall be
used.
C. For each species for which comparable
chronic toxicity values are available at two or
more different values of the water quality
characteristic, perform a least squares
regression of the chronic toxicity values on
the corresponding values of the water quality
characteristic to obtain the slope and its 95
percent confidence limits for each species.
Note: Because the best documented
relationship is that between hardness and
acute toxicity of metals in fresh water and a
log-log relationship fits these data, geometric
means and natural logarithms of both toxicity
and water quality are used in the rest of this
section. For relationships based on other
water quality characteristics, such as Ph,
temperature, no transformation or a different
transformation might fit the data better, and
appropriate changes will be necessary
throughout this section. It is probably
preferable, but not necessary, to use the same
transformation that was used with the acute
values! in section V of this appendix.
D. Decide whether the data for each species
are relevant, taking into account the range
and number of the tested values of the water
quality characteristic and the degree of
agreement within and between species. For
example, a slope based on six data points
might: be of limited value if it is based only
on data for a very narrow range of values of
the water quality characteristic. A slope
based on only two data points, however,
might be more useful if it is consistent with
other information and if the two points cover
a broad range of the water quality
characteristic. In addition, chronic values
that appear to be questionable in comparison
with other acute and chronic data available
for the same species and for other species in
the siane 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
ind ividual 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
noimalized chronic values on the
coiresponding normalized values of the
water quality characteristic to obtain the
pooled chronic slope, L, and its 95 percent
confidence limits.
If all normalized data are actually plotted,
the line of best fit will go through the point
1,1 in the center of the graph.
-------
Federal Register / Vol. 60, No. 56
Thursday, March 23, 1995
Rules and Regulations 15399
I. For each species, calculate the geometric
mean, M, of the toxicity values and the
geometric moan, P, of the values of the water
quality characteristic. (These are calculated
in sections VILE 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 die
equation:
Q-lnM— L(lnP-lnZ)
Note: Although it is not necessary, it is
recommondod that the same value of the
water quality characteristic be used here as
was used in section V of this appendix.
K. For each species, calculate a SMCV at
Z using the equation:
Note: Alternatively, the SMCV at Z can he
obtained by skipping section Vn.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
Oof this appendix.
M. If the SMCV at Z of a commercially or
recreatlonally 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:
•dM<*"
-------
15400 Federal Register / Vol. 60, No. 56 / Thursday. March 23, 1995 / Rules and Regulations
XII. Secondary Acute Value
If all eight minimum data requirements for
calculating an FAV using Tier I are not met,
a Secondary Acute Value (SAV) for the
waters of the Great Lakes System shall be
calculated for a chemical as follows:
To calculate a SAV, the lowest GMAV in
the database is divided by the Secondary
Acute Factor (S AF) (Table A-l of this
appendix) corresponding to the number of
satisfied minimum data requirements listed
hi the Tier I methodology (section IH.B.l of
this appendix). (Requirements for definitions,
data collection and data review, contained in
sections I, n, and IV shall be applied to
calculation of a SAV.) If all eight minimum
data requirements are satisfied, a Tier I
criterion calculation may be possible. In
order to calculate a SAV, the database must
contain, at a minimum, a genus mean acute
value (GMAV) for one of the following three
genera in the family Daphnidae—
Ceriodaphnia sp., Daphnia sp., or
Simocephalus sp.
If appropriate, the SAV shall "be made a
function of a water quality characteristic in
a manner similar to that described in Tier I.
XIII. Secondary Acute-Chronic Ratio
If three or more experimentally determined
ACRs, meeting the data collection and review
requirements of Section VI of this appendix,
are available for the chemical, determine the
FACR using the procedure described in
Section VI. If fewer than three acceptable
experimentally determined ACRs are
available, use enough assumed ACRs of 18 so
that the total number of ACRs equals three.
Calculate the Secondary Acute-Chronic Ratio
(SACR) as the geometric mean of the three
ACRs. Thus, if no experimentally determined
ACRs are available, the SACR is 18.
XIV. Secondary Chronic Value
Calculate the Secondary Chronic Value
(SCV) using one of the following:
A. SCV = -
B. SCV =
C. SCV =
FAV
SACR
SAV
FACR
SAV
SACR
(use FAV from Tier I)
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) ng/
L more than once every three years on the
average and if the one-hour average
concentration does not exceed (3) ng/L more
than once every three years on the average.
Where:
(1) = insert name of material
(2) = insert the SCC
(3) = insert the SMC
As discussed above, States and Tribes have
the discretion to specify alternative averaging
periods or frequencies (see section X.E. of
this appendix).
XVII. Appropriate Modifications
On the basis of all available pertinent
laboratory and field information, determine if
the Tier II value is consistent with sound
scientific evidence. If it is not, another value,
either higher or lower, shall be derived
consistent with the Guidance in this part.
TABLE A-1.— SECONDARY ACUTE
FACTORS
Number of minimum data re-
quirements satisfied
1
2
3
4
5 ,
g
7
Adjustment
factor
21.9
13.0
8.0
7.0
6.1
5.2
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.
/. 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
ambiisnt water. For the Guidance in this part,
BAFs, rather than BCFs, are used to calculate
Tier I criteria for human health and wildlife
and Tier II values for human health because
they 'better account for the total exposure of
aquatic organisms to chemicals.
C. For organic chemicals, baseline BAFs
can be derived using four methods. Measured
baseline BAFs are derived from 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
-------
Federal Register / Vol. 60, No. 56 / Thursday. March 23, 1995 / Rules and Regulations 15401
tissues and species can be integrated. In
addition, the baseline BAF is based on the
concentration of freely dissolved organic
chemicals in the ambient water to facilitate
extrapolation from one water to another.
D. For inorganic chemicals, baseline BAFs
can be derived using two of the four
methods. Baseline BAFs are derived using
either field-measured BAFs or by multiplying
laboratory-measured BCFs by a FCM. For
inorganic chemicals, BAFs are assumed to
equal BCFs (i.e., the FCM is 1.0), unless
chemical-specific biomagniilcation 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
cither 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.
Octanol-water partition coefficient (Kow).
The ration of the concentration of a substance
in the n-octanol phase to its concentration in
the aqueous phase in an equilibrated two-
phase octanol-water system. For log Kow, the
log of the octanol-water partition coefficient
is a base 10 logarithm.
Uptake. Acquisition of a substance from
the environment by an organism as a result
of any active or passive process.
II, Dofinitions
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
tho 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.
Bloaccumulation. The net accumulation of
a substance by an organism as a result of
uptake from all environmental sources.
Bloaccumulation factor (BAF). The ratio
(in L/kg) of a substance's concentration in
tissuo 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.
Bloconcentration factor (BCF). The ratio (in
L/kg) of a substance's concentration in tissue
of an aquatic organism to its concentration in
tho ambient water, in situations where the
organism is exposed through the water only
and tho ratio does not change substantially
over time.
Biota-sediment accumulation factor
(BSAF). The ratio (in kg of organic carbon/
kg of lipid) of a substance's lipid-nonnalized
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.
m. 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
(ADJURE) 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 tune period.
6. For organic chemicals with log KoW
greater than four, the concentrations of POC
and DOC in the ambient water shall be either
measured or reliably estimated.
7. For inorganic and organic chemicals,
BAFs shall be used only if they are expressed
on a wet weight basis; BAFs reported on a
dry weight basis cannot be converted to wet
weight unless a conversion factor is
measured or reliably estimated for the tissue
used in the determination of the BAF.
C. Field-Measured BSAFs. The following
procedural and quality assurance
requirements shall be met for field-measured
BSAFs:
1. The field studies used shall be limited
to those conducted in the Great Lakes System
with fish at or near the top of the aquatic
food chain (i.e., in trophic levels 3 and/or 4).
2. Samples of surface sediments (0-1 cm is
ideal) shall be from locations in which there
is net deposition of fine sediment and is
representative of average surface sediment in
the vicinity of the organism.
3. The KowS used shall be acceptable
quality as described in section ffl.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
'abo
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 flow-through or renewal
procedure.
4. For organic chemicals, the percent lipid
shall be either measured or reliably estimated
for the tissue used in the determination of the
BCF. '•
5. For organic chemicals with log K<,w
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 hi the test solutions in a
bioconcentration test, the BCF measured at
the lowest test concentration that is above
concentrations existing in the control water
shall be used (i.e., a BCF should be
calculated from a control ^treatment). The
concentrations of an inorganic chemical in a
bioconcentration test should be greater than
normal background levels and greater than
levels required for normal nutrition of the
test species if the chemical is a
micronutrient, but below levels that
adversely affect the species.
Bioaccummulation of an inorganic chemical
might be overestimated if concentrations are
at or below normal background levels due to,
for example, nutritional requirements of the
test organisms.
8. For inorganic and organic chemicals,
BCFs shall be used only if they are expressed
on a wet weight basis. BCPs 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 iof the BAF.
9. BCFs for organic chemicals may be
based on measurement or radioactivity only
when the BCF is intended'to include
metabolites or when there is confidence that
there is no interference due to metabolites.
10. The calculation of the BCF must
appropriately address growth dilution.
11. Other aspects of the methodology used
should be similar to those described by
ASTM (1990).
-------
15402 Federal Register / Vol. 60, No. 56 / Thursday, March 23. 1995 / Rules and Regulations
E. Predicted BCFs. The following
procedural and quality assurance
requirements shall be met for predicted
BCFs:
1. The Kow used shall be of acceptable
quality as described in section III.F below.
2. The predicted baseline BCF shall be
calculated using the equation: predicted
baseline BCF = Kow
where:
Kow = octanol-water partition coefficient.
F. Octanol-Water Partition Coefficient
(Kow). 1. The value of Kow used for an organic
chemical shall be determined by giving
priority to the experimental and
computational techniques used as follows:
Log Kow < 4:
Priority
Technique
fewer than three significant digits after the
decimal point.
G. This methodology provides overall
guidance for the derivation of BAFs, but it
cannot cover all the decisions that must be
made in the review and selection of
acceptable data. Professional judgment is
required throughout the process. A degree of
uncertainty is associated with the
determination of any BAF, BSAF, BCF or
Kow The amount of uncertainty in a baseline
BAF depends on both the quality of data
available and the method used to derive the
BAF.
H. Hereinafter in this methodology, the
terms BAF, BSAF, BCF and Kow refer to ones
that are consistent with the procedural and
quality assurance requirements given above.
Where:
CB=concentration of the organic chemical in
the tissue of aquatic biota (either whole
orgEinism or specified tissue) ((ig/g).
fi=fraction of the tissue that is lipid.
B. Bioavailability. By definition, baseline
BAFs ar.d 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
IV. Four Methods for Deriving Baseline BAFs water shall be calculated using the following
1 Slow-stir. Baseline BAFs shall be derived using the equation:
Generator-column. following four methods, which are listed
Shake-flask from most preferred to least preferred:
2 Reverse-phase liquid A. A measured baseline BAF for an organic
chromatography on or inorganic chemical derived from a Held where:
C18 chromatography study of acceptable quality. Cfdw=fr(Jely dissolved concentration of the
packing with extrapo- B. A predicted baseline BAF for an organic organic chemical in the ambient water;
lation to zero percent chemical derived using field-measured C'w=total concentration of the organic
solvent. BSAFs of acceptable quality. chemical in the ambient water;
3 Reverse-phase liquid C. A predicted baseline BAF for an organic f fraction of the total chemical in the
chromatography on or inorganic chemical derived from a BCF ambient water that is freely dissolved.
rift rhrnmatnnranhv measured in a laboratory study ol acceptable .
UiBcnromatograpny jitv and a FCM The fraction of the total chemical in the
»^™£«™ tn07Pm~ D. A predicted baseline BAF for an organic ambient water that is freely dissolved, ffd,
Sn solvent chemical derived from a Kow of acceptable shall bo calculated using the following
4 CaSed'byfhe quality and a FCM. equation:
CLOGP program. For comparative purposes, baseline B At s
innit ^ A. many of the four methods as available data *fd ~ (DOCKK ) ~ T
1X18 K°">4- allow. 1 + - ^-2^ + (POC)(Kow)
Priority Technique v. Calculation of Baseline BAFs for Organic
Chemicals where-
1 ,
1 .
2
vent.
Reverse-phase
. «~u., nn O1ft rhmma ClOBS UUl IUOA.C ally UIIIGIGUVJO v»*iw«.*»w* "*« — --
tograpny on o i o cnromd- ^ sampie is whole body or edible C. Food-Chain Multiplier. In the absence of
ography packing without ex- ^ b£ both the BAp (or BCp) and ^ a field..meagured BAF or a predicted BAF
trapolation to zero percent sol- £ercent lipid must be determined for the derived from a BSAF, a FCM shall be used
cht 'fl \, same tissue. The percent lipid of the tissue to calculate the baseline BAF for trophic
4 5 , , » j i, «, r-\r^o ™*. should be measured during the BAF or BCF levels 3 and 4 from a laboratory-measured or
5 Calculated by the CLOGP pro- gmdy> but m gome ^^ u can be reliably predicted BCF. For an organic chemical, the
flram- ___ estimated from measurements on tissue from pcM used shall be derived from Table B-l
9 Tl,» n nrp nrooram is a comouter other organisms. If percent lipid is not using the chemical's log Kow and linear
2. The CLOGP program is a computer reported for the test organisms in the original interpolation. A FCM greater than 1.0 applies
Program_available from PomonaCollege._A ^ ^ may be (.M*>A from ^ author. or> ^ ^ ^^ chemgals witfl a log Kow of
in the case of a laboratory study, lipid data four o]r more. The trophic level used shall
for the same or a comparable laboratory take into account the age or size of the fish
• u ! i v, 11 K» fi,= ™™r,»trin moan population of test organisms that were used species consumed by the human, avian or
organic chemcal shall be ™£"™*™:££* fn &e original study may be used. mammalian predator because, for some
of the available KowS with highest priorityor g ^ fipid.normalized concentration, C,, species of fish, the young are in trophic level
of a chemical in tissue is defined using the 3 whereas the adults are in trophic level 4.
following equation: D. Calculation of a Baseline BAF from a
fn'thVderivation of a BAF, the value used for c Field.Measured ^^^B^11 be
the Kow of a chemical should not be rounded C =-^- calculated from a field-measured BAF of
to fewer than three significant digits and a ^ f acceptable quality using the following
value for log Kow should not be rounded to 1 equation:
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15403
Baseline BAF -
Measured BAFJ 1
Whore:
BAF^sBAF based on total concentration in
tissue and water.
fi-fraction of the tissue that is lipid.
infraction 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-l for the
chemical.
E. Calculation of a Baseline BAF from a
Field-Measured BSAF. 1. A baseline BAF for
organic chemical "i" shall be calculated from
a field-measured BSAF of acceptable quality
using the following equation:
(Baseline BAF). = (Baseline BAF) . (BSAF), • (Kow).
* (BSAF)r - (Kow)r
Where:
(BSAF)|sBSAF for chemical "i".
(BSAF),sBSAF for the reference chemical
"r".
(Kow)i=octanol-water partition coefficient for
chemical "i".
(Kow)r=octanol-water partition coefficient for
the reference chemical "r".
2. A BSAF shall be calculated using the
following equation:
BSAF = -
-soc
Where:
Q=tho llpld-normalized concentration of the
chemical in tissue.
Cscc=tho organic carbon-normalized
concentration of the chemical in
sediment.
3. The organic carbon-normalized
concentration of a chemical in sediment,
Csoci shall be calculated using the following
equation:
c -
<--
oc
Where:
Cs=concentration of chemical in sediment
(ug/g sediment).
foc=fraction of the sediment that is organic
carbon.
4. Predicting BAFs from BSAFs requires
data from a steady-state (or near steady-state)
condition between sediment and ambient
water for both a reference chemical "r" with
a field-measured BAFiw and other chemicals
"n=i" for which BSAFs are to be determined.
5. The trophic level to which the baseline
BAF applies is the same as the trophic level
of the organisms used in the determination
of the BSAF. For each trophic level, a species
mean baseline BAF shall be calculated as the
geometric mean if more than one baseline
BAF is predicted from BSAFs for a given
species. For each trophic level, the geometric
mean of the species mean baseline BAFs
derived using BSAFs shall be calculated.
6. If a baseline BAF based on a measured
BSAF is available for either trophic level 3
or 4, but not both, a baseline BAF for the
other trophic level shall be calculated using
the ratio of the FCMs that are obtained by
linear interpolation from Table B-l for the
chemical. r
F. Calculation of a Baseline BAF from a
Laboratory-Measured BCF. A baseline BAF
for trophic level 3 and a:baseline BAF for
trophic level 4 shall be calculated from a
laboratory-measured BCF of acceptable
quality and a FCM using the following
equation:
Baseline BAF - (FCM^
Measured BCF!
Where:
BCFVBCF based on total concentration in
tissue and water.
{/•fraction of the tissue that is lipid.
frj=fractlon of the total chemical in the test
water that is freely dissolved.
FCMsthe food-chain multiplier obtained
from Table B-l by linear interpolation
for trophic level 3 or 4, as necessary.
For each trophic level, a species mean
basolino 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 Kow of acceptable quality
and a FCM using the following equation:
Baseline BAF=(FCM) (predicted baseline
BCFHFCM) (Kow)
Where:
FCM=the food-chain multiplier obtained
from Table B-l by linear interpolation
for trophic level 3 or 4, as necessary.
Kow=octanol-water partition coefficient.
V7. Human Health and Wildlife BAFs for
Organic Chemicals
A. To calculate human health and wildlife
BAFs for an organic chemical, the Kow of the
-------
15404 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules.and Regulations
chemical shall be used with a POC
concentration of 0.00000004 kg/L and a DOC
concentration of 0.000002 kg/L to yield the
fraction freely dissolved:
i+(DOC)(Kow)+(POC)(Kow)
10
(0.000002 kg/L)(KOW) + (0 00000004kg/ L)(KO
10
1 + (0.00000024 kg / L)(KOW )
B. The human health BAFs for an organic For trophic level 3:
chemical shall be calculated using the
following equations:
For trophic level 4:
Human Health BAF™3 = [(baseline BAF)(0.0182) + l](ffd)
Human Health BAF™ = [(baseline BAF)(0.0310) + l](ffd)
w, 4, respectively, that are used to derive human C. The wildlife BAFs for an organic
,. j j- j health criteria and values for the GLI. chemical shall be calculated using the
0.0182 and 0.0310 are the standardized nealm criteria ana vaiueb 101 me u following equations:
fraction lipid values for trophic levels 3 and For trophic level 3:
For trophic level 4:
Wildlife BAE£j =[(baseline BAF)(0.0646) + l](ffd)
Wildlife BAF^ =[(baseline BAF)(0.1031)+l](ffd)
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. lit an acceptable measured baseline BAF
is not available for an inorganic chemical and
one o:r more acceptable edible-portion
laboratory-measured BCFs are available for
the chemical, a predicted baseline BAF shall
be calculated by multiplying the geometric
mean of the BCFs times a FCM. The FCM
will be 1.0 unless chemical-specific
biomiagnification 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. SAFsfor 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
BCFsi are similar to whole-body BAFs or
BCFs:.
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15405
2. If one or more field-measured baseline
BAFs for an inorganic chemical are available
from studies conducted in the Great Lakes
System with whole body of fish or
invertebrates:
2. For each trophic level, a species mean
measured baseline BAF shall be calculated as
the geometric mean if more than one
measured BAF is available for a given
species,
b. For each trophic level, the geometric
moan of the species mean measured baseline
BAFs shall be used as the wildlife BAF for
that chemical.
3. If an acceptable measured baseline BAF
is not available for an inorganic chemical and
one or more acceptable whole-body
laboratory-measured BCFs are available for
the chemical, a predicted baseline BAF shall
be calculated by multiplying the geometric
mean of the BCFs times a FCM. The FCM
will be 1.0 unless chemical-specific
biomagnification data support using a
multiplier other than 1.0. The predicted
baseline BAF shall be used as the wildlife
BAF for that chemical.
Vni. Final Review
For both organic and inorganic chemicals,
human health and wildlife BAFs for both
trophic levels shall be reviewed for
consistency with all available data
concerning the bioaccumulation,
bioconcentration, and metabolism of the
chemical. For example, information
concerning octanol-water partitioning,
molecular size, or other physicochemical
properties that might enhance or inhibit
bioaccumulation should be considered for
organic chemicals. BAFs derived in
accordance with this methodology should be
modified if changes are justified by available
data.
IX. Literature Cited
ASTM. 1990. Standard Practice for
Conducting Bioconcentration Tests with
Fishes and Saltwater Bivalve Molluscs.
Standard E 1022. American Society for
Testing and Materials, Philadelphia, PA.
TABLE B-1.—FOOD-CHAIN MULTIPLIERS FOR TROPHIC LEVELS 2, 3 & 4
Log Kow
2.0
2.5
3.0
3.1
32
35
3.4
3.5
3.6
3.7
3.8
3.9
4.0
4.1
4.2
4.3 '
4.4
4.5
4.6
4.7
4.8
4.9
5.0
5.1
52
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6.0
6.1
6.3
6.4
6.5
6.6 ;
6.7
6.8
6.9
7.0
7.1
7.2
7.3
7A
7.5
7.6
7.7
7.8
7.9
8.0
8.1
Trophic
level 2
.uuu
.uuu
.uuu
.uuu
1.000
1.000
1 nnn
.UUU
.UUU
l.UUU
.UUU
.UUU
1.000
Trbphici
level 3
.UUb
1.010
.028
1.034
• 1 .042
1.053
i 1 .06.7
1.083
.103
1.128
1.161
1 1 .202
1 .253
1.315
.380
.491
1.614
1 .766
, 2.175
2.452
2.780
3.181
3.643
' 4.188
, 4.803
5.502
6.266
/.Usb
, 7.962
9./16
10.556
11.337
12.064
|1 2.691
1 o.Z2o
1 o.obZ
,14.223
1 4.355
14.OOO
14.305
14.142
1 0.802
1 0.474
1 2.987
12.517
11. AJ8
il 0.91 4
1 0.069
9.162
' 8.222
7.278
Trophic
level 4
1.000
1.002
1.007
1.007
1.009
1.012
1.014
1.019
1.023
1.033
1.042
1.054
1.072
1.096
1.130
1.178
1.242
1.334
1.459
1.633
1.871
2.193
2.612
3.162
3.873
4.742
5.821
7.079
8.551
10.209
12.050
13.964
15.996
17.783
19.907
21 .677
23.281
24.604
25.645
26.363
26.669
26.669
26.242
25.468
24.322
22.856
21 .038
1 8.967
16.749
14.388
12.050
9.840
7.798
fini!>
-------
154OS
Federal Register / Vol. 60. No. 56 / Thursday. March 23. 1995 / Rules and Regulation^
TABLE B-1 .—FOOD-CHAIN MULTIPLIERS FOR TROPHIC LEVELS 2, 3 & 4—Continued
Log K0w
8.2
8.3
8.4 ,
8.5
8.6
8.7
8.8
8.9
9.0
Trophic
level 2
1.000
1.000
1.000
1.000
1.000
' 1 000
1.000
1.000
1.000
Trophic1
levels
6.361
5.489
4.683
3.949
3.296
2.732
2.246
1.837
1.493
Trophic
level 4
4.519
3.311
2.371
1.663
1.146
0.778
0.521
0.345
0.226
' 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 water-oriented recreational
activities.
B. Definitions.
Acceptable daily exposure (ADE). An
estimate of the maximum daily dose of a
substance which is not expected to result in
adverse noncancer effects to the general
human population, including sensitive
subgroups.
Adverse effect. Any deleterious effect to
organisms due to exposure to a substance.
This includes effects which are or may
become debilitating, harmful or toxic to the
normal functions of the organism, but does
not include non-harmful effects such as
tissue discoloration alone or the induction of
enzymes involved in the metabolism of the
substance.
Carcinogen. A substance which causes an
increased incidence of benign or malignant
neoplasms, or substantially decreases the
time to develop neoplasms, in animals or
humans. The classification of carcinogens is
discussed in section II. A of appendix C to
part 132.
Human cancer criterion (HCC). A Human
Cancer Value (HCV) for a pollutant that
meets the minimum data requirements for
Tier I specified in appendix C.
Human cancer value (HCV). The maximum
ambient water concentration of a substance at
which a lifetime of exposure from either:
drinking the water, consuming fish from the
water, and water-related recreation activities;
or consuming fish from the water, and 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).
Th'e 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/kgrnay) which, over a lifetime of
exposure, is estimated to be associated with
a plausible upper bound incremental cancer
risk equal to one in 100,000.
Slope factor. Also known as qi*, 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 he 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.
n. Minimum Data Requirements
The best available toxicity data on the
adverse health effects of a chemical and the
best data on bioaccumulation factors shall be
used when developing human health Tier I
criteria or Tier II values. The best available
toxicity data shall include data from well-
-------
Federal Register / Vol. 60. No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15407
conducted epidemiologic and/or animal
studios which provide, in the case of
carcinogens, an adequate weight of evidence
of potential human carcinogenicity and, in
tho case of noncarcinogens, a dose-response
relationship involving critical effects
biologically relevant to humans. Such
Information should be obtained from the EPA
Integrated Risk Information System (IRIS)
database, the scientific literature, and other
informational databases, studies and/or
reports containing adverse health effects data
of adequate quality for use in this procedure.
Strong consideration shall be given to the
most currently available guidance provided
by IRIS in deriving criteria or values,
supplemented with any recent data not
incorporated into IRIS. When deviations from
IRIS are anticipated or considered necessary,
It is strongly recommended that such actions
bo communicated to the EPA Reference Dose
(RfD) and/or the Cancer Risk Assessment
Verification Endeavor (CRAVE) workgroup
immediately. The best available
bioaccumulation data shall include data from
field studies and well-conducted laboratory
studios.
A. Carcinogens. Tier I criteria and Tier U
values shall be derived using the
methodologies described in section III.A of
this appendix when there is adequate
ovidonce 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,
1988), or future modifications thereto, be
used in determining whether adequate
evidence of potential carcinogenic effects
exists. Carcinogens are classified, depending
on tho 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)
tho 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
ovidonco cannot be interpreted as showing
either tho presence or absence of a
carcinogenic effect.
Chemicals are described as "human
carcinogens" when there is sufficient
evidence from epidemiological studies to
support a causal association between
exposure to the chemicals and cancer.
Chemicals described as "probable human
carcinogens" include chemicals for which
the weight of evidence of human
carcinogenicity based on epidemiological
studies is limited. Limited human evidence
is that which indicates that a causal
Interpretation is credible, but that alternative
explanations, such as chance, bias, or
confounding, cannot adequately be excluded.
Probable human carcinogens are also agents
for which there is sufficient evidence from
animal studies and for which there is
inadequate evidence or no data from
epidemiologic studies. Sufficient animal
evidence is data which indicates that there is
an increased incidence of malignant tumors
or combined malignant and benign tumors:
(a) in multiple species or strains; (b) in
multiple experiments (e.g., with different
routes of administration or using different
dose levels); or (c) to an unusual degree in
a single experiment with regard to high
incidence, unusual site or type of tumor, or
early age at onset. Additional evidence may
be provided by data on dose-response effects,
as well as information from short-term tests
(such as mutagenicity/genotoxicity tests
which help determine whether the chemical
interacts directly with DNA) or on chemical
structure, metabolism or mode of action.
"Possible human carcinogens" are
chemicals with limited evidence of
carcinogenicity in animals in the absence of
human data. Limited animal evidence is
defined as data which suggests a
carcinogenic effect but are limited because:
(a) The studies involve a single species,
strain, or experiment and do not meet criteria
for sufficient evidence (see preceding
paragraph); or (b) the experiments are
restricted by inadequate dosage levels,
inadequate duration of exposure to the agent,
inadequate period of follow-up, poor
survival, too few animals, or inadequate
reporting; or (c) the studies indicate an
increase in the incidence of benign tumors
only. More specifically, this group can
include a wide variety of evidence, e.g., (a)
a malignant tumor response in a single well-
conducted 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 IHCC 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. TierU: Weight of evidence of possible
human carcinogenic effects sufficient to
derive a Tier U 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 limijted to available
information on mode of action such as
mutagenicity/genotoxicity (determinations of
whether the chemical interacts directly with
DNA), structure activity and metabolism. As
with the use of data on possible human
carcinogens in developing Tier I criteria, the
decision to use data on possible human
carcinogens to derive Tier II values shall be
made on a case-by-case basis.
B. Noncarcinogens. All available toxicity
data shall be evaluated considering the full
range of possible health;effects of a chemical,
i.e., acute/subacute, chronic/subchronic and
reproductive/developmental effects, in order
to best describe the dose-response
relationship of the chemical, and to calculate
human noncancer criteria and values which
will protect against the most sensitive
endpoint(s) of toxicity. Although it is
desirable to have an extensive database
which considers a wide range of possible
adverse effects, this type of data exists for a
very limited number of chemicals. For many
others, there is a range in quality and
quantity of data available. To assure
minimum reliability of criteria and values, it
is necessary to establish a minimum database
with which to develop Tier I criteria or Tier
II values. The following represent the
minimum data sets necessary for this
procedure.
1. Tier I: The minimum data set sufficient
to derive a Tier I human HNC shall include
at least one well-conducted epidemiologic
study or animal study. A well-conducted
epidemiologic study for a Tier I HNC must
quantify exposure level(s) and demonstrate
positive association between exposure to a
chemical and adverse effect(s) in humans. A
well-conducted study in animals must
demonstrate a dose response relationship
involving one or more critical effect(s)
biologically relevant to humans. (For
example, study results from an animal whose
pharmacokinetics and toxicokinetics match
those of a human would be considered most
biologically relevant.) Ideally, the duration of
a study should span multiple generations of
exposed test species or at least a major
portion of the lifespan of one generation.
This type of data is currently very limited. By
the use of uncertainty adjustments, shorter
term studies (such as 90-day subchronic
studies) with evaluation of more limited
effect(s) may be used to extrapolate to longer
exposures or to account for a variety of
adverse effects. For Tier I criteria developed
pursuant to this procedure, such a limited
study must be conducted for at least 90 days
in rodents or 10 percent of the lifespan of
other appropriate test species and
demonstrate a no observable adverse effect
level (NOAEL). Chronic studies of one year
or longer in rodents or 50 'percent of the
lifespan or greater in other appropriate test
species that demonstrate a lowest observable
adverse effect level (LOAEL) may be
sufficient for use in Tier I criterion derivation
if the effects observed at the LOAEL were
relatively mild and reversible as compared to
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 /
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 H: 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 dose-
response, and involving effects biologically
relevant to humans. Data from studies of
longer duration (greater than 28 days) and
LOAELs from such studies (greater than 28
days) may be more appropriate in some cases
for derivation of Tier II values. Use of a
LOAEL should be based on consideration of
the following information: severity of effect,
quality of the study and duration of the
study.
C. Bioaccumulation factors (BAFs).
1. Tier I for Carcinogens and
Noncarcinogens: To be considered a Tier I
cancer or noncancer human health criterion,
along with satisfying the minimum toxicity
data requirements of sections II. A.I and II.B.l
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.I
and II.B.1 of this appendix or the minimum
bioaccumulation data requirements of section
II.C.1 of this appendix.
m. Principles for Development of Tier I
Criteria or Tier H 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 H 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
be adjusted to give an average daily dose over
the study duration. Adjustments in the rate
of tumor response must be made for early
mortality in test species. The goodness-of-fit
of the model to the data must also be
assessed.
7. When a linear, non-threshold dose
response relationship is assumed, the RAD
shall be calculated using the following
equation:
RAD =
0.00001
Qi*
IO a lllloai iztsu iiiuiiiaiago v.w**»j**"«» •—•
(e.g., Global '86 or equivalent model). Global
'86 is the linearized multistage model,
derived by Howe, Crump and Van
Landingham (1986), which EPA uses to
determine cancer potencies. The 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 case-by-case basis.
6. Additional data selection and
adjustment decisions must also be made in
the process of quantifying risk. Consideration
must be given to tumor selection for
modeling, e.g., pooling estimates for multiple
tumor types and identifying and combining
benign and malignant tumors. All doses shall
Where:
RAD=risk associated dose in milligrams-of
toxicant per kilogram body weight per
day (mg/kg/day).
0.00001 (1x10 - 5)=incremental risk ot
developing cancer equal to one in
100,000.
q,*=slope factor (mg/kg/day)~l.
8. If human epidemiologic data and/or
other biological data (animal) indicate that a
chemical causes cancer via a threshold
mechaniism, 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. Noiacarcinogens shall generally be
assumed to have a threshold dose or
concentration below which no adverse effects
should be observed. Therefore, tKe Tier I
criterion or Tier H 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 gencitoxic 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
toxico logic 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., well-
condvicted 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 lowost administered dose (given a
relevimt route of exposure), should generally
be used.
-------
Federal Register
3. Minimum data requirements are
specified in section H.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
H.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 H.B of this appendix may be used
If it is based on relatively mild and reversible
affects.
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 bo used when extrapolating from
animal studies for which the exposure
duration is less than chronic, but greater than
subchronlc (e.g., 90 days or more in length),
or when other significant deficiencies in
study quality are present, and when useful
Thursday, March 23, 1995
Rules and Regulations 15409
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 Valu$ Derivation.
I.- 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 site-
specific criteria pursuant to procedure 1 in
appendix F to part 132.
BW = body weight of an average human
WC
-------
Thursday, March 23, 1995 / Rules and Regulations
^
FGrL3=mean consumption of trophic level 3
fish by regional sport fishers of
regionally caught freshwater fish=0.0036
FGrL4=mean consumption of trophic level 4
fish by regional sport fishers of
regionally caught freshwater fish=0.0114
kg/day. , .
BAFHtlrL3=human health bioaccumulation
factor for edible portion of trophic level
3 fish, as derived using the B AF
methodology in appendix B to part 132.
BAFHHTL4=human health bioaccumulation
factor for edible portion of trophic level
4 fish, as derived using the BAF
methodology in appendix B to part 132.
IV. References
A. Howe, R.B., K.S. Crump and C. Van
Landingham. 1986. Computer Program to
Extrapolate Quantitative Animal Toxicity
Data to Low Doses. Prepared for EPA under
subcontract S2-251U-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 ot
Water Resource Center (WH-550A), 401 M
St., SW., Washington, DC 20460.
Appendix D to Part 132—Great Lakes Water
Quality Initiative Methodology for the
Development of Wildlife Criteria
Great Lakes States and Tribes shall adopt
provisions consistent with (as protective as)
this appendix.
I. Introduction
A A Great Lakes Water Quality Wildlife
Criterion (GLWC) is the concentration of a
substance which is likely to, if not exceeded,
protect avian and mammalian wildlife
populations inhabiting the Great Lakes basin
from adverse effects resulting from the
ingestion of water and aquatic prey taken
from surface waters of the Great Lakes
System. These criteria are based on existing
toxicological studies of the substance of
concern and quantitative information about
the exposure of wildlife species to the
substance (i.e., food and water consumption
rates). Since toxicological and exposure data
for individual wildlife species are limited, a
GLWC is derived using a methodology
similar to that used to derive noncancer
human health criteria (Barnes and Dourson,
1988; NAS, 1977; NAS, 1980; U.S. EPA,
1980). Separate avian and mammalian values
are developed using taxonomic class-specific
toxicity data and exposure data for five
representative Great Lakes basin wildlife
species. The wildlife species selected are
representative of avian and mammalian
species resident in the Great Lakes basin
which are likely to experience the highest
exposures to bioaccumulative contaminants
through the aquatic food web; they are the
bald eagle, herring gull, belted kingfisher,
mink, and river otter.
B. This appendix establishes a
methodology which is required when
developing Tier I wildlife criteria for
bioaccumulative chemicals of concern
(BCCs). The use of the equation provided in
the methodology is encouraged, but not
required, for the development of Tier I
criteria or Tier II values for pollutants other
than those identified in Table 6-A for which
Tier I criteria or Tier II values are determined
to be necessary for the protection of wildlife
in the Great Lakes basin. A discussion of the
methodology for deriving Tier II values can
be found in the Great Lakes Water Quality
Initiative Technical Support Document for
Wildlife Criteria (Wildlife TSD).
C. In the event that this methodology is
used to develop criteria for pollutants other
than BCCs, or in the event that the Tier II
methodology described in the Wildlife TSD
is used to derive Tier II values, the
methodology for deriving bioaccumulation
factors under appendix B to part 132 must be
used in either derivation. For chemicals
which do not biomagnify to the extent of
BCCs, it may be appropriate to select
different representative species which are
better examples of species with the highest
exposures for the given chemical. The
equation presented in this methodology,
however, is still encouraged. In addition,
procedure 1 of appendix F of this part
describes the procedures for calculating 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.
H. Calculation of Wildlife Values for Tier I
Criteria
Table 4 of Part 132 and Table D-l of this
appendix contain criteria calculated by EPA
using the methodology provided below.
A. Equation for Avian and Mammalian
Wildlife Values. Tier I wildlife values for the
pollutants designated BCCs pursuant to part
132 are to be calculated using the equation
presented below.
WV=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.
UFA=Uncertainty Factor (UF) for
extrapolating toxicity data across species
(unitless). A species-specific UF shall be
selected and applied to each
representative species, consistent with
the equation.
UFs=UF for extrapolating from subcnromc to
chronic exposures (unitless).
UFL=UF for LOAEL to NOAEL extrapolations
(unitless).
Wt=Average weight in kilograms (kg) lor tne
representative species.
W=Ave:rage daily volume of water consumed
in liters per day (L/d) by the
representative species.
FTU=Average daily amount of food consumed
from trophic level i in kilograms per day
(kg/d) by the representative species.
BAFWLn.i=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
represientative 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.
TD
UFAxUFsxUFL
-xWt
Where:
m. Parameters of the Effect Component of
the Wildlife Criteria Methodology
A. Definitions. The following definitions
provide additional specificity and guidance
in the evaluation of toxicity data and the
application of this methodology.
Acceptable endpoints. For the purpose of
wildlife criteria derivation, acceptable
subchronic and chronic endpoints are those
which affect reproductive or developmental
success, organismal viability or growth, or
any other endpoint which is, or is directly
related to, parameters that influence
population dynamics.
-------
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.
• •wjwwtwu «**u t2£/au VJ1 Alltf OlUKC*
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
whore higher doses or concentrations
resulted in an adverse effect.
Subchronic effect. An adverse effect,
measured by assessing an acceptable
endpoint, resulting from continual exposure
fora 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
studios, where such studies are of adequate
quality. An acceptable field study must be of
subchronic or chronic duration, provide a
defensible, chemical-specific dose-response
curve in which cause and effect are clearly
established, and assess acceptable endpoints
as defined in this document. When
acceptable wildlife field studies are not
available, or determined to be of inadequate
quality, the needed toxicity information may
come from peer-reviewed laboratory studies.
When laboratory studies are used, preference
shall be given to laboratory studies with
wildlife species over traditional laboratory
animals to reduce uncertainties in making
interspeclos extrapolations. All available
laboratory data and field studies shall be
reviewed to corroborate the final GLWC, to
assess the reasonableness of the toxicity
value used, and to assess the appropriateness
of any UFs which are applied. When
evaluating the studies from which a test dose
is.derived in general, the following
requirements must be met:
1. The mammalian data must come from at
least one well-conducted study of 90 days or
greater designed to observe subchronic or
chronic effects as defined in this document.
2. The avian data must come from at least
one well-conducted study of 70 days or
greater designed to observe subchronic or
chronic effects as defined in this document.
3. In reviewing the studies from which a
TD is derived for use in calculating a WV,
studios 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 toxicitv
study. J
C. Selection ofTD 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
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 Cmg/kg), the TD shall be
multiplied by the average amount of food in
kilograms consumed daily by the test animals
(kg/d) and divided by the average weight of
the test animals in kilograms (kg).
E. Drinking and Feeding Rates. 1. When
drinking and feeding rates and body weight
are needed to express the TD in milligrams
of substance per kilograms per day (mg/kg/
d), they are obtained from the study from
which the TD was derived. If not already
determined, body weight, and drinking and .
feeding rates are to be converted to a wet
weight basis.
2. If the study does not provide the needed
values, the values shall be determined from
appropriate scientific literature. For studies
done with domestic laboratory animals,
either the Registry of Toxic Effects of
Chemical Substances (National Institute for
Occupational Safety and Health, the latest
edition, Cincinnati, OH), or
Recommendations for and Documentation of
Biological Values for Use in Risk Assessment
(U.S. EPA, 1988) should be consulted. When
these references do not contain exposure
information for the species used in a given
study, either the allom'etric 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. i
3. For mammalian species, the general
allometric equations are:
a. F = 0.0687 x (Wt)°-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)°-«>
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)o-«5
Where:
F = Feeding rate of avian species in kilograms
per day (kg/d) dry weight.
Wt = Average weight inkilograms (kg) of the
test animals.
b. W = 0.059 x (Wt)°-«7
Where:
W = Drinking rate of avian species in liters
per day (L/d). ;
Wt = Average weight in kilograms (kg) of the
test animals.
F. LOAEL to NOAEL Extrapolations (UFL).
In those cases in which a NOAEL is
unavailable as the TD and a LOAEL is
available, the LOAEL may be used to
estimate the NOAEL. If used, the LOAEL
shall be divided by an UF to estimate a
NOAEL for use in deriving WVs. The value
of the UF shall not be less than one and
should not exceed 10, depending on the
dose-response curve andiany other available
data, and is represented by UFL in the
equation expressed in Section II.A of this
appendix. Guidance for selecting an
appropriate UFL, based on a review of
available wildlife toxicity data, is available in
the Wildlife TSD.
G. Subchronic to Chronic Extrapolations
(USS). In instances where only subchronic
data are available, the TD may be derived
from subchronic data. In such cases, the TD
shall be divided by an UF to extrapolate from
subchronic to chronic levels. The value of the
UF shall not be less than one and should not
exceed 10, and is represented by UFS in the
equation expressed in Seqtion 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
-------
.
underestimates chronic effects. Guidance for
selecting an appropriate UFS, based on a
review of available wildlife toxicity data, is
available in the Wildlife TSD.
H Interspecies Extrapolations (UFfJ. 1.
The selection of the UFA shall be based on
the available toxicological data and on
available data concerning the
physicochemical, toxicokinetic, and
toxicodynamic properties of the substance m
question and the amount and quality of
available data. This value is an UF that is
intended to account for differences in
toxicological sensitivity among species.
Guidance for selecting an appropriate UFA,
based on a review of available wildlife
toxicity data, is available in the Wildlife TSD.
Additional discussion of an interspecies UF
located in appendix A to the Great Lakes
Water Quality Initiative Technical Support
Document for Human Health Criteria may be
useful in determining the appropriate value
for UFA.
2. For the derivation of Tier I criteria, a
UFA shall not be less than one and should
not exceed 100, and shall be applied to each
of the five representative species, based on
existing data and best professional judgment.
The value of UFA may differ for each of the
representative species.
3 For Tier I wildlife criteria, the UFA shall
be used only for extrapolating toxicity data
across species within a taxonomic class,
except as provided below. The Tier IUFA is
not intended for interclass extrapolations
because of the poorly defined comparative
toxicokinetic and toxicodynamic parameters
between mammals and birds. However, an
interclass extrapolation employing a UFA
may be used for a given chemical if it can
be supported by a validated biologically-
IV. Parameters of the Exposure Component
of the Wildlife Criteria Methodology
A Drinking and Feeding Rates of
Representative Species. The body weights
(Wt), feeding rates (FTH), 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 m
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 m
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 amd 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 tor,
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
;i Substance
2,3,7,8-TCDD
Criterion
(HO/L)
1.1 E-5
1.3E-3
7.4E-5
3.1 E-9
portea oy a vaiiuaicu un"«Bl>j"*v __—,/»•.•
TABLE D-2.-EXPOSURE PARAMETERS FOR THE FIVE REPRESENTATIVE SPECIES IDEMTIF.ED FOR PROTECTS
Species (units)
!—
Mink
Otter
Kingfisher
Herring gull
Bald eagle
NOTE: TL3=trophic level thre
Adult body
weight (kg)
_ _— — ^— ^— —
0.80
7.4
0.15
1.1
4.6
Water in-
gestion rate
(L/day)
.^ — — — —
0.081
0.600
0.017
0.063
0.160
• •
Food ingestion rate of prey in each
trophic level (kg/day)
TL3; 0.977; TL4: 0.244
TL3- 0.0672
TL3: 0.192; TL4: 0.0480
Other: 0.0267
PB- 00283; Other: 0.0121
Trophic level of prey (percent of diet)
TL3: 90; Other: 10.
TL3: 80; TL4: 20.
TUJ: 100.
Fish: 90— TL3: 80; TL4: 20.
Other: 10.
Fish: 92— TL3: 80; TL4: 20.
Birds: 8— PB: 70; non-aquatic: 30.
fish; TL4=rophic level for fish; PB=piscivorous birds; Other^on-aquatebi.dsanU ,ua aU
Appendix E to Part 132—Great Lakes Water
Quality Initiative Antidegradation Policy
Great Lakes States and Tribes shall adopt
provisions consistent with (as protective as)
appendix E to part 132.
The State or Tribe shall adopt an
antidegradation standard applicable to all
waters of the Great Lakes System and identify
the methods for implementing such a
standard. Consistent with 40 CFR 131.12, an
acceptable antidegradation standard and
implementation procedure are required
elements of a State's or Tribe's water quality
standards program. Consistent with 40 CFR
131.6, a complete water quality standards
submission needs to include both an
antidegradation standard and antidegradation
implementation procedures. At a minimum,
States and Tribes shall adopt provisions in
their antidegradation standard and
implementation methods consistent with
sections I, II, III and IV of this appendix,
applicable to pollutants identified as
bioaccumulative chemicals of concern
(BCCs).
I. Antidegradation Standard
This antidegradation standard shall be
applicable to any action or activity by any
source, point or nonpoint, of pollutants that
is anticipated to result in an increased
loading of BCCs to surface waters of the Great
Lakes System and for which independent
regulatory authority exists requiring
compliance with water quality standards.
Pursuant to this standard:
A. Existing instream water uses, as defined
pursuant to 40 CFR 131, and the level of
water quality necessary to protect existing
uses shall be maintained and protected.
Where designated uses of the waterbody are
unpaired, 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 ot
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 H. A of this appendix and that quality
-------
Federal Register
Thursday, March 23, 1995 / Rules and Regulations
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
Stato 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
Triba 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 sourco of pollutants to waters under its
Jurisdiction that specifies conditions under
which the source is allowed to operate.
High quality waters. High quality waters
are water bodies in which, on a parameter by
parameter basis, the quality of the waters
exceeds levels necessary to support
propagation offish, 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
Lako 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.
Lako 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
3£ MLbenchmark of 'he water quality that
shall be maintained and protected. Waters
that may be considered for designation as
Outstanding National Resource Waters
include, but are not limited to, water bodies
that are recognized as:
Important because of protection through
official action, such as Federal or State law,
Presidential or secretarial action,
international treaty, or interstate compact;
Having exceptional recreational
significance;
Having exceptional ecological significance;
Having other special environmental,
recreational, or ecological attributes; or
waters whose designation as Outstanding
National Resource Waters is reasonably
necessary for the protection of other waters
so designated.
Significant Lowering of Water Quality. A
significant lowering of water quality occurs
when there is a new or increased loading of
any BCC from any regulated existing or new
facility, either point source or nonpoint
source for which there is a control document
or reviewable action, as a result of any
activity including, but not limited to:
(1) Construction of a new regulated facility
or modification of an existing regulated
facility such that a new or modified control
document is required;
(2) Modification of an existing regulated
facility operating under a current control
document such that the production capacity
of the facility is increased;
(3) Addition of a new source of untreated
or pretreated effluent containing or expected
to contain any BCC to an existing wastewater
treatment works, whether public or private;
(4) A request for an increased limit in an
applicable control document;
(5) Other deliberate activities that, based
on the information available, could be
reasonably expected to result in an increased
loading of any BCC to any waters of the Great
Lakes System.
b. Notwithstanding the above, changes in
loadings of any BCC within the existing
capacity and processes, and that are covered
by the existing applicable control document
are not subject to an antidegradation review.
These changes include, but are not limited to:
(1) Normal operational variability;
(2) Changes in intake water pollutants;
(3) Increasing the production hours of the
facility, (e.g., adding a second shift); or
(4) Increasing the rate of production.
C. Also, excluded from an antidegradation
review are new effluent limits based on
improved monitoring data or new water
quality criteria or values that are not a result
of changes in pollutant loading.
B. For all waters, the Director shall ensure
that the level of water quality necessary to
protect existing uses is maintained. In order
to achieve this requirement, and consistent
with 40 CFR 131.10, Water quality standards
use designations must 'include all existing
uses. Controls shall be' established as
necessary on point and nonpoint sources of
pollutants to ensure that the criteria
applicable to the designated use are achieved
in the water and that any designated use of
a downstream water is'protected. Where
water quality does not support the designated
uses of a waterbody or ambient pollutant
concentrations exceed water quality criteria
applicable to that waterbody, the Director
shall not allow a lowering of water quality for
the pollutant or pollutants preventing the
attainment of such uses or exceeding such
criteria.
C. For Outstanding National Resource
Waters:
1. The Director shall ensure, through the
application of appropriate controls on
pollutant sources, that water quality is
maintained and protected.
2. Exception. A short-term, temporary (i.e.,
weeks or months) lowering of water quality
may be permitted by the Director.
D. For high quality waters, the Director
shall ensure that no action resulting in a
lowering of water qualify occurs unless an
antidegrada'tion demonstration has been
completed pursuant to section III of this
appendix and the information thus provided
is determined by the Director pursuant to
section IV of this appendix to adequately
support the lowering of water quality.
1. The Director shall establish conditions
in the control document; applicable to the
regulated facility that prohibit the regulated
facility from undertaking any deliberate
action, such that there would be an increase
in the rate of mass loading of any BCC, unless
an antidegradation demonstration is
provided to the Director and approved
pursuant to section IV of this appendix prior
to commencement of the, action. Imposition
of limits due to improved monitoring data or
new water quality criteria or values, or
changes in loadings of any BCC within the
existing capacity and processes, and that are
covered by the existing applicable control
document, are not subject to an
antidegradation review.
2. For BCCs known or believed to be
present in a discharge, from a point or
nonpoint source, a monitoring requirement
shall be included in the control document.
The control document shall also include a
provision requiring the source to notify the
Director or any increased loadings. Upon
notification, the Director shall require actions
as necessary to reduce or eliminate the
increased loading. ,
3. Fact Sheets prepared 'pursuant to 40 CFR
124.8 and 124.56 shall reflect any conditions
developed under sections JI.D.l 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
-------
•—• • •
Lake Superior bioaccumulative substances of
immediate concern from point sources in
these areas.
2. States and Tribes may designate all
waters of the Lake Superior Basin as
Outstanding International Resource Waters
for the purpose of restricting the increased
discharge of Lake Superior bioaccumulative
substances of immediate concern from point
sources consistent with the requirements of
sections III.C and IV.B of this appendix.
F. Exemptions. Except as the Director may
determine on a case-by-case basis that the -
application of these procedures is required to
adequately protect water quality, or as the
affected waterbody is an Outstanding
National Resource Water as defined in
section II. A of this appendix, the procedures
in this part do not apply to:
1. Short-term, temporary (i.e., weeks or
months) lowering of water quality;
2. Bypasses that are not prohibited at 40
CFR 122.41(m); and
3. Response actions pursuant to the
Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA),
as amended, or similar Federal, State or
Tribal authorities, undertaken to alleviate a
release into the environment of hazardous
substances, pollutants or contaminants
which may pose an imminent and substantial
danger to public health or welfare.
HI. Antidegradation Demonstration
Any entity seeking to lower water quality
in a high quality water or create a new or
increased discharge of Lake Superior
bioaccumulative substances of immediate
concern in a Lake Superior Outstanding
International Resource Water must first, as
required by sections II.D or II.E.2 of this
appendix, submit an antidegradation
demonstration for consideration by the
Director. States and Tribes should tailor the
level of detail and documentation in
antidegradation reviews, to the specific
circumstances encountered. The
antidegradation demonstration shall include
the following:
A Pollution Prevention Alternatives
Analysis. Identify any cost-effective pollution
prevention alternatives and techniques that
are available to the entity, that would
eliminate or significantly reduce the extent to
which the increased loading results in a
lowering of water quality.
B. Alternative or Enhanced Treatment
Analysis. Identify alternative or enhanced
treatment techniques that are available to the
entity that would eliminate the lowering of
water quality and their costs relative to the
cost of treatment necessary to achieve
applicable effluent limitations.
C. Lake Superior. If the States or Tribes
designate the waters of Lake Superior as
Outstanding International Resource Waters
pursuant to section II.E.2 of this appendix,
then any entity proposing a new or increased
discharge of any Lake Superior
bioaccumulative substance of immediate
concern to the Lake Superior Basin shall
identify the best technology in process and
treatment to eliminate or reduce the extent of
the lowering of water quality. In this case, the
requirements in section ffl.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 HI.D of this appendix.
IV. Antidegradation Decision
A. Once the Director determines that the
information provided by the entity proposing
to increase loadings is administratively
complete, the Director shall use that
information to determine whether or not the
lowering of water quality is necessary, and,
if it is necessary, whether or not the lowering
of water quality will support important social
and economic development in the area. If the
proposed lowering of water quality is either
not necessary, or will not support important
social and economic development, the
Director shall deny the request to lower water
quality. If the lowering of water quality is
necessary, and will support important social
and economic development, the Director may
allow all or part of the proposed lowering to
occur as necessary to accommodate the
important social and economic development.
In no event may the decision reached under
this section allow water quality to be lowered
below the minimum level required to fully
support existing and designated uses. The
decision of the Director shall be subject to the
public participation requirements of 40 CFR
25
B. If States designate the waters of Lake
Superior as Outstanding International
Resource Waters pursuant to section II.E.2 ot
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
LAUZAia €UMA • «»»«*«
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 lite,
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
modificaitiona may also be developed to
protect candidate (Cl) species being
considered by the U.S. Fish and Wildlife
Service (FWS) for listing under section 4 of
the ESA, where such modifications are
necessaiy to protect such species.
1. .Aquatic Life.
a Aquatic life criteria or values may be
modified on a site-specific basis to provide
an additional level of protection, pursuant to
authority reserved to the States and Tribes
under Clean Water Act (CWA) section 510.
Guidance on developing site-specific
criteria in these instances is provided in
Chapter 3 of the U.S. EPA Water Quality
Standards Handbook, Second Edition-
Revised (1994).
b. Less stringent site-specific modifications
to chronic or acute aquatic life criteria or
values may be developed when:
i. The local water quality characteristics
such as: Ph, hardness, temperature, color, etc.,
alter the biological availability or toxicity of
a pollutant; or
ii. The sensitivity of the aquatic organisms
specieii 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).
-------
d. Any modifications to protect threatened
or endangered aquatic species required by
procedure l.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,
il. Tho site-specific criteria may be
calculated using the recalculation procedure
for site-specific modifications described in
Chapter 3 of the U.S. EPA Water Quality
Standards Handbook, Second Edition-
Revised (1994).
2. Wildlife.
a. Wildlife water quality criteria may be
modified on a site-specific basis to provide
an additional level of protection, pursuant to
authority reserved to the States and Tribes
under CWA section 510.
b. Less stringent site-specific modifications
to wildlife water quality criteria may be
developed when a site-specific
bioaccumulation factor (BAF) is derived
which is lower than the system-wide BAF
derived under appendix B of this part. The
modification must consider both the mobility
of prey organisms and wildlife populations
In defining the site for which criteria are
developed. In addition, there must be a
showing that:
1. Any increased uptake of the toxicant by
pray 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 fullv
protected.
c. Any modification to protect endangered
or threatened wildlife species required by
procedure l.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. Tho methodology presented in appendix
D to part 132 is used, substituting
appropriate species-specific lexicological,
epideraiological, or exposure information,
Including changes to the BAF;
II. An Interspecies uncertainty factor of i
should bo 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;
ill. An intraspecles 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
too 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: y
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
paniculate organic carbon and the dissolved
organic carbon are different than those used
to derive the system-wide BAFs);
ii. Input parameters of the Gobas model,
such as the structure of the aquatic food web
and the disequilibrium constant, are different
at the site than those used to derive the
system-wide BAFs;
iii. The percent lipid of aquatic organisms
that are consumed and occur at the site is
different than that used to derive the 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 l.A of this appendix
shall be derived using procedures set forth in
the methodology in appendix B of this part.
4. Human Health.
a. Human health criteria or values may be
modified on a site-specific basis to provide
an additional level of protection, pursuant to
authority reserved to the States and Tribes
under CWA section 510. Human health
criteria or values shall be modified on a 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 site-specific modification to a
criterion or value as allowed in section 4.A
above, the State should notify the other Great
Lakes States of such a proposal and, for less
stringent criteria, supply appropriate
justification.
C. References.
U.S. EPA. 1984. Water Quality Standards
Handbook—Revised. Chapter 3 and
Appendices. U.S. Environmental Protection
Agency, Office of Water Resource Center
(RC-4100), 401 M Street, SW., Washington,
DC 20960.
Procedure 2: Variances from Water Quality
Standards for Point Sources
The Great Lakes States or Tribes may adopt
water quality standards (WQS) variance
procedures and may grant WQS variances for'
point sources pursuant to such procedures.
Variance procedures shall be consistent with
(as protective as) the provisions in this
procedure.
A. Applicability. A State or Tribe may grant
a variance to a WQS which is the basis of a
water quality-based effluent limitation
included in a National Pollutant Discharge
Elimination System (NPDES) permit. A WQS
variance applies only to the permittee
requesting the variance!and only to the
pollutant or pollutants specified in the
variance. A variance does not affect, or
require the State or Tribe to modify, the
corresponding water quality standard for the
waterbody as a whole. :
1. This provision shall not apply to new
Great Lakes dischargers or recommencing
dischargers.
2. A variance to a water quality standard
shall not be granted that would likely
jeopardize the continued existence of any
endangered or threatened species listed
under Section 4 of the Endangered Species
Act (ESA) or result in the destruction or
adverse modification of such species' critical
habitat.
3. A WQS variance shall not be granted if
standards will be attained by implementing
effluent limits required under sections 301(b)
and 306 of the Clean Water Act (CWA) and
by the permittee implementing cost-effective
and reasonable best management practices
for nonpoint source control.
B. Maximum Timeframe for Variances. A
WQS variance shall not exceed five years or
the term of the NPDES permit, whichever is
less. A State or Tribe shall review, and
modify as necessary, WQS variances as part
of each water quality standards review
pursuant to section 303(c) of the CWA.
C. Conditions to Granfra 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, fl0w", "depth, pools,
riffles, and the like, unrelated to chemical
water quality; preclude attainment of WQS;
or
-------
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.I,
above, the permittee shall also:
a. Show that the variance requested >
conforms to the requirements of the State s or
Tribe's antidegradation procedures; and
b. Characterize the extent of any increased
risk to human health and the environment
associated with granting the variance
compared with compliance with WQS absent
the variance, such that the State or Tribe is
able to conclude that any such increased risk
is consistent with the protection of the public
health, safety and welfare.
D Submittal of Variance Application. The
permittee shall submit an application for a
variance to the regulatory authority issuing
the permit. The application shall include:
1 All relevant information demonstrating
that attaining the WQS is not feasible based
on one or more of the conditions in section
C.1 of this procedure; and,
2. All relevant information demonstrating
compliance with the conditions in section
C.2 of this procedure.
E Public Notice of Preliminary Decision.
Upon receipt of a complete application for a
variance, and upon making a preliminary
decision regarding the variance, the State or
Tribe shall public notice the request and
preliminary decision for public comment
pursuant to the regulatory authority's
Administrative Procedures Act and shall
notify the other Great Lakes States and Tribes
of the preliminary decision. This public
notice requirement may be satisfied by
including the supporting information for the
variance and the preliminary decision in the
public notice of a draft NPDES permit.
F Final Decision on Variance Request The
State or Tribe shall issue a final decision on
the variance request within 90 days of the
expiration of the public comment period
required in section E of this procedure. If all
or part of the variance is approved by the
State or Tribe, the decision shall include all
permit conditions needed to implement those
parts of the variance so approved. Such
permit conditions shall, at a minimum,
require:
1 Compliance with an initial effluent
limitation which, at the time the variance is
granted, represents the level currently
achievable by the permittee, and which is no
less stringent than that achieved under the
previous permit;
2. That reasonable progress be made
toward attaining the water quality standards
for the waterbody as a whole through
appropriate conditions;
3. When the duration of a variance is
shorter than the duration of a permit,
compliance with an effluent limitation
sufficient to meet the underlying water
quality standard, upon the expiration of said
variance; and ••.„..
4. A provision that allows the permitting
authority to reopen and modify the permit
based on any State or Tribal triennial water
quality standards revisions to the variance.
The State shall deny a variance request if
the permittee fails to make the
demonstrations required under section C ot
this procedure.
G. Incorporating •variance mus *-(«"•»• -•«-
State or Tribe shall establish and incorporate
into the permittee's NPDES permit all
conditions needed to implement the variance
as determined in section F of this procedure.
H. Renewal of Variance. A variance may be
renewed, subject to the requirements of
sections A through G of this procedure. As
part of any renewal application, the
permittee shall again demonstrate that
attaining WQS is not feasible based on the
requirements of section C of this procedure.
The permittee's application shall also contain
information concerning its compliance with
the conditions incorporated into its permit as
part of the original variance pursuant to
sections F and G of this procedure. Renewal
of a variance may be denied if the permittee
did not comply with the conditions of the
original variance.
I. EPA Approval. All variances and
supporting information shall be submitted by
the State or Tribe to the appropriate EPA
regional office and shall include:
1 Relevant permittee applications
pursuant to section D of this procedure;
2. Public comments and records of any
public hearings pursuant to section E of this
procedure;
3. The final decision pursuant to section f
of this procedure; and,
4. NPDES permits issued pursuant to
section G of this procedure.
5. Items required by sections I.I through
13 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 1.4 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.
T State WQS Revisions. All variances shall
be appended to the State or Tribe WQS rules.
Procedure 3: Total Maximum Daily Loads,
Wasteload Allocations for Point Sources,
Load Allocations for Nonpoint Sources,
Wasteload Allocations in the Absence of a
TMDL, and Preliminary Wasteload
Allocations for Purposes of Determining the
Need for Water Quality Based Effluent
Limits
The Great Lakes States and Tribes shall
adopt provisions consistent with (as
protective as) this procedure 3 for the
purpose of developing Total Maximum Daily
Loads (TMDLs), Wasteload Allocations
(WLAs) in the Absence of TMDLs, and
Preliminary Wasteload Allocations for
Purposes of Determining the Need for Water
Quality Based Effluent Limits (WQBELs),
except as specifically provided.
A. Where a State or Tribe develops an
assessment and remediation plan that the
State or Tribe certifies meets the
requirements of sections B through F of this
procedure and public participation
requirements applicable to TMDLs, and that
has been approved by EPA as meeting those
requirements under 40 CFR 130.6, the
assessment and remediation plan may be
used in lieu of a TMDL for purposes of
appendix F to part 132. Assessment and
remediation plans under this procedure may
include, but are not limited to, Lakewide
Management Plans, Remedial Action Plans,
and State Water Quality Management Plans.
Also, any part of an assessment and
remediation plan that also satisfies one or
more requirements under Clean Water Act
(CWA) section 303(d) or implementing
regulations may be incorporated by reference
into a TMDL as appropriate. Assessment and
remediation plans under this section should
be tailored to the level of detail and
magnitude for the watershed and pollutant
being assessed.
B. General Conditions of Application.
Except as provided in § 132.4, the following
are conditions applicable to establishing
TMDLs for all pollutants and pollutant
parameters in the Great Lakes System, with
the exception of whole effluent toxicity,
unless otherwise provided in procedure 6 ot
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 liiiting 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,
beha.vior 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 ptollutants 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;
Si. Increases in pollutant loadings that are
reasonably anticipated to Occur;
-------
Federal Register / Vol. 60, No. 56
^—^-^—^—
iii. Anticipated decreases in pollutant
loadings if such decreased loadings are
technically feasible and are reasonably
anticipated to occur within a reasonable time
period 03 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 case-
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
BPA-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 verify
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
wator quality standards will be achieved
within the time-period established in the
TMDL.
4. WLA Values. If separate EPA-approved
or EPA-oslablished TMDLs are prepared for
different segments of the same watershed,
and the separate TMDLs each include WLAs
for tho same pollutant for one or more of the
samo 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
bo 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 bo described. If conservative modeling
assumptions are relied on to provide a MOS,
the specific assumptions providing the MOS
shall bo identified.
6. More Stringent Requirements. States and
Tribes may exercise authority reserved to
thorn under section 510 of the CWA to
develop more stringent TMDLs (including
iVLAS find IjAfil tlinn nro wanniitn,] I.M.<.;_
~w.ului, mviH auiugem IMULS imciudinj
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
outsldo of any applicable mixing zones.
TMDLs shall be sufficiently stringent so as to
prevent accumulation of the pollutant of
concern in sediments to levels injurious to
designated or existing uses, human health,
wildlife and aquatic life.
8. Wet Weather Events. Notwithstanding
the exception provided for the establishment
of controls on wet weather point sources in
§ 132.4(e)(l), 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-bv-
case basis.
9. Background Concentration of Pollutants.
The representative background concentration
of pollutants shall be established in
accordance with this subsection to develop
TMDLs, WLAs calculated in the absence of
a TMDL, or preliminary WLAs for purposes
of determining the need for WQBELs under
procedure 5 of appendix F. Background
loadings may be accounted for in a TMDL
through an allocation to a single
"background" category or through individual
allocations to the various background
sources.
a. Definition of Background. "Background"
represents all loadings that: (1) flow from
upstream waters into the specified
watershed, waterbody or waterbody segment
for which a TMDL, WLA in the absence of
a TMDL or preliminary WLA for the purpose
of determining the need for a WQBEL is
being developed; (2) enter the specified
watershed, waterbody or waterbody segment
through atmospheric deposition or sediment
release or resuspension; or (3) occur within
the watershed, waterbody or waterbody
segment as a result of chemical reactions.
b. Data considerations. When determining
what available data are acceptable for use in
calculating background, the State or Tribe
should use best professional judgment,
including consideration of the sampling
location and the reliability of the data
through comparison to reported analytical
detection levels and quantification levels.
When data in more than one of the data sets
or categories described in section B.Q.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;
ni*
• •
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
tne TMDL.
11. Reserved Allocations. TMDLs may
include reserved allocations of loading
capacity to accommodate1 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: (1J 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
tor 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 nbt authorize
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
CHUM maiuu ^ j, IMH/ snail nbt authorize
mixing zones for existing discharges of BCCs
to the Great Lakes System after March 23
2007. After March 23, 2007, 'WLAs
established through TMDLs, WLAs
established in the absence of TMDLs and
preliminary WLAs for purposes of
determining the need for WQBELs under
procedure 5 of appendix F for existing
dischrges of BCCs to the Great Lakes System
shall be set equal to the most stringent
applicable water quality criteria or values 'for
the BCCs in question.
5. Exception for Water Conservation. States
and Tribes may grant mixing'zones'for any
existing discharge of BCCs to the Great Lakes
-------
15418 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
System beyond the dates specified in
sections C.3 and C.4 of this procedure, where
it can he demonstrated, on a case-by-case •
basis, that failure to grant a mixing zone
would preclude water conservation measures
that would lead to overall load reductions in
BCCs, even though higher concentrations of
BCCs occur in the effluent. Such mixing
zones must also be consistent with sections
D and E of this procedure.
6. Exception for Technical and Economic
Considerations. States and Tribes may grant
mixing zones beyond the dates specified in
sections C.3 and C.4 of this procedure for any
existing discharges of a BCC to the Great
Lakes System upon the request of a
discharger subject to the limited
circumstances specified in sections C.6.a
through C.6.d below. Such mixing zones
shall also be consistent with sections D and
E of this procedure.
a. The permitting authority must determine
that:
i. The discharger is in compliance with and
will continue to implement all applicable
technology-based treatment and pretreatment
requirements of CWA sections 301, 302, 304,
306, 307,401, and 402, and is in compliance
with its existing NPDES water quality-based
effluent limitations, including those based on
a mixing zone; and
ii. The discharger has reduced and will
continue to reduce the loading of the BCC for
which a mixing zone is requested to the
maximum extent possible.
b. In making the determination in section
C.6.a above, the State or Tribal authority
should consider:
i. The availability and feasibility, including
cost effectiveness, of additional controls or
pollution prevention measures for reducing
and ultimately eliminating BCCs for that
discharger, including those used by similar
dischargers;
ii. Whether the discharger or affected
communities will suffer unreasonable
economic effects if the mixing zone is
eliminated;
iii. The extent to which the discharger will
implement an ambient monitoring plan to
ensure compliance with water quality criteria
at the edge of any authorized mixing zone or
to ensure consistency with any applicable
TMDL or such other strategy consistent with
section A of this procedure; and,
iv. Other information the State or Tribe
deems appropriate.
c. Any exceptions to the mixing zone
elimination provision for existing discharges
of BCCs granted pursuant to this section
shall:
i. Not result in any less stringent
limitations than those existing March 23,
1997;
ii. Not likely jeopardize the continued
existence of any endangered or threatened
species listed under section 4 of the ESA or
result in the destruction or adverse
modification of such species' critical habitat;
iii. Be limited to one permit term unless
the permitting authority makes a new
determination hi accordance with this
section for each successive permit
application in which a mixing zone for the
BCC(s) is sought;
iv. Reflect all information relevant to the
size of the mixing zone considered by the
State or Tribe under subsection b above;
v. Protect all designated and existing uses
of the receiving water;
vi. Meet all applicable aquatic life, wildlife
and human health criteria and values at the
edge of the mixing zone and, as appropriate,
within the mixing zone or be consistent with
any appropriate TMDL or such other strategy
consistent with section A of this procedure;
vii. Ensure the discharger has developed
and conducted a pollutant minimization
program for the BCC(s) if required to do so
under regulations adopted consistent with
procedure 8 of appendix F; and
viii. Ensure that alternative means for
reducing BCCs elsewhere in the watershed
are evaluated.
d. For each draft NPDES permit that would
allow a mixing zone for one or more BCCs
after March 23,2007, the fact sheet or
statement of basis for the draft permit,
required to be made available through public
notice under 40 CFR 124.6(e), shall:
i. Specify the mixing provisions used in
calculating the permit limits; and
ii. Identify each BCC for which a mixing
zone is proposed.
D. Deriving TMDLs, WLAs, and LAsfor
Point and Nonpoint Sources: WLAs in the
Absence of a TMDL; and Preliminary WLAs
for Purposes of Determining the Need for
WQBELsfor 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.I. 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.I,
C3 through C.6, and D. 1 through D.4 of this
procedure.
1. Individual point source WLAs and
preliminary WLAs for purposes of
determining the need for WQBELs under
procedure 5 of appendix F shall assume no
greater dilution than one part effluent to 10
parts receiving water for implementation of
numeric and narrative chronic criteria and
values (including, but not limited to human
cancer criteria, human cancer values, human
noncancer values, human noncancer criteria,
wildlife criteria, and chronic aquatic life
criteria and values) unless an alternative
mixing zone is demonstrated as appropriate
in a mixing zone demonstration conducted
pursuant to section F of this procedure. In no
case shall a mixing zone be granted that
exceeds the area where discharge-induced
mixing occurs.
2. Appropriate mixing zone assumptions to
be used in calculating load allocations for
nonpoint sources shall be determined,
consistent with applicable State or Tribal
requirements, on a case-by-case basis.
3. WLAs and preliminary WLAs based on
acute aquatic life criteria or values shall not
exceed the Final Acute Value (FAV), unless
a mixing zone demonstration is conducted
and approved pursuant to section F of this
procedure. If mixing zones from two or more
proximate sources interact or overlap, the
combined effect must be evaluated to ensure
that applicable criteria and values will be
met in the area where acute mixing zones
overlap.
4. In no case shall a mixing zone be granted
that would likely jeopardize the continued
existence of any endangered or threatened
species listed under section 4 of the ESA or
result la the destruction or adverse
modification of such species' critical habitat.
E. Deriving TMDLs, WLAs, and LAsfor
Point and Nonpoint Sources; WLAs in the
Absence of a TMDL; and Preliminary WLAs
for the Purposes of Determining the Need for
WQBEtefor 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.I
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 Si of this appendix for discharges
to tributaries and connecting channels must
be consistent with sections B.9, C.I, C.3
through C.6, and E.I 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
(IQIOO, for acute aquatic life criteria or
valuei;;
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.l.a through E.l.d of this
procedure.
2. leading Capacity. The loading capacity
is the greatest amount of loading that a water
can receive without violating water quality
standards. The loading capacity is initially
calculated at the farthest downstream
location in the watershed drainage basin. The
maximum allowable loading consistent with
the attainment of each applicable numeric
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15419
criterion or value for a given pollutant is
determined by multiplying the applicable
criterion or value by the flow at the farthest
downstream location in the tributary basin at
the design flow condition described above.
This loading is then compared to the
loadings at sites within the basin to assure
that applicable numeric criteria or values for
a given pollutant are not exceeded at all
applicable sites. The lowest load is then
selected as the loading capacity.
3. Polluant Degradation. TMDLs, WLAs in
the absence of a TMDL and preliminary
WLAs for purposes of determining the need
for WQBELs under procedure 5 of appendix
F shall be based on the assumption that a
pollutant does not degrade. However, the
regulatory authority may take into account
degradation of the pollutant if each of the
following conditions are met.
a. Scientifically valid field studies or other
relevant information demonstrate that
degradation of the pollutant is expected to
occur under the full range of environmental
conditions expected to be encountered;
b. Scientifically valid field studies or other
relevant Information address other factors
that affect the level of pollutants in the water
column including, but not limited to,
resuspension of sediments, chemical
speciation, and biological and chemical
transformation.
4. Acute Aquatic Life Criteria and Values.
WLAs and LAs established in a TMDL, WLAs
in tho 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
bo provided, if approved and implemented in
accordance with section F of this procedure.
In no case shall a permitting authority grant
a mixing zone that would likely jeopardize
the continued existence of any endangered or
threatened species listed under section 4 of
the ESA or result in the destruction or
adverse modification of such species' critical
habitat.
F. Mixing Zone Demonstration
Requirements.
1. For purposes of establishing a mixing
zone other than as specified in sections D
and E above, a mixing zone demonstration
must:
a. Describe the amount of dilution
occurring at the boundaries of the proposed
mixing zone and the size, shape, and location
of the area of mixing, including the manner
in which diffusion and dispersion occur;
b. For sources discharging to the open
waters of the Great Lakes (OWGLs), define
the location at which discharge-induced
mixing ceases;
c. Document the substrate character and
geomorphology within the mixing zone;
d. Show that the mixing zone does not
interfere with or block passage of fish or
aquatic life;
e. Show that the mixing zone will be
allowed only to the extent that the level of
the pollutant permitted in the waterbody
would not likely jeopardize the continued
existence of any endangered or threatened
species listed under section 4 of the ESA or
result in the destruction or adverse
modification of such species' critical habitat;
f. Show that the mixing zone does not
extend to drinking water intakes;
g. Show that the mixing zone would not
otherwise interfere with the designated or
existing uses of the receiving water or
downstream waters;
h. Document background water quality
concentrations;
i. Show that the mixing zone does not
promote undesirable aquatic life or result in
a dominance of nuisance species; and
j. Provide that by allowing additional
mixing/dilution:
i. Substances will not settle to form
objectionable deposits;
ii. Floating debris, oil, scum, and other
matter in concentrations that form .nuisances
will not be produced; and
iii. Objectionable color, odor, taste or
turbidity will not be produced.
2. In addition, the mixing zone
demonstration shall address the following
factors:
a. Whether or not adjacent mixing zones
overlap;
b. Whether organisms would be attracted to
the area of mixing as a result of the effluent
character; and
c. Whether the habitat supports endemic or
naturally occurring species.
3. The mixing zone demonstration must be
submitted to EPA for approval. Following
approval of a mixing zone demonstration
consistent with sections F.I and F.2,
adjustment to the dilution ratio specified in
section D.I 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 pn the assumption that a pollutant
does not degrade within the proposed mixing
zone, unless:
a. Scientifically valid field studies or other
relevant information demonstrate that
degradation of the pollutant is expected to
occur under the full range of environmental
conditions expected to be encountered; and
b. Scientifically valid field studies or other
relevant information address other factors
that affect the level of pollutants in the water
column including, but not limited to,
resuspension of sediments, chemical
speciation, and biological and chemical
transformation.
Procedure 4: Additiviry
The Great Lakes States and Tribes shall
adopt additivity provisions consistent with
(as protective as) this procedure.
A. The Great Lakes States and Tribes shall
adopt provisions to protect human health
from the potential adverse additive effects
from both the noncarcinogenic and
carcinogenic components of chemical
mixtures in effluents. For the chlorinated
dibenzo-p-dioxins (CDDs) and chlorinated
dibenzofurans (CDFs) listed in Table I,
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 I 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) byithe BEF for each
CDDs and CDFs in Table 2 below, and (c)
adding all final products from step (b). The
equation for calculating the 2,3,7,8-TCDD
toxicity equivalence concentration in effluent
is:
(TEC)tcdd = £(C)X
-------
15420 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
TABLE 1 .— TOXICITY EQUIVALENCY
FACTORS FOR CDDs AND CDFs—
Continued
Congener
12347 8-HxCDD
1 9 ^ R 7 8-HxCDD
1 9
-------
Federal Register / Vol. 60. No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15421
authority shall establish a WQBEL in an
NPDES permit for such pollutant.
C. Developing Necessary Data to Calculate
TheRValues 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
cancor, 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.l.b of this procedure.
d. The permitting authority shall compare
tho PHQ developed according to the
procedures set forth in section B of this
procedure to the PELs developed in
accordance with section C.l.c of this
procedure. If the PEQ exceeds any of the
PELs, tho permitting authority shall generate
or require the permittee to generate the data
necessary to derive Tier II values for
noncancor human health, acute aquatic life
and chronic aquatic life.
o. The data generated in accordance with
section Cl.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)(l)(vi)(C)
must bo 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.I 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 n 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 approved in accordance
with procedure 3.A. of appendix F. This
section and section E do not alter the
permitting authority's obligation under 40
CFR 122.44(d)(vii)(B) to develop effluent
limitations consistent with the assumptions
and requirements of any available WLA for
the discharge, which is part of a TMDL
prepared by the State or Tribe and approved
by EPA pursuant to 40 CFR 130.7, or
prepared by EPA pursuant to 40 CFR
130.7(d).
2. Definition of Same Body of Water.
a. This definition applies to this section
and section E of this procedure.
b. An intake pollutant is considered to be
from the same body of water as the discharge
if the permitting authority finds that the
intake pollutant would have reached the
vicinity of the outfall point in the receiving
water within a reasonable period had it not
been removed by the permittee. This finding
may be deemed established if:
i. The background concentration of the
pollutant in the receiving water (excluding
any amount of the pollutant in the facility's
discharge) is similar to that in the intake
water;
ii. There is a direct hydrological
connection between the intake and discharge
points; and
iii. Water quality characteristics (e.g.,
temperature, Ph, hardness) are similar in the
intake and receiving waters.
c. The permitting authority may also
consider other site-specific factors relevant to
the transport and fate of the pollutant to
make the finding in a particular case that a
pollutant would or would not have reached
the vicinity of the outfall point in the
receiving water within a reasonable period
had it not been removed by the permittee.
d. An intake pollutant from groundwater
may be considered to be from the same body
of water if the permitting authority
determines that the pollutant would have
reached the vicinity of the outfall point in the
receiving water within a reasonable period
had it not been removed by the permittee,
except that such a pollutant is not from the
same body of water if the groundwater
contains the pollutant partially or entirely
due to human activity, such as industrial,
commercial, or municipal operations,
disposed actions, or treatment processes.
e. An intake pollutant is the amount of a
pollutant that is present in waters of the
United States (including groundwater as
provided in section D.2,d of this procedure)
at the time it is withdrawn from such waters
by the discharger or other facility (e.g., public
water supply) supplying the discharger with
intake water.
3. Reasonable Potential Determination.
a. The permitting authority may use the
procedure described in this section of
procedure 5 in lieu of procedures 5.A
through C provided the conditions specified
below are met.
b. The permitting authority may determine
that there is no reasonable potential for the
discharge of an identified intake pollutant or
pollutant parameter to cause or contribute to
an excursion above a narrative or numeric
water quality criterion within an applicable
water quality standard where a discharger
demonstrates to the satisfaction of the
permitting authority (based upon information
provided in the permit application or other
information deemed necessary by the
permitting authority) that:
i. The facility withdraws 100 percent of the
intake water containing [the pollutant from
the same body of water into which the
discharge is made;
ii. The facility does not contribute any
additional mass of the identified intake
pollutant to its wastewater;
iii. The facility does not alter the identified
intake pollutant chemically or physically in
• a manner that would cause adverse water
quality impacts to occur that would not occur
if the pollutants were left in-stream;
iv. The facility does not increase the
identified intake pollutant concenbation, 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. i
c. Upon a finding under section D.3.b of
this procedure that a pollutant in the
-------
15422 Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations
discharge does not cause, have the reasonable
potential to cause, or contribute to an
excursion above an applicable water quality
standard, the permitting authority is not
required to include a WQBEL for the
identified intake pollutant in the facility's
permit, provided:
i. The NPDES permit fact sheet or
statement of basis includes a specific
determination that there is no reasonable
potential for the discharge of an identified
intake pollutant to cause or contribute to an
excursion above an applicable narrative or
numeric water quality criterion and
references appropriate supporting
documentation included in the
administrative record;
ii. The permit requires all influent,
effluent, and ambient monitoring necessary
to demonstrate that the conditions in section
D.3.b of this procedure are maintained during
the permit term; and
iii. The permit contains a reopener clause
authorizing modification or revocation and
reissuance of the permit if new information
indicates changes in the conditions in section
D.3.b of this procedure.
d. Absent a finding under section D.3.b of
this procedure that a pollutant in the
discharge does not cause, have the reasonable
potential to cause, or contribute to an
excursion above an applicable water quality
standard, the permitting authority shall use
the procedures under sections 5.A through C
of this procedure to determine whether a
discharge causes, has the reasonable
potential to cause, or contribute to an
excursion above an applicable narrative or
numeric water quality criterion.
E. Consideration of Intake Pollutants in
Establishing WQBELs.
1. General. This section applies only when
the concentration of the pollutant of concern
upstream of the discharge (as determined
using the provisions in procedure 3.B.9 of
appendix F) exceeds the most stringent
applicable water quality criterion for that
pollutant.
2. The requirements of sections D.1-D.2 of
this procedure shall also apply to this
section.
3. Intake Pollutants from the Same Body of
Water.
a. In cases where a facility meets the
conditions in sections D.S.b.i and D.S.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.
D. Where proper operation and
maintenance of a facility's treatment system
results in removal of a pollutant, the
permitting authority may establish
limitations that reflect the lower mass and/
or concentration of the pollutant achieved by
such treatment, taking into account the
feasibility of establishing such limits.
c. For pollutants contained in intake water
provided by a water system, the
concentration of the intake pollutant shall be
determined at the point where the raw water
supply is removed from the same body of
water, except that it shall be the point where
the water enters the water supplier's
distribution system where the water
treatment system removes any of the
identified pollutants from the raw water
supply. Mass shall be determined by
multiplying the concentration of the
pollutant determined in accordance with this
paragraph by the volume of the facility's
intake flow received from the water system.
4. Intake Pollutants from a Different Body
of Water. Where the pollutant in a facility's
discharge originates from a water of the
United States that is not the same body of
water as the receiving water (as determined
in accordance with section D.2 of this
procedure), WQBELs shall be established
based upon the most stringent applicable
water quality criterion for that pollutant.
5. Multiple Sources of Intake Pollutants.
Where a facility discharges intake pollutants
that originate in part from the same body of
water, and in part from a different body of
water, the permitting authority may apply the
procedures of sections E.3 and E.4 of this
procedure to derive an effluent limitation
reflecting the flow-weighted average of each
source of the pollutant, provided that
adequate monitoring to determine
compliance can be established and is
included in the permit.
F. Other Applicable Conditions.
1. In addition to the above procedures,
effluent limitations shall be established to
comply with all other applicable State, Tribal
and Federal laws and regulations, including
technology-based requirements and
antidegradation policies.
2. Once the permitting authority has
determined in accordance with this
procedure that a WQBEL must be included
in an NPDES permit, the permitting authority
shall:
a. Rely upon the WLA established for the
point source either as part of any TMDL
prepared under procedure 3 of this appendix
and approved by EPA pursuant to 40 CFR
130.7, or as part of an assessment and
remediation plan developed and approved in
accordance with procedure 3.A of this
appendix, or, in the absence of such TMDL
or plan, calculate WLAs for the protection of
acute and chronic aquatic life, wildlife and
human health consistent with the provisions
referenced in section A.1 of this procedure
for developing preliminary wasteload
allocations, and
b. Develop effluent limitations consistent
with these WLAs in accordance with existing
State or Tribal procedures for converting
WLAs into WQBELs.
3. When determining whether WQBELs are
necessary, information from 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 excuriiion 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^. 100/LC5o where the
LCso 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 (Tt7c). 100/NOEC or
100/IC25, where the NOEC and IC2s are
expressed as a percent effluent in the test
medium.
Inhibition concentration 25 (ICis). the
toxicant concentration that would cause a 25
percent reduction in a non-quantal biological
measurement for the test population. For
examplei, the ICis 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
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 this following:
1. A numeric acute WET criterion of 0.3
acute tcixic units (TUa) measured pursuant to
test methods in 40 CFR part 136, or a
numeric interpretation of a narrative criterion
establishing that 0.3 TUa measured pursuant
to test methods in 40 CFR part 136 is
necessary to protect aquatic life from acute
effects of WET. At the discretion of the
permitting authority, the foregoing
requirement shall not apply in an acute
mixing zone that is sized in accordance with
EPA-apiproved State and Tribal methods.
2. A aumeric chronic WET criterion of one
chronic toxicity unit (TUC) measured
pursuant to test methods in 40 CFR part 136,
or a numeric interpretation of a narrative
criterion establishing that one TUC measured
pursuant to test methods in 40 CFR part 136
is necessary to protect aquatic life from the
chronic effects of WET. At the discretion of
the permitting authority, the foregoing
requirements shall not apply within a
chronic mixing zone consistent with: (a)
procedures 3.D.1 and 3.D.4, for discharges to
the open of the Great Lakes (OWGL), inland
-------
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules and Regulations 15423
lakes and other waters of the Great Lakes
System with no appreciable flow relative to
their volume, or (b) procedure 3.E.5 for
discharges to tributaries and connecting
channels of the Great Lakes System.
B. WET Test Methods. All WET tests
performed to implement or ascertain
compliance with this procedure shall be
performed in accordance with methods
established in 40 CFR part 136.
C Permit Conditions.
1. Where a permitting authority determines
pursuant to section D of this procedure that
the WET of an effluent is or may be
discharged at a level that will cause, have the
reasonable potential to cause, or contribute to
an excursion above any numeric WET
criterion or narrative criterion within a
State's or Tribe's water quality standards, the
permitting authority:
a. Shall (except as provided in section
C.1.0 of this procedure) establish a Water
quality-based effluent limitation (WQBEL) or
WQBELs for WET consistent with section
C.l.b of this procedure;
b. Shall calculate WQBELs pursuant to
section Cl.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 S.E.l.a
(or where applicable, with procedure S.E.l.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.l,b (or where applicable, with procedure
3.E.1.0) for Great Lakes System tributaries
and connecting channels, with an allowance
for mixing zones no greater than specified
pursuant to section A.I of this procedure.
c. May specify in the NPDES permit the
conditions under which a permittee would
bo required to perform a toxicity reduction
evaluation.
d. May allow with respect to any WQBEL
established pursuant to section C.l.a of this
procedure an appropriate schedule of
compliance consistent with procedure 9 of
appendix F; and
o. 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 I22.44(d)(l)(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)(l)(ii) and, where representative
facility-specific WET effluent data are
available, apply the following requirements
in determining whether the WET of an
effluent is or may be discharged at a level
that will cause, have the reasonable potential
to cause, or contribute to an excursion above
any numeric WET criterion or narrative
criterion within a State's or Tribe's water
quality standards.
1. The permitting authority shall
characterize the toxicity of the discharge by:
a. Either averaging or using the maximum
of acute toxicity values collected within the
same day for each species to represent one
daily value. The maximum of all daily values
for the most sensitive species tested is used
for reasonable potential determinations;
b. Either averaging or using the maximum
of chronic toxicity values collected within
the same calendar month for each species to
represent one monthly value. The maximum
of such values, for the most sensitive species
tested, is used for reasonable potential
determinations:
c. Estimating the toxicity values for the
missing endpoint using a default 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:
(TUa effluent) (B) (effluent flow/
(Qad+effluent flow))>AC
Where TUa effluent is the maximum
measured acute toxicity of 100 percent
effluent determined-pursuant to section
D.l.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.I of this procedure and expressed
in TUa, and Qad is the amount of the
receiving water available for dilution
calculated using: (i) the specified design
flow(s) for tributaries and connecting
channels in section C.i.b of this procedure,
or where appropriate procedure S.E.l.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 OWGlis. 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 O.el Where there are 10
or more individual WET tests, the
multiplying factor takeia from Table F6-1
shall be based on a CV calculated as the
standard deviation of the acute toxicity
values found in the WET tests divided by the
arithmetic mean of those toxicity values.
3. The WET of an effluent is or may be
discharged at a level that will cause, have the
reasonable potential to cause, or contribute to
an excursion above any numeric chronic
WET criterion or numeric interpretation of a
narrative criterion within a State's or Tribe's
water quality standards, when, effluent-
specific information demonstrates that:
(TUC effluent) (B) (effluent flow/Qad-feffluent
flow))>CC
Where TUC effluent is the maximum
measured chronic toxicity value of 100
percent effluent determined in accordance
with section D.l.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 fhe numeric chronic
WET criterion or numeric interpretation of a
narrative criterion established pursuant to
section A. 2 of this procedure and expressed
in TUC, and Qad is the amount of the
receiving water available for dilution
calculated using: (i) the design flow(s) for
tributaries and connecting channels specified
in procedure S.E.l.a of appendix F, and
where appropriate procedure S.E.l.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 behased on a CV
of 0.6. Where there are 10 more individual
WET tests, the multiplying factor taken from
Table F6-1 of this proce'dure shall be based
on a CV calculated as the standard deviation
of the WET tests divided by the arithmetic
mean of the WET tests.
-------
15424
Federal Register / Vol. 60, No. 56 / Thursday, March 23. 1995 / Rules and Regulations
TABLE F6-1.-REASONABLE POTENTIAL MULTIPLYING FACTORS: 95% CONFIDENCE LEVEL AND 95% PROBABILITY BASIS
Number of Samples
i ....
2
3
4
f
o
9
10
11
12
13
14
15
•jg
17
18
19
20
30
40
50
60
80
on
inn
Coefficient of variation
0.1
1.4
1.3
1.2
1.2
"1.2
1.1
1.1
1.1
1.1
1.1
1.1
1.1
1.1
1.1
1.1
1.1
1.1
1.
1.
1.
1.
1.
1.
1.
1.
1.
1.
1
0.2
1.9
1.6
1.5
1.4
1.4
1.3
1.3
1.3
1.2
1.2
1.2
1.2
1.2
1.2
1.2
1.1
1.1
1.
1.
1.
1.
1.
1.
1.
1
1.
1.
1
0.3
2.6
2.0
1.8
1.7
1.6
1.5
1.4
1.4
1.4
1.3
1.V
1.3
1.3
•j j
1.2
1.2
1.2
1.2
1.2
1.2
1.
1.
1.
1.
1
1.
0.
0
0.4
3.6
2.5
2.1
1.9
1.8
1.7
1.6
1.6
1.5
1.5
1.4
1.4
1.4
1.4
1.3
1.5
1.!
1.3
1.3
1.2
1.
1.
1.
1.
1.
0.
0.
0.
0.5
4.7
3.1
2.5
2.2
2.1
1.9
1.8
1.7
1.7
1.6
1.6
1.5
1.5
1.4
1.4
1.4
1.4
1.3
1.3
1.
1.
1.
1.
1.
1.
0.
0.
0.
0.6
6.2
3.8
3.0
2.6
2.3
2.1
2.0
1.9
1.8
1.7
1.7
1.6
1.6
1.5
1.5
1.5
l!4
1.4
1.4
1.4
1.2
1.
1.
1.
0,
0.
0.
0.
0.7
8.0
4.6
3.5
2.9
2.6
2.4
2.2
2.1
2.0
1.9
1.8
1.7
1.7
1.6
1.6
1.6
1.5
1.5
1.5
1.4
1.
1.
1.
1.
0.
0.
0.
0
0.8
0.1
5.4
4.0
3.3
2.9
2.6
2.4
2.3
2.1
2.0
1.9
1.9
1.8
1.7
1.7
1.6
1.6
1.6
1 5
1.5
1.3
1.
1.
1.
0.
0.
0.
0.
0.9
2.6
6.4
4.6
3.7
3.2
2.9
2.6
2.4
2.3
2.2
2.1
2.0
1.9
1.8
1.8
1.7
1.7
1.6
1.6
1.5
1.3
1.2
1.
1.
0.
0.
0.
0.
.0
5.5
7.4
5.2
4.2
3.6
3.1
2.8
2.6
2.4
2.3
2.2
2.1
2.0
1.9
1.8
1.8
1.7
1.7
1.6
1.6
1.3
1.1
1.
1.
0.
0.
0.
0.
1.1
8./
8.5
5.8
4.6
3.9
3.4
3.1
2.8
2.6
2.4
2.3
2.2
2.1
2.0
1.9
1.9
1.8
1.7
1.
1.6
1.3
1.
1.
1.
0.
0.
0.
0.
1.2
22.3
9.7
6.5
5.0
4.2
3.7
3.3
3.0
2.8
2.6
2.4
2.3
2.2
2.1
2.0
1.9
1.9
1.8
1fi
1.
| 1.4
1.
1.
0.
0.
0.
0.
1.3
26.4
0.9
7.2
5.5
4.5
3.9
3.5
3.2
2.9
2.7
2.5
2.4
2.3
2.2
2.1
2.0
1.!
1.9
1 fl
1.
1.4
1.
1.
0.
0.
0.
0.
1.4
30.8
2.2
7.9
6.0
4.9
4.2
o./
3.3
3.1
2.8
2.7
2.5
2.4
2.3
2.2
2.1
2.(
1.J
1.5
1.
1.
1.
1
0.
0.
0.
0.
.5
35.6
3.6
8.6
6.4
5.2
4.5
3.9
3.5
3.2
3.0
2.8
2.6
2.5
2.!
2.2
2.1
2.0
2.0
1.9
1
1.
1
1.
1
0.
0.
0.
0.
.6
40.7
5.0
9.3
6.9
5.6
47
4.1
3.7
3.4
3.1
2.9
2.7
2.5
2.4
2.3
2.2
2.
2.0
2.
1
1.
•)
1.
1
0.
0.
0.
0.
.7
46.2
6.4
0.0
7.4
5.9
5.0
4.3
3.9
3.5
3.2
3.0
2.8
2.6
2.5
2.4
2.3
2.2
2.1
2.0
1.9
1 ,
1 ;
1.
1.
0.
0.
0.
0.
.8
b2.1
7.9
0.8
7.8
6.2
5.2
4.5
4.0
3.6
3.3
3.1
2.9
2.7
2.6
2.4
2.3
2.2
2.1
2.0
2.0
1
1 j
1
1.
0.
0.
0.
0.
1.9
58.4
9.5
1.5
8.3
6.6
5.5
4.7
4.2
3.8
3.4
3.2
3.0
2.8
2.6
2.5
2.4
2.3
2.2
2.
2.
1.
1 ••
1
1.
0.
0.
0.
0.
?n
64.9
21.1
2.3
8.8
6.9
5.7
4.9
4.3
3.9
3.6
3.3
3.0
2.9
2.7
2.5
2.4
2.3
2.2
2.1
2.0
1 5
1.3
1.1
1.0
0.9
0.8
0.8
0.7
Procedure 7: Loading Limits
The Great Lakes States and Tribes shall
adopt provisions consistent with (as
protective as) this procedure.
Whenever a water quality-based effluent
limitation (WQBEL) is developed, the
WQBEL shall be expressed as both a
concentration value and a corresponding
mass loading rate.
A. Both mass and concentration limits
shall be based on the same permit averaging
periods such as daily, weekly, or monthly
averages, or in other appropriate permit
averaging periods.
B. The mass loading rates shall be
calculated using effluent flow rates that are
consistent with those used in establishing the
WQBELs expressed in concentration.
Procedure 8: Water Quality-based Effluent
Limitations Below the Quantification Level
The Great Lakes States and Tribes shall
adopt provisions consistent with (as
protective as) this procedure.
When a water quality-based effluent
limitation (WQBEL) for a pollutant is
calculated to be less than the quantification
level: .
A. Permit Limits. The permitting authority
shall designate as the limit in the NPDES
permit the WQBEL exactly as calculated.
B. Analytical Method and Quantification
Level.
1. The permitting authority shall specify in
the permit the most sensitive, applicable,
analytical method, specified in or approved
under 40 CFR part 136, or other appropriate
method if one is not available under 40 CFR
part 136, to be used to monitor for the
presence and amount in an effluent of the
pollutant for which the WQBEL is
established; and shall specify in accordance
with section B.2 of this procedure, the
quantification level that can be achieved by
use of the specified analytical method.
2. The quantification level shall be the
minimum level (ML) specified in or
approved under 40 CFR part 136 for the
method for that pollutant. If no such ML
exists, or if the method is not specified or
approved under 40 CFR part 136, the
quantification level shall be the lowest
quantifiable level practicable. The permitting
authority may specify a higher quantification
level if the permittee demonstrates that a
higher quantification level is appropriate
because of effluent-specific matrix
interference.
3. The permit shall state that, for the
purpose of compliance assessment, the
analytical method specified in the permit
shall be used to monitor the amount of
pollutant in an effluent down to the
quantification level, provided that the analyst
has complied with the specified quality
assurance/quality control procedures in the
relevant method.
4. The permitting authority shall use
applicable State and Tribal procedures to
average and account for monitoring data. The
permitting authority may specify in the '
permit the value to be used to interpret
sample values below the quantification level.
C. Special Conditions. The permit shall
contain a reopener clause authorizing
modification or revocation and reissuance of
the permit if new information generated as a
result of special conditions included, in the
permit indicates that presence of the
pollutant in the discharge at levels above the
WQBE1L. 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 u 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,
Stateii and Tribes may consider cost-
effectiveness when establishing the
requirements of a PMP. The pollutant
minimization program shall include, but is
not limited to, the following:
1. An annual review and semi-annual
monitoring of potential sources of the
pollutant, which may include fish tissue
monitoring and other bio-uptake sampling;
2. Quarterly monitoring for the pollutant in
the influent to the wastewater treatment
system; .
3. Submittal of a control strategy designed
to proceed toward the goal of maintaining all
sources of the pollutant to the wastewater
collection system below the WQBEL;
4. When the sources of the pollutant are
discovered, appropriate cost-effective control
-------
Federal Register / Vol. 60, No. 56 / Thursday. March 23, 1995 / Rules and Regulations 15425
measures shall be implemented, consistent
with the control strategy; and
5. An annual status report that shall be sent
to the permitting authority including:
a. All minimization program monitoring
results for the previous year;
b. A list of potential sources of the
pollutant; and
c. A summary of all action taken to reduce
or eliminate the identified sources of the
pollutant.
6. Any information generated as a result of
procedure 8.D can be used to support a
request for subsequent permit modifications,
including revisions to (e.g., more or less
frequent monitoring), or removal of the
requirements of procedure 8.D, consistent
\vlth40 CFR 122.44,122.62 and 122.63.
Procedure 9: Compliance Schedules
Tho Great Lakes States and Tribes shall
adopt provisions consistent with (as
protective as) procedure 9 of appendix F of
part 132.
A. Limitations for New Great Lakes
Dischargers. When a permit issued on or after
March 23,1997 to a new Great Lakes
discharger (defined in Part 132.2) contains a
water quality-based effluent limitation
(WQBEL), the permittee shall comply with
such a limitation upon the commencement of
tha 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
tune 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 n 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 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 6560-60-P
------- |