[Federal Register Volume 60, Number 56 (Thursday, March 23, 1995)]
[Rules and Regulations]
[Pages 15366-15425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6671]
[[Page 15365]]
_______________________________________________________________________
Part III
Environmental Protection Agency
_______________________________________________________________________
40 CFR 9, 122, 123, 131, and 132
Final Water Quality Guidance for the Great Lakes System; Final Rule
Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / Rules
and Regulations
[[Page 15366]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 122, 123, 131, and 132
[FRL-5173-7]
RIN 2040-AC08
Final Water Quality Guidance for the Great Lakes System
AGENCY: U.S. Environmental Protection Agency.
ACTION: Final rule.
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SUMMARY: EPA is publishing Final Water Quality Guidance for the Great
Lakes System. Great Lakes States and Tribes will use the water quality
criteria, methodologies, policies, and procedures in the Guidance to
establish consistent, enforceable, long-term protection for fish and
shellfish in the Great Lakes and their tributaries, as well as for the
people and wildlife who consume them.
The Guidance was initially developed by the Great Lakes States,
EPA, and other Federal agencies in open dialogue with citizens, local
governments, and industries in the Great Lakes ecosystem. It will
affect all types of pollutants, but will target especially the types of
long-lasting pollutants that accumulate in the food web of large lakes.
The Guidance consists of water quality criteria for 29 pollutants
to protect aquatic life, wildlife, and human health, and detailed
methodologies to develop criteria for additional pollutants;
implementation procedures to develop more consistent, enforceable water
quality-based effluent limits in discharge permits, as well as total
maximum daily loads of pollutants that can be allowed to reach the
Lakes and their tributaries from all sources; and antidegradation
policies and procedures.
Under the Clean Water Act, the States of Illinois, Indiana,
Michigan, Minnesota, New York, Ohio, Pennsylvania, and Wisconsin must
adopt provisions into their water quality standards and NPDES permit
programs within two years (by March 23, 1997) that are consistent with
the Guidance, or EPA will promulgate the provisions for them. The
Guidance for the Great Lakes System will help establish consistent,
enforceable, long-term protection from all types of pollutants, but
will place short-term emphasis on the types of long-lasting pollutants
that accumulate in the food web and pose a threat to the Great Lakes
System. The Guidance includes minimum water quality criteria,
antidegradation policies, and implementation procedures that provide a
coordinated ecosystem approach for addressing existing and possible
pollutant problems and improves consistency in water quality standards
and permitting procedures in the Great Lakes System. In addition, the
Guidance provisions help establish consistent goals or minimum
requirements for Remedial Action Plans (RAPs) and Lakewide Management
Plans (LaMPs) that are critical to the success of international multi-
media efforts to protect and restore the Great Lakes ecosystem.
EFFECTIVE DATE: April 24, 1995.
ADDRESSES: The public docket for this rulemaking, including applicable
Federal Register documents, public comments in response to these
documents, the Final Water Quality Guidance for the Great Lakes System,
Response to Comments Document, other major supporting documents, and
the index to the docket are available for inspection and copying at
U.S. EPA Region 5, 77 West Jackson Blvd., Chicago, IL 60604 by
appointment only. Appointments may be made by calling Wendy Schumacher
(telephone 312-886-0142).
Information concerning the Great Lakes Initiative (GLI)
Clearinghouse is available from Ken Fenner, Water Quality Branch Chief,
(WQS-16J), U.S. EPA Region 5, 77 W. Jackson Blvd., Chicago, IL 60604
(312-353-2079).
Copies of the Information Collection Request for the Guidance are
available by writing or calling Sandy Farmer, Information Policy
Branch, EPA, 401 M St., S.W. (Mail Code 2136), Washington, DC 20460
(202-260-2740).
Selected documents supporting the Guidance are also available for
viewing by the public at locations listed in section XI of the
preamble.
Selected documents supporting the Guidance are available by mail
upon request for a fee. Selected documents are also available in
electronic format at no incremental cost to users of the Internet. See
section XI of the preamble for additional information.
FOR FURTHER INFORMATION CONTACT: Kenneth A. Fenner, Water Quality
Branch Chief (WQS-16J), U.S. EPA Region 5, 77 W. Jackson Blvd.,
Chicago, IL 60604 (312-353-2079).
SUPPLEMENTARY INFORMATION
Preamble Outline
I. Introduction
II. Background
III. Purpose of the Guidence
A. Use the Best Available Science to Protect Human Health,
Aquatic Life, and Wildlife
B. Recognize the Unique Nature of the Great Lakes Basin
Ecosystem
C. Promote Consistency in Standards and Implementation
Procedures While Allowing Appropriate Flexibility to States and
Tribes
D. Establish Equitable Strategies to Control Pollution Sources
E. Promote Pollution Prevention Practices
F. Provide Accurate Assessment of Costs and Benefits
IV. Sumarry of the Final Guidance
A. Water Quality Criteria and Methodologies
1. Protection of Aquatic Life
2. Protection of Human Health
3. Protection of Wildlife
4. Bioaccumulation Methodology
B. Implementation Procedures
1. Site-Specific Modifications
2. Variances from Water Quality Standards for Point Sources
3. TMDLs and Mixing Zones
4. Additivity
5. Determining the Need for WQBELs (Reasonable Potential)
6. Intake Pollutants
7. WET
8. Loading Limits
9. Levels of Quantification
10. Compliance Schedules
C. Antidegradation Provisions
D. Regulatory Requirements
V. Costs, Cost-Effectiveness and Benefits
A. Costs
B. Cost-Effectiveness
C. Benefits
VI. Regulatory Flexibility Act
VII. Enhancing the Intergovernmental Partnership Under Executive
Order 12875
VIII. Paperwork Reduction Act
IX. Endangered Species Act
X. Judicail Review of Provisions not Amended
XI. Supporting Documents
I. Introduction
Section 118(c)(2) of the Clean Water Act (CWA) (Pub. L. 92-500 as
amended by the Great Lakes Critical Programs Act of 1990 (CPA), Pub. L.
101-596, November 16, 1990) required EPA to publish proposed and final
water quality guidance on minimum water quality standards,
antidegradation policies, and implementation procedures for the Great
Lakes System. In response to these requirements, EPA published the
Proposed Water Quality Guidance for the Great Lakes System (proposed
Guidance) in the Federal Register on April 16, 1993 (58 FR 20802). EPA
also published four subsequent documents in the Federal Register
identifying corrections and requesting comments on additional related
materials (April 16, 1993, 58 FR 21046; August 9, 1993, 58 FR 42266;
September 13, 1993, 58 FR 47845; and August 30, 1994, 59 FR 44678). EPA
received over 26,500 pages of comments, data, and information from over
6,000 commenters in response to [[Page 15367]] these documents and from
meetings with members of the public.
After reviewing and analyzing the information in the proposal and
these comments, EPA has developed the Final Water Quality Guidance for
the Great Lakes System (final Guidance), published in this document and
codified in 40 CFR part 132, which includes six appendixes of detailed
methodologies, policies, and procedures. This preamble describes the
background and purpose of the final Guidance, and briefly summarizes
the major provisions. Detailed discussion of EPA's reasons for issuing
the final Guidance, analysis of comments and issues, description of
specific changes made to the proposed Guidance, and further description
of the final Guidance, are provided in ``Final Water Quality Guidance
for the Great Lakes System: Supplementary Information Document'' (SID),
(EPA, 1995, 820-B-95-001) and in additional technical and supporting
documents which are available in the docket for this rulemaking. Copies
of the SID and other supporting documents are also available from EPA
in electronic format, or in printed form for a fee upon request; see
section XI of this preamble.
II. Background
The Great Lakes are one of the outstanding natural resources of the
world. They have played a vital role in the history and development of
the United States and Canada, and have physical, chemical, and
biological characteristics that make them a unique ecosystem. The Great
Lakes themselves--Lakes Superior, Huron, Michigan, Erie and Ontario and
their connecting channels--plus all of the streams, rivers, lakes and
other bodies of water that are within the drainage basin of the Lakes
collectively comprise the Great Lakes System.
The System spans over 750 miles across eight States--New York,
Pennsylvania, Ohio, Michigan, Indiana, Illinois, Wisconsin and
Minnesota--and the Province of Ontario. The Lakes contain approximately
18 percent of the world's and 95 percent of the United States' fresh
surface water supply. The Great Lakes are a source of drinking water
and energy, and are used for recreational, transportation, agricultural
and industrial purposes by the more than 46 million Americans and
Canadians who inhabit the Great Lakes region, including 29 Native
American tribes. Over 1,000 industries and millions of jobs are
dependent upon water from the Great Lakes. The Great Lakes System also
supports hundreds of species of aquatic life, wildlife and plants along
more than 4,500 miles of coastline which boast six National Parks and
Lakeshores, six National Forests, seven National Wildlife Refuges, and
hundreds of State parks, forests and sanctuaries.
Because of their unique features, the Great Lakes are viewed as
important to the residents of the region, and to the Nation as a whole.
The natural resources of the region have contributed to the development
of its economy. The Lakes' natural beauty and aquatic resources form
the basis for heavy recreational activity. The Great Lakes Basin
Ecosystem--the interacting components of air, land, water and living
organisms, including humans, that live within the Great Lakes drainage
basin--is a remarkably diverse and unique ecosystem important in the
global ecology.
In the past few decades, the presence of environmental contaminants
in the Great Lakes has been of significant concern. In spite of the
fact that the Great Lakes contain 5,500 cubic miles of water that cover
a total surface area of 94,000 square miles, they have proved to be
sensitive to the effects of pollutants that accumulate in them. The
internal responses and processes that operate in the Great Lakes
because of their depth and long hydraulic residence times cause
pollutants to recycle between biota, sediments and the water column.
The first major basin-wide environmental problem in the Great Lakes
emerged in the late 1960s, when increased nutrients had dramatically
stimulated the growth of green plants and algae, reduced dissolved
oxygen levels, and accelerated the process of eutrophication. As oxygen
levels continued to drop, certain species of insects and fish were
displaced from affected areas of the Great Lakes Basin Ecosystem.
Environmental managers determined that a lakewide approach was
necessary to adequately control accelerated eutrophication. From the
late 1960s through the late 1970s, United States and Canadian
regulatory agencies agreed on measures to limit the loadings of
phosphorus, including effluent limits on all major municipal sewage
treatment facilities, limitations on the phosphorus content in
household detergents, and reductions in nonpoint source runoff
loadings. As a result of all of these efforts, open lake phosphorus
concentrations have declined, and phosphorus loadings from municipal
sewage treatment facilities have been reduced by an estimated 80 to 90
percent. These reductions have resulted in dramatic improvements in
nearshore water quality and measurable improvements in open lake
conditions.
More recently, scientists and public leaders have reached a general
consensus that the presence of environmentally persistent,
bioaccumulative contaminants is a serious environmental threat to the
Great Lakes Basin Ecosystem. Beginning in 1963, adverse environmental
impacts in the form of poor reproductive success and high levels of the
pesticide DDT were observed in herring gulls in Lake Michigan. Through
ongoing research, scientists have detected 362 contaminants in the
Great Lakes System. Of these, approximately one third have
toxicological data showing that they can have acute or chronic toxic
effects on aquatic life, wildlife and/or human health. Chemicals that
have been found to bioaccumulate at levels of concern in the Great
Lakes include, but are not limited to, polychlorinated biphenyls
(PCBs), mercury, DDT, dioxin, chlordane, and mirex. The main route of
exposure to these chemicals for humans is through the consumption of
Great Lakes fish.
Potential adverse human health effects by these pollutants
resulting from the consumption of fish include both the increased risk
of cancer and the potential for systemic or noncancer risks such as
kidney damage. EPA has calculated health risks to populations in the
Great Lakes basin from consumption of contaminated fish based on
exposure to eight bioaccumulative pollutants: chlordane, DDT, dieldrin,
hexachlorobenzene, mercury, PCBs, 2,3,7,8-TCDD, and toxaphene. These
chemicals were chosen based on their potential to cause adverse human
health effects (i.e., cancer or disease) and the availability of
information on fish tissue contaminant concentrations from the Great
Lakes.
Based on these data, EPA estimates that the lifetime cancer risks
for Native Americans in the Great Lakes System due to ingestion of
contaminated fish at current concentrations range from 1.8 x
10-\3\ (Lake 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-\4\ (9.7 in ten thousand) (Lake Superior) to 4.5 x
10-\3\ (4.5 in one thousand) (Lake Michigan). (See section I.B.2.a
of the SID.) In comparison, EPA has long maintained that 1 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.
[[Page 15368]]
EPA also estimates a high potential risk of systemic (noncancer)
injury to populations in the Great Lakes basin due to ingestion of fish
contaminated with these pollutants at current concentrations. The
systemic adverse health effects associated with the assessed
contaminants are described in section I.B of the SID.
Although the Great Lakes States and EPA have moved forward to deal
with these problems, control of persistent, bioaccumulative pollutants
proved to be more complex and difficult than dealing with nutrients. As
a result, inconsistencies began to be apparent in the ways various
States developed and implemented controls for the pollutants. By the
mid-1980s, such inconsistencies became of increasing concern to EPA and
State environmental managers.
EPA began the Great Lakes Water Quality Initiative (``Initiative'')
in cooperation with the Great Lakes States to establish a consistent
level of environmental protection for the Great Lakes ecosystem,
particularly in the area of State water quality standards and the
National Pollutant Discharge Elimination System (NPDES) programs. In
the spring of 1989, the Council of Great Lakes Governors unanimously
agreed to participate in the Initiative with EPA, because the
Initiative supported the principles and goals of the Great Lakes Toxic
Substances Control Agreement (Governors' Agreement). Signed in 1986 by
the Governors of all eight Great Lakes States, the 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 in the 30 years of effort
described above on the part of the Great Lakes stakeholders to define
and apply innovative, comprehensive environmental programs in
protecting and restoring the Great Lakes. In particular, this
publication of the final Guidance culminates six years of intensive,
cooperative effort that included participation by the eight Great Lakes
States, the environmental community, academia, industry, municipalities
and EPA Regional and National offices. [[Page 15369]]
The final Guidance will help establish consistent, enforceable,
long-term protection with respect to all types of pollutants, but will
place short-term emphasis on the types of long-lasting pollutants that
accumulate in the food web and pose a threat to the Great Lakes System.
The final Guidance will establish goals and minimum requirements that
will further the next phase of Great Lakes programs, including the
Great Lakes Toxic Reduction Effort's integrated, multi-media ecosystem
approach.
EPA and State development of the Guidance--from drafting through
proposal and now final publication--was guided by several general
principles that are discussed below.
A. Use the Best Available Science to Protect Human Health, Aquatic
Life, and Wildlife
EPA and the Initiative Committees have been committed throughout
the Initiative to using the best available science to develop programs
to protect the Great Lakes System. In the 1986 Governors' Agreement,
the Governors of the Great Lakes States recognized that the problem of
persistent toxic substances was the foremost environmental issue
confronting the Great Lakes. They also recognized that the regulation
of toxic contaminants was scientifically complex because the pollutants
are numerous, their pathways into the Lakes are varied, and their
effects on the environment, aquatic life and human health are not
completely understood. Based on the importance of the Great Lakes Basin
Ecosystem and the documented adverse effects from toxic contamination,
however, the Governors directed their environmental administrators to
jointly develop an agreement and procedure for coordinating the control
of toxic releases and achieving greater uniformity of regulations
governing such releases within the Great Lakes basin.
As discussed further above, the Initiative was subsequently created
to begin work on these goals. EPA and the Great Lakes States, with
input from interested parties in the basin, began collecting and
analyzing data, comparing regulatory requirements and technical
guidance in their various jurisdictions, and drafting specific
methodologies and procedures to control the discharge of toxic
contaminants. The provisions of the final Guidance were based in large
part on these prior efforts of the Initiative Committees, and
incorporate the best available science to protect human health,
wildlife and aquatic life in the Great Lakes System. For example, the
final Guidance includes new criteria and a methodology developed by the
Initiative Committees to specifically protect wildlife; incorporates
recent data on the bioavailability of metals into the aquatic life
criteria and methodologies; incorporates Great Lakes-specific data on
fish consumption rates and fish lipid contents into the human health
criteria; and provides a methodology to determine the bioaccumulation
properties of individual pollutants. Additionally, EPA understands that
the science of risk assessment is rapidly improving. Therefore, in
order to ensure that the scientific basis for the criteria
methodologies is always current and peer reviewed, EPA will review the
methodologies and revise them as appropriate every three years.
B. Recognize the Unique Nature of the Great Lakes Basin Ecosystem
The final Guidance also reflects the unique nature of the Great
Lakes Basin Ecosystem by establishing special provisions for chemicals
of concern. EPA and the Great Lakes States believe it is reasonable and
appropriate to establish special provisions for the chemicals of most
concern because of the physical, chemical and biological
characteristics of the Great Lakes System, and the documented
environmental harm to the ecosystem from the past and continuing
presence of these types of pollutants. The Initiative Committees
devoted considerable effort to identifying the chemicals of most
concern to the Great Lakes System--persistent, bioaccumulative
pollutants termed ``bioaccumulative chemicals of concern (BCCs)''--and
developing the most appropriate criteria, methodologies, policies, and
procedures to address them. The special provisions for BCCs, initially
developed by the Initiative Committees and incorporated into the final
Guidance, include antidegradation procedures, to ensure that future
problems are minimized; general phase-out and elimination of mixing
zones for BCCs, except in limited circumstances, to reduce their
overall loadings to the Lakes; more extensive data generation
requirements to ensure that they are not under-regulated for lack of
data; and development of water quality criteria that will protect
wildlife that feed on aquatic prey.
The final Guidance is designed not only to begin to address
existing problems, but also to prevent emerging and potential problems
posed by additional chemicals in the future which may damage the
overall health of the Great Lakes. The experience with such pollutants
as DDT and PCBs indicates that it takes many decades to overcome the
damage to the ecosystem caused by even short-term discharges, and that
prevention would have been dramatically less costly than clean-up.
Issuance of the final Guidance alone will not solve the existing long-
term problems in the Great Lakes System from these contaminants. Full
implementation of provisions consistent with the final Guidance will,
however, provide a coordinated ecosystem approach for addressing
possible pollutant problems before they produce adverse and long-
lasting basin-wide impacts, rather than waiting to see what the future
impacts of the pollutants might be before acting to control them. The
comprehensive approach used in the development of the final Guidance
provides regulatory authorities with both remedial and preventive ways
of gauging the actions and potential effects of chemical stressors upon
the Great Lakes Basin Ecosystem. The methodologies, policies and
procedures contained in the final Guidance provide mechanisms for
appropriately addressing both pollutants that have been or may in the
future be documented as chemicals of concern.
C. Promote Consistency in Standards and Implementation Procedures While
Allowing Appropriate Flexibility to States and Tribes
Promoting consistency in standards and implementation procedures
while providing for appropriate State flexibility was the third
principle in State and EPA development of the final Guidance. The
underlying rationale for the Governors' Agreement, the Initiative, and
the requirements set forth in the CPA was a recognition of the need to
promote consistency through adoption of minimum water quality
standards, antidegradation policies, and implementation procedures by
Great Lakes States and Tribes to protect human health, aquatic life and
wildlife. Although provisions in the CWA provide for the adoption of
and periodic revisions to State water quality criteria, such provisions
do not necessarily ensure that water quality criteria of adjoining
States are consistent within a shared water body. For example, ambient
water quality criteria in place in six of the eight Great Lakes States
to protect aquatic life from acute effects range from 1.79 g/L
to 15.0 g/L for cadmium, and from 0.21 g/L to 1.33
g/L for dieldrin. Other examples of variations in acute
aquatic life criteria include nickel, which ranges from 290.30
g/L to 852.669 g/L; lindane, [[Page 15370]] with a
range of no criteria in place to 1.32 g/L; and mercury,
ranging from 0.5 g/L to 2.4 g/L. Similar ranges and
disparities exist for chronic aquatic life criteria, and for water
quality criteria to protect human health.
Disparities also exist among State procedures to translate water
quality criteria into individual discharge permits. Wide variations
exist, for example, in procedures for the granting of mixing zones,
interpretation of background levels of pollutants, consideration of
pollutants present in intake waters, controls for pollutants present in
concentrations below the level of detection, and determination of
appropriate levels for pollutants discharged in mixtures with other
pollutants. Additionally, when addressing the accumulation of chemicals
by fish that will be consumed by humans and wildlife, some States
consider accumulation through multiple steps in the food chain
(bioaccumulation) while others consider only the single step of
concentration from the water column (bioconcentration). Further
disparities exist in different translator methodologies in deriving
numeric values for implementing narrative water quality criteria;
different assumptions when calculating total maximum daily loads
(TMDLs) and wasteload allocations (WLAs), including different
assumptions about background concentrations, mixing zones, receiving
water flows, or environmental fate; and different practices in deciding
what pollutants need to be regulated in a discharge, what effect
detection limits have on compliance determinations, and how to develop
whole effluent toxicity limitations.
These inconsistencies in State standards and implementation
procedures have resulted in the disparate regulation of point source
discharges. In the Governors' Agreement, the Governors recognized that
the water resources of the basin transcend political boundaries and
committed to taking steps to manage the Great Lakes as an integrated
ecosystem. The Great Lakes States, as participants in the Initiative
Committees, recommended provisions, based on their extensive experience
in administering State water programs and knowledge of the significant
differences in these programs within the basin, that were ultimately
included in the proposed Guidance. The final Guidance incorporates the
work begun by the Initiative Committees to identify these disparities
and improve consistency in water quality standards and permit
procedures in the Great Lakes System.
Although improved consistency in State water programs is a primary
goal of the final Guidance, it is also necessary to provide appropriate
flexibility to States and Tribes in the development and implementation
of water programs. In overseeing States' implementation of the CWA, EPA
has found that reasonable flexibility is not only necessary to
accommodate site-specific situations and unforeseen circumstances, but
is also appropriate to enable innovation and progress as new approaches
and information become available. Many commenters, including the Great
Lakes States, urged EPA to evaluate the appropriate level of
flexibility provided to States and Tribes in the proposed Guidance
provisions. EPA reviewed all sections of the proposed Guidance and all
comments received to determine the appropriate level of flexibility
needed to address these concerns while still providing a minimum level
of consistency between the State and Tribal programs. Based on this
review, the final Guidance provides flexibility for State and Tribal
adoption and implementation of provisions consistent with the final
Guidance in many areas, including the following:
--Antidegradation: Great Lakes States and Tribes may develop their own
approaches for implementing the prohibition against deliberate actions
of dischargers that increase the mass loading of BCCs without an
approved antidegradation demonstration. Furthermore, States and Tribes
have flexibility in adopting antidegradation provisions regarding non-
BCCs.
--TMDLs: Great Lakes States and Tribes may use assessment and
remediation plans for the purposes of appendix F to part 132 if the
State or Tribe certifies that the assessment and remediation plan meets
certain TMDL-related provisions in the final Guidance and public
participation requirements applicable to TMDLs, and if EPA approves
such plan. Thus, States have the flexibility in many cases to use
LAMPs, RAPs and State Water Quality Management Plans in lieu of TMDLs.
--Intake Credits: Great Lakes States and Tribes may consider the
presence of intake water pollutants in establishing water quality-based
effluent limits (WQBELs) in accordance with procedure 5 of appendix F.
--Site-Specific Modifications: Great Lakes States and Tribes may adopt
either more or less stringent modifications to human health, wildlife,
and aquatic life criteria and bioaccumulation factors (BAFs) based on
site-specific circumstances specified in procedure 1 of appendix F. All
criteria, however, must be sufficient not to cause jeopardy to
threatened or endangered species listed or proposed to be listed under
the Federal Endangered Species Act.
--Variances: Great Lakes States and Tribes may grant variances from
water quality standards based on the factors identified in procedure 2
of appendix F.
--Compliance Schedules: Great Lakes States and Tribes may allow
existing Great Lakes dischargers additional time to comply with permit
limits in order to collect data to derive new or revised Tier I
criteria and Tier II values in accordance with procedure 9 of appendix
F.
--Mixing Zones: Great Lakes States and Tribes may authorize mixing
zones for existing discharges of BCCs after the 10-year phase-out
period in accordance with procedure 3.B of appendix F, if the
permitting authority determines, among other things, that the
discharger has reduced its discharge of the BCC for which a mixing zone
is sought to the maximum extent possible. Water conservation efforts
that result in overall reductions of BCCs are also allowed even if they
result in higher effluent concentrations.
--Scientific Defensibility Exclusion: Great Lakes States and Tribes may
apply alternate procedures consistent with Federal, State, and Tribal
requirements upon demonstration that a provision in the final Guidance
would not be scientifically defensible if applied to a particular
pollutant in one or more sites. This provision is in Sec. 132.4(h) of
the final Guidance.
--Reduced Detail: In many instances, EPA has revised the proposed
Guidance to reduce the amount of detail in the provisions without
sacrificing the objectives of the provisions. Examples of such
revisions include simplification of procedures for developing TMDLs in
procedure 3 of appendix F, and simplification of procedures for
determining reasonable potential to exceed water quality standards in
procedure 5.B of appendix F.
--Other Provisions: Flexibility is also present in provisions for the
exercise of best professional judgment by the Great Lakes States and
Tribes when implementing many individual provisions in the final
Guidance including: determining the appropriate uncertainty factors in
the human health and wildlife criteria methodologies; selection of data
sets for establishing water quality criteria; identifying reasonable
and prudent [[Page 15371]] measures in antidegradation provisions; and
specifying appropriate margins of safety when developing TMDLs. In all
cases, of course, State and Tribal provisions would need to be
scientifically defensible and consistent with all applicable regulatory
requirements.
D. Establish Equitable Strategies to Control Pollution Sources
Many commenters argued that the proposed Guidance unfairly focused
on point source discharges. They asserted that nonpoint sources or
diffuse sources of pollution, such as air emissions, are responsible
for most of the loadings of some pollutants of concern in the Great
Lakes, that increased regulation of point sources will be inequitable
and expensive, and that the final Guidance will not result in any
environmental improvement given the large, continuing contribution of
toxic pollutants by nonpoint sources.
EPA recognizes that regulation of point source discharges alone
cannot address all existing or future environmental problems from toxic
pollutants in the Great Lakes. In addition to discharges from point
sources, toxic pollutants are also contributed to the Great Lakes from
industrial and municipal emissions to the air, resuspension of
pollutants from contaminated sediments, urban and agricultural runoff,
hazardous waste and Superfund sites, and spills. Restoration and
maintenance of a healthy ecosystem will require significant efforts in
all of these areas. EPA, Canada and the Great Lakes States and Tribes
are currently implementing or developing many voluntary and regulatory
programs to address these and other nonpoint sources of environmental
contaminants in the Great Lakes.
Additionally, EPA intends to use the scientific data developed in
the final Guidance and new or revised water quality criteria
subsequently adopted by Great Lakes States and Tribes in evaluating and
determining appropriate levels of control in other environmental
programs. For example, EPA's future biennial reports under section
112(m) of the Clean Air Act will consider the extent to which air
discharges cause or contribute to exceedances of water quality criteria
in assessing whether additional air emission standards or control
measures are necessary to prevent serious adverse effects. Similarly,
once provisions consistent with the final Guidance are adopted by the
Great Lakes States or Tribes, they will serve as applicable or relevant
and appropriate requirements (ARARs) for on-site responses under the
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA). EPA will also consider the data and criteria developed for
the final Guidance, including the information on BCCs, in developing or
evaluating LaMPs and RAPs under section 118 of the CWA and Article VI,
Annex 2 of the GLWQA; determination of corrective action requirements
under sections 3004(u), 3008(h), or 7003 of the Solid Waste Disposal
Act; new or existing chemical reviews under the Toxic Substances
Control Act (TSCA); pesticide reviews under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA); and reporting requirements for
toxic releases under the Emergency Planning and Community Right-to-Know
Act (EPCRA).
The final Guidance also includes provisions to address the
contribution of pollutants by nonpoint sources. First, the water
quality criteria to protect human health, wildlife and aquatic life,
and the antidegradation provisions apply to the waters in the Great
Lakes System regardless of whether discharges to the water are from
point or nonpoint sources. Accordingly, any regulatory programs for
nonpoint sources that require compliance with water quality standards
would also be subject to the criteria and antidegradation provisions of
the final Guidance once they are adopted into State or Tribal
standards.
Second, several elements of the final Guidance would, after State,
Tribal or Federal promulgation, require or allow permitting authorities
to consider the presence of pollutants in ambient waters--including
pollutants from nonpoint source dischargers--in establishing WQBELs for
point sources. For example, permit authorities may consider the
presence of other point or nonpoint source discharges when evaluating
whether to grant a variance from water quality criteria. Additionally,
the provisions for TMDLs address nonpoint sources by specifying that
the loading capacity of a receiving water that does not meet water
quality standards for a particular pollutant be allocated, where
appropriate, among nonpoint as well as point sources of the pollutant,
including, at a minimum, a margin of safety to account for technical
uncertainties in establishing the TMDL. The development of TMDLs is the
preferred mechanism for addressing equitable division of the loading
capacities of these nonattained waters. Because TMDLs have not been
completed for most nonattained waters, however, the final Guidance
promotes the development of TMDLs through a phased approach, where
appropriate, and provides for short-term regulatory relief to point
source dischargers in the absence of TMDLs through intake credits,
variances, and other water quality permitting procedures.
EPA received numerous comments on the problem posed in controlling
mercury in particular. Many commenters stated that since the primary
source of mercury is now atmospheric deposition, point sources
contribute only a minor portion of the total loading of mercury to the
Great Lakes System and further restriction of point source discharges
would have no apparent effect in improving water quality. Although EPA
believes that there is sufficient flexibility in the Guidance to handle
the unique problems posed by mercury (e.g., water quality variances,
phased TMDLs, intake credits), EPA is committed to developing a mercury
permitting strategy to provide a holistic, comprehensive approach for
dealing with this pollutant. EPA will publish this strategy no later
than two years following publication of this Guidance.
There are also many ongoing voluntary and regulatory activities
that address nonpoint sources of toxic pollutants to the Great Lakes
System, including activities taken under the Clean Air Act Amendments
of 1990 (CAAA), the CWA, and State regulatory and voluntary programs.
Some of these activities are summarized in the preamble to the proposed
Guidance (58 FR 20826-32) and section I.D of the SID.
In addition to the many ongoing activities, EPA and the Great Lakes
States, Tribes, and other federal agencies are pursuing a multi-media
program to prevent and to further reduce toxic loadings from all
sources of pollution to the Great Lakes System, with an emphasis on
nonpoint sources. This second phase of the Great Lakes Water Quality
Initiative, called the Great Lakes Toxic Reduction Effort (GLTRE), will
build on the open, participative public dialogue established during the
development of the final Guidance. Through the GLTRE, the Federal,
State, and Tribal agencies intend to coordinate and enhance the
effectiveness of ongoing actions and existing tools to prevent and
reduce nonpoint source and wet-weather point source contributions of
toxic pollutants in the Great Lakes System. A special emphasis will be
placed on BCCs identified in the final Guidance.
A partial list of ongoing actions that are being or could be
focused on BCCs includes: implementation of the CAAA to reduce
atmospheric deposition of toxics; Resource Conservation and Recovery
Act and CERCLA remedial actions to reduce loadings of toxics from
[[Page 15372]] hazardous waste sites; increased focus (through the
GLTRE) on toxic pollutants emanating from combined sewer overflows and
stormwater outfalls; application in the Great Lakes basin of the
National Contaminated Sediment Management Strategy; implementation of
spill prevention planning practices to minimize this potential source
of loadings to the Great Lakes; improved reporting of toxic pollutants
under the Toxic Release Inventory; public education on the dangers of
mercury and other BCCs; pesticide registration and re-registration
processes; development of a ``mass balance'' model for fate and
transport of pollutants in the Great Lakes; and, development of a
``virtual elimination strategy.'' These programs will prevent and
further reduce mass loadings of pollutants and facilitate equitable
division of the costs of any necessary control measures between point
and nonpoint sources.
In addition to the GLTRE, which is basin-wide in scope, a primary
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 of this publication in the Federal
Register (that is, by March 23, 1997), EPA will publish a final rule at
the end of that time period identifying the provisions of the final
Guidance that will apply to waters and discharges within that
jurisdiction. Additionally, when an Indian Tribe is authorized to
administer the NPDES or water quality standards program in the Great
Lakes basin, it will also need to adopt provisions consistent with the
final Guidance into their water programs.
The following sections provide a brief summary of the provisions of
the final Guidance. A more complete discussion of the final Guidance,
including EPA's analysis of major comments, issues, and a description
of specific changes made to the proposed Guidance, are contained in the
SID.
The parenthetical note at the beginning of each section provides
references to the primary provisions in the final Guidance being
discussed in the section, and to discussions in the SID. The final
Guidance is codified as 40 CFR 132, including appendixes A through F.
Note that appendix F consists of procedures 1 through 9. For ease of
reference, sections in appendix F may be referred to by appending the
section designation to the procedure number. For example, section A.1
of procedure 1 may be referred to as procedure 1.A.1 of appendix F.
[[Page 15373]]
A. Water Quality Criteria and Methodologies
1. Protection of Aquatic Life
(Secs. 132.3(a), 132.3(b), 132.4(a)(2); Tables 1 and 2 to part 132;
appendix A to part 132; section III, SID)
The final Guidance contains numeric criteria to protect aquatic
life for 15 pollutants, and a two-tiered methodology to derive criteria
(Tier I) or values (Tier II) for additional pollutants discharged to
the Great Lakes System. Aquatic life criteria are derived to establish
ambient concentrations for pollutants, which, if not exceeded in the
Great Lakes System, will protect fish, invertebrates, and other aquatic
life from adverse effects due to that pollutant. The final Guidance
includes both acute and chronic criteria to protect aquatic life from
acute and chronic exposures to pollutants.
Tier I aquatic life criteria for each chemical are based on
laboratory toxicity data for a variety of aquatic species (e.g., fish
and invertebrates) which are representative of species in the
freshwater aquatic environment as a whole. The Guidance also includes a
Tier II methodology to be used in the absence of the full set of data
needed to meet Tier I data requirements. For pollutants for which Tier
I criteria have not been adopted into State or Tribal water quality
standards, States must use methodologies consistent with either the
Tier I or Tier II methodologies, depending on the data available, in
conjunction with whole effluent toxicity requirements in the final
Guidance (see section IV.B.5 of this preamble), to implement their
existing narrative water quality criteria that prohibit toxic
pollutants in toxic amounts in all waters. The Great Lakes States and
Tribes are not required to use the Tier II methodology to adopt numeric
criteria into their water quality standards.
Use of the two-tiered final Guidance methodologies in these
situations will enable regulatory authorities to translate narrative
criteria to derive TMDLs and individual NPDES permit limits on a more
uniform basis. EPA and the States determined that there is a need to
regulate pollutants more consistently in the Great Lakes System when
faced with limited numbers of criteria. Many of the Great Lakes States
are already employing procedures similar to the approach in the final
Guidance to implement narrative criteria. EPA determined the Tier II
approach improves upon existing mechanisms by utilizing all available
data.
The two-tiered methodology allows the application of the final
Guidance to all pollutants, except those listed in Table 5 of part 132
(see section IV.E of this preamble). The Tier I aquatic life
methodology includes data requirements very similar to those used in
current guidelines for developing National water quality criteria
guidance under section 304(a) of the CWA. For example, both require
that acceptable toxicity data for aquatic species in at least eight
different families representing differing habitats and taxonomic groups
must exist before a Tier I numeric criterion can be derived. The Tier
II aquatic life methodology is used to derive Tier II values which can
be calculated with fewer toxicity data than Tier I. Tier II values can,
in certain instances, be based on toxicity data from a single taxonomic
family, provided the data are acceptable. The Tier II methodology
generally produces more stringent values than the Tier I methodology,
to reflect greater uncertainty in the absence of additional toxicity
data. As more data become available, the derived Tier II values tend to
become less conservative. That is, they more closely approximate Tier I
numeric criteria. EPA and the States believe it is desirable to
continue to supplement toxicity data to ultimately derive Tier I
numeric criteria.
One difference from the existing National water quality criteria
guidelines is that the final Guidance methodology for aquatic life
deletes the provision in the National guidelines to use a Final Residue
Value (FRV) in deriving a criterion. The FRV is intended to prevent
concentrations of pollutants in commercially or recreationally
important aquatic species from affecting the marketability of those
species or affecting wildlife that consume them by preventing the
exceedance of applicable Food and Drug Administration action levels and
concentrations that affect wildlife. The final Guidance provides
specific, separate methodologies to protect wildlife and human health
(discussed below) which EPA believes will provide more accurate and
appropriate levels of protection than the FRVs.
For pollutants without Tier I criteria but with enough data to
derive Tier II values for aquatic life, the proposal would have
required permittees to meet permit limits based on both Tier II values
and whole effluent toxicity (WET) testing. In response to comments, the
final Guidance clarifies that States and Tribes may adopt provisions
allowing use of indicator parameter limits consistent with 40 CFR
122.44(d)(1)(vi)(C). When deriving limits to meet narrative criteria,
States and Tribes have the option of using an indicator parameter
limit, including use of a WET limit under appropriate conditions, in
lieu of a Tier II-based limit. If use of an indicator parameter is
allowed, the State or Tribe must ensure that the indicator parameter
will attain the ``applicable water quality standard'' (as described in
40 CFR 122.44(d)(1)(vi)(C). The ``applicable water quality standard''
in this instance would be the State's or Tribe's narrative water
quality standard that protects aquatic life.
Finally, the aquatic criteria for metals in the proposed Guidance
were expressed as total recoverable concentrations. The final Guidance
expresses the criteria for metals in dissolved form because the
dissolved metal more closely approximates the bioavailable fraction of
metal in the water column than does the total recoverable metal. The
dissolved criteria are obtained by multiplying the chronic and/or acute
criterion by appropriate conversion factors in Table 1 or 2. This is
consistent with many comments on the issue and with the policy on
metals detailed in ``Office of Water Policy and Technical Guidance on
Interpretation and Implementation of Aquatic Life Metals Criteria''
(October 1, 1993). A document describing the methodology to convert
total recoverable metals criteria to dissolved metals criteria was
published in the Federal Register on August 30, 1994 (59 FR 44678). If
a State or Tribe fails to adopt approvable aquatic life criteria for
metals, EPA will promulgate criteria expressed as dissolved
concentrations.
EPA Region 5, in cooperation with EPA Regions 2 and 3 and
Headquarters offices, and the Great Lakes States and Tribes, will
establish a Great Lakes Initiative (GLI) Clearinghouse to assist States
and Tribes in developing numeric Tier I water quality criteria for
aquatic life, human health and wildlife and Tier II water quality
values for aquatic life and human health. As additional toxicological
data and exposure data become available or additional Tier I numeric
criteria and Tier II values are calculated by EPA, States, or Tribes,
Region 5 will ensure that this information is disseminated to the Great
Lakes States and Tribes. EPA believes operation of the GLI
Clearinghouse will help ensure consistency during implementation of the
final Guidance.
2. Protection of Human Health
(Secs. 132.3(c), 132.4(a)(4); Table 3 to part 132; appendix C to
part 132; section V of the SID)
The final Guidance contains numeric human health criteria for 18
pollutants, and includes Tier I and Tier II methodologies to derive
cancer and [[Page 15374]] non-cancer human health criteria for
additional pollutants. The proposed Guidance contained numeric criteria
for 20 pollutants, but two pollutants were deleted because they do not
meet the more restrictive minimum data requirements for BAFs used in
the final Guidance.
Tier I human health criteria are derived to establish ambient
concentrations of chemicals which, if not exceeded in the Great Lakes
System, will protect individuals from adverse health impacts from that
chemical due to consumption of aquatic organisms and water, including
incidental water consumption related to recreational activities in the
Great Lakes System. For each chemical, chronic criteria are derived to
reflect long-term consumption of food and water from the Great Lakes
System. Tier II values are intended to provide a conservative, interim
level of protection in the establishment of a permit limit, and are
distinguished from the Tier I approach by the amount and quality of
data used for derivation.
The final Guidance differs from current National water quality
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).
In contrast, as discussed in section II above, the cancer risk from
ingestion of contaminated fish at current concentrations in the Great
Lakes System are as high as 1.2 x 10-\2\ (1.2 in 100). The
proposed and final Guidance establishes 10-\5\ (one in one hundred
thousand) as the risk level used for deriving criteria and values for
individual carcinogens. This is within the range historically used in
EPA actions, and approved for State actions, designed to protect human
health. The majority of the Great Lakes States use 10-\5\ as a
baseline risk level in establishing their water quality standards.
The methodology is designed to protect humans who drink water or
consume fish from the Great Lakes System. The portion of the
methodology addressing fish consumption includes a factor describing
how much fish humans consume per day. The final Guidance includes a
Great 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 therefore consistent with Executive Order
12898.
In developing bioaccumulation factors, the proposed Guidance used a
5.0 percent lipid value for fish consumed by humans, based on Great
Lakes-specific data. The current National methodology uses a 3.0
percent lipid value. The final Guidance uses a 3.10 percent lipid value
for trophic level 4 fish and 1.82 for trophic level 3 fish. These
percent lipid values are based on an analysis of the West et al. study
cited above and data from State fish contaminant monitoring programs.
The final Guidance contains specific technical guidelines
concerning the range of uncertainty factors that may be applied by the
State and Tribal agencies on the basis of their best professional
judgment. The final Guidance places a cap of 30,000 on the combined
product of uncertainty factors that may be applied in the derivation of
non-cancer Tier II values and a combined uncertainty factor of 10,000
for Tier I criteria. The likely maximum combined uncertainty factor for
Tier I criteria in most cases is 3,000. The SID discusses further the
use of the uncertainty factors in the derivation of human health
criteria and values.
The proposed Guidance used an 80 percent relative source
contribution (RSC) from surface water pathways for BCCs, and a 100
percent RSC for all other pollutants, in deriving noncancer criteria.
The RSC concept is applied in the National drinking water regulations
and is intended to account, at least in part, for exposures from other
sources for those bioaccumulative pollutants for which surface water
pathways are likely to be major contributors to human exposure. The
final Guidance uses the more protective 80 percent RSC for all
pollutants in deriving noncancer criteria. This change was made because
of concern that for non-BCCs as well as [[Page 15375]] BCCs, there may
be other sources of exposures for noncarcinogens.
3. Protection of Wildlife
(Secs. 132.3(d), 132.4(a)(5); Table 4 to part 132; appendix D to
part 132; section VI of the SID)
The final Guidance contains numeric criteria to protect wildlife
for four pollutants and a methodology to derive Tier I criteria for
additional BCCs. Wildlife criteria are derived to establish ambient
concentrations of chemicals which, if not exceeded, will protect
mammals and birds from adverse impacts from that chemical due to
consumption of food and/or water from the Great Lakes System.
These are EPA's first water quality criteria specifically for the
protection of wildlife. The methodology is based largely on the
noncancer human health paradigm. It focuses, however, on endpoints
related to reproduction and population survival rather than the
survival of individual members of a species. The methodology
incorporates pollutant-specific effect data for a variety of mammals
and birds and species-specific exposure parameters for two mammals and
three birds representative of mammals and birds resident in the Great
Lakes basin which are likely to experience significant exposure to
bioaccumulative contaminants through the aquatic food web.
In the proposal, EPA included a two-tiered approach similar to that
for aquatic life and human health. In response to comments, the final
Guidance requires States and Tribes to adopt provisions consistent with
only the Tier I wildlife methodology, and only to apply this
methodology for BCCs (see section IV.A.4 below). The TSD provides
discretionary guidelines for the use of Tier I and Tier II
methodologies for other pollutants. The wildlife methodology was
limited to the BCCs because these are the chemicals of greatest concern
to the higher trophic level wildlife species feeding from the aquatic
food web in the Great Lakes basin. This decision is consistent with
comments made by the EPA Science Advisory Board (SAB) who agreed that
the initial focus for wildlife criteria development should be on
persistent, bioaccumulative organic contaminants (USEPA, 1994, EPA-SAB-
EPEC-ADV-94-001).
Numerous commenters were concerned that the mercury criterion for
wildlife was not scientifically appropriate. After review of all
comments and a reevaluation of all the data, the mercury criterion for
wildlife has been increased from 180 pg/L to 1300 pg/L. EPA believes
the 1300 pg/L is protective of wildlife in the Great Lakes System.
In developing bioaccumulation factors, the proposed Guidance used a
7.9 percent lipid value for fish consumed by wildlife. The final
Guidance uses a 10.31 percent lipid value for trophic level 4 fish and
6.46 for trophic level 3 fish. These percent lipid values are based on
the actual prey species consumed by the representative wildlife species
specified in the methodology, and are used to estimate the BAFs for the
trophic levels which those species consume. The percent lipid is based
on the preferential consumption patterns of wildlife and cross-
referenced with fish weight and size and appropriate percent lipid.
This approach is a more accurate reflection of the lipid content of the
fish consumed by wildlife species than the approach used in the
proposal.
4. Bioaccumulation Methodology
(Sec. 132.4(a)(3); appendix B to part 132; section IV of the SID)
The proposed Guidance incorporated BAFs in the derivation of
criteria and values to protect human health and wildlife.
Bioaccumulation refers to the uptake and retention of a substance by an
aquatic organism from its surrounding medium and from food. For certain
chemicals, uptake through the aquatic food chain is the most important
route of exposure for wildlife and humans. The wildlife criteria and
the human health criteria and values incorporate appropriate BAFs in
order to more accurately account for the total exposure to a chemical.
Current EPA guidelines for the derivation of human health water quality
criteria use BCFs, which measure only uptake from water, when 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
[[Page 15376]] account for the metabolism or degradation of the
pollutants in the environment. States and Tribes may identify more BCCs
as additional BAF data become available. The final Guidance designates
as BCCs only those chemicals with human health BAFs greater than 1000
that were derived from either a field-measured BAF or a predicted BAF
based on a field-measured BSAF (for non-metals) or from a 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
(Secs. 132.4(a)(7), 132.4(e); appendix F to part 132; section VIII of
the SID)
This section of the preamble discusses nine specific procedures
contained in the final Guidance for implementing water quality
standards and developing NPDES permits to attain the standards.
1. Site-Specific Modifications
(Procedure 1 of appendix F to part 132; section VIII.A of the SID)
The proposed Guidance would have allowed States and Tribes to adopt
site-specific modifications to water quality criteria and values under
certain circumstances. States and Tribes could modify aquatic life
criteria to be either more stringent or less stringent when local water
quality characteristics altered the biological availability or toxicity
of a pollutant, or where local species' sensitivities differed from
tested species. Less stringent modifications to chronic aquatic life
criteria could also be made to reflect local physical and hydrological
conditions. States and Tribes could also modify BAFs and human health
and wildlife criteria to be more stringent, but not less stringent than
the final Guidance.
The final Guidance retains most of the above provisions, but in
addition allows less stringent modifications to acute aquatic life
criteria and values to reflect local physical and hydrological
conditions, less stringent modifications to BAFs in developing human
health and wildlife criteria, and the use of fish consumption rates
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 [[Page 15377]] States and
Tribes in exercising the exception provision with special focus on the
technical and economic feasibility criteria. This guidance will also
consider the notice, public hearing, monitoring and pollution
prevention demonstration elements of the exception criteria.
The final Guidance also retains many of the proposed provisions for
calculating background concentrations used in TMDLs and WLAs
established in the absence of TMDLs. The procedure addressing data
points below the level of detection, however, has been modified so that
it no longer specifies the use of default values (i.e., half of the
level of detection).
The final TMDL procedures do not require that TMDLs be established
for point sources prior to the issuance/reissuance of NPDES permits.
The final Guidance defers to the existing National program for
determining when a TMDL is required. Lastly, the final Guidance allows
assessment and remediation plans that are approved by EPA under 40 CFR
130.6 to be used in lieu of a TMDL for purposes of appendix F as long
as they meet the general conditions of a TMDL as outlined by procedure
3 of appendix F, and the public participation requirements applicable
to TMDLs.
4. Additivity
(Procedure 4 of appendix F to part 132; section VIII.D of the SID)
EPA has traditionally developed numeric water quality criteria on a
single pollutant basis. While some potential environmental hazards
involve significant exposure to only a single compound, most instances
of contamination in surface waters involve mixtures of two or more
pollutants. The individual pollutants in such mixtures can act or
interact in various ways which may affect the magnitude and nature of
risks or effects on human health, aquatic life and wildlife. WET tests
are available to generally address interactive effects of mixtures on
aquatic organisms. EPA's 1986 ``Guidelines for the Health Risk
Assessment of Chemical Mixtures'' set forth principles and procedures
for human health risk assessment of chemical mixtures. There are
currently no technical guidelines on how to assess effects on wildlife
from chemical mixtures.
The preamble for the proposed Guidance discussed several possible
approaches to address additive effects from multiple pollutants.
Proposed regulatory language was provided for two specific options,
each with separate provisions related to aquatic life, wildlife and
human health. One approach was developed by the Initiative Committees,
modified to delete the application of toxicity equivalency factors
(TEFs) for PCBs to wildlife. The other approach was developed by EPA.
Neither approach addressed the possible toxicologic interactions
between pollutants in a mixture (e.g., synergism or antagonism) because
of the limited data available on these interactive effects. In the
absence of contrary data, both approaches recommended that the risk to
human health from individual carcinogens in a mixture be considered
additive, and that a 10-5 risk level be adopted as a cap for the
cancer risk associated with mixtures. Both approaches also proposed
using TEFs to assess the risk to humans and wildlife from certain
chemical classes. The TEF approach converts the concentration of
individual components in a mixture of chemicals to an ``equivalent''
concentration expressed in terms of a reference chemical. Both
approaches used the 17 TEFs for dioxins and furans identified in the
1989 EPA document, ``Estimating Risks Associated with Exposures to
Mixtures of Chlorinated Dibenzo-p-Dioxins and -Dibenzofurans,'' and the
1989 update.
The final Guidance includes a general requirement for States and
Tribes to adopt an additivity provision consistent with procedure 4 of
appendix F to protect human health from the potential additive adverse
effects from both the noncarcinogenic and carcinogenic components of
chemical mixtures in effluents. The final Guidance also requires the
use of the 17 TEFs included in the proposed Guidance to protect human
health from the potential additive adverse effects in effluents.
5. Determining the Need for WQBELs (Reasonable Potential)
(Procedure 5 of appendix F to part 132; section VIII.E of the SID)
EPA's existing regulations require NPDES permits to include WQBELs
to control all pollutants or pollutant parameters which the permitting
authority determines are or may be discharged at a level which will
cause, have the reasonable potential to cause or contribute to an
excursion of any applicable water quality standard. If the permitting
authority determines that a discharge has the reasonable potential to
cause or contribute to an excursion of an applicable numeric water
quality criterion, it must include a WQBEL for the individual pollutant
in the permit. In the absence of an adopted numeric water quality
criterion for an individual pollutant, the permitting authority must
derive appropriate WQBELs from the State or Tribal narrative water
quality criterion by either calculating a numeric criterion for the
pollutant; applying EPA's water quality criteria developed under
section 304(a) of the CWA, supplemented with other information where
necessary; or establishing effluent limitations on an indicator
pollutant. See 40 CFR 122.44(d)(1).
The final Guidance implements these National requirements by
specifying procedures for determining whether a discharge has the
reasonable potential to cause or contribute to an exceedance of Tier I
criteria or Tier II values based on facility-specific effluent data.
The final Guidance also specifies procedures for determining whether
permitting authorities must generate or require permittees to generate
data sufficient to calculate Tier II values when specified pollutants
of concern in the Great Lakes System are known or suspected of being
discharged, but neither Tier I criteria nor Tier II values have been
derived due to a lack of toxicological data. EPA believes that the data
necessary to calculate Tier II values for aquatic life, wildlife and
human health currently exists for most of the specified pollutants of
concern.
The final Guidance maintains all the basic requirements from the
proposed procedure. Some minor changes are that the procedure no longer
includes a special provision for effluent dominated streams, and the
procedure allows a broader range of statistical approaches to be used
when evaluating effluent data, which provides added simplicity and
flexibility to States and Tribes.
Another change from the proposal is the relationship in the final
Guidance between the reasonable potential and TMDL procedures. Numerous
commenters pointed out that the proposed Guidance indicated that TMDLs
would be required for any water receiving effluent from a discharger
found to exhibit reasonable potential. Given the fact that there are
many waterbodies in the Great Lakes basin for which TMDLs have not been
developed, and the obvious need for permitting to proceed in the
interim until TMDLs are completed, the final Guidance provides that the
permitting authority can establish waste load allocations and WQBELs in
the absence of a TMDL or an assessment and remediation plan developed
and approved in accordance with procedure 3.A of appendix F. A more
detailed discussion of the assessment and remediation plan and its
relationship to a TMDL can be found in section VIII.C.2 of the SID.
Procedures for establishing such WLAs are therefore addressed in the
final Guidance. [[Page 15378]]
6. Intake Pollutants
(Procedures 5.D and 5.E of appendix F to part 132; section VIII.E of
the SID)
The proposed Guidance allowed a permitting authority to determine
that the return of an identified intake water pollutant to the same
body of water under specified circumstances does not cause, have the
reasonable potential to cause, or contribute to an excursion above
water quality standards, and therefore, that a WQBEL would not be
required for that pollutant. Under the proposal, this ``pass through''
of intake water pollutants would be allowed if the facility returns the
intake water containing the pollutant of concern to the same waterbody;
does not contribute additional mass of pollutant; does not increase the
concentration of the intake water pollutant; and does not discharge at
a time or location, or alter the pollutant in a manner which would
cause adverse impacts to occur that would not occur if the pollutant
were left in-stream.
EPA received numerous comments on the proposal. Some commenters
argued that the proposed provision was too narrow because relief would
not be available if the facility added any amount of the pollutant to
the discharge, even where the facility was not contributing any
additional mass or concentration to the waterbody than was contained in
the intake water. After consideration of public comments, EPA decided
to expand the intake pollutant provisions to include not only a
reasonable potential procedure like the one contained in the proposal,
but also a provision that allows the permitting authority to take into
account the presence of pollutants in intake water in deriving WQBELs.
Specifically, the final Guidance authorizes the permitting authority to
establish limits based on a principle of ``no net addition'' (i.e., the
limit would allow the mass and concentration of the pollutant in the
discharge up to the mass and concentration of the pollutant in the
intake water). This provision would be available where the facility's
discharge is to the same body of water as the intake water, and could
be applied for up to 12 years after publication of the final Guidance.
After that time, if a TMDL or comparable plan that meets the
requirements of procedure 3 of appendix F has not been completed, the
facility's WQBEL must be established in accordance with the
``baseline'' provisions in procedure 5.F.2 of appendix F. This time
limit provides a period of relief for dischargers that are not causing
increased impacts on the waterbody by virtue of their discharge that
would not have occurred had the pollutant remained in-stream, while
maintaining the incentive for development of a comprehensive assessment
and remediation plan for achieving attainment of water quality
standards, which EPA believes is a critical element of the final
Guidance for addressing pollutants for which a large contributor to
non-attainment is nonpoint source pollution.
The final Guidance allows States and Tribes to address intake
pollutants in a manner consistent with assessment and remediation plans
that have been developed through mechanisms other than TMDLs in order
to provide flexibility where such plans comprehensively address the
point and non-point sources of non-attainment in a waterbody and the
means for attaining compliance with standards.
EPA believes that 12 years provides sufficient time for States to
develop and complete the water quality assessments that would serve as
the basis for establishing effluent limits (including ``no net
addition'' limits, where appropriate) under procedure 3.A of appendix
F. However, EPA also recognizes that unforeseen events could delay
State completion of these assessments, and therefore will, at 7 years
following promulgation, in consultation with the States, evaluate the
progress of the assessments. If this evaluation shows that completion
of the assessments may not be accomplished by the 12 year date, EPA
will revisit these provisions, and consider proposing extensions if
appropriate.
Under the final Guidance, the permitting authority can permit the
discharge of intake pollutants to a different body of water that is in
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 VIII.F of the SID)
Existing EPA regulations define WET as ``the aggregate toxic effect
of an effluent measured directly by a toxicity test.'' These
regulations require WET limits to be included in permits in most
circumstances in which the WET of a discharge has the reasonable
potential to cause or contribute to an in-stream excursion above either
a State's numeric criteria for toxicity or narrative criteria for water
quality (40 CFR 122.2, 122.44(d)(1)). The regulations allow States and
Tribes the flexibility to control for WET with either numeric or
narrative criteria. Current technical guidelines recommend that no
discharge should exceed 0.3 acute toxic units (TUa = 100/LC50) at the
edge of an acute mixing zone and 1.0 chronic toxic units (TUc = 100/
NOEC, the No Observed Effect Concentration) at the edge of a chronic
mixing zone.
The proposed Guidance would have continued to allow States and
Tribes the flexibility to choose to control WET with either numeric or
narrative criteria, but specified that no discharge could exceed 1.0
TUa at the point of discharge (i.e., no acute mixing zones) and
1.0 TUc at the edge of a chronic mixing zone (with some
exceptions). In addition, the proposal contained minimum requirements
for appropriate test methods to measure WET and for permit conditions,
and procedures for determining whether or not limits for WET are
necessary.
The final Guidance differs principally from the proposal in
requiring States and Tribes to adopt 0.3 TUa and 1.0 TUc
either as numeric criteria or as an equivalent numeric interpretation
of narrative criteria. The final Guidance also allows the use of acute
mixing zones for the application of the acute criterion. This approach
will promote consistency among States and Tribes in controlling WET,
while still permitting considerable flexibility regarding
implementation measures, consistent with current National policies and
guidelines. [[Page 15379]]
8. Loading Limits
(Procedure 9 of appendix F to part 132; section VIII.G of the SID)
The final Guidance provides that WQBELs be expressed in terms of
both concentration and mass loading rate, except for those pollutants
that cannot appropriately be expressed in terms of mass. These
provisions clarify the application of existing Federal regulations at
40 CFR 122.45(f), and are consistent with current EPA guidance which
requires the inclusion of any limits determined necessary based on best
professional judgment to meet water quality standards, including, where
appropriate, mass loading rate limits. They are also consistent with
the antidegradation policy for the Great Lakes System in appendix E of
the final Guidance.
9. Levels of Quantification
(Procedure 8 of appendix F to part 132; section VIII.H of the SID)
Many of the pollutants of concern in the Great Lakes System cause
unacceptable toxic effects at very low concentrations. This results in
instances where WQBELs are below levels of reliable quantification.
When this occurs, the permitting authority may not be able to determine
whether the pollutant concentration is above or below the WQBEL. The
final Guidance requires adoption of pollutant minimization programs
(PMPs) for such permits to increase the likelihood that the
concentration of the pollutant is as close to the effluent limit as
possible. The PMP is an ongoing, iterative process that requires, among
other things, internal wastestream monitoring and submission of status
reports. The use of PMPs for facilities with pollutants below the level
of quantification is consistent with existing EPA guidance.
Unlike the proposal, however, the final Guidance eliminates
additional minimum requirements for BCCs. For example, the final
Guidance recommends but does not require bio-uptake studies that had
been proposed to assess impacts to the receiving water and evaluate the
effectiveness of the PMP.
10. Compliance Schedules
(Procedure 9 of appendix F to part 132; section VIII.I of the SID)
The final Guidance includes a procedure that allows Great Lakes
States and Tribes to include schedules of compliance in permits for
existing Great Lakes dischargers for effluent limitations based on new
water quality criteria and certain other requirements. Generally,
compliance schedules may provide for up to five years to comply with
the effluent limitation in question and may, in specified cases, allow
the compliance schedule to go beyond the term of the permit. Existing
Great Lakes dischargers are those whose construction commenced before
March 23, 1997. Thus the term, existing Great Lakes discharges, covers
expanding dischargers who were ineligible for compliance schedules
under the proposal. The final Guidance also provides the opportunity
for States and Tribes to allow dischargers additional time to comply
with effluent limitations based on Tier II values while conducting
studies to justify modifications of those limitations.
C. Antidegradation Provisions
(Sec. 132.4(a)(6); appendix E to part 132; section VII of the SID)
EPA's existing regulations, at 40 CFR 131.6, establish an
antidegradation policy as one of the minimum requirements of an
acceptable water quality standards submittal. Section 131.12 describes
the required elements of an antidegradation policy. These are:
protection of water quality necessary to maintain existing uses,
protection of high quality waters (those where water quality exceeds
levels necessary to support propagation of fish, shellfish, and
wildlife and recreation in and on the waters) and protection of water
quality in those water bodies identified as outstanding National
resources.
The proposed Guidance provided detailed procedures for implementing
antidegradation that were not part of the existing regulations. The
detailed implementation procedures were intended to result in greater
consistency in how antidegradation was applied throughout the Great
Lakes System. The proposed Guidance specified, among other things, how
high quality waters should be identified, what activities should and
should not require review under antidegradation, and the information
necessary to support a request to lower water quality and the
procedures to be followed by a Tribe or State in making a decision
whether or not to allow a lowering of water quality.
The final Guidance maintains the overall structure of the proposed
Guidance while allowing Tribes and States greater flexibility in how
antidegradation is implemented. As in the proposal, the final Guidance
is composed of an antidegradation standard, antidegradation
implementation procedures, antidegradation demonstration and
antidegradation decision. However, many of the detailed requirements
found in the proposed Guidance appear in the SID accompanying the final
Guidance as nonbinding guidelines, including provisions specific to
non-BCCs.
Key elements of the proposed Guidance that are retained in the
final Guidance for BCCs include: identification of high quality waters
on a pollutant-by-pollutant basis; requirements for States and Tribes
to adopt an antidegradation standard consistent with the final Guidance
for BCCs; minimum requirements for conducting an antidegradation review
of any activity expected to result in a significant lowering of water
quality due to BCCs, minimum requirements for notifying permitting
authorities of increases in discharges of BCCs; and, minimum
requirements for an antidegradation demonstration consisting of a
pollution prevention analysis, an alternative treatment analysis and a
showing that the significant lowering of water quality will allow for
important social and economic development. Significant changes from the
proposed Guidance include: encouraging, but not requiring, States and
Tribes to adopt provisions consistent with the antidegradation standard
and implementation procedures for non-BCCs; replacement of numeric
existing effluent quality-based (EEQ) limits as a means of implementing
antidegradation for BCCs with a narrative description of the types of
activities that will trigger an antidegradation review; and greater
flexibility in the implementation, demonstration and decision
components. A detailed discussion of the basis for each of the changes
is provided in Section VII the SID.
D. Regulatory Requirements
(Part 132; Tables 5 and 6 to part 132; section II of the SID)
The Great Lakes States must adopt water quality standards, 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 [[Page 15380]] require
Great Lakes States and Tribes to adopt criteria, methodologies,
policies, and procedures consistent with the criteria, methodologies,
policies, and procedures contained in part 132--that is, the
definitions in Sec. 132.2, the numeric criteria in Tables 1 through 4,
the criteria development methodologies in appendixes A through D, the
antidegradation policy in appendix E, and the implementation procedures
in appendix F. Section 132.5 specifies the procedures for States and
Tribes to make their submissions to EPA, and for EPA to approve or
disapprove the submissions. The section specifies that in reviewing
submissions, EPA will consider provisions of State and Tribal
submissions to be ``consistent with'' the final Guidance if each
provision is as protective as the corresponding provision of the final
Guidance. If a State or Tribe fails to make a submission, or if
provisions of the submission are not consistent with the final
Guidance, Sec. 132.5 provides that EPA will publish a final rule in the
Federal Register identifying the final Guidance provisions that will
apply to discharges within the particular State or Federal Indian
Reservation.
Section 132.4 specifies that water quality criteria adopted by
States and Tribes consistent with the final Guidance will apply to all
waters of the Great Lakes System, regardless of designated uses of the
waters in most cases, with some variations in human health criteria
depending on whether the waters are designated for drinking water use.
Section 132.4 also contains certain exceptions in applying the final
Guidance methodologies and procedures. First, States and Tribes do not
have to adopt and apply the final Guidance methodologies and procedures
for the 14 pollutants listed in Table 5 of part 132. EPA believes that
some or all of the methodologies and procedures are not scientifically
appropriate for these pollutants. Second, if a State or Tribe
demonstrates that the final Guidance methodologies or procedures are
not scientifically defensible for a particular pollutant, the State or
Tribe may use alternate methodologies or procedures so long as they
meet all applicable Federal, State, and Tribal laws. Third, Sec. 132.4
specifies that for wet-weather point sources, States and Tribes
generally do not have to adopt and apply the final Guidance
implementation procedures. The exception is the TMDL general condition
for wet weather events. Fourth, pursuant to section 510 of the CWA,
part 132 specifies that nothing in the final Guidance prohibits States
or Tribes from adopting provisions more stringent than the final
Guidance.
As discussed further in section IX of this preamble, Sec. 132.4
also provides that State and Tribal submissions will need to include
any provisions that EPA determines, based on EPA's authorities under
the CWA and the results of consultation with the U.S. Fish and Wildlife
Service (FWS) under section 7 of the ESA, are necessary to ensure that
water quality is not likely to cause jeopardy to any endangered or
threatened species listed under the ESA.
Part 132 extends the requirements of section 118(c)(2)(C) to Indian
Tribes within the Great Lakes basin for which EPA has approved water
quality standards under section 303 of the CWA or which EPA has
authorized to administer an NPDES program under section 402 of the CWA.
EPA believes that inclusion of Great Lakes Tribes in this way is
necessary and appropriate to be consistent with section 518 of the CWA.
The reasons for EPA's proposal are discussed further in the preamble to
the proposed Guidance (58 FR 20834), and section II.D.3 of the SID. As
a practical matter, no Great Lakes Tribes currently have approved water
quality standards or authorized NPDES programs, so the submission
requirements of part 132 do not apply to any Great Lakes Tribes. Tribes
that are approved or authorized in the future, however, will need to
adopt provisions consistent with the final Guidance in their water
programs.
V. Costs, Cost-Effectiveness and Benefits
(Section IX of the SID)
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and
therefore subject to Office of Management and Budget (OMB) review and
the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, competition, jobs, the environment, public health or safety,
or State, local, or Tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action''
because it raises novel policy issues arising out of the development of
a comprehensive ecosystem-based approach for a large geographic area
involving several States, Tribal governments, local governments, and a
large number of regulated dischargers. This approach, including the
Great Lakes Water Quality Initiative which developed the core concepts
of the final Guidance, is a unique and precedential approach to the
implementation of environmental programs. As such, this action was
submitted to OMB for review pursuant to Executive Order 12866. Changes
made in response to OMB suggestions or recommendations will be
documented in the public record.
The following is a summary of major elements of the ``Regulatory
Impact Analysis of the Final Great Lakes Water Quality Guidance'' (RIA)
(EPA 820-B-95-011) that has been prepared in compliance with Executive
Order 12866. Further discussion is included in section IX of the SID,
and in the full RIA, which is available in the docket for this
rulemaking.
The provisions of the final Guidance are not enforceable
requirements until adopted by States or Tribes, or promulgated by EPA
for a particular State or Tribe. Therefore, this publication of the
final Guidance does not have an immediate effect on dischargers. Until
actions are taken to promulgate and implement these provisions (or
equally protective provisions consistent with the final Guidance),
there will be no economic effect on any dischargers. For the purposes
of the RIA, EPA's analysis of costs and benefits assumes that either
State or EPA promulgations occur consistent with the final Guidance
within the next two years.
Under the CWA, costs cannot be a basis for adopting water quality
criteria that will not be protective of designated uses. If a range of
scientifically defensible criteria that are protective can be
identified, however, costs may be considered in selecting a particular
criterion within that range. Costs may also be relevant under the
antidegradation standard as applied to high quality waters.
EPA has assessed compliance costs for facilities that could be
affected by provisions adopted by States or Tribes consistent with the
final Guidance. EPA has also assessed basin-wide risk reduction
benefits to sport anglers and Native American subsistence anglers in
the basin, and benefits for three case study sites in the Great Lakes
System. [[Page 15381]] The methodology used in each assessment and the
results of these assessments are discussed below.
EPA solicited public comment and supporting data on the RIA
methodology used to estimate both costs and benefits for implementation
of the proposed Guidance. EPA evaluated these comments and supporting
data as well as comments provided by OMB and revised the RIA
methodology prior to performing these assessments for the final
Guidance.
A. Costs
Based on the information provided by each State and a review of the
permit files, EPA identified about 3,800 direct dischargers that could
be affected by State or Tribal adoption or subsequent EPA promulgation,
if necessary, of requirements consistent with the final Guidance. Of
these, about 590 are major dischargers and the remaining 3,210 are
minor dischargers. Of the 590 majors, about 275 are industrial
facilities and 315 are publicly owned treatment works (POTWs). Out of
these dischargers, EPA used a stratified random sampling procedure to
select 59 facilities (50 major and nine minor) that it considered
representative of all types and sizes of facilities in the basin.
EPA divided the major facilities into nine industrial categories
and a category for POTWs. The nine industrial categories are: mining,
food and food products, pulp and paper, inorganic chemical
manufacturing, organic chemical manufacturing/petroleum refining,
metals manufacturing, electroplating/metal fabrication, steam electric
power plants, and miscellaneous facilities.
For each major and minor facility in the sample, EPA estimated
incremental costs to comply with subsequently promulgated provisions
consistent with the final Guidance, using a baseline of compliance with
the requirements of section 303(c)(2)(B) of the CWA. Using a decision
matrix, costs were developed for two different scenarios--a ``low-end''
cost scenario and a ``high-end'' cost scenario--to account for the
range of regulatory flexibility available to States and Tribes when
adopting and implementing provisions consistent with the final
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 costs for minor facilities are
negligible at an estimated $500 per facility.
The costs described above account for the costs of eliminating
mixing zones for BCCs except in narrow circumstances, costs related to
implementation of Tier II values, and specific calculated costs related
to intake credits. The cost assessment also projects the potential cost
savings across the different scenarios that facilities may realize if
States or Tribes use existing regulatory relief mechanisms to modify or
eliminate the need for a WQBEL for an identified pollutant (e.g.,
variances, TMDLs, site-specific modifications to criteria, and changes
in designated uses).
In addition to the cost estimates described above, EPA estimated
the cost to comply with requirements consistent with the
antidegradation provisions of the final Guidance. This potential future
cost is expressed as a ``lost opportunity'' cost for facilities
impacted by the antidegradation requirements. This cost could result in
the addition of about $22 million each year.
B. Cost-Effectiveness
EPA estimated the cost-effectiveness of the final Guidance in terms
of the cost of reducing the loadings of toxic pollutants from point
sources. The cost-effectiveness (cost per pound removed) is derived by
dividing the annualized costs of implementing the final
[[Page 15382]] Guidance by the toxicity-weighted pounds (pound-
equivalents) of pollutants removed. Pound-equivalents are calculated by
multiplying pounds of each pollutant removed by the toxic weight (based
on the toxicity of copper) for that pollutant.
It is estimated that implementation of provisions consistent with
the final Guidance would be responsible for the reduction of about six
to eight million toxic pounds per year, or 16 to 22 percent of the
toxic-weighted baseline for the low- and high-end scenarios,
respectively. The cost-effectiveness of the scenarios, over the
baseline, is quite good, ranging from $10 to $50 per pound-equivalent.
Approximately 80 percent of the pollutant load reduction from
implementation of the final Guidance, regardless of the scenario, is
attributable to reducing BCCs as a result of PMPs and end-of-pipe
treatment. The largest pollutant load reductions occur for chlordane,
dieldrin, heptachlor, lead, and pentachlorobenzene.
In a separate analysis, EPA also investigated the cost-
effectiveness of regulating point and nonpoint sources of mercury and
PCBs, two contaminants associated with fish advisories in the Great
Lakes basin. Although data and resource constraints limited the
findings from these analyses, the preliminary results indicate that
point sources may factor cost-effectively into pollutant reduction
scenarios. For both contaminants, the cost-effectiveness of point and
nonpoint source controls are likely to be highly site-specific.
C. Benefits
The benefits analysis is intended to provide insight into both the
types and potential magnitude of the economic benefits expected to
arise as a result of implementation of provisions adopted by States and
Tribes consistent with the final Guidance. To the extent feasible,
empirical estimates of the potential magnitude of the benefits are
developed and then compared to the estimated costs of implementing
provisions adopted by States and Tribes consistent with the final
Guidance.
The benefits analysis is based on a case study approach, using
benefits transfer applied to three case studies. The case study
approach was used because it is more amenable to meaningful benefit-
cost analyses than are studies of larger aggregate areas. Although the
results obtained for a case study site may not apply uniformly to the
entire Great Lakes basin, the case study approach does provide a
pragmatic and realistic perspective of how implementation of the final
Guidance can generate benefits, the types of benefits anticipated, and
how these benefits compare to costs.
The case studies include: (1) the lower Fox River drainage,
including Green Bay, located on Lake Michigan in northeastern
Wisconsin; (2) the Saginaw River and Saginaw Bay, located on Lake Huron
in northeastern Michigan; and (3) the Black River, located on Lake Erie
in north-central Ohio. The case studies were selected from a list of
candidate sites (i.e., designated Areas of Concern (AOCs) in the Great
Lakes basin) on the basis of data availability and the relevance of the
water quality problems to the final Guidance (i.e., areas in which
problems were more likely to be associated with on-going point source
discharges rather than historic loadings from Superfund sites and other
sources). Geographic diversity was also considered in selecting the
sites so that the analyses might better promote a broad perspective of
the final Guidance's benefits and costs.
For each of the three case studies, EPA estimated future toxics-
oriented water quality benefits, and then attributed a percentage of
these benefits to implementation of the final Guidance. The attribution
of benefits was based only on the estimated reduction in loadings from
point sources at the case study sites and information on the relative
contribution of point sources to total loadings in the basin. EPA did
not attempt to calculate the longer-term benefits to human health,
wildlife, and aquatic life once the final Guidance provisions are fully
implemented by nonpoint sources as well as point sources and the
minimum protection levels are attained in the ambient water.
In the Fox River and Green Bay case study, total annual
undiscounted benefits attributable to the final Guidance range from
$0.3 million to $8.5 million (first quarter 1994 dollars). Human health
benefits account for between 29 percent and 72 percent of the estimated
benefits, recreational fishing accounts for between eight percent and
45 percent, and nonuse/ecologic benefits account for between nine
percent and 23 percent. Municipal and industrial dischargers in this
case study are estimated to incur annualized costs of about $3.6
million.
In the Saginaw River/Bay case study, total annual undiscounted
benefits range from $0.2 million to $7.7 million. Recreational fishing
benefits account for between 36 percent and 60 percent of the estimated
benefits, non-use benefits account for between 18 percent and 30
percent, and human health benefits account for between eight percent
and 36 percent. Total annualized costs to municipal and industrial
dischargers are estimated to be about $2.6 million.
In the Black River case study, total annual undiscounted benefits
range from $0.4 million to $1.5 million. Recreational fishing benefits
account for between 48 percent and 63 percent of the estimated
benefits, and nonuse benefits account for between 32 percent and 44
percent. Total annualized costs to municipal and industrial dischargers
are estimated to be $2.1 million.
An inherent limitation of the case study approach is the inability
to extrapolate from a limited set of river-based sites to the Great
Lakes basin as a whole. Accordingly, extrapolation of the case study
results to the Great Lakes basin is not recommended. However, as noted
above, the three case studies were selected on the basis of data
availability, the relative importance of point source discharges to the
watersheds' problems, and an attempt to portray spatial diversity
throughout the Great Lakes basin. Thus, there is no reason to conclude
that the selected sites are not reflective of the basin, even though
benefits (and costs) tend to be highly site-specific. In addition, the
benefits extend from the case study rivers into the larger, open-water
environment of the Great Lakes.
The representativeness of the case study sites was assessed by
comparing the percentage of total benefits estimated to accrue in the
case study areas to the percentage of basin-wide costs incurred by the
case study sites. Benefits-related measures (such as population,
recreational angling days, and nonconsumptive recreation days) were
used in place of total benefits for this analysis because there is no
estimate of benefits for the entire Great Lakes basin. The three case
studies combine to account for nearly 14 percent of the total cost of
the final Guidance, nearly 17 percent of the loadings reductions, and
from four percent to 10 percent of the benefits proxies (i.e., basin-
wide population, recreational angling, nonconsumptive recreation, and
commercial fishery harvest). Thus, the three case studies may represent
a reasonably proportionate share of costs and benefits.
In addition to the case study analyses, a basin-wide risk
assessment was conducted for Great Lakes anglers. EPA collected data
and information on the consumption of Great Lakes basin fish to
estimate baseline risk levels and reductions in risks due to
implementation of the final Guidance for two populations at risk: Great
Lakes sport anglers (including minority and [[Page 15383]] low-income
anglers) and Native Americans engaged in subsistence fishing in the
basin. For sport anglers, EPA estimated that the projected reduction in
loadings from point sources based on controls consistent with the final
Guidance would result in a reduction of annual excess lifetime cancer
cases (potential cancer cases assuming a 70-year lifetime exposure
period) of 2.2 to 4.1 for low-income minorities in lakeshore counties;
0.4 to 0.8 for other minorities in lakeshore counties; and 21.9 to 41.9
for all other sport anglers. For Native American subsistence anglers,
EPA estimated that reductions from point source loadings attributable
to the final Guidance would result in a reduction of excess lifetime
cancer cases of between 0.1 and 0.3 using a low fish ingestion scenario
and 0.5 to 1.1 using a high fish ingestion scenario. Note that these
estimates do not include the long-term benefits (including reduced
cancer cases) that will result once the final Guidance provisions are
fully implemented and the minimum protection levels are attained in the
ambient water.
In total, using the most conservative consumption scenario for
Native Americans, these reductions represent between 0.35 and 0.67
excess cancer cases per year, and potential basin-wide benefits of the
final Guidance for this one benefits category of between $0.7 million
and $6.7 million per year, based on the estimated value of a
statistical life of between $2.0 million and $10.0 million. Comparison
to case study results, which were based on a more comprehensive sample
of facilities within case study areas than was possible for the entire
basin, indicates these values likely underestimate the potential risk
reduction benefits of the final Guidance at the basin level. For
example, if the average percentage load reduction for PCBs for the
three case studies is used to reflect reductions in PCBs for the basin,
the reduction in excess cancer cases increases to between three and six
cases per year, and potential benefits increase to between $6.6 and $60
million per year.
The reduction in pollutant loadings for PCBs was likely understated
in the basin-wide analysis because the analysis did not count pollutant
load reduction benefits when the current State-based permit limit and
the final Guidance-based permit limit were both below the pollutant
analytical method detection limit (MDL). Only three sample facilities
in the population of 59 sample facilities used to project basin-wide
costs and human health benefits had State-based permit limits for PCBs.
Since the current State-based permit limit and the final Guidance-based
permit limit were below the MDL in all three facilities, ``zero''
reduction in PCB loadings for the basin was estimated. This, of course,
is an artifact of the methodology and the size of the sample population
selected for the analysis, and would not occur, as demonstrated in the
case study analysis, if a larger sample population had been used.
VI. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (RFA), EPA generally is
required to conduct a final regulatory flexibility analysis (FRFA)
describing the impact of the regulatory action on small entities as
part of the final rulemaking. However, under section 605(b) of the RFA,
if EPA certifies that the rule will not have a significant economic
impact on a substantial number of small entities, EPA is not required
to prepare a FRFA.
Implementation of the final Guidance is dependent upon future
promulgation of provisions consistent with it by State or Tribal
agencies or, if necessary, EPA. Until actions are taken to promulgate
and implement these provisions, or equally protective provisions
consistent with the final Guidance, there will be no economic effect of
this rule on any entities, large or small. For that reason, and
pursuant to Section 605(b) of the RFA, EPA is certifying that this rule
itself will not have a significant economic impact on a substantial
number of small entities.
Although EPA is certifying that this rule will not have a
significant economic impact on a substantial number of small entities,
and therefore is not required to prepare a FRFA, it is nevertheless
including for public information in the RIA a discussion of the
possible economic effects to small entities that could result from
State or Tribal adoption of provisions consistent with the final
Guidance or subsequent EPA promulgation, if necessary. As discussed
above, small facilities are projected to incur costs of only
approximately $500 per facility to comply with subsequently promulgated
requirements that are consistent with the final Guidance. Accordingly,
EPA believes there will be no significant economic impact on a
substantial number of small entities as a result of State or Tribal
implementation of the final Guidance.
VII. Enhancing the Intergovernmental Partnership Under Executive
Order 12875
In compliance with Executive Order 12875 (58 FR 58093, October 28,
1993), EPA has involved State, Tribal, and local governments in the
development of the final Guidance.
As described in section II above, the core elements of the final
Guidance were developed by the Great Lakes States, EPA, and other
Federal agencies in open dialogue with citizens, local governments, and
industries in the Great Lakes ecosystem over a five-year period through
the Initiative. The Initiative process marks the first time that EPA
has developed a major rulemaking effort in the water program through a
regional public forum. The Initiative process is described further in
the preamble to the proposed Guidance (58 FR 20820-23) and section II
of this preamble.
In addition to the participation by State and local governments in
the initial development of the proposed Guidance and in the public
comment process, several activities have been carried out since the
publication of the proposed Guidance. These include:
(1) On April 26, 1994, EPA held a public meeting to solicit
additional information from interested parties on the proposed
Guidance. As part of EPA's outreach efforts to State, Tribal and local
governments, a special invitation was sent inviting elected officials
and other State, Tribal and local representatives to participate in the
public meeting. EPA specifically welcomed Tribal and local officials
and opened the floor to them to hear and discuss their specific
concerns and views on the final Guidance.
(2) A series of meetings and teleconferences were held with Great
Lakes States in early 1994 to discuss their comments on several issues,
including development of water quality criteria, State adoption
requirements, WET, BAFs, additivity, compliance schedules, anti-
backsliding, nonpoint sources, and international concerns.
(3) In October, 1994, EPA met with each individual State in the
Great Lakes basin to discuss the nature, form, and scope of the
proposed Guidance, and State concerns with implementation of the
provisions under consideration. The following issues were discussed at
each of the meetings: intake credits, antidegradation and EEQ, wildlife
criteria, excluded pollutants (e.g., ammonia and chlorine), elimination
of mixing zones, site-specific modifications, fish consumption,
appropriate degrees of flexibility for implementation (e.g., guidance
vs. regulation), and implementation procedures.
(4) In 1994 and 1995, EPA met with representatives of the National
Wildlife Federation to discuss EPA's activities in developing the final
Guidance in [[Page 15384]] accordance with the terms of a consent
decree governing the schedule for development of the final Guidance.
(5) In 1994, EPA also met with elected officials and other
representatives from several local communities in the Great Lakes basin
to discuss issues regarding the economic impact of the proposed
Guidance on local communities and POTWs. Issues discussed include cost
impacts associated with implementing water quality criteria,
methodologies, and implementation procedures; dealing with pollution
from nonpoint sources; public outreach to control pollutants such as
mercury instead of costly end-of-pipe treatment; and applicability of
provisions in the final Guidance to the National water quality program.
(6) EPA held an additional 18 consultations with the regulated
community throughout 1994. Such meetings allowed representatives of
dischargers to share additional data, which has been placed in the
docket for this rulemaking, and concerns about a range of issues,
including cost concerns, that the dischargers expect to arise in
implementation of the final Guidance.
(7) In 1994, EPA met with State representatives to conduct initial
planning for implementation of the GLI Clearinghouse. All Great Lakes
States agreed to participate in this effort, which will involve the
sharing of toxicological and other data to assist in the development of
additional water quality criteria and values.
The results of the above efforts have assisted in the development
of the final Guidance through broad communication with a full range of
interested parties, sharing of additional information, and
incorporation of features to improve the implementation of the final
Guidance.
EPA has estimated the total annual State government burden to
implement the final Guidance as approximately 5,886 hours, resulting in
a State government cost of $175,992 annually. Such burden and costs
were estimated based upon the burden and costs associated with
developing water quality criteria, review of antidegradation policy
demonstrations, review of approvable control strategies and BCC
monitoring data, and review of variance requests. The total annual
local government burden is estimated to be 42,296 hours with an
associated cost of $2,008,624. All of the burden and costs to local
governments are associated with being a regulated entity as an operator
of a POTW.
VIII. Paperwork Reduction Act
The information collection requirements in this final Guidance have
been approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501
et seq., and have been assigned OMB control number 2040-0180. EPA has
prepared an Information Collection Request (ICR) document (ICR No.
1639.02). A copy of ICR 1639.02 may be obtained by writing to Ms. Sandy
Farmer, Information Policy Branch, EPA 2136, Washington, D.C. 20460, or
by calling (202) 260-2740.
The annual public reporting and record keeping burden for this
regulation is estimated to be 128,787 hours for the affected 3,795
permittees, or an average of 34 hours. This includes the total annual
burden to local governments as POTW operators, estimated to be 45,296
hours. The total annual burden to State governments is estimated to be
5,886 hours. These estimates include time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden to Chief, Information Policy Branch, Mail Code 2136, U.S.
Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460;
and to the Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, DC 20503.
In this rulemaking EPA is also amending the table of currently
approved ICR control numbers issued by OMB for various regulations into
40 CFR 9.1. This amendment updates the table to accurately display
those information requirements promulgated under the CWA. The affected
regulations are codified at 40 CFR parts 122, 123, 131, and 132. EPA
will continue to present OMB control numbers in a consolidated table
format. The table will be codified in 40 CFR part 9 of EPA's
regulations and in each 40 CFR volume containing EPA regulations. The
table lists the section numbers with reporting and recordkeeping
requirements, and the current OMB control numbers. This display of the
OMB control numbers and their subsequent codification in the CFR
satisfies the requirements of the Paperwork Reduction Act (44 U.S.C.
3501 et seq.) and OMB's implementing regulations at 5 CFR part 1320.
The ICR for this rulemaking was previously subject to public notice
and comment prior to OMB approval. As a result, EPA finds that there is
``good cause'' under section 553(b)(B) of the Administrative Procedure
Act (5 U.S.C. 553(b)(B)) to amend this table without prior notice and
comment. Due to the technical nature of the table, further notice and
comment would be unnecessary.
IX. Endangered Species Act
Pursuant to section 7(a)(2) of the ESA, EPA consulted with the FWS
concerning EPA's publication of the final Guidance. EPA and the FWS
have now completed both informal and formal consultation conducted over
a two-year period.
As a result of the consultation, as well as an analysis of
comments, EPA modified several provisions of the final Guidance. The
procedure for site-specific modifications provides that Great Lakes
States and Tribes must make site-specific modifications to criteria and
values where necessary to ensure the resulting water quality does not
cause jeopardy to listed or proposed species. Similarly, the
antidegradation policy and implementation procedures restrict certain
actions States and Tribes may take to allow lowering of water quality
in high quality waters, or to adopt variances or mixing zones.
Additionally, the regulatory requirements were modified to require
Great Lakes States and Tribes to include in their part 132 submissions
any provisions that EPA determines, based on EPA's authorities under
the CWA and the results of consultation under section 7 of the ESA, are
necessary to ensure that water quality is not likely to cause jeopardy
to listed species. EPA and the FWS also agreed on how further
consultations will be conducted as the final Guidance is implemented.
The two agencies also agreed that EPA will undertake a review of water
quality standards and implementation of those standards for ammonia and
chlorine in the Great Lakes basin as part of EPA's responsibilities
under section 303(c) of the CWA.
During the consultation, two issues were identified that required
formal consultation, as defined in 40 CFR part 402. These issues were:
the absence of toxicological data concerning effects of contaminants on
three species of freshwater mussels in the Great Lakes basin, and the
adequacy of the wildlife criteria methodology to protect three
endangered or threatened wildlife species in the basin. On February 21,
1995, the FWS provided EPA with a written Biological Opinion (Opinion)
on these issues. The Opinion is available in the docket for this
rulemaking. On both issues, the FWS concluded that the water quality
resulting from implementation of the final Guidance will not cause
jeopardy to the listed species. To minimize the amount or extent of any
incidental take that might [[Page 15385]] occur, the FWS consulted
closely with EPA to develop a coordinated approach. The final Opinion
specified reasonable and prudent measures that the FWS considers
necessary or appropriate to minimize such impact. EPA has agreed to
implement the measures, and the FWS and EPA will continue to work
cooperatively during the implementation.
X. Judicial Review of Provisions Not Amended
In some situations, EPA has renumbered or included other editorial
changes to regulations that have been promulgated in past rulemakings.
Additionally, to provide for ease in reading changes to existing
regulations, EPA has in some cases repeated entire sections, including
portions not changed. The promulgation of this final rule, however,
does not provide another opportunity to seek judicial review on the
substance of the existing regulations.
XI. Supporting Documents
All documents that are referenced in this preamble are available
for inspection and photocopying in the docket for this rulemaking at
the address listed at the beginning of this preamble. A reasonable fee
will be charged for photocopies.
Selected documents supporting the final Guidance are also available
for viewing by the public at locations listed below:
Illinois: Illinois State Library, 300 South 2nd Street,
Springfield, IL 62701 (217-785-5600)
Indiana: Indiana Department of Environmental Management, Office of
Water Management, 100 North Senate Street, Indianapolis, IN 46204 (317-
232-8671)
Michigan: Library of Michigan, Government Documents Service, 717
West Allegan, Lansing, MI 48909 (517-373-1300); Detroit Public Library,
Sociology and Economics Department, 5201 Woodward Avenue, Detroit, MI
48902 (313-833-1440)
Minnesota: Minnesota Pollution Control Agency, Library, 520
Lafayette, St. Paul, MN (612-296-7719)
New York: U.S. EPA Region 2 Library, Room 402, 26 Federal Plaza,
New York, NY 10278 (212-264-2881); U.S. EPA Public Information Office,
Carborundum Center, Suite 530, 345 Third Street, Niagara Falls, NY
14303 (716-285-8842); New York State Department of Environmental
Conservation (NYSDEC), Room 310, 50 Wolf Road, Albany, NY 12333 (518-
457-7463); NYSDEC, Region 6, 7th Floor, State Office Building, 317
Washington Street, Watertown, NY 13602 (315-785-2513); NYSDEC, Region
7, 615 Erie Boulevard West, Syracuse, NY 13204 (315-426-7400); NYSDEC,
Region 8, 6274 East Avon-Lima Road, Avon, NY 14414 (716-226-2466);
NYSDEC, Region 9, 270 Michigan Avenue, Buffalo, NY 14203 (716-851-7070)
Ohio: Ohio Environmental Protection Agency Library--Central
District Office, 1800 Watermark Road, Columbus, OH 43215 (614-644-
3024); U.S. EPA Eastern District Office, 25809 Central Ridge Road,
Westlake, OH 44145 (216-522-7260)
Pennsylvania: Pennsylvania Department of Environmental Resources,
230 Chestnut Street, Meadville, PA 16335 (814-332-6945); U.S. EPA
Region 3 Library, 8th Floor, 841 Chestnut Building, Philadelphia, PA
19107-4431 (215-597-7904)
Wisconsin: Water Resources Center, University of Wisconsin-Madison,
2nd Floor, 1975 Willow Drive, Madison, WI (608-262-3069)
EPA is also making a number of documents available in electronic
format at no incremental cost to users of the Internet. These documents
include the contents of this Federal Register document, the SID, many
documents listed below, and other supporting materials.
The documents listed below are also available for a fee upon
written request or telephone call to the National Technical Information
Center (NTIS), U.S. Department of Commerce, 5285 Port Royal Road,
Springfield, VA 22161 (telephone 800-553-6847 or 703-487-4650).
Alternatively, copies may be obtained for a fee upon written request or
telephone call to the Educational Resources Information Center/
Clearinghouse for Science, Mathematics, and Environmental Education
(ERIC/CSMEE), 1200 Chambers Road, Room 310, Columbus, OH 43212 (614-
292-6717). When ordering, please include the NTIS or ERIC/CSMEE
accession number.
A. Final Water Quality Guidance for the Great Lakes System:
Supplementary Information Document (SID). NTIS Number: PB95187266. ERIC
Number: D046.
B. Great Lakes Water Quality Initiative Criteria Document for the
Protection of Aquatic Life in Ambient Water. NTIS Number: PB95187282.
ERIC Number: D048.
C. Great Lakes Water Quality Initiative Technical Support Document
for the Procedure to Determine Bioaccumulation Factors. NTIS Number:
PB95187290. ERIC Number: D049.
D. Great Lakes Water Quality Initiative Criteria Document for the
Protection of Human Health. NTIS Number: PB95187308. ERIC Number: D050.
E. Great Lakes Water Quality Initiative Technical Support Document
for Human Health Criteria and Values. NTIS Number: PB95187316. ERIC
Number: D051.
F. Great Lakes Water Quality Initiative Criteria Document for the
Protection of Wildlife: DDT; Mercury; 2,3,7,8-TCDD; PCBs. NTIS Number:
PB95187324. ERIC Number: D052.
G. Great Lakes Water Quality Initiative Technical Support Document
for Wildlife Criteria. NTIS Number: PB95187332. ERIC Number: D053.
H. Assessment of Compliance Costs Resulting from Implementation of
the Final Great Lakes Water Quality Guidance. NTIS Number: PB95187340.
ERIC Number: D054.
I. Regulatory Impact Analysis of the Final Great Lakes Water
Quality Guidance. NTIS Number: PB95187357. ERIC Number: D055.
List of Subjects
40 CFR Part 9
Reporting and recordkeeping requirements.
40 CFR Part 122
Administrative practice and procedure, Confidential business
information, Great Lakes, Hazardous substances, Reporting and
recordkeeping requirements, Water pollution control.
40 CFR Part 123
Administrative practice and procedure, Confidential business
information, Great Lakes, Hazardous substances, Indians-lands,
Intergovernmental relations, Penalties, Reporting and recordkeeping
requirements, Water pollution control.
40 CFR Part 131
Great Lakes, Reporting and recordkeeping requirements, Water
pollution control.
40 CFR Part 132
Administrative practice and procedure, Great Lakes, Indians-lands,
Intergovernmental relations, Reporting and recordkeeping requirements,
Water pollution control.
Dated: March 13, 1995.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, parts
9, 122, 123, and 131 are amended, and part 132 is added as follows:
[[Page 15386]]
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
2. Section 9.1 is amended as follows:
a. By adding in numerical order the entry ``122.44(r)'' under the
heading ``EPA Administered Permit Programs: The National Pollutant
Discharge Elimination System''.
b. By revising the entries under the heading ``State Permit
Requirements'';
c. By adding in numerical order the entries ``131.1'' and ``131.5''
and by revising the entries ``131.20'', ``131.21'' and ``131.22'' under
the heading ``Water Quality Standards Regulations''; and
d. By adding in numerical order a new heading and new entries for
``Water Quality Guidance for the Great Lakes System'' to read as
follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
40 CFR citation OMB control No.
EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System
* * * * *
122.44(r)............................................. 2040-0180
* * * * *
State Permit Requirements
123.21-123.24......................................... 2040-0057,
2040-0170
123.25................................................ 2040-0004,
2040-0110,
2040-0170,
2040-0180
123.26-123.29......................................... 2040-0057,
2040-0170
123.43................................................ 2040-0057,
2040-0170
123.44................................................ 2040-0057,
2040-0170,
2040-0180
123.45................................................ 2040-0057,
2040-0170
123.62................................................ 2040-0057,
2040-0170,
2040-0180
123.63................................................ 2040-0057,
2040-0170,
2040-0180
123.64................................................ 2040-0057,
2040-0170
Water Quality Standards Regulation
131.1................................................. 2040-0180
131.5................................................. 2040-0180
* * * * *
131.20................................................ 2040-0049
131.21................................................ 2040-0049,
2040-0180
131.22................................................ 2040-0049
* * * * *
Water Quality Guidance for the Great Lakes System
132.1................................................. 2040-0180
132.2................................................. 2040-0180
132.3................................................. 2040-0180
132.4................................................. 2040-0180
132.5................................................. 2040-0180
Appendix A............................................ 2040-0180
Appendix B............................................ 2040-0180
Appendix C............................................ 2040-0180
Appendix D............................................ 2040-0180
Appendix E............................................ 2040-0180
Appendix F............................................ 2040-0180
* * * * *
PART 122--EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT
DISCHARGE ELIMINATION SYSTEM
3. The authority citation for part 122 continues to read as
follows:
Authority: The Clean Water Act, 33 U.S.C. 1251 et seq.
4. Section 122.44 is amended by adding a new paragraph (r) to read
as follows:
Sec. 122.44 Establishing limitations, standards, and other permit
conditions (applicable to State NPDES programs, see Sec. 123.25).
* * * * *
(r) Great Lakes. When a permit is issued to a facility that
discharges into the Great Lakes System (as defined in 40 CFR 132.2),
conditions promulgated by the State, Tribe, or EPA pursuant to 40 CFR
part 132.
PART 123--STATE PROGRAM REQUIREMENTS
5. The authority citation for part 123 continues to read as
follows:
Authority: Clean Water Act, 33 U.S.C. 1251 et seq.
6. Section 123.25 is amended by removing ``and'' at the end of
paragraph (a)(36), removing the period at the end of paragraph (a)(37)
and adding ``; and'' in its place, and adding a new paragraph (a)(38)
to read as follows:
Sec. 123.25 Requirements for permitting.
(a) * * *
(38) For a Great Lakes State or Tribe (as defined in 40 CFR 132.2),
40 CFR part 132 (NPDES permitting implementation procedures only).
* * * * *
7. Section 123.44 is amended by adding a new paragraph (c)(9) to
read as follows:
Sec. 123.44 EPA review of and objections to State permits.
* * * * *
(c) * * *
(9) For a permit issued by a Great Lakes State or Tribe (as defined
in 40 CFR 132.2), the permit does not satisfy the conditions
promulgated by the State, Tribe, or EPA pursuant to 40 CFR part 132.
* * * * *
8. Section 123.62 is amended by adding a new paragraph (f) to read
as follows:
Sec. 123.62 Procedures for revision of State programs.
* * * * *
(f) Revision of a State program by a Great Lakes State or Tribe (as
defined in 40 CFR 132.2) to conform to section 118 of the CWA and 40
CFR part 132 shall be accomplished pursuant to 40 CFR part 132.
9. Section 123.63 is amended by adding a new paragraph (a)(6) and
adding and reserving paragraph (b) to read as follows:
Sec. 123.63 Criteria for withdrawal of State programs.
(a) * * *
(6) Where a Great Lakes State or Tribe (as defined in 40 CFR 132.2)
fails to adequately incorporate the NPDES permitting implementation
procedures promulgated by the State, Tribe, or EPA pursuant to 40 CFR
part 132 into individual permits.
(b) [Reserved]
PART 131--WATER QUALITY STANDARDS
10. The authority citation for part 131 continues to read as
follows:
Authority: 33 U.S.C. 1251 et seq.
11. Section 131.1 is revised to read as follows:
Sec. 131.1 Scope.
This part describes the requirements and procedures for developing,
reviewing, revising, and approving water quality standards by the
States as authorized by section 303(c) of the Clean Water Act.
Additional specific procedures for developing, reviewing, revising, and
approving water quality standards for Great Lakes States or Great Lakes
Tribes (as defined in 40 CFR 132.2) to conform to section 118 of the
[[Page 15387]] Clean Water Act and 40 CFR part 132, are provided in 40
CFR part 132.
12. Section 131.5 is amended by revising paragraph (a)(5), by
redesignating paragraph (b) as paragraph (c), and by adding a new
paragraph (b) to read as follows:
Sec. 131.5 EPA Authority.
(a) * * *
(5) Whether the State submission meets the requirements included in
Sec. 131.6 of this part and, for Great Lakes States or Great Lakes
Tribes (as defined in 40 CFR 132.2) to conform to section 118 of the
Act, the requirements of 40 CFR part 132.
(b) If EPA determines that the State's or Tribe's water quality
standards are consistent with the factors listed in paragraphs (a)(1)
through (a)(5) of this section, EPA approves the standards. EPA must
disapprove the State's or Tribe's water quality standards and
promulgate Federal standards under section 303(c)(4), and for Great
Lakes States or Great Lakes Tribes under section 118(c)(2)(C) of the
Act, if State or Tribal adopted standards are not consistent with the
factors listed in paragraphs (a)(1) through (a)(5) of this section. EPA
may also promulgate a new or revised standard when necessary to meet
the requirements of the Act.
* * * * *
13. Section 131.21 is amended by revising paragraph (b) to read as
follows:
Sec. 131.21 EPA review and approval of water quality standards.
* * * * *
(b) The Regional Administrator's approval or disapproval of a State
water quality standard shall be based on the requirements of the Act as
described in Secs. 131.5 and 131.6, and, with respect to Great Lakes
States or Tribes (as defined in 40 CFR 132.2), 40 CFR part 132.
* * * * *
14. Part 132 is added as follows:
PART 132--WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM
Sec.
132.1 Scope, purpose, and availability of documents.
132.2 Definitions.
132.3 Adoption of criteria.
132.4 State adoption and application of methodologies, policies
and procedures.
132.5 Procedures for adoption and EPA review.
132.6 Application of part 132 requirements in Great Lakes States
and Tribes. [Reserved]
Tables to Part 132
Appendix A to Part 132--Great Lakes Water Quality Initiative
Methodologies for Development of Aquatic Life Criteria and Values
Appendix B to Part 132--Great Lakes Water Quality Initiative
Methodology for Development of Bioaccumulation Factors
Appendix C to Part 132--Great Lakes Water Quality Initiative
Methodology for Development of Human Health Criteria and Values
Appendix D to Part 132--Great Lakes Water Quality Initiative
Methodology for the Development of Wildlife Criteria
Appendix E to Part 132--Great Lakes Water Quality Initiative
Antidegradation Policy
Appendix F to Part 132--Great Lakes Water Quality Initiative
Implementation Procedures
Authority: 33 U.S.C. 1251 et seq.
Sec. 132.1 Scope, purpose, and availability of documents.
(a) This part constitutes the Water Quality Guidance for the Great
Lakes System (Guidance) required by section 118(c)(2) of the Clean
Water Act (33 U.S.C. 1251 et seq.) as amended by the Great Lakes
Critical Programs Act of 1990 (Pub. L. 101-596, 104 Stat. 3000 et
seq.). The Guidance in this part identifies minimum water quality
standards, antidegradation policies, and implementation procedures for
the Great Lakes System to protect human health, aquatic life, and
wildlife.
(b) The U.S. Environmental Protection Agency, Great Lakes States,
and Great Lakes Tribes will use the Guidance in this part to evaluate
the water quality programs of the States and Tribes to assure that they
are protective of water quality. State and Tribal programs do not need
to be identical to the Guidance in this part, but must contain
provisions that are consistent with (as protective as) the Guidance in
this part. The scientific, policy and legal basis for EPA's development
of each section of the final Guidance in this part is set forth in the
preamble, Supplementary Information Document, Technical Support
Documents, and other supporting documents in the public docket. EPA
will follow the guidance set out in these documents in reviewing the
State and Tribal water quality programs in the Great Lakes for
consistency with this part.
(c) The Great Lakes States and Tribes must adopt provisions
consistent with the Guidance in this part applicable to waters in the
Great Lakes System or be subject to EPA promulgation of its terms
pursuant to this part.
(d) EPA understands that the science of risk assessment is rapidly
improving. Therefore, to ensure that the scientific basis for the
methodologies in appendices A through D are always current and peer
reviewed, EPA will review the methodologies and revise them, as
appropriate, every 3 years.
(e) Certain documents referenced in the appendixes to this part
with a designation of NTIS and/or ERIC are available for a fee upon
request to the National Technical Information Center (NTIS), U.S.
Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161.
Alternatively, copies may be obtained for a fee upon request to the
Educational Resources Information Center/Clearinghouse for Science,
Mathematics, and Environmental Education (ERIC/CSMEE), 1200 Chambers
Road, Room 310, Columbus, Ohio 43212. When ordering, please include the
NTIS or ERIC/CSMEE accession number.
Sec. 132.2 Definitions.
The following definitions apply in this part. Terms not defined in
this section have the meaning given by the Clean Water Act and EPA
implementing regulations.
Acute-chronic ratio (ACR) is a standard measure of the acute
toxicity of a material divided by an appropriate measure of the chronic
toxicity of the same material under comparable conditions.
Acute toxicity is concurrent and delayed adverse effect(s) that
results from an acute exposure and occurs within any short observation
period which begins when the exposure begins, may extend beyond the
exposure period, and usually does not constitute a substantial portion
of the life span of the organism.
Adverse effect is any deleterious effect to organisms due to
exposure to a substance. This includes effects which are or may become
debilitating, harmful or toxic to the normal functions of the organism,
but does not include non-harmful effects such as tissue discoloration
alone or the induction of enzymes involved in the metabolism of the
substance.
Bioaccumulation is the net accumulation of a substance by an
organism as a result of uptake from all environmental sources.
Bioaccumulation factor (BAF) is the ratio (in L/kg) of a
substance's concentration in tissue of an aquatic organism to its
concentration in the ambient water, in situations where both the
organism and its food are exposed and the ratio does not change
substantially over time.
Bioaccumulative chemical of concern (BCC) is any chemical that has
the potential to cause adverse effects which, upon entering the surface
waters, by itself or as its toxic transformation
[[Page 15388]] product, accumulates in aquatic organisms by a human
health bioaccumulation factor greater than 1000, after considering
metabolism and other physicochemical properties that might enhance or
inhibit bioaccumulation, in accordance with the methodology in appendix
B of this part. Chemicals with half-lives of less than eight weeks in
the water column, sediment, and biota are not BCCs. The minimum BAF
information needed to define an organic chemical as a BCC is either a
field-measured BAF or a BAF derived using the BSAF methodology. The
minimum BAF information needed to define an inorganic chemical,
including an organometal, as a BCC is either a field-measured BAF or a
laboratory-measured BCF. BCCs include, but are not limited to, the
pollutants identified as BCCs in section A of Table 6 of this part.
Bioconcentration is the net accumulation of a substance by an
aquatic organism as a result of uptake directly from the ambient water
through gill membranes or other external body surfaces.
Bioconcentration factor (BCF) is the ratio (in L/kg) of a
substance's concentration in tissue of an aquatic organism to its
concentration in the ambient water, in situations where the organism is
exposed through the water only and the ratio does not change
substantially over time.
Biota-sediment accumulation factor (BSAF) is the ratio (in kg of
organic carbon/kg of lipid) of a substance's lipid-normalized
concentration in tissue of an aquatic organism to its organic carbon-
normalized concentration in surface sediment, in situations where the
ratio does not change substantially over time, both the organism and
its food are exposed, and the surface sediment is representative of
average surface sediment in the vicinity of the organism.
Carcinogen is a substance which causes an increased incidence of
benign or malignant neoplasms, or substantially decreases the time to
develop neoplasms, in animals or humans. The classification of
carcinogens is discussed in section II.A of appendix C to part 132.
Chronic toxicity is concurrent and delayed adverse effect(s) that
occurs only as a result of a chronic exposure.
Connecting channels of the Great Lakes are the Saint Mary's River,
Saint Clair River, Detroit River, Niagara River, and Saint Lawrence
River to the Canadian Border.
Criterion continuous concentration (CCC) is an estimate of the
highest concentration of a material in the water column to which an
aquatic community can be exposed indefinitely without resulting in an
unacceptable effect.
Criterion maximum concentration (CMC) is an estimate of the highest
concentration of a material in the water column to which an aquatic
community can be exposed briefly without resulting in an unacceptable
effect.
EC50 is a statistically or graphically estimated concentration that
is expected to cause one or more specified effects in 50 percent of a
group of organisms under specified conditions.
Endangered or threatened species are those species that are listed
as endangered or threatened under section 4 of the Endangered Species
Act.
Existing Great Lakes discharger is any building, structure,
facility, or installation from which there is or may be a ``discharge
of pollutants'' (as defined in 40 CFR 122.2) to the Great Lakes System,
that is not a new Great Lakes discharger.
Federal Indian reservation, Indian reservation, or reservation
means all land within the limits of any Indian reservation under the
jurisdiction of the United States Government, notwithstanding the
issuance of any patent, and including rights-of-way running through the
reservation.
Final acute value (FAV) is (a) a calculated estimate of the
concentration of a test material such that 95 percent of the genera
(with which acceptable acute toxicity tests have been conducted on the
material) have higher GMAVs, or (b) the SMAV of an important and/or
critical species, if the SMAV is lower than the calculated estimate.
Final chronic value (FCV) is (a) a calculated estimate of the
concentration of a test material such that 95 percent of the genera
(with which acceptable chronic toxicity tests have been conducted on
the material) have higher GMCVs, (b) the quotient of an FAV divided by
an appropriate acute-chronic ratio, or (c) the SMCV of an important
and/or critical species, if the SMCV is lower than the calculated
estimate or the quotient, whichever is applicable.
Final plant value (FPV) is the lowest plant value that was obtained
with an important aquatic plant species in an acceptable toxicity test
for which the concentrations of the test material were measured and the
adverse effect was biologically important.
Genus mean acute value (GMAV) is the geometric mean of the SMAVs
for the genus.
Genus mean chronic value (GMCV) is the geometric mean of the SMCVs
for the genus.
Great Lakes means Lake Ontario, Lake Erie, Lake Huron (including
Lake St. Clair), Lake Michigan, and Lake Superior; and the connecting
channels (Saint Mary's River, Saint Clair River, Detroit River, Niagara
River, and Saint Lawrence River to the Canadian Border).
Great Lakes States and Great Lakes Tribes, or Great Lakes States
and Tribes means the States of Illinois, Indiana, Michigan, Minnesota,
New York, Ohio, Pennsylvania, and Wisconsin, and any Indian Tribe as
defined in this part which is located in whole or in part within the
drainage basin of the Great Lakes, and for which EPA has approved water
quality standards under section 303 of the Clean Water Act or which EPA
has authorized to administer an NPDES program under section 402 of the
Clean Water Act.
Great Lakes System means all the streams, rivers, lakes and other
bodies of water within the drainage basin of the Great Lakes within the
United States.
Human cancer criterion (HCC) is a Human Cancer Value (HCV) for a
pollutant that meets the minimum data requirements for Tier I specified
in appendix C of this part.
Human cancer value (HCV) is the maximum ambient water concentration
of a substance at which a lifetime of exposure from either: drinking
the water, consuming fish from the water, and water-related recreation
activities; or consuming fish from the water, and water-related
recreation activities, will represent a plausible upper-bound risk of
contracting cancer of one in 100,000 using the exposure assumptions
specified in the Methodologies for the Development of Human Health
Criteria and Values in appendix C of this part.
Human noncancer criterion (HNC) is a Human Noncancer Value (HNV)
for a pollutant that meets the minimum data requirements for Tier I
specified in appendix C of this part.
Human noncancer value (HNV) is the maximum ambient water
concentration of a substance at which adverse noncancer effects are not
likely to occur in the human population from lifetime exposure via
either: drinking the water, consuming fish from the water, and water-
related recreation activities; or consuming fish from the water, and
water-related recreation activities using the Methodologies for the
Development of Human Health Criteria and Values in appendix C of this
part.
Indian Tribe or Tribe means any Indian Tribe, band, group, or
community recognized by the Secretary of the Interior and exercising
governmental authority over a Federal Indian reservation.
LC50 is a statistically or graphically estimated concentration that
is expected [[Page 15389]] to be lethal to 50 percent of a group of
organisms under specified conditions.
Load allocation (LA) is the portion of a receiving water's loading
capacity that is attributed either to one of its existing or future
nonpoint sources or to natural background sources, as more fully
defined at 40 CFR 130.2(g). Nonpoint sources include: in-place
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, [[Page 15390]] commercial, and industrial) from a combined
sewer overflow; or any other stormwater discharge for which a permit is
required under section 402(p) of the Clean Water Act. A storm water
discharge associated with industrial activity which is mixed with
process wastewater shall not be considered a wet weather point source.
Sec. 132.3 Adoption of criteria.
The Great Lakes States and Tribes shall adopt numeric water quality
criteria for the purposes of section 303(c) of the Clean Water Act
applicable to waters of the Great Lakes System in accordance with
Sec. 132.4(d) that are consistent with:
(a) The acute water quality criteria for protection of aquatic life
in Table 1 of this part, or a site-specific modification thereof in
accordance with procedure 1 of appendix F of this part;
(b) The chronic water quality criteria for protection of aquatic
life in Table 2 of this part, or a site-specific modification thereof
in accordance with procedure 1 of appendix F of this part;
(c) The water quality criteria for protection of human health in
Table 3 of this part, or a site-specific modification thereof in
accordance with procedure 1 of appendix F of this part; and
(d) The water quality criteria for protection of wildlife in Table
4 of this part, or a site-specific modification thereof in accordance
with procedure 1 of appendix F of this part.
Sec. 132.4 State adoption and application of methodologies, policies
and procedures.
(a) The Great Lakes States and Tribes shall adopt requirements
applicable to waters of the Great Lakes System for the purposes of
sections 118, 301, 303, and 402 of the Clean Water Act that are
consistent with:
(1) The definitions in Sec. 132.2;
(2) The Methodologies for Development of Aquatic Life Criteria and
Values in appendix A of this part;
(3) The Methodology for Development of Bioaccumulation Factors in
appendix B of this part;
(4) The Methodologies for Development of Human Health Criteria and
Values in appendix C of this part;
(5) The Methodology for Development of Wildlife Criteria in
appendix D of this part;
(6) The Antidegradation Policy in appendix E of this part; and
(7) The Implementation Procedures in appendix F of this part.
(b) Except as provided in paragraphs (g), (h), and (i) of this
section, the Great Lakes States and Tribes shall use methodologies
consistent with the methodologies designated as Tier I methodologies in
appendixes A, C, and D of this part, the methodology in appendix B of
this part, and the procedures in appendix F of this part when adopting
or revising numeric water quality criteria for the purposes of section
303(c) of the Clean Water Act for the Great Lakes System.
(c) Except as provided in paragraphs (g), (h), and (i) of this
section, the Great Lakes States and Tribes shall use methodologies and
procedures consistent with the methodologies designated as Tier I
methodologies in appendixes A, C, and D of this part, the Tier II
methodologies in appendixes A and C of this part, the methodology in
appendix B of this part, and the procedures in appendix F of this part
to develop numeric criteria and values when implementing narrative
water quality criteria adopted for purposes of section 303(c) of the
Clean Water Act.
(d) The water quality criteria and values adopted or developed
pursuant to paragraphs (a) through (c) of this section shall apply as
follows:
(1) The acute water quality criteria and values for the protection
of aquatic life, or site-specific modifications thereof, shall apply to
all waters of the Great Lakes System.
(2) The chronic water quality criteria and values for the
protection of aquatic life, or site-specific modifications thereof,
shall apply to all waters of the Great Lakes System.
(3) The water quality criteria and values for protection of human
health, or site-specific modifications thereof, shall apply as follows:
(i) Criteria and values derived as HCV-Drinking and HNV-Drinking
shall apply to the Open Waters of the Great Lakes, all connecting
channels of the Great Lakes, and all other waters of the Great Lakes
System that have been designated as public water supplies by any State
or Tribe in accordance with 40 CFR 131.10.
(ii) Criteria and values derived as HCV-Nondrinking and 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 establishing controls on the discharge of any pollutant to the
Great Lakes System by any point source with the following exceptions:
(1) The Great Lakes States and Tribes are not required to apply
these implementation procedures in establishing controls on the
discharge of any pollutant by a wet weather point source. Any adopted
implementation procedures shall conform with all applicable Federal,
State and Tribal requirements.
(2) The Great Lakes States and Tribes may, but are not required to,
apply procedures consistent with procedures 1, 2, 3, 4, 5, 7, 8, and 9
of appendix F of this part in establishing controls on the discharge of
any pollutant set forth in Table 5 of this part. Any procedures applied
in lieu of these implementation procedures shall conform with all
applicable Federal, State, and Tribal requirements.
(f) The Great Lakes States and Tribes shall apply an
antidegradation policy consistent with the policy in appendix E for all
applicable purposes under the Clean Water Act, including 40 CFR 131.12.
(g) For pollutants listed in Table 5 of this part, the Great Lakes
States and Tribes shall:
(1) Apply any methodologies and procedures acceptable under 40 CFR
part 131 when developing water quality criteria or implementing
narrative criteria; and
(2) Apply the implementation procedures in appendix F of this part
or alternative procedures consistent with all applicable Federal,
State, and Tribal laws.
(h) For any pollutant other than those in Table 5 of this part for
which the State or Tribe demonstrates that a methodology or procedure
in this part is not scientifically defensible, the Great Lakes States
and Tribes shall:
(1) Apply an alternative methodology or procedure acceptable under
40 CFR part 131 when developing water quality criteria; or
(2) Apply an alternative implementation procedure that is
consistent with all applicable Federal, State, and Tribal laws.
(i) Nothing in this part shall prohibit the Great Lakes States and
Tribes from adopting numeric water quality criteria, narrative
criteria, or water quality values that are more stringent than criteria
or values specified in Sec. 132.3 or that would be derived from
application of the methodologies set forth in appendixes A, B, C, and D
of this part, or to adopt antidegradation standards and implementation
procedures more [[Page 15391]] stringent than those set forth in
appendixes E and F of this part.
Sec. 132.5 Procedures for adoption and EPA review.
(a) Except as provided in paragraph (c) of this section, the Great
Lakes States and Tribes shall adopt and submit for EPA review and
approval the criteria, methodologies, policies, and procedures
developed pursuant to this part no later than September 23, 1996.
(b) The following elements must be included in each submission to
EPA for review:
(1) The criteria, methodologies, policies, and procedures developed
pursuant to this part;
(2) Certification by the Attorney General or other appropriate
legal authority pursuant to 40 CFR 123.62 and 40 CFR 131.6(e) as
appropriate;
(3) All other information required for submission of National
Pollutant Discharge Elimination System (NPDES) program modifications
under 40 CFR 123.62; and
(4) General information which will aid EPA in determining whether
the criteria, methodologies, policies and procedures are consistent
with the requirements of the Clean Water Act and this part, as well as
information on general policies which may affect their application and
implementation.
(c) The Regional Administrator may extend the deadline for the
submission required in paragraph (a) of this section if the Regional
Administrator believes that the submission will be consistent with the
requirements of this part and can be reviewed and approved pursuant to
this section no later than March 23, 1997.
(d) If a Great Lakes State or Tribe makes no submission pursuant to
this part to EPA for review, the requirements of this part shall apply
to discharges to waters of the Great Lakes System located within the
State or Federal Indian reservation upon EPA's publication of a final
rule indicating the effective date of the part 132 requirements in the
identified jurisdictions.
(e) If a Great Lakes State or Tribe submits criteria,
methodologies, policies, and procedures pursuant to this part to EPA
for review that contain substantial modifications of the State or
Tribal NPDES program, EPA shall issue public notice and provide a
minimum of 30 days for public comment on such modifications. The public
notice shall conform with the requirements of 40 CFR 123.62.
(f) After review of State or Tribal submissions under this section,
and following the public comment period in subparagraph (e) of this
section, if any, EPA shall either:
(1) Publish notice of approval of the submission in the Federal
Register within 90 days of such submission; or
(2) Notify the State or Tribe within 90 days of such submission
that EPA has determined that all or part of the submission is
inconsistent with the requirements of the Clean Water Act or this part
and identify any necessary changes to obtain EPA approval. If the State
or Tribe fails to adopt such changes within 90 days after the
notification, EPA shall publish a notice in the Federal Register
identifying the approved and disapproved elements of the submission and
a final rule in the Federal Register identifying the provisions of part
132 that shall apply to discharges within the State or Federal Indian
reservation.
(g) EPA's approval or disapproval of a State or Tribal submission
shall be based on the requirements of this part and of the Clean Water
Act. EPA's determination whether the criteria, methodologies, policies,
and procedures in a State or Tribal submission are consistent with the
requirements of this part will be based on whether:
(1) For pollutants listed in Tables 1, 2, 3, and 4 of this part.
The Great Lakes State or Tribe has adopted numeric water quality
criteria as protective as each of the numeric criteria in Tables 1, 2,
3, and 4 of this part, taking into account any site-specific criteria
modifications in accordance with procedure 1 of appendix F of this
part;
(2) For pollutants other than those listed in Tables 1, 2, 3, 4,
and 5 of this part. The Great Lakes State or Tribe demonstrates that
either:
(i) It has adopted numeric criteria in its water quality standards
that were derived, or are as protective as or more protective than
could be derived, using the methodologies in appendixes A, B, C, and D
of this part, and the site-specific criteria modification procedures in
accordance with procedure 1 of appendix F of this part; or
(ii) It has adopted a procedure by which water quality-based
effluent limits and total maximum daily loads are developed using the
more protective of:
(A) Numeric criteria adopted by the State into State water quality
standards and approved by EPA prior to March 23, 1997; or
(B) Water quality criteria and values derived pursuant to
Sec. 132.4(c); and
(3) For methodologies, policies, and procedures. The Great Lakes
State or Tribe has adopted methodologies, policies, and procedures as
protective as the corresponding methodology, policy, or procedure in
Sec. 132.4. The Great Lakes State or Tribe may adopt provisions that
are more protective than those contained in this part. Adoption of a
more protective element in one provision may be used to offset a less
protective element in the same provision as long as the adopted
provision is as protective as the corresponding provision in this part;
adoption of a more protective element in one provision, however, is not
justification for adoption of a less protective element in another
provision of this part.
(h) A submission by a Great Lakes State or Tribe will need to
include any provisions that EPA determines, based on EPA's authorities
under the Clean Water Act and the results of consultation under section
7 of the Endangered Species Act, are necessary to ensure that water
quality is not likely to jeopardize the continued existence of any
endangered or threatened species listed under section 4 of the
Endangered Species Act or result in the destruction or adverse
modification of such species' critical habitat.
(i) EPA's approval of the elements of a State's or Tribe's
submission will constitute approval under section 118 of the Clean
Water Act, approval of the submitted water quality standards pursuant
to section 303 of the Clean Water Act, and approval of the submitted
modifications to the State's or Tribe's NPDES program pursuant to
section 402 of the Clean Water Act.
Sec. 132.6 Application of part 132 requirements in Great Lakes States
and Tribes. [Reserved]
Tables to Part 132
Table 1.--Acute Water Quality Criteria for Protection of Aquatic Life
in Ambient Water
EPA recommends that metals criteria be expressed as dissolved
concentrations (see appendix A, I.A.4 for more information regarding
metals criteria).
(a)
------------------------------------------------------------------------
Conversion
Chemical CMC(g/ factor
L) (CF)
------------------------------------------------------------------------
Arsenic (III).............................. a,b339.8 1.000
Chromium (VI).............................. a,b16.02 0.982
Cyanide.................................... c22 n/a
Dieldrin................................... d0.24 n/a
Endrin..................................... d0.086 n/a
Lindane.................................... d0.95 n/a
Mercury (II)............................... a,b1.694 0.85
Parathion.................................. d0.065 n/a
Selenium................................... a,b19.34 0.922
------------------------------------------------------------------------
aCMC=CMCtr.
bCMCd=(CMCtr) CF. The CMCd shall be rounded to two significant digits.
[[Page 15392]]
cCMC should be considered free cyanide as CN.
dCMC=CMCt.
Notes:
The term ``n/a'' means not applicable.
CMC is Criterion Maximum Concentration.
CMCtr is the CMC expressed as total recoverable.
CMCd is the CMC expressed as a dissolved concentration.
CMCt is the CMC expressed as a total concentration.
(b)
------------------------------------------------------------------------
Conversion
Chemical mA bA factor
(CF)
------------------------------------------------------------------------
Cadmiuma,b............................ 1.128 -3.6867 0.85
Chromium (III)a,b..................... 0.819 +3.7256 0.316
Coppera,b............................. 0.9422 -1.700 0.960
Nickela,b............................. 0.846 +2.255 0.998
Pentachlorophenolc.................... 1.005 -4.869 n/a
Zinca,b............................... 0.8473 +0.884 0.978
------------------------------------------------------------------------
aCMCtr=exp { mA [ln (hardness)]+bA}.
bCMCd=(CMCtr) CF. The CMCd shall be rounded to two significant digits.
cCMCt=exp mA { [pH]+bA}. The CMCt shall be rounded to two significant
digits.
Notes:
The term ``exp'' represents the base e exponential function.
The term ``n/a'' means not applicable.
CMC is Criterion Maximum Concentration.
CMCtr is the CMC expressed as total recoverable.
CMCd is the CMC expressed as a dissolved concentration.
CMCt is the CMC expressed as a total concentration.
Table 2.--Chronic Water Quality Criteria for Protection of Aquatic Life
in Ambient Water
EPA recommends that metals criteria be expressed as dissolved
concentrations (see appendix A, I.A.4 for more information regarding
metals criteria).
(a)
------------------------------------------------------------------------
Conversion
Chemical CCC(g/ factor
L) (CF)
------------------------------------------------------------------------
Arsenic (III).............................. a,b147.9 1.000
Chromium (VI).............................. a,b10.98 0.962
Cyanide.................................... c5.2 n/a
Dieldrin................................... d0.056 n/a
Endrin..................................... d0.036 n/a
Mercury (II)............................... a,b0.9081 0.85
Parathion.................................. d0.013 n/a
Selenium................................... a,b5 0.922
------------------------------------------------------------------------
aCCC=CCCtr.
bCCCd=(CCCtr) CF. The CCCd shall be rounded to two significant digits.
cCCC should be considered free cyanide as CN.
dCCC=CCCt.
Notes:
The term ``n/a'' means not applicable.
CCC is Criterion Continuous Concentration.
CCCtr is the CCC expressed as total recoverable.
CCCd is the CCC expressed as a dissolved concentration.
CCCt is the CCC expressed as a total concentration.
(b)
------------------------------------------------------------------------
Conversion
Chemical mc bc factor(CF)
------------------------------------------------------------------------
Cadmiuma,b................................ 0.7852 -2.715 0.850
Chromium (III)a,b......................... 0.819 +0.6848 0.860
Coppera,b................................. 0.8545 -1.702 0.960
Nickela,b................................. 0.846 +0.0584 0.997
Pentachlorophenolc........................ 1.005 -5.134 n/a
Zinca,b................................... 0.8473 +0.884 0.986
------------------------------------------------------------------------
aCCCtr=exp {mc[ln (hardness)]+bc}.
bCCCd=(CCCtr) (CF). The CCCd shall be rounded to two significant digits.
cCMCt=exp {mA[pH]+bA}. The CMCt shall be rounded to two significant
digits.
Notes:
The term ``exp'' represents the base e exponential function.
The term ``n/a'' means not applicable.
CCC is Criterion Continuous Concentration.
CCCtr is the CCC expressed as total recoverable.
CCCd is the CCC expressed as a dissolved concentration.
CCCt is the CCC expressed as a total concentration.
Table 3.--Water Quality Criteria for Protection of Human Health
----------------------------------------------------------------------------------------------------------------
HNV (g/L) HCV (g/L)
Chemical -----------------------------------------------------------
Drinking Nondrinking Drinking Nondrinking
----------------------------------------------------------------------------------------------------------------
Benzene............................................. 1.9E1 5.1E2 1.2E1 3.1E2
Chlordane........................................... 1.4E-3 1.4E-3 2.5E-4 2.5E-4
Chlorobenzene....................................... 4.7E2 3.2E3
Cyanides............................................ 6.0E2 4.8E4
DDT................................................. 2.0E-3 2.0E-3 1.5E-4 1.5E-4
Dieldrin............................................ 4.1E-4 4.1E-4 6.5E-6 6.5E-6
2,4-Dimethylphenol.................................. 4.5E2 8.7E3
2,4-Dinitrophenol................................... 5.5E1 2.8E3
Hexachlorobenzene................................... 4.6E-2 4.6E-2 4.5E-4 4.5E-4
Hexachloroethane.................................... 6.0 7.6 5.3 6.7
Lindane............................................. 4.7E-1 5.0E-1
Mercury1............................................ 1.8E-3 1.8E-3
Methylene chloride.................................. 1.6E3 9.0E4 4.7E1 2.6E3
PCBs (class)........................................ 3.9E-6 3.9E-6
2,3,7,8-TCDD........................................ 6.7E-8 6.7E-8 8.6E-9 8.6E-9
Toluene............................................. 5.6E3 5.1E4
Toxaphene........................................... 6.8E-5 6.8E-5
[[Page 15393]]
Trichloroethylene................................... 2.9E1 3.7E2
----------------------------------------------------------------------------------------------------------------
\1\Includes methylmercury.
Table 4.--Water Quality Criteria for Protection of Wildlife
------------------------------------------------------------------------
Criteria
Chemical (g/
L)
------------------------------------------------------------------------
DDT and metabolites....................................... 1.1E-5
Mercury (including methylmercury)......................... 1.3E-3
PCBs (class).............................................. 7.4E-5
2,3,7,8-TCDD.............................................. 3.1E-9
------------------------------------------------------------------------
Table 5.--Pollutants Subject to Federal, State, and Tribal Requirements
Alkalinity
Ammonia
Bacteria
Biochemical oxygen demand (BOD)
Chlorine
Color
Dissolved oxygen
Dissolved solids
pH
Phosphorus
Salinity
Temperature
Total and suspended solids
Turbidity
Table 6.--Pollutants of Initial Focus in the Great Lakes Water Quality
Initiative
A. Pollutants that are bioaccumulative chemicals of concern
(BCCs):
Chlordane
4,4'-DDD; p,p'-DDD; 4,4'-TDE; p,p'-TDE
4,4'-DDE; p,p'-DDE
4,4'-DDT; p,p'-DDT
Dieldrin
Hexachlorobenzene
Hexachlorobutadiene; hexachloro-1, 3-butadiene
Hexachlorocyclohexanes; BHCs
alpha-Hexachlorocyclohexane; alpha-BHC
beta-Hexachlorocyclohexane; beta-BHC
delta-Hexachlorocyclohexane; delta-BHC
Lindane; gamma-hexachlorocyclohexane; gamma-BHC
Mercury
Mirex
Octachlorostyrene
PCBs; polychlorinated biphenyls
Pentachlorobenzene
Photomirex
2,3,7,8-TCDD; dioxin
1,2,3,4-Tetrachlorobenzene
1,2,4,5-Tetrachlorobenzene Toxaphene
B. Pollutants that are not bioaccumulative chemicals of concern:
Acenaphthene
Acenaphthylene
Acrolein; 2-propenal
Acrylonitrile
Aldrin
Aluminum
Anthracene
Antimony
Arsenic
Asbestos
1,2-Benzanthracene; benz[a]anthracene
Benzene
Benzidine
Benzo[a]pyrene; 3,4-benzopyrene
3,4-Benzofluoranthene; benzo[b]fluoranthene
11,12-Benzofluoranthene; benzo[k]fluoranthene
1,12-Benzoperylene; benzo[ghi]perylene
Beryllium
Bis(2-chloroethoxy) methane
Bis(2-chloroethyl) ether
Bis(2-chloroisopropyl) ether
Bromoform; tribomomethane
4-Bromophenyl phenyl ether
Butyl benzyl phthalate
Cadmium
Carbon tetrachloride; tetrachloromethane
Chlorobenzene
p-Chloro-m-cresol; 4-chloro-3-methylphenol
Chlorodibromomethane
Chlorethane
2-Chloroethyl vinyl ether
Chloroform; trichloromethane
2-Chloronaphthalene
2-Chlorophenol
4-Chlorophenyl phenyl ether
Chlorpyrifos
Chromium
Chrysene
Copper
Cyanide
2,4-D; 2,4-Dichlorophenoxyacetic acid
DEHP; di(2-ethylhexyl) phthalate
Diazinon
1,2:5,6-Dibenzanthracene; dibenz[a,h]anthracene
Dibutyl phthalate; di-n-butyl phthalate
1,2-Dichlorobenzene
1,3-Dichlorobenzene
1,4-Dichlorobenzene
3,3'-Dichlorobenzidine
Dichlorobromomethane; bromodichloromethane
1,1-Dichloroethane
1,2-Dichloroethane
1,1-Dichloroethylene; vinylidene chloride
1,2-trans-Dichloroethylene
2,4-Dichlorophenol
1,2-Dichloropropane
1,3-Dichloropropene; 1,3-dichloropropylene
Diethyl phthalate
2,4-Dimethylphenol; 2,4-xylenol
Dimethyl phthalate
4,6-Dinitro-o-cresol; 2-methyl-4,6-dinitrophenol
2,4-Dinitrophenol
2,4-Dinitrotoluene
2,6-Dinitrotoluene
Dioctyl phthalate; di-n-octyl phthalate
1,2-Diphenylhydrazine
Endosulfan; thiodan
alpha-Endosulfan
beta-Endosulfan
Endosulfan sulfate
Endrin
Endrin aldehyde
Ethylbenzene
Fluoranthene
Fluorene; 9H-fluorene
Fluoride
Guthion
Heptachlor
Heptachlor epoxide
Hexachlorocyclopentadiene
Hexachloroethane
Indeno[1,2,3-cd]pyrene; 2,3-o-phenylene pyrene
Isophorone
Lead
Malathion
Methoxychlor
Methyl bromide; bromomethane
Methyl chloride; chloromethane
Methylene chloride; dichloromethane
Napthalene
Nickel
Nitrobenzene
2-Nitrophenol
4-Nitrophenol
N-Nitrosodimethylamine
N-Nitrosodiphenylamine
N-Nitrosodipropylamine; N-nitrosodi-n-propylamine
Parathion
Pentachlorophenol
Phenanthrene
Phenol
Iron
Pyrene
Selenium
Silver
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
Thallium
Toluene; methylbenzene
1,2,4-Trichlorobenzene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichloroethylene; trichloroethene
2,4,6-Trichlorophenol
Vinyl chloride; chloroethylene; chloroethene
Zinc
Appendix A to part 132--Great Lakes Water Quality Initiative
Methodologies for Developments of Aquatic Life Criteria and Values
Methodology for Deriving Aquatic Life Criteria: Tier I
Great Lakes States and Tribes shall adopt provisions consistent
with (as protective as) this appendix. [[Page 15394]]
I. Definitions
A. Material of Concern. When defining the material of concern
the following should be considered:
1. Each separate chemical that does not ionize substantially in
most natural bodies of water should usually be considered a separate
material, except possibly for structurally similar organic compounds
that only exist in large quantities as commercial mixtures of the
various compounds and apparently have similar biological, chemical,
physical, and toxicological properties.
2. For chemicals that ionize substantially in most natural
bodies of water (e.g., some phenols and organic acids, some salts of
phenols and organic acids, and most inorganic salts and coordination
complexes of metals and metalloid), all forms that would be in
chemical equilibrium should usually be considered one material. Each
different oxidation state of a metal and each different non-
ionizable covalently bonded organometallic compound should usually
be considered a separate material.
3. The definition of the material of concern should include an
operational analytical component. Identification of a material
simply as ``sodium,'' for example, implies ``total sodium,'' but
leaves room for doubt. If ``total'' is meant, it must be explicitly
stated. Even ``total'' has different operational definitions, some
of which do not necessarily measure ``all that is there'' in all
samples. Thus, it is also necessary to reference or describe the
analytical method that is intended. The selection of the operational
analytical component should take into account the analytical and
environmental chemistry of the material and various practical
considerations, such as labor and equipment requirements, and
whether the method would require measurement in the field or would
allow measurement after samples are transported to a laboratory.
a. The primary requirements of the operational analytical
component are that it be appropriate for use on samples of receiving
water, that it be compatible with the available toxicity and
bioaccumulation data without making extrapolations that are too
hypothetical, and that it rarely result in underprotection or
overprotection of aquatic organisms and their uses. Toxicity is the
property of a material, or combination of materials, to adversely
affect organisms.
b. Because an ideal analytical measurement will rarely be
available, an appropriate compromise measurement will usually have
to be used. This compromise measurement must fit with the general
approach that if an ambient concentration is lower than the
criterion, unacceptable effects will probably not occur, i.e., the
compromise measure must not err on the side of underprotection when
measurements are made on a surface water. What is an appropriate
measurement in one situation might not be appropriate for another.
For example, because the chemical and physical properties of an
effluent are usually quite different from those of the receiving
water, an analytical method that is appropriate for analyzing an
effluent might not be appropriate for expressing a criterion, and
vice versa. A criterion should be based on an appropriate analytical
measurement, but the criterion is not rendered useless if an ideal
measurement either is not available or is not feasible.
Note: The analytical chemistry of the material might have to be
taken into account when defining the material or when judging the
acceptability of some toxicity tests, but a criterion must not be
based on the sensitivity of an analytical method. When aquatic
organisms are more sensitive than routine analytical methods, the
proper solution is to develop better analytical methods.
4. It is now the policy of EPA that the use of dissolved metal
to set and measure compliance with water quality standards is the
recommended approach, because dissolved metal more closely
approximates the bioavailable fraction of metal in the water column
that does total recoverable metal. One reason is that a primary
mechanism for water column toxicity is adsorption at the gill
surface which requires metals to be in the dissolved form. Reasons
for the consideration of total recoverable metals criteria include
risk management considerations not covered by evaluation of water
column toxicity. A risk manager may consider sediments and food
chain effects and may decide to take a conservative approach for
metals, considering that metals are very persistent chemicals. This
approach could include the use of total recoverable metal in water
quality standards. A range of different risk management decisions
can be justified. EPA recommends that State water quality standards
be based on dissolved metal. EPA will also approve a State risk
management decision to adopt standards based on total recoverable
metal, if those standards are otherwise approvable under this
program.
B. Acute Toxicity. Concurrent and delayed adverse effect(s) that
results from an acute exposure and occurs within any short
observation period which begins when the exposure begins, may extend
beyond the exposure period, and usually does not constitute a
substantial portion of the life span of the organism. (Concurrent
toxicity is an adverse effect to an organism that results from, and
occurs during, its exposure to one or more test materials.) Exposure
constitutes contact with a chemical or physical agent. Acute
exposure, however, is exposure of an organism for any short period
which usually does not constitute a substantial portion of its life
span.
C. Chronic Toxicity. Concurrent and delayed adverse effect(s)
that occurs only as a result of a chronic exposure. Chronic exposure
is exposure of an organism for any long period or for a substantial
portion of its life span.
II. Collection of Data
A. Collect all data available on the material concerning
toxicity to aquatic animals and plants.
B. All data that are used should be available in typed, dated,
and signed hard copy (e.g., publication, manuscript, letter,
memorandum, etc.) with enough supporting information to indicate
that acceptable test procedures were used and that the results are
reliable. In some cases, it might be appropriate to obtain written
information from the investigator, if possible. Information that is
not available for distribution shall not be used.
C. Questionable data, whether published or unpublished, must not
be used. For example, data must be rejected if they are from tests
that did not contain a control treatment, tests in which too many
organisms in the control treatment died or showed signs of stress or
disease, and tests in which distilled or deionized water was used as
the dilution water without the addition of appropriate salts.
D. Data on technical grade materials may be used if appropriate,
but data on formulated mixtures and emulsifiable concentrates of the
material must not be used.
E. For some highly volatile, hydrolyzable, or degradable
materials, it might be appropriate to use only results of 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.
III. Required Data
A. Certain data should be available to help ensure that each of
the major kinds of possible adverse effects receives adequate
consideration. An adverse effect is a change in an organism that is
harmful to the organism. Exposure means contact with a chemical or
physical agent. Results of acute and chronic toxicity tests with
representative species of aquatic animals are necessary so that data
available for tested species can be considered a useful indication
of the sensitivities of appropriate untested species. Fewer data
concerning toxicity to aquatic plants are usually available because
procedures for conducting tests with plants and interpreting the
results of such tests are not as well developed.
B. To derive a Great Lakes Tier I criterion for aquatic
organisms and their uses, the following must be available:
1. Results of acceptable acute (or chronic) tests (see section
IV or VI of this appendix) with at least one species of freshwater
animal in at least eight different families such that all of the
following are included: [[Page 15395]]
a. The family Salmonidae in the class Osteichthyes;
b. One other family (preferably a commercially or recreationally
important, warmwater species) in the class Osteichthyes (e.g.,
bluegill, channel catfish);
c. A third family in the phylum Chordata (e.g., fish,
amphibian);
d. A planktonic crustacean (e.g., a cladoceran, copepod);
e. A benthic crustacean (e.g., ostracod, isopod, amphipod,
crayfish);
f. An insect (e.g., mayfly, dragonfly, damselfly, stonefly,
caddisfly, mosquito, midge);
g. A family in a phylum other than Arthropoda or Chordata (e.g.,
Rotifera, Annelida, Mollusca);
h. A family in any order of insect or any phylum not already
represented.
2. Acute-chronic ratios (see section VI of this appendix) with
at least one species of aquatic animal in at least three different
families provided that of the three species:
a. At least one is a fish;
b. At least one is an invertebrate; and
c. At least one species is an acutely sensitive freshwater
species (the other two may be saltwater species).
3. Results of at least one acceptable test with a freshwater
algae or vascular plant is desirable but not required for criterion
derivation (see section VIII of this appendix). If plants are among
the aquatic organisms most sensitive to the material, results of a
test with a plant in another phylum (division) should also be
available.
C. If all required data are available, a numerical criterion can
usually be derived except in special cases. For example, derivation
of a chronic criterion might not be possible if the available ACRs
vary by more than a factor of ten with no apparent pattern. Also, if
a criterion is to be related to a water quality characteristic (see
sections V and VII of this appendix), more data will be required.
D. Confidence in a criterion usually increases as the amount of
available pertinent information increases. Thus, additional data are
usually desirable.
IV. Final Acute Value
A. Appropriate measures of the acute (short-term) toxicity of
the material to a variety of species of aquatic animals are used to
calculate the Final Acute Value (FAV). The calculated Final Acute
Value is a calculated estimate of the concentration of a test
material such that 95 percent of the genera (with which acceptable
acute toxicity tests have been conducted on the material) have
higher Genus Mean Acute Values (GMAVs). An acute test is a
comparative study in which organisms, that are subjected to
different treatments, are observed for a short period usually not
constituting a substantial portion of their life span. However, in
some cases, the Species Mean Acute Value (SMAV) of a commercially or
recreationally important species of the Great Lakes System is lower
than the calculated FAV, then the SMAV replaces the calculated FAV
in order to provide protection for that important species.
B. Acute toxicity tests shall be conducted using acceptable
procedures. For good examples of acceptable procedures see American
Society for Testing and Materials (ASTM) Standard E 729, Guide for
Conducting Acute Toxicity Tests with Fishes, Macroinvertebrates, and
Amphibians.
C. Except for results with saltwater annelids and mysids,
results of acute tests during which the test organisms were fed
should not be used, unless data indicate that the food did not
affect the toxicity of the test material. (Note: If the minimum
acute-chronic ratio data requirements (as described in section
III.B.2 of this appendix) are not met with freshwater data alone,
saltwater data may be used.)
D. Results of acute tests conducted in unusual dilution water,
e.g., dilution water in which total organic carbon or particulate
matter exceeded five mg/L, should not be used, unless a relationship
is developed between acute toxicity and organic carbon or
particulate matter, or unless data show that organic carbon or
particulate matter, etc., do not affect toxicity.
E. Acute values must be based upon endpoints which reflect the
total severe adverse impact of the test material on the organisms
used in the test. Therefore, only the following kinds of data on
acute toxicity to aquatic animals shall be used:
1. Tests with daphnids and other cladocerans must be started
with organisms less than 24 hours old and tests with midges must be
started with second or third instar larvae. It is preferred that the
results should be the 48-hour EC50 based on the total percentage of
organisms killed and immobilized. If such an EC50 is not available
for a test, the 48-hour LC50 should be used in place of the desired
48-hour EC50. An EC50 or LC50 of longer than 48 hours can be used as
long as the animals were not fed and the control animals were
acceptable at the end of the test. An EC50 is a statistically or
graphically estimated concentration that is expected to cause one or
more specified effects in 50% of a group of organisms under
specified conditions. An LC50 is a statistically or graphically
estimated concentration that is expected to be lethal to 50% of a
group of organisms under specified conditions.
2. It is preferred that the results of a test with embryos and
larvae of barnacles, bivalve molluscs (clams, mussels, oysters and
scallops), sea urchins, lobsters, crabs, shrimp and abalones be the
96-hour EC50 based on the percentage of organisms with incompletely
developed shells plus the percentage of organisms killed. If such an
EC50 is not available from a test, of the values that are available
from the test, the lowest of the following should be used in place
of the desired 96-hour EC50: 48- to 96-hour EC50s based on
percentage of organisms with incompletely developed shells plus
percentage of organisms killed, 48- to 96-hour EC50s based upon
percentage of organisms with incompletely developed shells, and 48-
hour to 96-hour LC50s. (Note: If the minimum acute-chronic ratio
data requirements (as described in section III.B.2 of this appendix)
are not met with freshwater data alone, saltwater data may be used.)
3. It is preferred that the result of tests with all other
aquatic animal species and older life stages of barnacles, bivalve
molluscs (clams, mussels, oysters and scallops), sea urchins,
lobsters, crabs, shrimp and abalones be the 96-hour EC50 based on
percentage of organisms exhibiting loss of equilibrium plus
percentage of organisms immobilized plus percentage of organisms
killed. If such an EC50 is not available from a test, of the values
that are available from a test the lower of the following should be
used in place of the desired 96-hour EC50: the 96-hour EC50 based on
percentage of organisms exhibiting loss of equilibrium plus
percentage of organisms immobilized and the 96-hour LC50.
4. Tests whose results take into account the number of young
produced, such as most tests with protozoans, are not considered
acute tests, even if the duration was 96 hours or less.
5. If the tests were conducted properly, acute values reported
as ``greater than'' values and those which are above the solubility
of the test material should be used, because rejection of such acute
values would bias the Final Acute Value by eliminating acute values
for resistant species.
F. If the acute toxicity of the material to aquatic animals has
been shown to be related to a water quality characteristic such as
hardness or particulate matter for freshwater animals, refer to
section V of this appendix.
G. The agreement of the data within and between species must be
considered. Acute values that appear to be questionable in
comparison with other acute and chronic data for the same species
and for other species in the same genus must not be used. For
example, if the acute values available for a species or genus differ
by more than a factor of 10, rejection of some or all of the values
would be appropriate, absent countervailing circumstances.
H. If the available data indicate that one or more life stages
are at least a factor of two more resistant than one or more other
life stages of the same species, the data for the more resistant
life stages must not be used in the calculation of the SMAV because
a species cannot be considered protected from acute toxicity if all
of the life stages are not protected.
I. For each species for which at least one acute value is
available, the SMAV shall be calculated as the geometric mean of the
results of all acceptable flow-through acute toxicity tests in which
the concentrations of test material were measured with the most
sensitive tested life stage of the species. For a species for which
no such result is available, the SMAV shall be calculated as the
geometric mean of all acceptable acute toxicity tests with the most
sensitive tested life stage, i.e., results of flow-through tests in
which the concentrations were not measured and results of static and
renewal tests based on initial concentrations (nominal
concentrations are acceptable for most test materials if measured
concentrations are not available) of test material. A renewal test
is a test with aquatic organisms in which either the test solution
in a test chamber is removed and replaced at least once during the
test or the test organisms are transferred into a new test solution
of the same composition at least once during the test. A static test
is a test with aquatic organisms in which the solution
[[Page 15396]] and organisms that are in a test chamber at the
beginning of the test remain in the chamber until the end of the
test, except for removal of dead test organisms.
Note 1: Data reported by original investigators must not be
rounded off. Results of all intermediate calculations must not be
rounded off to fewer than four significant digits.
Note 2: The geometric mean of N numbers is the Nth root of the
product of the N numbers. Alternatively, the geometric mean can be
calculated by adding the logarithms of the N numbers, dividing the
sum by N, and taking the antilog of the quotient. The geometric mean
of two numbers is the square root of the product of the two numbers,
and the geometric mean of one number is that number. Either natural
(base e) or common (base 10) logarithms can be used to calculate
geometric means as long as they are used consistently within each
set of data, i.e., the antilog used must match the logarithms used.
Note 3: Geometric means, rather than arithmetic means, are used
here because the distributions of sensitivities of individual
organisms in toxicity tests on most materials and the distributions
of sensitivities of species within a genus are more likely to be
lognormal than normal. Similarly, geometric means are used for ACRs
because quotients are likely to be closer to lognormal than normal
distributions. In addition, division of the geometric mean of a set
of numerators by the geometric mean of the set of denominators will
result in the geometric mean of the set of corresponding quotients.
J. For each genus for which one or more SMAVs are available, the
GMAV shall be calculated as the geometric mean of the SMAVs
available for the genus.
K. Order the GMAVs from high to low.
L. Assign ranks, R, to the GMAVs from ``1'' for the lowest to
``N'' for the highest. If two or more GMAVs are identical, assign
them successive ranks.
M. Calculate the cumulative probability, P, for each GMAV as R/
(N+1).
N. Select the four GMAVs which have cumulative probabilities
closest to 0.05 (if there are fewer than 59 GMAVs, these will always
be the four lowest GMAVs).
O. Using the four selected GMAVs, and Ps, calculate
[GRAPHIC][TIFF OMITTED]TR23MR95.104
Note: Natural logarithms (logarithms to base e, denoted as ln)
are used herein merely because they are easier to use on some hand
calculators and computers than common (base 10) logarithms.
Consistent use of either will produce the same result.
P. If for a commercially or recreationally important species of
the Great Lakes System the geometric mean of the acute values from
flow-through tests in which the concentrations of test material were
measured is lower than the calculated Final Acute Value (FAV), then
that geometric mean must be used as the FAV instead of the
calculated FAV.
Q. See section VI of this appendix.
V. Final Acute Equation
A. When enough data are available to show that acute toxicity to
two or more species is similarly related to a water quality
characteristic, the relationship shall be taken into account as
described in sections V.B through V.G of this appendix or using
analysis of covariance. The two methods are equivalent and produce
identical results. The manual method described below provides an
understanding of this application of covariance analysis, but
computerized versions of covariance analysis are much more
convenient for analyzing large data sets. If two or more factors
affect toxicity, multiple regression analysis shall be used.
B. For each species for which comparable acute toxicity values
are available at two or more different values of the water quality
characteristic, perform a least squares regression of the acute
toxicity values on the corresponding values of the water quality
characteristic to obtain the slope and its 95 percent confidence
limits for each species.
Note: Because the best documented relationship is that between
hardness and acute toxicity of metals in fresh water and a log-log
relationship fits these data, geometric means and natural logarithms
of both toxicity and water quality are used in the rest of this
section. For relationships based on other water quality
characteristics, such as Ph, temperature, no transformation or a
different transformation might fit the data better, and appropriate
changes will be necessary throughout this section.
C. Decide whether the data for each species are relevant, taking
into account the range and number of the tested values of the water
quality characteristic and the degree of agreement within and
between species. For example, a slope based on six data points might
be of limited value if it is based only on data for a very narrow
range of values of the water quality characteristic. A slope based
on only two data points, however, might be useful if it is
consistent with other information and if the two points cover a
broad enough range of the water quality characteristic. In addition,
acute values that appear to be questionable in comparison with other
acute and chronic data available for the same species and for other
species in the same genus should not be used. For example, if after
adjustment for the water quality characteristic, the acute values
available for a species or genus differ by more than a factor of 10,
rejection of some or all of the values would be appropriate, absent
countervailing justification. If useful slopes are not available for
at least one fish and one invertebrate or if the available slopes
are too dissimilar or if too few data are available to adequately
define the relationship between acute toxicity and the water quality
characteristic, return to section IV.G of this appendix, using the
results of tests conducted under conditions and in waters similar to
those commonly used for toxicity tests with the species.
D. For each species, calculate the geometric mean of the
available acute values and then divide each of the acute values for
the species by the geometric mean for the species. This normalizes
the acute values so that the geometric mean of the normalized values
for each species individually and for any combination of species is
1.0.
E. Similarly normalize the values of the water quality
characteristic for each species individually using the same
procedure as above.
F. Individually for each species perform a least squares
regression of the normalized [[Page 15397]] acute values of the
water quality characteristic. The resulting slopes and 95 percent
confidence limits will be identical to those obtained in section
V.B. of this appendix. If, however, the data are actually plotted,
the line of best fit for each individual species will go through the
point 1,1 in the center of the graph.
G. Treat all of the normalized data as if they were all for the
same species and perform a least squares regression of all of the
normalized acute values on the corresponding normalized values of
the water quality characteristic to obtain the pooled acute slope,
V, and its 95 percent confidence limits. If all of the normalized
data are actually plotted, the line of best fit will go through the
point 1,1 in the center of the graph.
H. For each species calculate the geometric mean, W, of the
acute toxicity values and the geometric mean, X, of the values of
the water quality characteristic. (These were calculated in sections
V.D and V.E of this appendix).
I. For each species, calculate the logarithm, Y, of the SMAV at
a selected value, Z, of the water quality characteristic using the
equation:
Y=ln W-V(ln X-ln Z)
J. For each species calculate the SMAV at X using the equation:
SMAV=eY
Note: Alternatively, the SMAVs at Z can be obtained by skipping
step H above, using the equations in steps I and J to adjust each
acute value individually to Z, and then calculating the geometric
mean of the adjusted values for each species individually. This
alternative procedure allows an examination of the range of the
adjusted acute values for each species.
K. Obtain the FAV at Z by using the procedure described in
sections IV.J through IV.O of this appendix.
L. If, for a commercially or recreationally important species of
the Great Lakes System the geometric mean of the acute values at Z
from flow-through tests in which the concentrations of the test
material were measured is lower than the FAV at Z, then the
geometric mean must be used as the FAV instead of the FAV.
M. The Final Acute Equation is written as:
FAV=e(V[ln(water quality characteristic)]+A-V[ln Z]),
where:
V=pooled acute slope, and A=ln(FAV at Z).
Because V, A, and Z are known, the FAV can be calculated for any
selected value of the water quality characteristic.
VI. Final Chronic Value
A. Depending on the data that are available concerning chronic
toxicity to aquatic animals, the Final Chronic Value (FCV) can be
calculated in the same manner as the FAV or by dividing the FAV by
the Final Acute-Chronic Ratio (FACR). In some cases, it might not be
possible to calculate a FCV. The FCV is (a) a calculated estimate of
the concentration of a test material such that 95 percent of the
genera (with which acceptable chronic toxicity tests have been
conducted on the material) have higher GMCVs, or (b) the quotient of
an FAV divided by an appropriate ACR, or (c) the SMCV of an
important and/or critical species, if the SMCV is lower than the
calculated estimate or the quotient, whichever is applicable.
Note: As the name implies, the ACR is a way of relating acute
and chronic toxicities.
B. Chronic values shall be based on results of flow-through
(except renewal is acceptable for daphnids) chronic tests in which
the concentrations of test material in the test solutions were
properly measured at appropriate times during the test. A chronic
test is a comparative study in which organisms, that are subjected
to different treatments, are observed for a long period or a
substantial portion of their life span.
C. Results of chronic tests in which survival, growth, or
reproduction in the control treatment was unacceptably low shall not
be used. The limits of acceptability will depend on the species.
D. Results of chronic tests conducted in unusual dilution water,
e.g., dilution water in which total organic carbon or particulate
matter exceeded five mg/L, should not be used, unless a relationship
is developed between chronic toxicity and organic carbon or
particulate matter, or unless data show that organic carbon,
particulate matter, etc., do not affect toxicity.
E. Chronic values must be based on endpoints and lengths of
exposure appropriate to the species. Therefore, only results of the
following kinds of chronic toxicity tests shall be used:
1. Life-cycle toxicity tests consisting of exposures of each of
two or more groups of individuals of a species to a different
concentration of the test material throughout a life cycle. To
ensure that all life stages and life processes are exposed, tests
with fish should begin with embryos or newly hatched young less than
48 hours old, continue through maturation and reproduction, and
should end not less than 24 days (90 days for salmonids) after the
hatching of the next generation. Tests with daphnids should begin
with young less than 24 hours old and last for not less than 21
days, and for ceriodaphnids not less than seven days. For good
examples of acceptable procedures see American Society for Testing
and Materials (ASTM) Standard E 1193 Guide for conducting renewal
life-cycle toxicity tests with Daphnia magna and ASTM Standard E
1295 Guide for conducting three-brood, renewal toxicity tests with
Ceriodaphnia dubia. Tests with mysids should begin with young less
than 24 hours old and continue until seven days past the median time
of first brood release in the controls. For fish, data should be
obtained and analyzed on survival and growth of adults and young,
maturation of males and females, eggs spawned per female, embryo
viability (salmonids only), and hatchability. For daphnids, data
should be obtained and analyzed on survival and young per female.
For mysids, data should be obtained and analyzed on survival,
growth, and young per female.
2. Partial life-cycle toxicity tests consist of exposures of
each of two more groups of individuals of a species of fish to a
different concentration of the test material through most portions
of a life cycle. Partial life-cycle tests are allowed with fish
species that require more than a year to reach sexual maturity, so
that all major life stages can be exposed to the test material in
less than 15 months. A life-cycle test is a comparative study in
which organisms, that are subjected to different treatments, are
observed at least from a life stage in one generation to the same
life-stage in the next generation. Exposure to the test material
should begin with immature juveniles at least two months prior to
active gonad development, continue through maturation and
reproduction, and end not less than 24 days (90 days for salmonids)
after the hatching of the next generation. Data should be obtained
and analyzed on survival and growth of adults and young, maturation
of males and females, eggs spawned per female, embryo viability
(salmonids only), and hatchability.
3. Early life-stage toxicity tests consisting of 28- to 32-day
(60 days post hatch for salmonids) exposures of the early life
stages of a species of fish from shortly after fertilization through
embryonic, larval, and early juvenile development. Data should be
obtained and analyzed on survival and growth.
Note: Results of an early life-stage test are used as
predictions of results of life-cycle and partial life-cycle tests
with the same species. Therefore, when results of a 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:
a. In an acceptable chronic test;
b. Which did cause an unacceptable amount of adverse effect on
one or more of the specified biological measurements; and,
c. Above which all tested concentrations also caused such an
effect.
Note: Because various authors have used a variety of terms and
definitions to interpret and report results of chronic tests,
reported results should be reviewed carefully. The amount of effect
that is considered unacceptable is often based on a statistical
hypothesis test, but might also be defined in terms of a specified
percent reduction from the controls. A small percent reduction
(e.g., three percent) might be considered acceptable even if it is
statistically significantly different from the control, whereas a
large percent reduction (e.g., 30 percent) might be considered
unacceptable even if it is not statistically significant.
G. If the chronic toxicity of the material to aquatic animals
has been shown to be related [[Page 15398]] to a water quality
characteristic such as hardness or particulate matter for freshwater
animals, refer to section VII of this appendix.
H. If chronic values are available for species in eight families
as described in section III.B.1 of this appendix, a SMCV shall be
calculated for each species for which at least one chronic value is
available by calculating the geometric mean of the results of all
acceptable life-cycle and partial life-cycle toxicity tests with the
species; for a species of fish for which no such result is
available, the SMCV is the geometric mean of all acceptable early
life-stage tests. Appropriate GMCVs shall also be calculated. A GMCV
is the geometric mean of the SMCVs for the genus. The FCV shall be
obtained using the procedure described in sections IV.J through IV.O
of this appendix, substituting SMCV and GMCV for SMAV and GMAV
respectively. See section VI.M of this appendix.
Note: Section VI.I through VI.L are for use when chronic values
are not available for species in eight taxonomic families as
described in section III.B.1 of this appendix.
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=FAVFACR
If there is a Final Acute Equation rather than a FAV, see also
section V of this appendix.
M. If the SMCV of a commercially or recreationally important
species of the Great Lakes System is lower than the calculated FCV,
then that SMCV must be used as the FCV instead of the calculated
FCV.
N. See section VIII of this appendix.
VII. Final Chronic Equation
A. A Final Chronic Equation can be derived in two ways. The
procedure described in section VII.A of this appendix will result in
the chronic slope being the same as the acute slope. The procedure
described in sections VII.B through N of this appendix will usually
result in the chronic slope being different from the acute slope.
1. If ACRs are available for enough species at enough values of
the water quality characteristic to indicate that the ACR appears to
be the same for all species and appears to be independent of the
water quality characteristic, calculate the FACR as the geometric
mean of the available SMACRs.
2. Calculate the FCV at the selected value Z of the water
quality characteristic by dividing the FAV at Z (see section V.M of
this appendix) by the FACR.
3. Use V=pooled acute slope (see section V.M of this appendix),
and
L=pooled chronic slope.
4. See section VII.M of this appendix.
B. When enough data are available to show that chronic toxicity
to at least one species is related to a water quality
characteristic, the relationship should be taken into account as
described in sections C through G below or using analysis of
covariance. The two methods are equivalent and produce identical
results. The manual method described below provides an understanding
of this application of covariance analysis, but computerized
versions of covariance analysis are much more convenient for
analyzing large data sets. If two or more factors affect toxicity,
multiple regression analysis shall be used.
C. For each species for which comparable chronic toxicity values
are available at two or more different values of the water quality
characteristic, perform a least squares regression of the chronic
toxicity values on the corresponding values of the water quality
characteristic to obtain the slope and its 95 percent confidence
limits for each species.
Note: Because the best documented relationship is that between
hardness and acute toxicity of metals in fresh water and a log-log
relationship fits these data, geometric means and natural logarithms
of both toxicity and water quality are used in the rest of this
section. For relationships based on other water quality
characteristics, such as Ph, temperature, no transformation or a
different transformation might fit the data better, and appropriate
changes will be necessary throughout this section. It is probably
preferable, but not necessary, to use the same transformation that
was used with the acute values in section V of this appendix.
D. Decide whether the data for each species are relevant, taking
into account the range and number of the tested values of the water
quality characteristic and the degree of agreement within and
between species. For example, a slope based on six data points might
be of limited value if it is based only on data for a very narrow
range of values of the water quality characteristic. A slope based
on only two data points, however, might be more useful if it is
consistent with other information and if the two points cover a
broad range of the water quality characteristic. In addition,
chronic values that appear to be questionable in comparison with
other acute and chronic data available for the same species and for
other species in the same genus in most cases should not be used.
For example, if after adjustment for the water quality
characteristic, the chronic values available for a species or genus
differ by more than a factor of 10, rejection of some or all of the
values is, in most cases, absent countervailing circumstances,
appropriate. If a useful chronic slope is not available for at least
one species or if the available slopes are too dissimilar or if too
few data are available to adequately define the relationship between
chronic toxicity and the water quality characteristic, it might be
appropriate to assume that the chronic slope is the same as the
acute slope, which is equivalent to assuming that the ACR is
independent of the water quality characteristic. Alternatively,
return to section VI.H of this appendix, using the results of tests
conducted under conditions and in waters similar to those commonly
used for toxicity tests with the species.
E. Individually for each species, calculate the geometric mean
of the available chronic values and then divide each chronic value
for a species by the mean for the species. This normalizes the
chronic values so that the geometric mean of the normalized values
for each species individually, and for any combination of species,
is 1.0.
F. Similarly, normalize the values of the water quality
characteristic for each species individually.
G. Individually for each species, perform a least squares
regression of the normalized chronic toxicity values on the
corresponding normalized values of the water quality characteristic.
The resulting slopes and the 95 percent confidence limits will be
identical to those obtained in section VII.B of this appendix. Now,
however, if the data are actually plotted, the line of best fit for
each individual species will go through the point 1,1 in the center
of the graph.
H. Treat all of the normalized data as if they were all the same
species and perform a least squares regression of all of the
normalized chronic values on the corresponding normalized values of
the water quality characteristic to obtain the pooled chronic slope,
L, and its 95 percent confidence limits.
If all normalized data are actually plotted, the line of best
fit will go through the point 1,1 in the center of the
graph. [[Page 15399]]
I. For each species, calculate the geometric mean, M, of the
toxicity values and the geometric mean, P, of the values of the
water quality characteristic. (These are calculated in sections
VII.E and F of this appendix.)
J. For each species, calculate the logarithm, Q, of the SMCV at
a selected value, Z, of the water quality characteristic using the
equation:
Q=ln M--L(ln P-ln Z)
Note: Although it is not necessary, it is recommended that the
same value of the water quality characteristic be used here as was
used in section V of this appendix.
K. For each species, calculate a SMCV at Z using the equation:
SMCV=eQ
Note: Alternatively, the SMCV at Z can be obtained by skipping
section VII.J of this appendix, using the equations in sections
VII.J and K of this appendix to adjust each chronic value
individually to Z, and then calculating the geometric means of the
adjusted values for each species individually. This alternative
procedure allows an examination of the range of the adjusted chronic
values for each species.
L. Obtain the FCV at Z by using the procedure described in
sections IV.J through O of this appendix.
M. If the SMCV at Z of a commercially or recreationally
important species of the Great Lakes System is lower than the
calculated FCV at Z, then that SMCV shall be used as the FCV at Z
instead of the calculated FCV.
N. The Final Chronic Equation is written as:
FCV=e(L[ln(water quality characteristic)]+lnS-L[lnZ])
Where:
L=pooled chronic slope and S = FCV at Z.
Because L, S, and Z are known, the FCV can be calculated for any
selected value of the water quality characteristic.
VIII. Final Plant Value
A. A Final Plant Value (FPV) is the lowest plant value that was
obtained with an important aquatic plant species in an acceptable
toxicity test for which the concentrations of the test material were
measured and the adverse effect was biologically important.
Appropriate measures of the toxicity of the material to aquatic
plants are used to compare the relative sensitivities of aquatic
plants and animals. Although procedures for conducting and
interpreting the results of toxicity tests with plants are not well-
developed, results of tests with plants usually indicate that
criteria which adequately protect aquatic animals and their uses
will, in most cases, also protect aquatic plants and their uses.
B. A plant value is the result of a 96-hour test conducted with
an alga or a chronic test conducted with an aquatic vascular plant.
Note: A test of the toxicity of a metal to a plant shall not be
used if the medium contained an excessive amount of a complexing
agent, such as EDTA, that might affect the toxicity of the metal.
Concentrations of EDTA above 200 g/L should be considered
excessive.
C. The FPV shall be obtained by selecting the lowest result from
a test with an important aquatic plant species in which the
concentrations of test material are measured and the endpoint is
biologically important.
IX. Other Data
Pertinent information that could not be used in earlier sections
might be available concerning adverse effects on aquatic organisms.
The most important of these are data on cumulative and delayed
toxicity, reduction in survival, growth, or reproduction, or any
other adverse effect that has been shown to be biologically
important. Delayed toxicity is an adverse effect to an organism that
results from, and occurs after the end of, its exposure to one or
more test materials. Especially important are data for species for
which no other data are available. Data from behavioral,
biochemical, physiological, microcosm, and field studies might also
be available. Data might be available from tests conducted in
unusual dilution water (see sections IV.D and VI.D of this
appendix), from chronic tests in which the concentrations were not
measured (see section VI.B of this appendix), from tests with
previously exposed organisms (see section II.F.3 of this appendix),
and from tests on formulated mixtures or emulsifiable concentrates
(see section II.D of this appendix). Such data might affect a
criterion if the data were obtained with an important species, the
test concentrations were measured, and the endpoint was biologically
important.
X. Criterion
A. A criterion consists of two concentrations: the CMC and the
Criterion Continuous Concentration (CCC).
B. The CMC is equal to one-half the FAV. The CMC is an estimate
of the highest concentration of a material in the water column to
which an aquatic community can be exposed briefly without resulting
in an unacceptable effect.
C. The CCC is equal to the lowest of the FCV or the FPV (if
available) unless other data (see section IX of this appendix) show
that a lower value should be used. The CCC is an estimate of the
highest concentration of a material in the water column to which an
aquatic community can be exposed indefinitely without resulting in
an unacceptable effect. If toxicity is related to a water quality
characteristic, the CCC is obtained from the Final Chronic Equation
or FPV (if available) that results in the lowest concentrations in
the usual range of the water quality characteristic, unless other
data (see section IX) show that a lower value should be used.
D. Round both the CMC and the CCC to two significant digits.
E. The criterion is stated as:
The procedures described in the Tier I methodology indicate
that, except possibly where a commercially or recreationally
important species is very sensitive, aquatic organisms should not be
affected unacceptably if the four-day average concentration of (1)
does not exceed (2) g/L more than once every three years on
the average and if the one-hour average concentration does not
exceed (3) g/L more than once every three years on the
average.
Where:
(1) = insert name of material
(2) = insert the CCC
(3) = insert the CMC
If the CMC averaging period of one hour or the CCC averaging
period of four days is inappropriate for the pollutant, or if the
once-in-three-year allowable excursion frequency is inappropriate
for the pollutant or for the sites to which a criterion is applied,
then the State may specify alternative averaging periods or
frequencies. The choice of an alternative averaging period or
frequency shall be justified by a scientifically defensible analysis
demonstrating that the alternative values will protect the aquatic
life uses of the water. Appropriate laboratory data and/or well-
designed field biological surveys shall be submitted to EPA as
justification for differing averaging periods and/or frequencies of
exceedance.
XI. Final Review
A. The derivation of the criterion should be carefully reviewed
by rechecking each step of the Guidance in this part. Items that
should be especially checked are:
1. If unpublished data are used, are they well documented?
2. Are all required data available?
3. Is the range of acute values for any species greater than a
factor of 10?
4. Is the range of SMAVs for any genus greater than a factor of
10?
5. Is there more than a factor of 10 difference between the four
lowest GMAVs?
6. Are any of the lowest GMAVs questionable?
7. Is the FAV reasonable in comparison with the SMAVs and GMAVs?
8. For any commercially or recreationally important species of
the Great Lakes System, is the geometric mean of the acute values
from flow-through tests in which the concentrations of test material
were measured lower than the FAV?
9. Are any of the chronic values used questionable?
10. Are any chronic values available for acutely sensitive
species?
11. Is the range of acute-chronic ratios greater than a factor
of 10?
12. Is the FCV reasonable in comparison with the available acute
and chronic data?
13. Is the measured or predicted chronic value for any
commercially or recreationally important species of the Great Lakes
System below the FCV?
14. Are any of the other data important?
15. Do any data look like they might be outliers?
16. Are there any deviations from the Guidance in this part? Are
they acceptable?
B. On the basis of all available pertinent laboratory and field
information, determine if the criterion is consistent with sound
scientific evidence. If it is not, another criterion, either higher
or lower, shall be derived consistent with the Guidance in this
part.
Methodology for Deriving Aquatic Life Values: Tier II [[Page 15400]]
XII. Secondary Acute Value
If all eight minimum data requirements for calculating an FAV
using Tier I are not met, a Secondary Acute Value (SAV) for the
waters of the Great Lakes System shall be calculated for a chemical
as follows:
To calculate a SAV, the lowest GMAV in the database is divided
by the Secondary Acute Factor (SAF) (Table A-1 of this appendix)
corresponding to the number of satisfied minimum data requirements
listed in the Tier I methodology (section III.B.1 of this appendix).
(Requirements for definitions, data collection and data review,
contained in sections I, II, and IV shall be applied to calculation
of a SAV.) If all eight minimum data requirements are satisfied, a
Tier I criterion calculation may be possible. In order to calculate
a SAV, the database must contain, at a minimum, a genus mean acute
value (GMAV) for one of the following three genera in the family
Daphnidae--Ceriodaphnia sp., Daphnia sp., or Simocephalus sp.
If appropriate, the SAV shall be made a function of a water
quality characteristic in a manner similar to that described in Tier
I.
XIII. Secondary Acute-Chronic Ratio
If three or more experimentally determined ACRs, meeting the
data collection and review requirements of Section VI of this
appendix, are available for the chemical, determine the FACR using
the procedure described in Section VI. If fewer than three
acceptable experimentally determined ACRs are available, use enough
assumed ACRs of 18 so that the total number of ACRs equals three.
Calculate the Secondary Acute-Chronic Ratio (SACR) as the geometric
mean of the three ACRs. Thus, if no experimentally determined ACRs
are available, the SACR is 18.
XIV. Secondary Chronic Value
Calculate the Secondary Chronic Value (SCV) using one of the
following:
[GRAPHIC][TIFF OMITTED]TR23MR95.099
If appropriate, the SCV will be made a function of a water
quality characteristic in a manner similar to that described in Tier
I.
XV. Commercially or Recreationally Important Species
If for a commercially or recreationally important species of the
Great Lakes System the geometric mean of the acute values or chronic
values from flow-through tests in which the concentrations of the
test materials were measured is lower than the calculated SAV or
SCV, then that geometric mean must be used as the SAV or SCV instead
of the calculated SAV or SCV.
XVI. Tier II Value
A. A Tier II value shall consist of two concentrations: the
Secondary Maximum Concentration (SMC) and the Secondary Continuous
Concentration (SCC).
B. The SMC is equal to one-half of the SAV.
C. The SCC is equal to the lowest of the SCV or the Final Plant
Value, if available, unless other data (see section IX of this
appendix) show that a lower value should be used.
If toxicity is related to a water quality characteristic, the
SCC is obtained from the Secondary Chronic Equation or FPV, if
available, that results in the lowest concentrations in the usual
range of the water quality characteristic, unless other data (See
section IX of this appendix) show that a lower value should be used.
D. Round both the SMC and the SCC to two significant digits.
E. The Tier II value is stated as:
The procedures described in the Tier II methodology indicate
that, except possibly where a locally important species is very
sensitive, aquatic organisms should not be affected unacceptably if
the four-day average concentration of (1) does not exceed (2)
g/L more than once every three years on the average and if
the one-hour average concentration does not exceed (3) g/L
more than once every three years on the average.
Where:
(1) = insert name of material
(2) = insert the SCC
(3) = insert the SMC
As discussed above, States and Tribes have the discretion to
specify alternative averaging periods or frequencies (see section
X.E. of this appendix).
XVII. Appropriate Modifications
On the basis of all available pertinent laboratory and field
information, determine if the Tier II value is consistent with sound
scientific evidence. If it is not, another value, either higher or
lower, shall be derived consistent with the Guidance in this part.
Table A-1.-- Secondary Acute Factors
------------------------------------------------------------------------
Adjustment
Number of minimum data requirements satisfied factor
------------------------------------------------------------------------
1........................................................... 21.9
2........................................................... 13.0
3........................................................... 8.0
4........................................................... 7.0
5........................................................... 6.1
6........................................................... 5.2
7........................................................... 4.3
------------------------------------------------------------------------
Appendix B to Part 132--Great Lakes Water Quality Initiative
Methodology for Deriving Bioaccumulation Factors
Great Lakes States and Tribes shall adopt provisions consistent
with (as protective as) this appendix.
I. Introduction
A. The purpose of this methodology is to describe procedures for
deriving bioaccumulation factors (BAFs) to be used in the
calculation of Great Lakes Water Quality Guidance (Guidance) human
health Tier I criteria and Tier II values and wildlife Tier I
criteria. A subset of the human health BAFs are also used to
identify the chemicals that are considered bioaccumulative chemicals
of concern (BCCs).
B. Bioaccumulation reflects uptake of a substance by aquatic
organisms exposed to the substance through all routes (i.e., ambient
water and food), as would occur in nature. Bioconcentration reflects
uptake of a substance by aquatic organisms exposed to the substance
only through the ambient water. Both BAFs and bioconcentration
factors (BCFs) are proportionality constants that describe the
relationship between the concentration of a substance in aquatic
organisms and its concentration in the ambient water. For the
Guidance in this part, BAFs, rather than BCFs, are used to calculate
Tier I criteria for human health and wildlife and Tier II values for
human health because they better account for the total exposure of
aquatic organisms to chemicals.
C. For organic chemicals, baseline BAFs can be derived using
four methods. Measured baseline BAFs are derived from field-measured
BAFs; predicted baseline BAFs are derived using biota-sediment
accumulation factors (BSAFs) or are derived by multiplying a
laboratory-measured or predicted BCF by a food-chain multiplier
(FCM). The lipid content of the aquatic organisms is used to account
for partitioning of organic chemicals within organisms so that data
from different [[Page 15401]] tissues and species can be integrated.
In addition, the baseline BAF is based on the concentration of
freely dissolved organic chemicals in the ambient water to
facilitate extrapolation from one water to another.
D. For inorganic chemicals, baseline BAFs can be derived using
two of the four methods. Baseline BAFs are derived using either
field-measured BAFs or by multiplying laboratory-measured BCFs by a
FCM. For inorganic chemicals, BAFs are assumed to equal BCFs (i.e.,
the FCM is 1.0), unless chemical-specific biomagnification data
support using a FCM other than 1.0.
E. Because both humans and wildlife consume fish from both
trophic levels 3 and 4, two baseline BAFs are needed to calculate
either a human health criterion or value or a wildlife criterion for
a chemical. When appropriate, ingestion through consumption of
invertebrates, plants, mammals, and birds in the diet of wildlife
species to be protected may be taken into account.
II. Definitions
Baseline BAF. For organic chemicals, a BAF that is based on the
concentration of freely dissolved chemical in the ambient water and
takes into account the partitioning of the chemical within the
organism; for inorganic chemicals, a BAF that is based on the wet
weight of the tissue.
Baseline BCF. For organic chemicals, a BCF that is based on the
concentration of freely dissolved chemical in the ambient water and
takes into account the partitioning of the chemical within the
organism; for inorganic chemicals, a BCF that is based on the wet
weight of the tissue.
Bioaccumulation. The net accumulation of a substance by an
organism as a result of uptake from all environmental sources.
Bioaccumulation factor (BAF). The ratio (in L/kg) of a
substance's concentration in tissue of an aquatic organism to its
concentration in the ambient water, in situations where both the
organism and its food are exposed to and the ratio does not change
substantially over time.
Bioconcentration. The net accumulation of a substance by an
aquatic organism as a result of uptake directly from the ambient
water through gill membranes or other external body surfaces.
Bioconcentration factor (BCF). The ratio (in L/kg) of a
substance's concentration in tissue of an aquatic organism to its
concentration in the ambient water, in situations where the organism
is exposed through the water only and the ratio does not change
substantially over time.
Biota-sediment accumulation factor (BSAF). The ratio (in kg of
organic carbon/kg of lipid) of a substance's lipid-normalized
concentration in tissue of an aquatic organism to its organic
carbon-normalized concentration in surface sediment, in situations
where the ratio does not change substantially over time, both the
organism and its food are exposed, and the surface sediment is
representative of average surface sediment in the vicinity of the
organism.
Depuration. The loss of a substance from an organism as a result
of any active or passive process.
Food-chain multiplier (FCM). The ratio of a BAF to an
appropriate BCF.
Octanol-water partition coefficient (KOW). The ration of
the concentration of a substance in the n-octanol phase to its
concentration in the aqueous phase in an equilibrated 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.
III. Review and Selection of Data
A. Data Sources. Measured BAFs, BSAFs and BCFs are assembled
from available sources including the following:
1. EPA Ambient Water Quality Criteria documents issued after
January 1, 1980.
2. Published scientific literature.
3. Reports issued by EPA or other reliable sources.
4. Unpublished data.
One useful source of references is the Aquatic Toxicity
Information Retrieval (AQUIRE) database.
B. Field-Measured BAFs. The following procedural and quality
assurance requirements shall be met for field-measured BAFs:
1. The field studies used shall be limited to those conducted in
the Great Lakes System with fish at or near the top of the aquatic
food chain (i.e., in trophic levels 3 and/or 4).
2. The trophic level of the fish species shall be determined.
3. The site of the field study should not be so unique that the
BAF cannot be extrapolated to other locations where the criteria and
values will apply.
4. For organic chemicals, the percent lipid shall be either
measured or reliably estimated for the tissue used in the
determination of the BAF.
5. The concentration of the chemical in the water shall be
measured in a way that can be related to particulate organic carbon
(POC) and/or dissolved organic carbon (DOC) and should be relatively
constant during the steady-state time period.
6. For organic chemicals with log Kow greater than four,
the concentrations of POC and DOC in the ambient water shall be
either measured or reliably estimated.
7. For inorganic and organic chemicals, BAFs shall be used only
if they are expressed on a wet weight basis; BAFs reported on a dry
weight basis cannot be converted to wet weight unless a conversion
factor is measured or reliably estimated for the tissue used in the
determination of the BAF.
C. Field-Measured BSAFs. The following procedural and quality
assurance requirements shall be met for field-measured BSAFs:
1. The field studies used shall be limited to those conducted in
the Great Lakes System with fish at or near the top of the aquatic
food chain (i.e., in trophic levels 3 and/or 4).
2. Samples of surface sediments (0-1 cm is ideal) shall be from
locations in which there is net deposition of fine sediment and is
representative of average surface sediment in the vicinity of the
organism.
3. The Kows used shall be acceptable quality as described
in section III.F below.
4. The site of the field study should not be so unique that the
resulting BAF cannot be extrapolated to other locations where the
criteria and values will apply.
5. The tropic level of the fish species shall be determined.
6. The percent lipid shall be either measured or reliably
estimated for the tissue used in the determination of the BAF.
D. Laboratory-Measured BCFs. The following procedural and
quality assurance requirements shall be met for 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 Kow greater than four,
the concentrations of POC and DOC in the test solution shall be
either measured or reliably estimated.
6. Laboratory-measured BCFs should be determined using fish
species, but BCFs determined with molluscs and other invertebrates
may be used with caution. For example, because invertebrates
metabolize some chemicals less efficiently than vertebrates, a
baseline BCF determined for such a chemical using invertebrates is
expected to be higher than a comparable baseline BCF determined
using fish.
7. If laboratory-measured BCFs increase or decrease as the
concentration of the chemical increases in the test solutions in a
bioconcentration test, the BCF measured at the lowest test
concentration that is above concentrations existing in the control
water shall be used (i.e., a BCF should be calculated from a control
treatment). The concentrations of an inorganic chemical in a
bioconcentration test should be greater than normal background
levels and greater than levels required for normal nutrition of the
test species if the chemical is a micronutrient, but below levels
that adversely affect the species. Bioaccummulation of an inorganic
chemical might be overestimated if concentrations are at or below
normal background levels due to, for example, nutritional
requirements of the test organisms.
8. For inorganic and organic chemicals, BCFs shall be used only
if they are expressed on a wet weight basis. BCFs reported on a dry
weight basis cannot be converted to wet weight unless a conversion
factor is measured or reliably estimated for the tissue used in the
determination of the BAF.
9. BCFs for organic chemicals may be based on measurement or
radioactivity only when the BCF is intended to include metabolites
or when there is confidence that there is no interference due to
metabolites.
10. The calculation of the BCF must appropriately address growth
dilution.
11. Other aspects of the methodology used should be similar to
those described by ASTM (1990). [[Page 15402]]
E. Predicted BCFs. The following procedural and quality
assurance requirements shall be met for predicted BCFs:
1. The Kow used shall be of acceptable quality as described
in section III.F below.
2. The predicted baseline BCF shall be calculated using the
equation: predicted baseline BCF = Kow
where:
Kow = octanol-water partition coefficient.
F. Octanol-Water Partition Coefficient (Kow). 1. The value
of Kow used for an organic chemical shall be determined by
giving priority to the experimental and computational techniques
used as follows:
Log Kow < 4:="" ------------------------------------------------------------------------="" priority="" technique="" ------------------------------------------------------------------------="" 1..................................="" slow-stir.="" 1..................................="" generator-column.="" 1..................................="" shake-flask.="" 2..................................="" reverse-phase="" liquid="" chromatography="" on="" c18="" chromatography="" packing="" with="" extrapolation="" to="" zero="" percent="" solvent.="" 3..................................="" reverse-phase="" liquid="" chromatography="" on="" c18="" chromatography="" packing="" without="" extrapolation="" to="" zero="" percent="" solvent.="" 4..................................="" calculated="" by="" the="" clogp="" program.="" ------------------------------------------------------------------------="" log="">ow > 4:
------------------------------------------------------------------------
Priority Technique
------------------------------------------------------------------------
1............ Slow Stir.
1............ Generator-column.
2............ Reverse-phase liquid chromatography on C18 chromatography
packing with extrapolation to zero percent solvent.
3............ Reverse-phase liquid chromatography on C18 chromatography
packing without extrapolation to zero percent solvent.
4............ Shake-flask.
5............ Calculated by the CLOGP program.
------------------------------------------------------------------------
2. The CLOGP program is a computer program available from Pomona
College. A value of Kow that seems to be different from the
others should be considered an outlier and not used. The value of
Kow used for an organic chemical shall be the geometric mean of
the available Kows with highest priority or can be calculated
from the arithmetic mean of the available log Kow with the
highest priority. Because it is an intermediate value in the
derivation of a BAF, the value used for the Kow of a chemical
should not be rounded to fewer than three significant digits and a
value for log Kow should not be rounded to fewer than three
significant digits after the decimal point.
G. This methodology provides overall guidance for the derivation
of BAFs, but it cannot cover all the decisions that must be made in
the review and selection of acceptable data. Professional judgment
is required throughout the process. A degree of uncertainty is
associated with the determination of any BAF, BSAF, BCF or Kow.
The amount of uncertainty in a baseline BAF depends on both the
quality of data available and the method used to derive the BAF.
H. Hereinafter in this methodology, the terms BAF, BSAF, BCF and
Kow refer to ones that are consistent with the procedural and
quality assurance requirements given above.
IV. Four Methods for Deriving Baseline BAFs
Baseline BAFs shall be derived using the following four methods,
which are listed from most preferred to least preferred:
A. A measured baseline BAF for an organic or inorganic chemical
derived from a field study of acceptable quality.
B. A predicted baseline BAF for an organic chemical derived
using field-measured BSAFs of acceptable quality.
C. A predicted baseline BAF for an organic or inorganic chemical
derived from a BCF measured in a laboratory study of acceptable
quality and a FCM.
D. A predicted baseline BAF for an organic chemical derived from
a Kow of acceptable quality and a FCM.
For comparative purposes, baseline BAFs should be derived for
each chemical by as many of the four methods as available data
allow.
V. Calculation of Baseline BAFs for Organic Chemicals
A. Lipid Normalization. 1. It is assumed that BAFs and BCFs for
organic chemicals can be extrapolated on the basis of percent lipid
from one tissue to another and from one aquatic species to another
in most cases.
2. Because BAFs and BCFs for organic chemicals are related to
the percent lipid, it does not make any difference whether the
tissue sample is whole body or edible portion, but both the BAF (or
BCF) and the percent lipid must be determined for the same tissue.
The percent lipid of the tissue should be measured during the BAF or
BCF study, but in some cases it can be reliably estimated from
measurements on tissue from other organisms. If percent lipid is not
reported for the test organisms in the original study, it may be
obtained from the author; or, in the case of a laboratory study,
lipid data for the same or a comparable laboratory population of
test organisms that were used in the original study may be used.
3. The lipid-normalized concentration, Cl, of a chemical in
tissue is defined using the following equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.100
Where:
CB=concentration of the organic chemical in the tissue of
aquatic biota (either whole organism or specified tissue)
(g/g).
fl=fraction of the tissue that is lipid.
B. Bioavailability. By definition, baseline BAFs and BCFs for
organic chemicals, whether measured or predicted are based on the
concentration of the chemical that is freely dissolved in the
ambient water in order to account for bioavailability. For the
purposes of this Guidance in this part, the relationship between the
total concentration of the chemical in the water (i.e., that which
is freely dissolved plus that which is sorbed to particulate organic
carbon or to dissolved organic carbon) to the freely dissolved
concentration of the chemical in the ambient water shall be
calculated using the following equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.101
Where:
Cfdw=freely dissolved concentration of the organic
chemical in the ambient water;
Ctw=total concentration of the organic chemical in the
ambient water;
ffd=fraction of the total chemical in the ambient water that is
freely dissolved.
The fraction of the total chemical in the ambient water that is
freely dissolved, ffd, shall be calculated using the following
equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.102
Where:
DOC=concentration of dissolved organic carbon, kg of dissolved
organic carbon/L of water.
KOW=octanol-water partition coefficient of the chemical.
POC=concentration of particulate organic carbon, kg of particulate
organic carbon/L of water.
C. Food-Chain Multiplier. In the absence of a field-measured BAF
or a predicted BAF derived from a BSAF, a FCM shall be used to
calculate the baseline BAF for trophic levels 3 and 4 from a
laboratory-measured or predicted BCF. For an organic chemical, the
FCM used shall be derived from Table B-1 using the chemical's log
KOW and linear interpolation. A FCM greater than 1.0 applies to
most organic chemicals with a log KOW of four or more. The
trophic level used shall take into account the age or size of the
fish species consumed by the human, avian or mammalian predator
because, for some species of fish, the young are in trophic level 3
whereas the adults are in trophic level 4.
D. Calculation of a Baseline BAF from a Field-Measured BAF. A
baseline BAF shall be calculated from a field-measured BAF of
acceptable quality using the following equation:
[[Page 15403]]
[GRAPHIC][TIFF OMITTED]TR23MR95.103
Where:
BAFtT=BAF based on total concentration in tissue and
water.
fl=fraction of the tissue that is lipid.
ffd=fraction of the total chemical that is freely dissolved in
the ambient water.
The trophic level to which the baseline BAF applies is the same as
the trophic level of the organisms used in the determination of the
field-measured BAF. For each trophic level, a species mean measured
baseline BAF shall be calculated as the geometric mean if more than
one measured baseline BAF is available for a given species. For each
trophic level, the geometric mean of the species mean measured
baseline BAFs shall be calculated. If a baseline BAF based on a
measured BAF is available for either trophic level 3 or 4, but not
both, a measured baseline BAF for the other trophic level shall be
calculated using the ratio of the FCMs that are obtained by linear
interpolation from Table B-1 for the chemical.
E. Calculation of a Baseline BAF from a Field-Measured BSAF. 1.
A baseline BAF for organic chemical ``i'' shall be calculated from a
field-measured BSAF of acceptable quality using the following
equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.105
Where:
(BSAF)i=BSAF for chemical ``i''.
(BSAF)r=BSAF for the reference chemical ``r''.
(KOW)i=octanol-water partition coefficient for chemical
``i''.
(KOW)r=octanol-water partition coefficient for the
reference chemical ``r''.
2. A BSAF shall be calculated using the following equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.106
Where:
Ct=the lipid-normalized concentration of the chemical in
tissue.
CSOC=the organic carbon-normalized concentration of the
chemical in sediment.
3. The organic carbon-normalized concentration of a chemical in
sediment, CSOC, shall be calculated using the following
equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.107
Where:
CS=concentration of chemical in sediment (g/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
BAFlfd and other chemicals ``n=i'' for which BSAFs are to
be determined.
5. The trophic level to which the baseline BAF applies is the
same as the trophic level of the organisms used in the determination
of the BSAF. For each trophic level, a species mean baseline BAF
shall be calculated as the geometric mean if more than one baseline
BAF is predicted from BSAFs for a given species. For each trophic
level, the geometric mean of the species mean baseline BAFs derived
using BSAFs shall be calculated.
6. If a baseline BAF based on a measured BSAF is available for
either trophic level 3 or 4, but not both, a baseline BAF for the
other trophic level shall be calculated using the ratio of the FCMs
that are obtained by linear interpolation from Table B-1 for the
chemical.
F. Calculation of a Baseline BAF from a Laboratory-Measured BCF.
A baseline BAF for trophic level 3 and a baseline BAF for trophic
level 4 shall be calculated from a laboratory-measured BCF of
acceptable quality and a FCM using the following equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.108
Where:
BCFtT=BCF based on total concentration in tissue and
water.
fl=fraction of the tissue that is lipid.
ffd=fraction of the total chemical in the test water that is
freely dissolved.
FCM=the food-chain multiplier obtained from Table B-1 by linear
interpolation for trophic level 3 or 4, as necessary.
For each trophic level, a species mean baseline BAF shall be
calculated as the geometric mean if more than one baseline BAF is
predicted from laboratory-measured BCFs for a given species. For
each trophic level, the geometric mean of the species mean baseline
BAFs based on 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 BCF)=(FCM) (KOW)
Where:
FCM=the food-chain multiplier obtained from Table B-1 by linear
interpolation for trophic level 3 or 4, as necessary.
KOW=octanol-water partition coefficient.
VI. Human Health and Wildlife BAFs for Organic Chemicals
A. To calculate human health and wildlife BAFs for an organic
chemical, the KOW of the [[Page 15404]] chemical shall be used
with a POC concentration of 0.00000004 kg/L and a DOC concentration
of 0.000002 kg/L to yield the fraction freely dissolved:
[GRAPHIC][TIFF OMITTED]TR23MR95.109
B. The human health BAFs for an organic chemical shall be
calculated using the following equations:
For trophic level 3:
[GRAPHIC][TIFF OMITTED]TR23MR95.110
For trophic level 4:
[GRAPHIC][TIFF OMITTED]TR23MR95.111
Where:
0.0182 and 0.0310 are the standardized fraction lipid values for
trophic levels 3 and 4, respectively, that are used to derive human
health criteria and values for the GLI.
C. The wildlife BAFs for an organic chemical shall be calculated
using the following equations:
For trophic level 3:
[GRAPHIC][TIFF OMITTED]TR23MR95.112
For trophic level 4:
[GRAPHIC][TIFF OMITTED]TR23MR95.113
Where:
0.0646 and 0.1031 are the standardized fraction lipid values for
trophic levels 3 and 4, respectively, that are used to derive
wildlife criteria for the GLI.
VII. Human Health and Wildlife BAFs for Inorganic Chemicals
A. For inorganic chemicals, the baseline BAFs for trophic levels
3 and 4 are both assumed to equal the BCF determined for the
chemical with fish, i.e., the FCM is assumed to be 1 for both
trophic levels 3 and 4. However, a FCM greater than 1 might be
applicable to some metals, such as mercury, if, for example, an
organometallic form of the metal biomagnifies.
B. BAFs for Human Health Criteria and Values.
1. Measured BAFs and BCFs used to determine human health BAFs
for inorganic chemicals shall be based on edible tissue (e.g.,
muscle) of freshwater fish unless it is demonstrated that whole-body
BAFs or BCFs are similar to edible-tissue BAFs or BCFs. BCFs and
BAFs based on measurements of aquatic plants and invertebrates
should not be used in the derivation of human health criteria and
values.
2. If one or more field-measured baseline BAFs for an inorganic
chemical are available from studies conducted in the Great Lakes
System with the muscle of fish:
a. For each trophic level, a species mean measured baseline BAF
shall be calculated as the geometric mean if more than one measured
BAF is available for a given species; and
b. For each trophic level, the geometric mean of the species
mean measured baseline BAFs shall be used as the human health BAF
for that chemical.
3. If an acceptable measured baseline BAF is not available for
an inorganic chemical and one or more acceptable edible-portion
laboratory-measured BCFs are available for the chemical, a predicted
baseline BAF shall be calculated by multiplying the geometric mean
of the BCFs times a FCM. The FCM will be 1.0 unless chemical-
specific biomagnification data support using a multiplier other than
1.0. The predicted baseline BAF shall be used as the human health
BAF for that chemical.
C. BAFs for Wildlife Criteria.
1. Measured BAFs and BCFs used to determine wildlife BAFs for
inorganic chemicals shall be based on whole-body freshwater fish and
invertebrate data unless it is demonstrated that edible-tissue BAFs
or BCFs are similar to whole-body BAFs or BCFs.
[[Page 15405]]
2. If one or more field-measured baseline BAFs for an inorganic
chemical are available from studies conducted in the Great Lakes
System with whole body of fish or invertebrates:
2. For each trophic level, a species mean measured baseline BAF
shall be calculated as the geometric mean if more than one measured
BAF is available for a given species.
b. For each trophic level, the geometric mean of the species
mean measured baseline BAFs shall be used as the wildlife BAF for
that chemical.
3. If an acceptable measured baseline BAF is not available for
an inorganic chemical and one or more acceptable whole-body
laboratory-measured BCFs are available for the chemical, a predicted
baseline BAF shall be calculated by multiplying the geometric mean
of the BCFs times a FCM. The FCM will be 1.0 unless chemical-
specific biomagnification data support using a multiplier other than
1.0. The predicted baseline BAF shall be used as the wildlife BAF
for that chemical.
VIII. Final Review
For both organic and inorganic chemicals, human health and
wildlife BAFs for both trophic levels shall be reviewed for
consistency with all available data concerning the bioaccumulation,
bioconcentration, and metabolism of the chemical. For example,
information concerning octanol-water partitioning, molecular size,
or other physicochemical properties that might enhance or inhibit
bioaccumulation should be considered for organic chemicals. BAFs
derived in accordance with this methodology should be modified if
changes are justified by available data.
IX. Literature Cited
ASTM. 1990. Standard Practice for Conducting Bioconcentration
Tests with Fishes and Saltwater Bivalve Molluscs. Standard E 1022.
American Society for Testing and Materials, Philadelphia, PA.
Table B-1.--Food-Chain Multipliers for Trophic Levels 2, 3 & 4
------------------------------------------------------------------------
Trophic Trophic\1\ Trophic
Log Kow level 2 level 3 level 4
------------------------------------------------------------------------
2.0.............................. 1.000 1.005 1.000
2.5.............................. 1.000 1.010 1.002
3.0.............................. 1.000 1.028 1.007
3.1.............................. 1.000 1.034 1.007
3.2.............................. 1.000 1.042 1.009
3.3.............................. 1.000 1.053 1.012
3.4.............................. 1.000 1.067 1.014
3.5.............................. 1.000 1.083 1.019
3.6.............................. 1.000 1.103 1.023
3.7.............................. 1.000 1.128 1.033
3.8.............................. 1.000 1.161 1.042
3.9.............................. 1.000 1.202 1.054
4.0.............................. 1.000 1.253 1.072
4.1.............................. 1.000 1.315 1.096
4.2.............................. 1.000 1.380 1.130
4.3.............................. 1.000 1.491 1.178
4.4.............................. 1.000 1.614 1.242
4.5.............................. 1.000 1.766 1.334
4.6.............................. 1.000 1.950 1.459
4.7.............................. 1.000 2.175 1.633
4.8.............................. 1.000 2.452 1.871
4.9.............................. 1.000 2.780 2.193
5.0.............................. 1.000 3.181 2.612
5.1.............................. 1.000 3.643 3.162
5.2.............................. 1.000 4.188 3.873
5.3.............................. 1.000 4.803 4.742
5.4.............................. 1.000 5.502 5.821
5.5.............................. 1.000 6.266 7.079
5.6.............................. 1.000 7.096 8.551
5.7.............................. 1.000 7.962 10.209
5.8.............................. 1.000 8.841 12.050
5.9.............................. 1.000 9.716 13.964
6.0.............................. 1.000 10.556 15.996
6.1.............................. 1.000 11.337 17.783
6.2.............................. 1.000 12.064 19.907
6.3.............................. 1.000 12.691 21.677
6.4.............................. 1.000 13.228 23.281
6.5.............................. 1.000 13.662 24.604
6.6.............................. 1.000 13.980 25.645
6.7.............................. 1.000 14.223 26.363
6.8.............................. 1.000 14.355 26.669
6.9.............................. 1.000 14.388 26.669
7.0.............................. 1.000 14.305 26.242
7.1.............................. 1.000 14.142 25.468
7.2.............................. 1.000 13.852 24.322
7.3.............................. 1.000 13.474 22.856
7.4.............................. 1.000 12.987 21.038
7.5.............................. 1.000 12.517 18.967
7.6.............................. 1.000 11.708 16.749
7.7.............................. 1.000 10.914 14.388
7.8.............................. 1.000 10.069 12.050
7.9.............................. 1.000 9.162 9.840
8.0.............................. 1.000 8.222 7.798
8.1.............................. 1.000 7.278 6.012
[[Page 15406]]
8.2.............................. 1.000 6.361 4.519
8.3.............................. 1.000 5.489 3.311
8.4.............................. 1.000 4.683 2.371
8.5.............................. 1.000 3.949 1.663
8.6.............................. 1.000 3.296 1.146
8.7.............................. 1.000 2.732 0.778
8.8.............................. 1.000 2.246 0.521
8.9.............................. 1.000 1.837 0.345
9.0.............................. 1.000 1.493 0.226
------------------------------------------------------------------------
\1\The FCMs for trophic level 3 are the geometric mean of the FCMs for
sculpin and alewife.
Appendix C to Part 132--Great Lakes Water Quality Initiative
Methodologies for Development of Human Health Criteria and Values
Great Lakes States and Tribes shall adopt provisions consistent
with (as protective as) this appendix.
I. Introduction
Great Lakes States and Tribes shall adopt provisions consistent
with this appendix C to ensure protection of human health.
A. Goal. The goal of the human health criteria for the Great
Lakes System is the protection of humans from unacceptable exposure
to toxicants via consumption of contaminated fish and drinking water
and from ingesting water as a result of participation in 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). The highest tested
dose or concentration of a substance which resulted in no observed
adverse effect in exposed test organisms where higher doses or
concentrations resulted in an adverse effect.
Quantitative structure activity relationship (OSAR) or structure
activity relationship (SAR). A mathematical relationship between a
property (activity) of a chemical and a number of descriptors of the
chemical. These descriptors are chemical or physical characteristics
obtained experimentally or predicted from the structure of the
chemical.
Relative source contribution (RSC). The factor (percentage) used
in calculating an HNV or HNC to account for all sources of exposure
to a contaminant. The RSC reflects the percent of total exposure
which can be attributed to surface water through water intake and
fish consumption.
Risk associated dose (RAD). A dose of a known or presumed
carcinogenic substance in (mg/kg/day) which, over a lifetime of
exposure, is estimated to be associated with a plausible upper bound
incremental cancer risk equal to one in 100,000.
Slope factor. Also known as q1*, slope factor is the
incremental rate of cancer development calculated through use of a
linearized multistage model or other appropriate model. It is
expressed in (mg/kg/day) of exposure to the chemical in question.
Threshold effect. An effect of a substance for which there is a
theoretical or empirically established dose or concentration below
which the effect does not occur.
Uncertainty factor (UF). One of several numeric factors used in
operationally deriving criteria from experimental data to account
for the quality or quantity of the available data.
C. Level of Protection. The criteria developed shall provide a
level of protection likely to be without appreciable risk of
carcinogenic and/or noncarcinogenic effects. Criteria are a function
of the level of designated risk or no adverse effect estimation,
selection of data and exposure assumptions. Ambient criteria for
single carcinogens shall not be set at a level representing a
lifetime upper-bound incremental risk greater than one in 100,000 of
developing cancer using the hazard assessment techniques and
exposure assumptions described herein. Criteria affording protection
from noncarcinogenic effects shall be established at levels that,
taking into account uncertainties, are considered likely to be
without an appreciable risk of adverse human health effects (i.e.,
acute, subchronic and chronic toxicity including reproductive and
developmental effects) during a lifetime of exposure, using the risk
assessment techniques and exposure assumptions described herein.
D. Two-tiered Classification. Chemical concentration levels in
surface water protective of human health shall be derived based on
either a Tier I or Tier II classification. The two Tiers are
primarily distinguished by the amount of toxicity data available for
deriving the concentration levels and the quantity and quality of
data on bioaccumulation.
II. Minimum Data Requirements
The best available toxicity data on the adverse health effects
of a chemical and the best data on bioaccumulation factors shall be
used when developing human health Tier I criteria or Tier II values.
The best available toxicity data shall include data from well-
[[Page 15407]] conducted epidemiologic and/or animal studies which
provide, in the case of carcinogens, an adequate weight of evidence
of potential human carcinogenicity and, in the case of
noncarcinogens, a dose-response relationship involving critical
effects biologically relevant to humans. Such information should be
obtained from the EPA Integrated Risk Information System (IRIS)
database, the scientific literature, and other informational
databases, studies and/or reports containing adverse health effects
data of adequate quality for use in this procedure. Strong
consideration shall be given to the most currently available
guidance provided by IRIS in deriving criteria or values,
supplemented with any recent data not incorporated into IRIS. When
deviations from IRIS are anticipated or considered necessary, it is
strongly recommended that such actions be communicated to the EPA
Reference Dose (RfD) and/or the Cancer Risk Assessment Verification
Endeavor (CRAVE) workgroup immediately. The best available
bioaccumulation data shall include data from field studies and well-
conducted laboratory studies.
A. Carcinogens. Tier I criteria and Tier II values shall be
derived using the methodologies described in section III.A of this
appendix when there is adequate evidence of potential human
carcinogenic effects for a chemical. It is strongly recommended that
the EPA classification system for chemical carcinogens, which is
described in the 1986 EPA Guidelines for Carcinogenic Risk
Assessment (U.S. EPA, 1986), or future modifications thereto, be
used in determining whether adequate evidence of potential
carcinogenic effects exists. Carcinogens are classified, depending
on the weight of evidence, as either human carcinogens, probable
human carcinogens, or possible human carcinogens. The human evidence
is considered inadequate and therefore the chemical cannot be
classified as a human carcinogen, if one of two conditions exists:
(a) there are few pertinent data, or (b) the available studies,
while showing evidence of association, do not exclude chance, bias,
or confounding and therefore a casual interpretation is not
credible. The animal evidence is considered inadequate, and
therefore the chemical cannot be classified as a probable or
possible human carcinogen, when, because of major qualitative or
quantitative limitations, the evidence cannot be interpreted as
showing either the presence or absence of a carcinogenic effect.
Chemicals are described as ``human carcinogens'' when there is
sufficient evidence from epidemiological studies to support a causal
association between exposure to the chemicals and cancer. Chemicals
described as ``probable human carcinogens'' include chemicals for
which the weight of evidence of human carcinogenicity based on
epidemiological studies is limited. Limited human evidence is that
which indicates that a causal interpretation is credible, but that
alternative explanations, such as chance, bias, or confounding,
cannot adequately be excluded. Probable human carcinogens are also
agents for which there is sufficient evidence from animal studies
and for which there is inadequate evidence or no data from
epidemiologic studies. Sufficient animal evidence is data which
indicates that there is an increased incidence of malignant tumors
or combined malignant and benign tumors: (a) in multiple species or
strains; (b) in multiple experiments (e.g., with different routes of
administration or using different dose levels); or (c) to an unusual
degree in a single experiment with regard to high incidence, unusual
site or type of tumor, or early age at onset. Additional evidence
may be provided by data on dose-response effects, as well as
information from short-term tests (such as mutagenicity/genotoxicity
tests which help determine whether the chemical interacts directly
with DNA) or on chemical structure, metabolism or mode of action.
``Possible human carcinogens'' are chemicals with limited
evidence of carcinogenicity in animals in the absence of human data.
Limited animal evidence is defined as data which suggests a
carcinogenic effect but are limited because: (a) The studies involve
a single species, strain, or experiment and do not meet criteria for
sufficient evidence (see preceding paragraph); or (b) the
experiments are restricted by inadequate dosage levels, inadequate
duration of exposure to the agent, inadequate period of follow-up,
poor survival, too few animals, or inadequate reporting; or (c) the
studies indicate an increase in the incidence of benign tumors only.
More specifically, this group can include a wide variety of
evidence, e.g., (a) a malignant tumor response in a single 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 I HCC shall generally include
human carcinogens, probable human carcinogens and can include, on a
case-by-case basis, possible human carcinogens if studies have been
well-conducted albeit based on limited evidence, when compared to
studies used in classifying human and probable human carcinogens.
The decision to use data on a possible human carcinogen for deriving
Tier I criteria shall be a case-by-case determination. In
determining whether to derive a Tier I HCC, additional evidence that
shall be considered includes but is not limited to available
information on mode of action, such as mutagenicity/genotoxicity
(determinations of whether the chemical interacts directly with
DNA), structure activity, and metabolism.
2. Tier II: Weight of evidence of possible human carcinogenic
effects sufficient to derive a Tier II human cancer value shall
include those possible human carcinogens for which there are at a
minimum, data sufficient for quantitative risk assessment, but for
which data are inadequate for Tier I criterion development due to a
tumor response of marginal statistical significance or inability to
derive a strong dose-response relationship. In determining whether
to derive Tier II human cancer values, additional evidence that
shall be considered includes but is not limited to available
information on mode of action such as mutagenicity/genotoxicity
(determinations of whether the chemical interacts directly with
DNA), structure activity and metabolism. As with the use of data on
possible human carcinogens in developing Tier I criteria, the
decision to use data on possible human carcinogens to derive Tier II
values shall be made on a case-by-case basis.
B. Noncarcinogens. All available toxicity data shall be
evaluated considering the full range of possible health effects of a
chemical, i.e., acute/subacute, chronic/subchronic and reproductive/
developmental effects, in order to best describe the dose-response
relationship of the chemical, and to calculate human noncancer
criteria and values which will protect against the most sensitive
endpoint(s) of toxicity. Although it is desirable to have an
extensive database which considers a wide range of possible adverse
effects, this type of data exists for a very limited number of
chemicals. For many others, there is a range in quality and quantity
of data available. To assure minimum reliability of criteria and
values, it is necessary to establish a minimum database with which
to develop Tier I criteria or Tier II values. The following
represent the minimum data sets necessary for this procedure.
1. Tier I: The minimum data set sufficient to derive a Tier I
human HNC shall include at least one well-conducted epidemiologic
study or animal study. A well-conducted epidemiologic study for a
Tier I HNC must quantify exposure level(s) and demonstrate positive
association between exposure to a chemical and adverse effect(s) in
humans. A well-conducted study in animals must demonstrate a dose
response relationship involving one or more critical effect(s)
biologically relevant to humans. (For example, study results from an
animal whose pharmacokinetics and toxicokinetics match those of a
human would be considered most biologically relevant.) Ideally, the
duration of a study should span multiple generations of exposed test
species or at least a major portion of the lifespan of one
generation. This type of data is currently very limited. By the use
of uncertainty adjustments, shorter term studies (such as 90-day
subchronic studies) with evaluation of more limited effect(s) may be
used to extrapolate to longer exposures or to account for a variety
of adverse effects. For Tier I criteria developed pursuant to this
procedure, such a limited study must be conducted for at least 90
days in rodents or 10 percent of the lifespan of other appropriate
test species and demonstrate a no observable adverse effect level
(NOAEL). Chronic studies of one year or longer in rodents or 50
percent of the lifespan or greater in other appropriate test species
that demonstrate a lowest observable adverse effect level (LOAEL)
may be sufficient for use in Tier I criterion derivation if the
effects observed at the LOAEL were relatively mild and reversible as
compared to [[Page 15408]] effects at higher doses. This does not
preclude the use of a LOAEL from a study (of chronic duration) with
only one or two doses if the effects observed appear minimal when
compared to effect levels observed at higher doses in other studies.
2. Tier II: When the minimum data for deriving Tier I criteria
are not available to meet the Tier I data requirements, a more
limited database may be considered for deriving Tier II values. As
with Tier I criteria, all available data shall be considered and
ideally should address a range of adverse health effects with
exposure over a substantial portion of the lifespan (or multiple
generations) of the test species. When such data are lacking it may
be necessary to rely on less extensive data in order to establish a
Tier II value. With the use of appropriate uncertainty factors to
account for a less extensive database, the minimum data sufficient
to derive a Tier II value shall include a NOAEL from at least one
well-conducted short-term repeated dose study. This study shall be
of at least 28 days duration, in animals demonstrating a 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.1
and II.B.1 of this appendix, a chemical must have the following
minimum bioaccumulation data. For all organic chemicals either: (a)
a field-measured BAF; (b) a BAF derived using the BSAF methodology;
or (c) a chemical with a BAF less than 125 regardless of how the BAF
was derived. For all inorganic chemicals, including organometals
such as mercury, either: (a) a field-measured BAF or (b) a
laboratory-measured BCF.
2. Tier II for Carcinogens and Noncarcinogens: A chemical is
considered a Tier II cancer or noncancer human health value if it
does not meet either the minimum toxicity data requirements of
sections II.A.1 and II.B.1 of this appendix or the minimum
bioaccumulation data requirements of section II.C.1 of this
appendix.
III. Principles for Development of Tier I Criteria or Tier II Values
The fundamental components of the procedure to calculate Tier I
criteria or Tier II values are the same. However, certain of the
aspects of the procedure designed to account for short-duration
studies or other limitations in data are more likely to be relevant
in deriving Tier II values than Tier I criteria.
A. Carcinogens.
1. A non-threshold mechanism of carcinogenesis shall be assumed
unless biological data adequately demonstrate the existence of a
threshold on a chemical-specific basis.
2. All appropriate human epidemiologic data and animal cancer
bioassay data shall be considered. Data specific to an
environmentally appropriate route of exposure shall be used. Oral
exposure should be used preferentially over dermal and inhalation
since, in most cases, the exposure routes of greatest concern are
fish consumption and drinking water/incidental ingestion. The risk
associated dose shall be set at a level corresponding to an
incremental cancer risk of one in 100,000. If acceptable human
epidemiologic data are available for a chemical, it shall be used to
derive the risk associated dose. If acceptable human epidemiologic
data are not available, the risk associated dose shall be derived
from available animal bioassay data. Data from a species that is
considered most biologically relevant to humans (i.e., responds most
like humans) is preferred where all other considerations regarding
quality of data are equal. In the absence of data to distinguish the
most relevant species, data from the most sensitive species tested,
i.e., the species showing a carcinogenic effect at the lowest
administered dose, shall generally be used.
3. When animal bioassay data are used and a non-threshold
mechanism of carcinogenicity is assumed, the data are fitted to a
linearized multistage computer model (e.g., Global '86 or equivalent
model). Global '86 is the linearized multistage model, derived by
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 be adjusted to give an average
daily dose over the study duration. Adjustments in the rate of tumor
response must be made for early mortality in test species. The
goodness-of-fit of the model to the data must also be assessed.
7. When a linear, non-threshold dose response relationship is
assumed, the RAD shall be calculated using the following equation:
[GRAPHIC][TIFF OMITTED]TR23MR95.114
Where:
RAD=risk associated dose in milligrams of toxicant per kilogram body
weight per day (mg/kg/day).
0.00001 (1 x 10-5)=incremental risk of developing cancer equal
to one in 100,000.
q1*=slope factor (mg/kg/day)-1.
8. If human epidemiologic data and/or other biological data
(animal) indicate that a chemical causes cancer via a threshold
mechanism, the risk associated dose may, on a case-by-case basis, be
calculated using a method which assumes a threshold mechanism is
operative.
B. Noncarcinogens.
1. Noncarcinogens shall generally be assumed to have a threshold
dose or concentration below which no adverse effects should be
observed. Therefore, the Tier I criterion or Tier II value is the
maximum water concentration of a substance at or below which a
lifetime exposure from drinking the water, consuming fish caught in
the water, and ingesting water as a result of participating in
water-related recreation activities is likely to be without
appreciable risk of deleterious effects.
For some noncarcinogens, there may not be a threshold dose below
which no adverse effects should be observed. Chemicals acting as
genotoxic teratogens and germline mutagens are thought to possibly
produce reproductive and/or developmental effects via a genetically
linked mechanism which may have no threshold. Other chemicals also
may not demonstrate a threshold. Criteria for these types of
chemicals will be established on a case-by-case basis using
appropriate assumptions reflecting the likelihood that no threshold
exists.
2. All appropriate human and animal toxicologic data shall be
reviewed and evaluated. To the maximum extent possible, data most
specific to the environmentally relevant route of exposure shall be
used. Oral exposure data should be used preferentially over dermal
and inhalation since, in most cases, the exposure routes of greatest
concern are fish consumption and drinking water/incidental
ingestion. When acceptable human data are not available (e.g., well-
conducted epidemiologic studies), animal data from species most
biologically relevant to humans shall be used. In the absence of
data to distinguish the most relevant species, data from the most
sensitive animal species tested, i.e., the species showing a toxic
effect at the lowest administered dose (given a relevant route of
exposure), should generally be used. [[Page 15409]]
3. Minimum data requirements are specified in section II.B of
this appendix. The experimental exposure level representing the
highest level tested at which no adverse effects were demonstrated
(NOAEL) from studies satisfying the provisions of section II.B of
this appendix shall be used for criteria calculations. In the
absence of a NOAEL, the LOAEL from studies satisfying the provisions
of section II.B of this appendix may be used if it is based on
relatively mild and reversible effects.
4. Uncertainty factors shall be used to account for the
uncertainties in predicting acceptable dose levels for the general
human population based upon experimental animal data or limited
human data.
a. An uncertainty factor of 10 shall generally be used when
extrapolating from valid experimental results from studies on
prolonged exposure to average healthy humans. This 10-fold factor is
used to protect sensitive members of the human population.
b. An uncertainty factor of 100 shall generally be used when
extrapolating from valid results of long-term studies on
experimental animals when results of studies of human exposure are
not available or are inadequate. In comparison to a, above, this
represents an additional 10-fold uncertainty factor in extrapolating
data from the average animal to the average human.
c. An uncertainty factor of up to 1000 shall generally be used
when extrapolating from animal studies for which the exposure
duration is less than chronic, but greater than subchronic (e.g., 90
days or more in length), or when other significant deficiencies in
study quality are present, and when useful long-term human data are
not available. In comparison to b, above, this represents an
additional UF of up to 10-fold for less than chronic, but greater
than subchronic, studies.
d. An UF of up to 3000 shall generally be used when
extrapolating from animal studies for which the exposure duration is
less than subchronic (e.g., 28 days). In comparison to b above, this
represents an additional UF of up to 30-fold for less than
subchronic studies (e.g., 28-day). The level of additional
uncertainty applied for less than chronic exposures depends on the
duration of the study used relative to the lifetime of the
experimental animal.
e. An additional UF of between one and ten may be used when
deriving a criterion from a LOAEL. This UF accounts for the lack of
an identifiable NOAEL. The level of additional uncertainty applied
may depend upon the severity and the incidence of the observed
adverse effect.
f. An additional UF of between one and ten may be applied when
there are limited effects data or incomplete sub-acute or chronic
toxicity data (e.g., reproductive/developmental data). The level of
quality and quantity of the experimental data available as well as
structure-activity relationships may be used to determine the factor
selected.
g. When deriving an UF in developing a Tier I criterion or Tier
II value, the total uncertainty, as calculated following the
guidance of sections 4.a through f, cited above, shall not exceed
10,000 for Tier I criteria and 30,000 for Tier II values.
5. All study results shall be converted, as necessary, to the
standard unit for acceptable daily exposure of milligrams of
toxicant per kilogram of body weight per day (mg/kg/day). Doses
shall be adjusted for continuous exposure (i.e., seven days/week, 24
hours/day, etc.).
C. Criteria and Value Derivation.
1. Standard Exposure Assumptions. The following represent the
standard exposure assumptions used to calculate Tier I criteria and
Tier II values for carcinogens and noncarcinogens. Higher levels of
exposure may be assumed by States and Tribes pursuant to Clean Water
Act (CWA) section 510, or where appropriate in deriving site-
specific criteria pursuant to procedure 1 in appendix F to part 132.
BW = body weight of an average human (BW = 70kg).
WCd = per capita water consumption (both drinking and
incidental exposure) for surface waters classified as public water
supplies = two liters/day.
--or--
WCr = per capita incidental daily water ingestion for
surface waters not used as human drinking water sources = 0.01
liters/day.
FC = per capita daily consumption of regionally caught
freshwater fish = 0.015kg/day (0.0036 kg/day for trophic level 3 and
0.0114 kg/day for trophic level 4).
BAF = bioaccumulation factor for trophic level 3 and trophic
level 4, as derived using the BAF methodology in appendix B to part
132.
2. Carcinogens. The Tier I human cancer criteria or Tier II
values shall be calculated as follows:
[GRAPHIC][TIFF OMITTED]TR23MR95.115
Where:
HCV=Human Cancer Value in milligrams per liter (mg/L).
RAD=Risk associated dose in milligrams toxicant per kilogram body
weight per day (mg/kg/day) that is associated with a lifetime
incremental cancer risk equal to one in 100,000.
BW=weight of an average human (BW=70 kg).
WCd=per capita water consumption (both drinking and incidental
exposure) for surface waters classified as public water supplies=two
liters/day.
or
WCr=per capita incidental daily water ingestion for surface
waters not used as human drinking water sources=0.01 liters/day.
FCTL3=mean consumption of trophic level 3 of regionally caught
freshwater fish=0.0036 kg/day.
FCTL4=mean consumption of trophic level 4 of regionally caught
freshwater fish=0.0114 kg/day.
BAFHHTL3=bioaccumulation factor for trophic level 3 fish,
as derived using the BAF methodology in appendix B to part 132.
BAFHHTL4=bioaccumulation factor for trophic level 4 fish,
as derived using the BAF methodology in appendix B to part 132.
3. Noncarcinogens. The Tier I human noncancer criteria or Tier
II values shall be calculated as follows:
[GRAPHIC][TIFF OMITTED]TR23MR95.116
Where:
HNV=Human noncancer value in milligrams per liter (mg/L).
ADE=Acceptable daily exposure in milligrams toxicant per kilogram
body weight per day (mg/kg/day).
RSC=Relative source contribution factor of 0.8. An RSC derived from
actual exposure data may be developed using the methodology outlined
by the 1980 National Guidelines (see 45 FR 79354).
BW=weight of an average human (BW=70 kg).
WCd=per capita water consumption (both drinking and incidental
exposure) for surface waters classified as public water supplies=two
liters/day.
or
WCr=per capita incidental daily water ingestion for surface
waters not used as human drinking water sources=0.01 liters/
day. [[Page 15410]]
FCTL3=mean consumption of trophic level 3 fish by regional
sport fishers of regionally caught freshwater fish=0.0036 kg/day.
FCTL4=mean consumption of trophic level 4 fish by regional
sport fishers of regionally caught freshwater fish=0.0114 kg/day.
BAFHHTL3=human health bioaccumulation factor for edible
portion of trophic level 3 fish, as derived using the BAF
methodology in appendix B to part 132.
BAFHHTL4=human health bioaccumulation factor for edible
portion of trophic level 4 fish, as derived using the BAF
methodology in appendix B to part 132.
IV. References
A. Howe, R.B., K.S. Crump and C. Van Landingham. 1986. Computer
Program to Extrapolate Quantitative Animal Toxicity Data to Low
Doses. Prepared for EPA under subcontract #2-251U-2745 to Research
Triangle Institute.
B. U.S. Environmental Protection Agency. 1980. Water Quality
Criteria Availability, Appendix C Guidelines and Methodology Used in
the Preparation of Health Effects Assessment Chapters of the Consent
Decree Water Quality Criteria Documents. Available from U.S.
Environmental Protection Agency, Office of Water Resource Center
(WH-550A), 401 M St., SW., Washington, DC 20460.
C. U.S. Environmental Protection Agency. 1986. Guidelines for
Carcinogen Risk Assessment. Available from U.S. Environmental
Protection Agency, Office of Water Resource Center (WH-550A), 401 M
St., SW., Washington, DC 20460.
Appendix D to Part 132--Great Lakes Water Quality Initiative
Methodology for the Development of Wildlife Criteria
Great Lakes States and Tribes shall adopt provisions consistent
with (as protective as) this appendix.
I. Introduction
A. A Great Lakes Water Quality Wildlife Criterion (GLWC) is the
concentration of a substance which is likely to, if not exceeded,
protect avian and mammalian wildlife populations inhabiting the
Great Lakes basin from adverse effects resulting from the ingestion
of water and aquatic prey taken from surface waters of the Great
Lakes System. These criteria are based on existing toxicological
studies of the substance of concern and quantitative information
about the exposure of wildlife species to the substance (i.e., food
and water consumption rates). Since toxicological and exposure data
for individual wildlife species are limited, a GLWC is derived using
a methodology similar to that used to derive noncancer human health
criteria (Barnes and Dourson, 1988; NAS, 1977; NAS, 1980; U.S. EPA,
1980). Separate avian and mammalian values are developed using
taxonomic class-specific toxicity data and exposure data for five
representative Great Lakes basin wildlife species. The wildlife
species selected are representative of avian and mammalian species
resident in the Great Lakes basin which are likely to experience the
highest exposures to bioaccumulative contaminants through the
aquatic food web; they are the bald eagle, herring gull, belted
kingfisher, mink, and river otter.
B. This appendix establishes a methodology which is required
when developing Tier I wildlife criteria for bioaccumulative
chemicals of concern (BCCs). The use of the equation provided in the
methodology is encouraged, but not required, for the development of
Tier I criteria or Tier II values for pollutants other than those
identified in Table 6-A for which Tier I criteria or Tier II values
are determined to be necessary for the protection of wildlife in the
Great Lakes basin. A discussion of the methodology for deriving Tier
II values can be found in the Great Lakes Water Quality Initiative
Technical Support Document for Wildlife Criteria (Wildlife TSD).
C. In the event that this methodology is used to develop
criteria for pollutants other than BCCs, or in the event that the
Tier II methodology described in the Wildlife TSD is used to derive
Tier II values, the methodology for deriving bioaccumulation factors
under appendix B to part 132 must be used in either derivation. For
chemicals which do not biomagnify to the extent of BCCs, it may be
appropriate to select different representative species which are
better examples of species with the highest exposures for the given
chemical. The equation presented in this methodology, however, is
still encouraged. In addition, procedure 1 of appendix F of this
part describes the procedures for calculating site-specific wildlife
criteria.
D. The term ``wildlife value'' (WV) is used to denote the value
for each representative species which results from using the
equation presented below, the value obtained from averaging species
values within a class, or any value derived from application of the
site-specific procedure provided in procedure 1 of appendix F of
this part. The WVs calculated for the representative species are
used to calculate taxonomic class-specific WVs. The WV is the
concentration of a substance which, if not exceeded, should better
protect the taxon in question.
E. ``Tier I wildlife criterion,'' or ``Tier I criterion'' is
used to denote the number derived from data meeting the Tier I
minimum database requirements, and which will be protective of the
two classes of wildlife. It is synonymous with the term ``GLWC,''
and the two are used interchangeably.
II. Calculation of Wildlife Values for Tier I Criteria
Table 4 of Part 132 and Table D-1 of this appendix contain
criteria calculated by EPA using the methodology provided below.
A. Equation for Avian and Mammalian Wildlife Values. Tier I
wildlife values for the pollutants designated BCCs pursuant to part
132 are to be calculated using the equation presented below.
[GRAPHIC][TIFF OMITTED]TR23MR95.117
Where:
WV=Wildlife Value in milligrams of substance per liter (mg/L).
TD=Test Dose (TD) in milligrams of substance per kilograms per day
(mg/kg-d) for the test species. This shall be either a NOAEL or a
LOAEL.
UFA=Uncertainty Factor (UF) for extrapolating toxicity data
across species (unitless). A species-specific UF shall be selected
and applied to each representative species, consistent with the
equation.
UFS=UF for extrapolating from subchronic to chronic exposures
(unitless).
UFL=UF for LOAEL to NOAEL extrapolations (unitless).
Wt=Average weight in kilograms (kg) for the representative species.
W=Average daily volume of water consumed in liters per day (L/d) by
the representative species.
FTLi=Average daily amount of food consumed from trophic level i
in kilograms per day (kg/d) by the representative species.
BAFWLTLi=Bioaccumulation factor (BAF) for wildlife food in
trophic level i in liters per kilogram (L/kg), developed using the
BAF methodology in appendix B to part 132, Methodology for
Development of Bioaccumulation Factors. For consumption of
piscivorous birds by other birds (e.g., herring gull by eagles), the
BAF is derived by multiplying the trophic level 3 BAF for fish by a
biomagnification factor to account for the biomagnification from
fish to the consumed birds.
B. Identification of Representative Species for Protection. For
bioaccumulative chemicals, piscivorous species are identified as the
focus of concern for wildlife criteria development in the Great
Lakes. An analysis of known or estimated exposure components for
avian and mammalian wildlife species is presented in the Wildlife
TSD. This analysis identifies three avian species (eagle, kingfisher
and herring gull) and two mammalian species (mink and otter) as
representative species for protection. The TD obtained from toxicity
data for each taxonomic class is used to calculate WVs for each of
the five representative species.
C. Calculation of Avian and Mammalian Wildlife Values and GLWC
Derivation. The avian WV is the geometric mean of the WVs calculated
for the three representative avian species. The mammalian WV is the
geometric mean of the WVs calculated for the two representative
mammalian species. The lower of the mammalian and avian WVs must be
selected as the GLWC.
III. Parameters of the Effect Component of the Wildlife Criteria
Methodology
A. Definitions. The following definitions provide additional
specificity and guidance in the evaluation of toxicity data and the
application of this methodology.
Acceptable endpoints. For the purpose of wildlife criteria
derivation, acceptable subchronic and chronic endpoints are those
which affect reproductive or developmental success, organismal
viability or growth, or any other endpoint which is, or is directly
related to, parameters that influence population dynamics.
[[Page 15411]]
Chronic effect. An adverse effect that is measured by assessing
an acceptable endpoint, and results from continual exposure over
several generations, or at least over a significant part of the test
species' projected life span or life stage.
Lowest-observed-adverse-effect-level (LOAEL). The lowest tested
dose or concentration of a substance which resulted in an observed
adverse effect in exposed test organisms when all higher doses or
concentrations resulted in the same or more severe effects.
No-observed-adverse-effect-level (NOAEL). The highest tested
dose or concentration of a substance which resulted in no observed
adverse effect in exposed test organisms where higher doses or
concentrations resulted in an adverse effect.
Subchronic effect. An adverse effect, measured by assessing an
acceptable endpoint, resulting from continual exposure for a period
of time less than that deemed necessary for a chronic test.
B. Minimum Toxicity Database for Tier I Criteria Development. A
TD value is required for criterion calculation. To derive a Tier I
criterion for wildlife, the data set shall provide enough data to
generate a subchronic or chronic dose-response curve for any given
substance for both mammalian and avian species. In reviewing the
toxicity data available which meet the minimum data requirements for
each taxonomic class, the following order of preference shall be
applied to select the appropriate TD to be used for calculation of
individual WVs. Data from peer-reviewed field studies of wildlife
species take precedence over other types of studies, where such
studies are of adequate quality. An acceptable field study must be
of subchronic or chronic duration, provide a defensible, chemical-
specific dose-response curve in which cause and effect are clearly
established, and assess acceptable endpoints as defined in this
document. When acceptable wildlife field studies are not available,
or determined to be of inadequate quality, the needed toxicity
information may come from peer-reviewed laboratory studies. When
laboratory studies are used, preference shall be given to laboratory
studies with wildlife species over traditional laboratory animals to
reduce uncertainties in making interspecies extrapolations. All
available laboratory data and field studies shall be reviewed to
corroborate the final GLWC, to assess the reasonableness of the
toxicity value used, and to assess the appropriateness of any UFs
which are applied. When evaluating the studies from which a test
dose is derived in general, the following requirements must be met:
1. The mammalian data must come from at least one well-conducted
study of 90 days or greater designed to observe subchronic or
chronic effects as defined in this document.
2. The avian data must come from at least one well-conducted
study of 70 days or greater designed to observe subchronic or
chronic effects as defined in this document.
3. In reviewing the studies from which a TD is derived for use
in calculating a WV, studies involving exposure routes other than
oral may be considered only when an equivalent oral daily dose can
be estimated and technically justified because the criteria
calculations are based on an oral route of exposure.
4. In assessing the studies which meet the minimum data
requirements, preference should be given to studies which assess
effects on developmental or reproductive endpoints because, in
general, these are more important endpoints in ensuring that a
population's productivity is maintained. The Wildlife TSD provides
additional discussion on the selection of an appropriate toxicity
study.
C. Selection of TD Data. In selecting data to be used in the
derivation of WVs, the evaluation of acceptable endpoints, as
defined in Section III.A of this appendix, will be the primary
selection criterion. All data not part of the selected subset may be
used to assess the reasonableness of the toxicity value and the
appropriateness of the Ufs which are applied.
1. If more than one TD value is available within a taxonomic
class, based on different endpoints of toxicity, that TD, which is
likely to reflect best potential impacts to wildlife populations
through resultant changes in mortality or fecundity rates, shall be
used for the calculation of WVs.
2. If more than one TD is available within a taxonomic class,
based on the same endpoint of toxicity, the TD from the most
sensitive species shall be used.
3. If more than one TD based on the same endpoint of toxicity is
available for a given species, the TD for that species shall be
calculated using the geometric mean of those TDs.
D. Exposure Assumptions in the Determination of the TD. 1. In
those cases in which a TD is available in units other than
milligrams of substance per kilograms per day (mg/kg/d), the
following procedures shall be used to convert the TD to the
appropriate units prior to calculating a WV.
2. If the TD is given in milligrams of toxicant per liter of
water consumed by the test animals (mg/L), the TD shall be
multiplied by the daily average volume of water consumed by the test
animals in liters per day (L/d) and divided by the average weight of
the test animals in kilograms (kg).
3. If the TD is given in milligrams of toxicant per kilogram of
food consumed by the test animals (mg/kg), the TD shall be
multiplied by the average amount of food in kilograms consumed daily
by the test animals (kg/d) and divided by the average weight of the
test animals in kilograms (kg).
E. Drinking and Feeding Rates. 1. When drinking and feeding
rates and body weight are needed to express the TD in milligrams of
substance per kilograms per day (mg/kg/d), they are obtained from
the study from which the TD was derived. If not already determined,
body weight, and drinking and feeding rates are to be converted to a
wet weight basis.
2. If the study does not provide the needed values, the values
shall be determined from appropriate scientific literature. For
studies done with domestic laboratory animals, either the Registry
of Toxic Effects of Chemical Substances (National Institute for
Occupational Safety and Health, the latest edition, Cincinnati, OH),
or Recommendations for and Documentation of Biological Values for
Use in Risk Assessment (U.S. EPA, 1988) should be consulted. When
these references do not contain exposure information for the species
used in a given study, either the allometric equations from Calder
and Braun (1983) and Nagy (1987), which are presented below, or the
exposure estimation methods presented in Chapter 4 of the Wildlife
Exposure Factors Handbook (U.S. EPA, 1993), should be applied to
approximate the needed feeding or drinking rates. Additional
discussion and recommendations are provided in the Wildlife TSD. The
choice of the methods described above is at the discretion of the
State or Tribe.
3. For mammalian species, the general allometric equations are:
a. F = 0.0687 x (Wt)0.82
Where:
F = Feeding rate of mammalian species in kilograms per day (kg/d)
dry weight.
Wt = Average weight in kilograms (kg) of the test animals.
b. W = 0.099 x (Wt)0.90
Where:
W = Drinking rate of mammalian species in liters per day (L/d).
Wt = Average weight in kilograms (kg) of the test animals.
4. For avian species, the general allometric equations are:
a. F = 0.0582 (Wt)0.65
Where:
F = Feeding rate of avian species in kilograms per day (kg/d) dry
weight.
Wt = Average weight in kilograms (kg) of the test animals.
b. W = 0.059 x (Wt)0.67
Where:
W = Drinking rate of avian species in liters per day (L/d).
Wt = Average weight in kilograms (kg) of the test animals.
F. LOAEL to NOAEL Extrapolations (UFL). In those cases in
which a NOAEL is unavailable as the TD and a LOAEL is available, the
LOAEL may be used to estimate the NOAEL. If used, the LOAEL shall be
divided by an UF to estimate a NOAEL for use in deriving WVs. The
value of the UF shall not be less than one and should not exceed 10,
depending on the dose-response curve and any other available data,
and is represented by UFL in the equation expressed in Section
II.A of this appendix. Guidance for selecting an appropriate
UFL, based on a review of available wildlife toxicity data, is
available in the Wildlife TSD.
G. Subchronic to Chronic Extrapolations (USS). In instances
where only subchronic data are available, the TD may be derived from
subchronic data. In such cases, the TD shall be divided by an UF to
extrapolate from subchronic to chronic levels. The value of the UF
shall not be less than one and should not exceed 10, and is
represented by UFS in the equation expressed in Section II.A of
this appendix. This factor is to be used when assessing highly
bioaccumulative substances where toxicokinetic considerations
suggest that a bioassay of limited length
[[Page 15412]] underestimates chronic effects. Guidance for
selecting an appropriate UFS, based on a review of available
wildlife toxicity data, is available in the Wildlife TSD.
H. Interspecies Extrapolations (UFA). 1. The selection of
the UFA shall be based on the available toxicological data and
on available data concerning the physicochemical, toxicokinetic, and
toxicodynamic properties of the substance in question and the amount
and quality of available data. This value is an UF that is intended
to account for differences in toxicological sensitivity among
species. Guidance for selecting an appropriate UFA, based on a
review of available wildlife toxicity data, is available in the
Wildlife TSD. Additional discussion of an interspecies UF located in
appendix A to the Great Lakes Water Quality Initiative Technical
Support Document for Human Health Criteria may be useful in
determining the appropriate value for UFA.
2. For the derivation of Tier I criteria, a UFA shall not
be less than one and should not exceed 100, and shall be applied to
each of the five representative species, based on existing data and
best professional judgment. The value of UFA may differ for
each of the representative species.
3. For Tier I wildlife criteria, the UF