[Federal Register Volume 64, Number 191 (Monday, October 4, 1999)]
[Proposed Rules]
[Pages 53632-53648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25436]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 132

[FRL-6447-4]
RIN 2040-AD32


Proposal To Amend the Final Water Quality Guidance for the Great 
Lakes System To Prohibit Mixing Zones for Bioaccumulative Chemicals of 
Concern

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is today proposing to amend the Final Water Quality 
Guidance for the Great Lakes System (Guidance)(40 CFR Part 132) to 
prohibit mixing zones for bioaccumulative chemicals of concern (BCCs) 
in the Great Lakes System, subject to a limited exception for existing 
discharges. For existing discharges, the regulation would prohibit 
mixing zones for BCCs starting 10 years after the publication date of 
the final BCC mixing zone rule. New discharges of BCCs would be subject 
to the mixing zone prohibition immediately upon commencing discharge. 
EPA had promulgated a mixing zone provision similar to this proposed 
regulation on March 23, 1995, as part of the Water Quality Guidance for 
the Great Lakes System required by section 118(c)(2) of the Clean Water 
Act. The provision was vacated by the U.S. Court of Appeals for the 
District of Columbia Circuit in the case of American Iron & Steel 
Institute v. EPA, 115 F.3d 979 (D.C. Cir. 1997), and was remanded to 
the Agency for further consideration. This proposed regulation

[[Page 53633]]

reflects EPA's reconsideration of the factual record in response to 
that remand.

DATES: EPA will accept public comments on the proposal until December 
3, 1999.

ADDRESSES: An original and 4 copies of all comments on the proposal 
should be addressed to Mary Willis Jackson, Water Quality Branch (WT-
15J), U.S. EPA Region 5, 77 West Jackson Blvd., Chicago, Illinois, 
60604. The public docket for this rulemaking, including the proposed 
rule, economic analysis and other supporting documents 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 Mary Willis Jackson (telephone 312-886-3717).

FOR FURTHER INFORMATION CONTACT: Mark L. Morris (4301), U.S. EPA, 401 M 
Street, SW, Washington, D.C. 20460 (202-260-0312).
SUPPLEMENTARY INFORMATION:

Potentially Affected Entities

    Entities potentially affected by today's action are those 
discharging or intending to discharge BCCs to waters of the United 
States in the Great Lakes System. Categories and entities that may 
ultimately be affected include:

------------------------------------------------------------------------
           Category            Examples of potentially affected entities
------------------------------------------------------------------------
Industry.....................  Industries discharging or intending to
                                discharge BCCs to waters in the Great
                                Lakes System as defined in 40 CFR 132.2.
Municipalities...............  Publicly owned treatment works
                                discharging or intending to discharge
                                BCCs to waters of the Great Lakes System
                                as defined in 40 CFR 132.2.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be affected by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be affected by this action. Other types of entities 
not listed in the table could also be affected. To determine whether 
your facility is affected by this action, you should carefully examine 
the definition of ``Great Lakes System'' in 40 CFR 132.2 and examine 
the preamble to 40 CFR Part 132, which describes the Part 132 
regulations. If you have any questions regarding the applicability of 
this action to a particular entity, consult the person listed in the 
preceding FOR FURTHER INFORMATION CONTACT section.

I. Legal Authority

    This regulation is being proposed under the authority of sections 
118, 301, 303, 402, and 501 of the Clean Water Act.

II. Background

    Section 118(c)(2) of the Clean Water Act (CWA), as amended by the 
Great Lakes Critical Programs Act of 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. On March 23, 1995, EPA published a final rule 
entitled ``Final Water Quality Guidance for the Great Lakes System'' in 
order to satisfy this requirement. See 60 FR 15366. The 1995 Guidance 
included ambient water quality criteria for 29 pollutants, including 
BCCs, that reflect the maximum ambient concentrations of those 
pollutants that could be present in waters of the Great Lakes Basin 
without impairing aquatic life, wildlife or human health. The 1995 
Guidance also included implementation procedures that Great Lakes 
States and Tribes are to use to prepare total maximum daily load (TMDL) 
analyses and to develop water quality-based effluent limits (WQBELs) 
for facilities discharging these pollutants. See 40 CFR Part 132. The 
Great Lakes States are the States of Illinois, Indiana, Michigan, 
Minnesota, Ohio, New York, Pennsylvania, and Wisconsin. The Great Lakes 
Tribes are those Tribes as defined in 40 CFR 132.2. Great Lakes Tribes 
consist of any Tribe within the Great Lakes Basin for which EPA has 
approved water quality standards under section 303 or that EPA has 
authorized to administer a National Pollutant Discharge Elimination 
System (NPDES) program under section 402 of the CWA.
    Among the implementation procedures in the 1995 Guidance was 
Procedure 3.C. in Appendix F. Under this procedure, NPDES permits would 
have been prohibited from including mixing zones in the calculation of 
water quality-based effluent limits for new discharges of BCCs after 
March 23, 1997, or for existing discharges of BCCs after March 23, 
2007. EPA also codified limited exceptions for existing discharges to 
account for water conservation and technical and economic 
considerations.
    Great Lakes States and Tribes were required to adopt regulations 
consistent with the criteria and implementation procedures specified in 
the 1995 Guidance by March 23, 1997, and to submit those regulations to 
EPA for approval or disapproval. See 40 CFR 132.5. In the event EPA 
disapproves a State's or Tribe's submission, EPA would promulgate 
criteria and implementation procedures as necessary to be consistent 
with the Guidance. See CWA section 118(c)(2)(C).
    After being promulgated, the Guidance was challenged in the U.S. 
Court of Appeals for the District of Columbia Circuit. On June 6, 1997, 
the Court issued a decision upholding virtually all of the provisions 
contained in the 1995 Guidance. American Iron and Steel Institute, et 
al. v. EPA (AISI), 115 F.3d 979 (D.C. Cir. 1997). However, the Court 
vacated the provisions of the Guidance that would eliminate mixing 
zones for BCCs. 115 F.3d at 985. The Court held that EPA had ``failed 
to address whether the measure is cost-justified,'' and remanded the 
provision to EPA for an opportunity to address this issue. 115 F.3d at 
997. On April 23, 1998, EPA published a notice amending the 1995 
Guidance to remove the BCC mixing zone provisions from 40 CFR Part 132. 
See 63 FR 20107 (April 23, 1998).

III. Discussion of the Proposed Regulations

A. Introduction

    Today EPA is proposing to amend 40 CFR Part 132, Appendix F, 
Procedure 3, to reinstate the mixing zone provisions for BCCs. As 
discussed in more detail below, EPA has determined that the proposed 
BCC mixing zone provisions at Procedure 3.C. are important for several 
reasons. First, phasing out existing mixing zones for BCCs and 
prohibiting new ones will ensure that the Guidance codified at 40 CFR 
Part 132 conforms, as required by statute, with the objectives and 
provisions of the international agreement between the United States and 
Canada to restore and maintain the environmental integrity of the Great 
Lakes Basin ecosystem. See CWA section 118(c)(2)(A). See also AISI, 115 
F.3d at 1001-02 (finding that the BCC mixing zone provisions conform to 
the Great Lakes Water Quality

[[Page 53634]]

Agreement). See also the Great Lakes Water Quality Agreement, Article 
IV(1)(f). Second, EPA has determined that because of their highly 
bioaccumulative nature BCCs present a significant potential risk to 
human health, aquatic life and wildlife in the Great Lakes System when 
discharged at levels above water quality criteria. The persistent and 
toxic nature of BCCs is amplified in the Great Lakes by the tendency of 
the Lakes to act as ``sinks'' for pollutants discharged to the Great 
Lakes Basin. Third, the effect of BCC contamination on salmonid sport 
fisheries and other uses is already documented in the Great Lakes. As a 
result, EPA has concluded that the benefits associated with the 
proposed BCC mixing zone provisions justify the costs that would be 
imposed upon regulated entities. EPA also recognizes, however, that 
some dischargers may suffer unreasonable economic effects if mixing 
zones for existing BCC discharges are not authorized. Therefore, EPA is 
proposing a limited exception that would allow minimal BCC mixing zones 
under these circumstances. (For a discussion of the potential costs and 
benefits of the proposed rule, see section V below.)
    A mixing zone is the area beyond a point source outfall in which 
ambient concentrations of a particular pollutant are allowed to exceed 
the otherwise applicable water quality criterion for that pollutant. In 
other words, when a discharger wishes to use the receiving water to 
dilute its polluted effluent, the mixing zone comprises the area of 
dispersal in the receiving water where the pollutants in the effluent 
are not yet sufficiently diluted to meet the applicable water quality 
criteria. Outside the mixing zone, the water quality criterion applies, 
and the discharger's permit limit must be calculated so that the 
criterion is met at the edge of the mixing zone. In the absence of a 
mixing zone, the discharger's permit limit would need to be calculated 
so that the applicable water quality criterion or criteria are met at 
the end of the discharger's pipe. In those situations, the discharger 
would be prohibited from using the receiving water to dilute its 
effluent, and instead would need to rely on wastewater treatment or 
pollution prevention measures to assure that its effluent meets the 
applicable water quality criteria. Because a mixing zone assumes that 
the applicable water quality criteria will be met at the edge or outer 
circumference of the mixing zone, it necessarily follows that a mixing 
zone is available only if the receiving water itself is achieving water 
quality standards for the pollutant(s) for which a mixing zone is 
sought, or if the receiving water will achieve water quality standards 
for the pollutant(s) through a TMDL. If the receiving water is 
impaired, e.g., if pollutants are already present or are expected to 
remain in the water column at levels that exceed the most stringent 
applicable water quality criterion for the particular pollutant, it 
follows that no mixing zone would be available for discharges of that 
pollutant (because there would be no ``clean'' water available for 
dilution).
    Thus, it is important to note that the proposed regulation 
prohibiting mixing zones for BCCs in the Great Lakes System would 
affect only those receiving waters: (1) That are achieving water 
quality standards for the BCC in question at the time of permit 
issuance; or (2) that are expected to achieve such standards within a 
reasonable time through the implementation of a TMDL under CWA section 
303(d). As noted above, if water quality standards are not being met in 
the receiving water for the BCC in question, or are not expected to be 
met, then no mixing zone would be available for the pollutant 
irrespective of this proposed rule. See discussion in the Supplemental 
Information Document for the Guidance at pages 338-358 about 
permissible approaches for establishing permit limits for discharges to 
non-attained waters, including setting limits at criteria end-of-pipe.
    Although the decision whether to authorize a mixing zone in a 
particular receiving water or for particular pollutants customarily is 
committed to the States' discretion, EPA has determined for 
environmental and public policy reasons that all Great Lakes States and 
Tribes should implement a consistent approach. The proposed regulations 
therefore describe minimum mixing zone requirements for the Great Lakes 
System. The Great Lakes States and Tribes would be required to adopt 
requirements consistent with (as protective as) any final mixing zone 
BCC procedure for waters within the Great Lakes System. See CWA section 
118(c)(2)(C). Under the authority reserved to them by CWA section 510, 
States and Tribes remain free to apply more stringent mixing zone 
requirements than these proposed regulations would establish.
    Five of the Great Lakes States (Illinois, Indiana, Minnesota, 
Michigan, and Wisconsin) already have adopted requirements to eliminate 
(for existing discharges, phase-out) mixing zones for BCCs that they 
submitted to EPA for approval as part of their original Part 132 
submissions. EPA has taken no action on those provisions because they 
are not presently subject to the adoption and submission requirements 
of 40 CFR 132.4(a) and 132.5(a). However, assuming that the five States 
retain those requirements and that they are as protective as the final 
rule, EPA would approve those prior submissions under the procedures 
set forth in 40 CFR 132.5(f).
    Any Great Lakes State or Tribe that has not adopted BCC mixing zone 
provisions as protective as those ultimately adopted by EPA (e.g., New 
York, Ohio, and Pennsylvania) would need to adopt such provisions and 
submit them to EPA for approval or disapproval pursuant to 40 CFR 132.5 
within eighteen months after publication in the Federal Register of the 
final BCC mixing zone rule. If a Great Lakes State or Tribe fails to do 
so or if EPA disapproves the submission, EPA, after giving the State or 
Tribe an opportunity to make any necessary changes, would publish a 
final rule six months later identifying the BCC mixing zone provisions 
that would apply to waters and discharges within that jurisdiction. See 
40 CFR 132.5(d) and (f). EPA believes that the 18 months time frame for 
State adoption and submission is reasonable because it accommodates the 
legislative or rulemaking processes that the Great Lakes States and 
Tribes may need to undertake in order to adopt provisions consistent 
with the final rule. It also allows EPA six months following the 
submission by the Great Lakes State or Tribe to approve the submission 
or, in the event of a disapproval, to promulgate its own requirements 
within the two-year period specified by 33 U.S.C. 118(c)(2)(C). In 
today's action, EPA proposes to amend 40 CFR 132.5(a) and (c) to apply 
these procedures to the proposed reinstatement of the BCC mixing zone 
rule.

B. Components of the Today's Proposed Regulation

    Procedure 3.C., as proposed by EPA today, would impose the 
following limitations on the availability of mixing zones for 
discharges of BCCs to the Great Lakes System. (The Great Lakes System 
is defined at 40 CFR 132.2.) EPA's regulations applicable to the Great 
Lakes System define a BCC, in essence, as any chemical that (1) 
accumulates in aquatic organisms by a human health bioaccumulation 
factor greater than 1000 (after considering various specified factors), 
and (2) has the potential upon entering the surface waters to cause 
adverse effects, either by

[[Page 53635]]

itself or in the form of its toxic transformation product, as a result 
of that accumulation. See 40 CFR 132.2.
    First, the regulation would prohibit the establishment of mixing 
zones for new discharges of BCCs to the Great Lakes System. See 
Procedure 3.C.1. That prohibition would take effect as soon as EPA has 
approved the State's or Tribe's submission with respect to this 
prohibition or has published a notice identifying that prohibition as 
applying within the State's or Tribe's jurisdiction. The regulation 
would define a new discharge, for the purpose of Procedure 3.C., as (i) 
a ``discharge of pollutants'' (as defined in 40 CFR 122.2) to the Great 
Lakes System from a building, structure, facility, or installation, the 
construction of which commences after the date the prohibition in 
Procedure 3.C.1. takes effect in that State or Tribe; (ii) a new 
discharge from an existing Great Lakes discharger that commences after 
the date the prohibition in Procedure 3.C.1. takes effect in that State 
or Tribe; or (iii) an expanded discharge from an existing Great Lakes 
discharger that commences after the date the prohibition in Procedure 
3.C.1. takes effect in that State or Tribe, except for those expanded 
discharges resulting from changes in loadings of any BCC within the 
existing capacity and processes (e.g., normal operational variability, 
changes in intake water pollutants, increasing the production hours of 
the facility or adding additional shifts, or increasing the rate of 
production), and that are covered by the existing applicable control 
document. See Procedure 3.C.2. All other discharges of BCCs would be 
defined as existing discharges. Second, the regulation would prohibit 
the establishment of mixing zones for existing discharges of BCCs 10 
years after the publication date of the final BCC mixing zone rule, 
subject to two exceptions. See Procedure 3.C.4.
    The first exception, to promote water conservation, would allow 
States and Tribes to grant mixing zones for any existing discharge of 
BCCs 10 years after the publication date of the final BCC mixing zone 
rule where it can be demonstrated, on a case-by-case basis, that 
failure to grant a mixing zone would preclude water conservation 
measures that would lead to overall load reductions in BCCs, even 
though higher concentrations of BCCs occur in the effluent. See 
Procedure 3.C.5. The water conservation exception would not be 
available to new discharges of BCCs because point sources responsible 
for those discharges can more readily design and engineer new unit 
operations and processes within the facility that will maintain BCC 
discharges at levels at or below the applicable water quality criteria, 
while also conserving water.
    The second exception is intended to accommodate technical and 
economic considerations. Under this exception, a facility with an 
existing discharge of BCCs could qualify for a mixing zone for one or 
more BCCs 10 years after the publication date of the final BCC mixing 
zone rule if the State or Tribe determines that the discharger is 
complying with all applicable CWA requirements for the BCC in question 
and is reducing to the maximum extent possible the loading of the BCC 
for which the mixing zone is sought. See Procedure 3.C.6.a. (This 
exception is described in more detail in section III.B.2. below.) The 
purpose of this exception is to ensure that the BCC mixing zone phase-
out does not result in unjustified economic impacts in situations where 
the phase-out may be technically and economically infeasible. However, 
this exception is intended to apply only in limited circumstances.
    Any mixing zones authorized under proposed Procedure 3.C. for 
existing discharges--whether established during the phase-out period 
prior to the date 10 years from publication date of the final BCC 
mixing zone rule or after that date pursuant to one of the exceptions 
identified above--would need to be consistent with 40 CFR Part 132, 
Appendix F, Procedures 3.D. and 3.E. See Procedure 3.C.7. Those 
provisions were promulgated as part of the Guidance in 1995 and are 
currently in effect for the Great Lakes System. For a discussion of 
those provisions, see the Supplemental Information Document at 273-288. 
See also AISI v. EPA, 115 F.2d at 997-998 (upholding their validity).
    Today's proposed amendments to Part 132 are similar to the rule EPA 
promulgated in March 1995 except that the phase-out of mixing zones for 
BCCs would occur 10 years after the publication date of the new rule 
rather than on March 23, 2007, as originally promulgated. In addition, 
EPA has reorganized and revised some of the language in Procedure 3.C. 
of the proposal to improve clarity, reduce repetitiveness with other 
Part 132 requirements, and ease implementation.
1. Exception for Water Conservation
    The proposed amendments to 40 CFR Part 132 would authorize an 
exception to the mixing zone phase-out for BCCs for existing discharges 
from a facility implementing water conservation measures. EPA 
recognizes that, as a result of water conservation measures, 
concentrations of a BCC in an effluent may increase slightly, while the 
mass of the BCC being discharged does not. EPA concludes that because 
water conservation is desirable, an exception may be appropriate in 
certain circumstances. The primary concern for BCCs is the mass of the 
pollutant entering the nearshore waters of the Great Lakes System. This 
exception would authorize a mixing zone only when the associated water 
conservation measures will lead to overall reductions in loadings of 
BCCs. In addition, EPA continues to be concerned about any allowable 
increases in concentration above criteria and is also proposing to 
restrict mixing zones under the water conservation provision to those 
allowed for non-BCCs (i.e., a 10:1 dilution ratio for lakes and 25 
percent of design flow for tributaries). See 40 CFR Part 132, Appendix 
F, Procedure 3.D. and 3.E. This proposed mixing zone exception is 
virtually identical to the provision promulgated in 1995.
2. Exception for Technical and Economic Considerations
    Under the proposed exception for technical and economic 
considerations, a Great Lakes State or Tribe could authorize a mixing 
zone for existing discharges of BCCs 10 years after the publication 
date of the final BCC mixing zone rule, but only under the limited 
circumstances specified below. The State or Tribal permitting authority 
would be required to make two affirmative findings: (1) The discharger 
is complying with all applicable requirements of Clean Water Act 
sections 118, 301, 302, 303, 304, 306, 307, 401, and 402, including 
existing NPDES water-quality based effluent limitations, for the BCC 
for which a mixing zone is requested; and (2) the discharger has 
reduced and will continue to reduce to the maximum extent possible its 
discharge of the BCC for which a mixing zone is requested. See 
Procedure 3.C.6.a.
    The proposed regulation provides that, in making a finding that a 
discharger has reduced the discharge of BCCs for which the mixing zone 
is sought to the maximum extent possible, the State or Tribe would need 
to consider the feasibility and cost-effectiveness of additional 
controls or pollution prevention measures that are available to the 
facility for reducing and, if possible, ultimately eliminating the BCC 
in question. See Procedure 3.C.6.a(ii). Relevant treatment or pollution 
prevention strategies would include strategies applicable to the 
facility's upstream sources, if appropriate (e.g., a municipality's 
industrial users). After evaluating feasible BCC reduction strategies

[[Page 53636]]

available to the discharger, the State or Tribe would need to document 
for the record why the implementation of some or all of them could not 
reasonably be expected to eliminate the discharger's need for a BCC 
mixing zone. By proposing to require the reduction of the BCC 
discharges to the maximum extent possible, EPA thus intends to ensure 
that the exception is available only to dischargers that are doing 
their best to reduce the level at which that biaccumulative toxic 
chemical enters the Great Lakes.
    When determining whether the discharger is reducing the BCC in 
question to the maximum extent possible, the State or Tribe would also 
need to consider whether the discharger, or affected community or 
communities, will suffer unreasonable economic effects if the mixing 
zone is eliminated. See Procedure 3.C.6.a(ii). In evaluating economic 
impacts, EPA would expect the State or Tribe to consider the costs of 
all pollution reduction options including available treatment 
technologies and control strategies beyond those already being 
implemented. Costs should reflect design and current operating flow. 
EPA would also expect the State or Tribe to evaluate information on the 
facility's current financial health including, where appropriate, 
existing municipal and pretreatment user charges and existing 
profitability. Also potentially relevant, where appropriate, would be 
information on the current profitability and overall financial health 
of the facility's parent corporation, where such information is 
available.
    Finally, in determining whether unreasonable economic effects would 
occur, EPA would also expect the State or Tribe to consider the 
potential effects on employment rates and tax revenues and, where 
appropriate, on user fees from increased costs associated with meeting 
water quality criteria in the absence of a mixing zone. The factors to 
be considered in assessing economic impacts would likely vary on a 
facility-by-facility basis. (See Interim Economic Guidance for Water 
Quality Standards--Workbook, March 1995, EPA-823-B-95-002.)
    As noted, a mixing zone for a BCC would be granted under the 
proposed exception only if the State or Tribe determines that the 
discharger is meeting all currently applicable CWA requirements for the 
BCC in question and is reducing its loadings of that BCC to maximum 
extent possible, based on a consideration of technical and economic 
factors. Therefore, under this proposal, an exception to the BCC mixing 
zone provision would not be granted if cost-effective pollution 
prevention and/or other control and treatment strategies exist that 
make it technically possible for the discharger to achieve the 
applicable water quality criteria at the point of discharge, and if the 
discharger, or affected community or communities, will not suffer 
unreasonable (i.e., severe) economic effects in implementing such 
strategies.
    EPA emphasizes that the proposed exception to the elimination of 
mixing zones for existing discharges of BCCs is intended to be granted 
only in exceptional circumstances. In addition, the proposed exception 
would authorize a BCC mixing zone that is very limited in scope. For 
example, as discussed in more detail below, the mixing zone would need 
to be designed so that it is no larger than necessary to account for 
the technical constraints and economic effects to which the discharger 
is subject. Finally, in no circumstances under the proposed regulation 
could the amount of allowed mixing exceed the maximum mixing zones 
specified for non-BCCs in sections D (discharges to Lakes) and E 
(discharges to tributaries) of 40 CFR Part 132, Appendix F, Procedure 
3. These provisions, which were upheld in AISI, 115 F.3d at 997-98, 
apply to all mixing zones in the Great Lakes System, regardless of the 
type of pollutant being discharged.
    If, under the proposed regulation, the State or Tribe decides to 
allow a mixing zone for existing discharges of BCCs 10 years after the 
publication date of the final BCC mixing zone rule, the mixing zone 
would be subject to the following conditions. First, no mixing zone for 
existing discharges of BCCs could result in limitations that are less 
stringent than those existing prior to the publication date of the 
final BCC mixing zone rule. See Procedure 3.C.6.b(i). Second, the 
permitting authority would need to calculate the mixing zone so that it 
is no larger than necessary to account for the technical constraints 
and economic effects that justified the mixing zone in the first place. 
See Procedure 3.C.6.b(ii).
    The first and second requirements are consistent with the United 
States' international agreement to virtually eliminate persistent toxic 
substances from the Great Lakes System and are intended to ensure that 
the discharger would indeed reduce its discharges of the BCC to the 
maximum extent possible before being allowed to use the receiving water 
for dilution. Thus, under these proposed requirements, if the State or 
Tribe determines that it would be technically and economically feasible 
for a facility to implement controls or pollution prevention strategies 
beyond those currently in force in order to reduce its discharge of the 
BCC in question, then the mixing zone would need to reflect reasonable 
estimates of the additional anticipated reductions.
    In other words, the BCC mixing zone would correspond not to what 
the facility actually is discharging, but rather to what it could 
discharge if it employed technically and economically feasible measures 
to reduce its BCC discharge to the maximum extent possible. Through 
this provision, EPA intends to encourage all dischargers seeking a BCC 
mixing zone to implement controls and pollution prevention strategies 
relevant to that BCC prior to seeking regulatory relief. Because 
dischargers would have ten years to employ additional controls and 
strategies in order to phase-out their dependence on mixing zones, EPA 
believes this would be a reasonable requirement. In the event that 
further reductions could be achieved (perhaps using technologies or 
measures identified through the permitting process), a discharger could 
still qualify for a mixing zone, but would be compelled to achieve 
those further reductions, as reflected in its new mixing zone.
    Third, any BCC mixing zone would need to ensure the attainment of 
applicable acute and chronic aquatic life, wildlife, and human health 
criteria and values within and at the edge of the mixing zone, 
respectively. In non-attained waters, any mixing zone granted for BCCs 
under the exception would need to be consistent with the TMDL or 
comparable assessment and remediation plan under Procedure 3.A. of 
Appendix F of the 1995 Guidance. See Procedure 3.C.6.b(iii).
    In addition, any permit authorizing a BCC mixing zone under this 
exception, when appropriate, would need to require the discharger to 
develop and implement an ambient monitoring plan. See Procedure 
3.C.6.b(iv). Monitoring data compiled by dischargers could be used to 
supplement State or Tribal monitoring data and provide additional 
information on the receiving water's assimilative capacity and on the 
extent of impacts, if any, associated with the mixing zones. Ambient 
monitoring data would be used, in attained waters, to ensure that the 
applicable water quality criterion for the BCC is attained at the edge 
of the mixing zone and, in non-attained waters, to ensure that the 
projected improvement in water quality under the TMDL or comparable 
assessment and remediation plan is occurring. Ambient monitoring data 
can also be used to provide the basis for future decisions on the 
granting of

[[Page 53637]]

mixing zones for BCCs, including any adjustments to the size of a 
future mixing zone (e.g., if data show that the receiving water did not 
assimilate the pollutant as quickly as originally believed). The State 
or Tribe is encouraged to seek additional information, as necessary, to 
determine whether a mixing zone for BCCs is warranted for an existing 
discharge.
    Fourth, the proposed regulation would limit the exception to the 
BCC mixing zone prohibition to one permit term. Mixing zones may not be 
granted thereafter unless the State or Tribe makes the necessary 
findings discussed above for each successive permit application in 
which a mixing zone for BCCs is sought. See Procedure 3.C.6.b(v).
    EPA expects that exceptions to the BCC mixing zone provision would 
be granted solely at the discretion of the State or Tribe on a case-by-
case basis. Because of the importance of controlling BCCs in the Great 
Lakes System, it is critical that the public have an opportunity to 
comment on discharge-specific exceptions to the general policy of 
prohibiting mixing zones for existing dischargers of BCCs. The proposed 
amendments to 40 CFR Part 132 would provide that each draft permit that 
includes a mixing zone for one or more BCCs after the phase-out period 
must specify, either in the fact sheet or in the statement of basis for 
the draft permit, the mixing zone provisions used in calculating the 
permit limits and must identify each BCC for which a mixing zone is 
proposed. See Procedure 3.C.6.c. The draft permit, including the fact 
sheet or statement of basis, must be publicly noticed and made 
available for public comment under 40 CFR 124.6(e). The proposed 
amendments to Part 132 would specify that any mixing zone for existing 
BCC discharges authorized under Procedure 3.C.3, 3.C.5, or 3.C.6 of 
Appendix F must also be consistent with Procedure 3.D. and 3.E. of 
Appendix F of Part 132. See Procedure 3.C.7.
    Under the proposed amendments to Part 132, the mixing zone 
prohibition would be limited to BCCs. BCCs are the pollutants of 
primary concern in the Great Lakes System. Documented widespread 
impacts warrant the special emphasis on controlling BCCs. See section I 
of the ``Final Water Quality Guidance for the Great Lakes System: 
Supplementary Information Document'' (SID) (EPA, March 1995, 820-B-95-
001), and the preamble to the ``Proposed Water Quality Guidance for the 
Great Lakes System'' (58 FR 20802, April 16, 1993). In addition, States 
already have the discretion under section 510 of the CWA to eliminate 
mixing zones for other persistent chemicals such as lead and cadmium.
    The proposed amendments to Part 132 would establish a 10-year 
phase-out period for existing discharges. However, this would begin 
after the publication date of the final BCC mixing zone rule. EPA 
believes that a longer period would not be reasonable to phase out BCC 
mixing zones for existing discharges because five of the eight Great 
Lakes States already have similar BCC mixing zone provisions in their 
State regulations and the remaining States have known since 1997 that 
EPA intended to reinstate this provision in Part 132 to ensure 
consistency with the United States' international agreement to 
virtually eliminate persistent toxic substances from the Great Lakes 
System. In addition, EPA has not chosen to reduce the phase-out period 
to less than 10 years (e.g., March 23, 2007, as promulgated in the 1995 
Guidance) because EPA believes that affected dischargers will probably 
need 10 years to come into compliance.

IV. Request for Public Comment on Exceptions for New Discharges of 
BCCs From Municipalities

    As discussed above, today's proposal would prohibit mixing zones 
for new discharges of BCCs to the Great Lakes System. EPA is requesting 
comment on providing a narrow exception for new discharges of BCCs from 
municipalities. Under Michigan's current regulations, a municipality 
could obtain a variance for a new discharge of BCCs when necessary to 
prevent a public health threat to the community. Michigan's variance 
procedure was adopted to address, for example, a situation where a 
community with failing septic systems had to be connected to a new POTW 
to avert a potential public health threat from failing septic tanks. 
Under EPA's proposed rule the State could not authorize a mixing zone 
for a new POTW discharge to accommodate BCCs contained in the 
community's wastewater even if it were not technically and economically 
feasible for the POTW to achieve its criteria-based WQBEL. EPA requests 
comment on whether it would be appropriate to allow a narrow exception 
for new discharges of BCCs from municipalities that commence for the 
purpose of averting a threat to public health. EPA also requests 
comment whether narrow exceptions for municipalities would be 
reasonable in other situations.

V. Economic Analysis

    As explained more fully below and in section VI.B., EPA's proposed 
rule would not itself establish any requirements directly applicable to 
regulated entities. The mixing zone provisions would not be enforceable 
against new or existing discharges until separate steps are taken by 
States and Tribes to adopt and implement them. Therefore, this proposed 
rule does not have an immediate effect on dischargers or the community. 
Until actions are taken to adopt and implement the final version of 
this rule, there will be no economic effect on any dischargers or the 
community.
    Even after BCC mixing zone provisions are adopted and implemented, 
EPA believes that they would not have a significant economic impact on 
a substantial number of dischargers because most BCCs are already 
banned from use and/or production or are severely restricted in use. 
Therefore, EPA does not expect BCCs that are banned or severely 
restricted to be present in discharger effluent above criteria levels. 
For the few remaining BCCs that may be contaminating effluent as a 
result of household products or products and chemicals used in 
production, municipalities and commercial and industrial users of those 
products should be able to substitute away from these products, rely on 
cleaner technologies that do not require their use or produce BCCs as a 
by-product, or engineer source controls to reduce releases of BCCs to 
acceptable levels. In addition, for existing discharges, there is some 
flexibility and discretion in how the proposed rule would be 
implemented by States and Tribes to account for technical and economic 
considerations. While EPA expects that implementation of today's rule 
would ultimately result in some new or revised permit conditions for 
existing dischargers, promulgation of this proposal would not impose 
any of these as yet unknown requirements on dischargers.
    Nonetheless, consistent with the intent of E.O. 12866, EPA has 
evaluated (within the limits of these uncertainties) the possible 
impacts that might ultimately result from this rulemaking. The 
following sections discuss this evaluation.

A. Need for the Regulation

    EPA has devoted considerable effort to identifying BCCs and 
developing the most appropriate criteria, methodologies, policies, and 
procedures to address them. The 1995 Guidance incorporated 
bioaccumulation factors (BAFs) in the derivation of criteria and values 
to protect human health and wildlife and to identify the BCCs.

[[Page 53638]]

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. Previous EPA guidelines for the 
derivation of human health water quality criteria used bioconcentration 
factors (BCFs), which measure only uptake from water. 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. Therefore, the Guidance included methods for deriving BAFs 
for non-polar organic chemicals and identified 22 BCCs by these 
methods.
    Today's proposed rule would prohibit mixing zones for BCCs and thus 
would require NPDES permit limitations to be set equal to water quality 
criteria for those pollutants. BCCs are not compatible with mixing 
zones because of their persistent and bioaccumulative nature. Thus, for 
BCCs, it is the mass of the pollutant that is problematic, not just the 
concentration; therefore, mixing zones are not appropriate because by 
definition they allow an increase in the mass discharged to the 
receiving waters.
    For pollutants that quickly degrade and do not bioaccumulate, 
limited mixing zones are often acceptable. However, for persistent and 
highly bioaccumulative pollutants, mixing zones create ``hot spots'' in 
the environment where bioaccumulation of toxic pollutants in fish and 
other aquatic organisms can significantly exceed safe levels for 
consumption by wildlife and humans. Therefore, this proposal reflects 
EPA's judgment that mixing zones for BCCs (even of the limited size 
authorized by 40 CFR Part 132 under certain conditions) should be 
prohibited absent exceptional circumstances.
    The Guidance currently allows a minimum 10:1 dilution ratio for 
lake discharges and 25 percent of the critical stream flow for 
tributary discharges in calculating mixing zones for all pollutants, 
including BCCs. Larger mixing zones are also allowed if a demonstration 
is performed. See 40 CFR Part 132, Appendix F, Procedure 3.D. and 3.E. 
Thus, with the currently allowable dilution, the mass of BCCs 
discharged from point sources to specific nearshore areas of the Great 
Lakes System could be reduced significantly, e.g., by a factor of 10 to 
100 in certain situations, if mixing zones for BCCs are prohibited.
    Virtually all species of Great Lakes fish use the nearshore waters 
for one or more critical life stages or functions. The nearshore waters 
are areas of permanent residence for some fishes, migratory pathways 
for anadromous fishes, and temporary feeding or nursery grounds for 
other species from the offshore waters. Fish species diversity and 
production in the nearshore waters are higher than in offshore waters; 
they are generally highest in the shallower, more enriched embayments 
with large tributary systems. Thus, because the food web that 
bioaccumulates BCCs is concentrated near shore where natural sinks 
exist in the Great Lakes Basin, the elimination of mixing zones for 
these pollutants will further reduce the probability of adverse 
effects. The potential problem with allowing mixing zones for BCCs is 
that the increased loading of these pollutants increases the 
probability of adverse effects. The goal of virtual elimination of 
these substances in the international agreement between the United 
States and Canada reflects these concerns.

B. Potential Benefits Associated With Prohibiting Mixing Zones for BCCs

    This proposal to prohibit mixing zones for BCCs targets the types 
of long-lasting pollutants that accumulate in the food web. The BCCs 
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. For humans and 
wildlife, the main route of exposure to BCCs is through the consumption 
of Great Lakes fish. Potential adverse effects to aquatic life, 
wildlife, and humans associated with exposure to BCCs are described 
below.
    In aquatic organisms, effects of BCCs range from death to 
impairment of reproduction, development, and growth (Sweeney et al., 
1993). Effects have been documented at all levels of biological 
response from changes in physiological function to recruitment and 
development of benthic communities (Beattie et al., 1996; Landrum et 
al., 1991; Sasson-Brickson and Burton, 1991). Examples of the types of 
observed effects include biochemical responses (e.g., decreased calcium 
and magnesium metabolism, depressed in serum calcium, elevated skeletal 
magnesium, reduced whole body lipid content, elevated muscle water 
content); liver abnormalities (e.g., enlarged livers or reduced liver 
weights); skeletal abnormalities (e.g., scoliosis and lordosis); 
reproductive toxicity (e.g., egg mortality, fry deformities, reduced 
fertilization success, reduced embryo survival, reproductive failure); 
and somatic (non-reproductive) mutations (Palace et al., 1996; Zabel 
and Peterson, 1996).
    In wildlife, birds exposed to BCCs have exhibited biochemical 
dysfunction and metabolic effects (e.g., abnormal serum chemistry, 
reduced levels of dopamine, zinc and calcium metabolism, reduced body 
temperature), behavioral/neurological disorders, and reproductive 
impairment (e.g., reduced numbers of eggs, abnormal courtship behavior, 
impaired nest building abilities, reduced eggshell thickness, delayed 
reproduction, reduced hatchability, reduced sperm concentration, 
chromosome abnormalities in embryos) (Elliott et al., 1996). Birth 
defects (e.g., cleft palate, heart defects), hepatic disorders and 
enlarged liver, and reproductive impairment and/or failure (e.g., high 
rate of kit death, increased stillbirths and abortions, altered 
menstrual cycles, lower birth rates) have been observed in small 
mammals.
    Low concentrations of BCCs in birds and mammals have adverse 
effects on growth and development, reproduction, behavior, motor 
coordination, vision, hearing, histology, and metabolism (Driver et 
al., 1991). Chronic effects on wildlife include changes in enzyme 
production, hormonal balance, calcium metabolism, changes in behavior 
and reproduction, eggshell thinning, embryo mortality, and decreased 
hatchling survival. Studies on Great Lakes double-crested cormorant 
hatchlings revealed significantly increased congenital abnormalities, 
decreased hatchability, and increased birth defects as a result of 
exposure to BCCs (Larson et al., 1996). Rats fed BCC-contaminated Great 
Lakes walleye, whitefish, and lake trout exhibited abnormal 
neurological/behavioral effects. Farm raised lake trout injected with a 
single BCC had increased oxidative stress and altered liver function 
(Palace et al., 1996).
    Potential adverse human health effects resulting from the 
consumption of fish containing BCCs include both the increased risk of 
cancer and the potential for systemic or noncancer risks such as kidney 
damage (U.S. EPA, 1997). Acute exposure can result in kidney damage, 
kidney failure, seizures, gastrointestinal damage, cardiovascular 
collapse, shock, and death (U.S. EPA, 1997). Chronic exposure can 
result in neurotoxicity, fetotoxicity, endocrine effects, hematological 
effects, reproductive dysfunction, sensory and

[[Page 53639]]

equilibrium disturbances, involuntary muscle activity, nausea, 
confusion, weakness, dizziness, headache, tremor, twitching, 
disorientation, convulsions, liver toxicity, diarrhea, sweating, 
wheezing, productive cough, pulmonary edema, paralysis, coma, 
psychosis, irritability, hyperactivity, aggressiveness, impairment of 
peripheral vision, blindness, slurred speech, disturbances in 
sensations, impairments of hearing, speech, and motor coordination, 
immunological, development, and reproductive impairment, and death 
(U.S. EPA, 1997). BCCs have been found to be mutagenic, genotoxic, and 
carcinogenic, causing liver and other types of cancer (U.S. EPA, 1997).
    Risks to pregnant women and children are of particular concern 
(U.S. EPA, 1997). BCCs can induce heritable chromosomal changes in 
women which could result in birth defects in their infants, cross the 
human placenta contributing to exposure of the fetus through placental 
transfer, and accumulate in body tissues persisting for long periods of 
time. Unfortunately, exposure prior to pregnancy can contribute to the 
overall maternal body burden and result in exposure of the developing 
individual. Maternal reproductive dysfunction associated with exposure 
to BCCs can result in decreased fertility, premature labor, spontaneous 
abortion, reproductive hormone disorders, increased stillbirths, lack 
of mammary function, reduced libido, and delayed estrus. Fetal exposure 
can result in fetotoxicity which includes birth defects such as low 
birth weight, small head circumference, skeletal anomalies, 
malformations such as scoliosis and cleft palates, respiratory 
distress, heart defects and cardiac dysfunction, cranio-facial 
abnormalities, delayed bone development, central nervous system 
disorders, cataracts, neurological/behavioral effects, kidney 
abnormalities, immune dysfunction, and liver disorders and damage.
    Children may be at greater risk than adults. BCCs can accumulate in 
human milk. As a result, lactation may provide a significant dietary 
source of BCCs in infants of mothers who have been exposed. Lactational 
exposure is of significant concern because of the rapid transfer of the 
chemical through breast milk. Risks to infants and children include 
central nervous system effects, mortality, low IQ scores, cataracts, 
congestive heart failure, skin disorders such as lesions, cancers such 
as neuroblastoma and acute leukemia, immune system dysfunction and 
immunosuppression, skeletal disorders such as osteoporosis, 
neurological/behavioral effects such as weakness, convulsions, abnormal 
behavior, seizures, learning disorders, and endocrinological disorders.
    However, quantifying and monetizing the potential benefits 
associated with the water quality improvements is a challenging 
exercise in the best of circumstances. For today's proposal, the 
speculative and site-specific nature of the potential impacts further 
complicate the task. Although EPA has evaluated the potential cost 
impact of eliminating mixing zones for BCCs under improved analytical 
detection methods assuming that all other conditions remain unchanged, 
it is not meaningful to make predictions of the host of site-specific 
factors that will influence the level of potential benefits in the 
future. These factors include the site-specific water quality 
conditions, the health of the aquatic and aquatic-dependent ecosystems, 
the baseline level of use of the Great Lakes water resources, the 
availability of substitute water resources, and the willingness-to-pay 
for improvements in the Great Lakes water resources by the user and 
non-user populations.
    However, because of the persistent and highly toxic nature of the 
pollutants regulated, EPA expects that the proposed rule will result in 
a range of benefits including human health risk reductions (for both 
cancer and noncancer risks) and ecologic values associated with 
improving the health of aquatic life and wildlife. In this respect, 
EPA's benefit analysis is unchanged from the analysis performed at the 
time EPA promulgated the 1995 Guidance. In evaluating that provision, 
the Court in the AISI case found that EPA ``appears adequately to have 
explained the environmental justification for its decision.'' AISI, 115 
F.3d at 997.

C. Potential Costs Associated With Today's Proposal To Prohibit Mixing 
Zones for BCCs

    In the AISI litigation, Petitioners pointed to a comment made in a 
public hearing on the 1995 Guidance by a municipal discharger that was 
concerned about spending $300,000 to remove less than a pound of 
mercury from its discharge. These Petitioners argued that even after 
employing adjustments for relative toxicity, EPA had not provided 
adequate justification for requiring dischargers to incur these 
extraordinary costs. The AISI Court agreed and remanded this portion of 
the 1995 Guidance to EPA to address whether the BCC mixing zone 
prohibition is cost-justified.
    EPA believes that this proposal to prohibit mixing zones for BCCs 
is justified even in view of the costs it could pose. As a preliminary 
matter, EPA notes that the costs associated with the proposed rule are 
highly speculative for a number of reasons. First, EPA assumes that 
this proposed rule would have no effect in waters where water quality 
standards are not being met for the BCC in question or are not expected 
to be met, because no mixing zone would be available for the pollutant 
irrespective of this proposed rule since no dilution (``clean'' water) 
would be available for mixing with the discharge. For those waters, 
this proposed rule would have no cost impact until the water attains 
water quality standards for BCCs or until a TMDL or comparable 
mechanism is established that will lead toward water quality standards 
attainment. EPA is unable to forecast at this time when and where those 
events might occur and, correspondingly, what point source discharges 
might be affected and to what degree. Second, irrespective of this 
proposal, some Great Lakes States already prohibit mixing zones for 
BCCs or have incorporated flexibility into their regulations to ensure 
that control of BCCs, such as mercury, do not result in extraordinary 
costs. Therefore, this proposed rule would have little or no effect in 
those States. Third, as noted above, the proposal contains a mechanism 
for existing discharges by which Great Lakes States can mitigate 
conditions of potential widespread social and economic hardship 
resulting from today's proposed rule. Thus, some potential costs may 
never materialize.
    Nonetheless, EPA evaluated potential cost impacts to the universe 
of point source facilities located in the Great Lakes Basin based on 
two conservative assumptions: (1) that, but for the proposal, all 
facilities would receive a mixing zone for BCCs; and (2) that few 
facilities would obtain an exception to the mixing zone prohibition 
contained in the proposed rule. In other words, EPA's cost analysis 
assumes that every facility discharging or planning to discharge BCCs 
to the Great Lakes System would need to reduce the BCCs in its effluent 
to levels corresponding to criteria end-of-pipe, regardless of current 
water quality conditions or State regulations. At the time EPA issued 
the Final Water Quality Guidance for the Great Lakes System in 1995, 
EPA had evaluated potential costs of all of its provisions, including 
the original provision to prohibit mixing zones for BCCs. EPA presented 
the findings of these analyses in the ``Assessment of

[[Page 53640]]

Compliance Costs Resulting from Implementation of the Final Great Lakes 
Water Quality Guidance'' (EPA, 1995,820-B-95-010). As part of this 
rulemaking, EPA has evaluated just the incremental impact of today's 
proposal to prohibit mixing zones for BCCs.
    For this proposed rule, EPA departed from its 1995 Guidance cost 
evaluation in two respects. First, EPA considered new effluent data 
that was not evaluated as part of the cost analysis for the 1995 
Guidance. Second, EPA changed the way it estimated the amount of 
pollutant loads that would need to be removed--and hence the costs 
incurred--under this proposal. With respect to the data, EPA evaluated 
the same sample of facilities used for evaluation of the 1995 Guidance. 
However, EPA subsequently collected additional data on pollutants in 
the effluent of nine publicly owned treatment works (POTWs) in the 
sample using ``high-resolution'' and ``super-clean'' methods for 
detecting pollutants. Thus, EPA supplemented the original data set with 
this data, which showed the infrequent presence and relatively low 
concentrations of BCCs in effluents using state-of-the-art analytical 
methods. This information is particularly significant because these 
methods are more sensitive than the analytical methods that dischargers 
are currently required to use, and thus provide a more accurate picture 
of effluent quality than most of EPA's discharger-generated data. Thus, 
for this proposal, EPA evaluated potential costs both with and without 
the new data.
    EPA's second departure from its 1995 Guidance analysis involved the 
methodology for estimating potential compliance costs associated with 
the BCC mixing zone provision. In 1995, EPA's sensitivity analysis for 
the BCC mixing zone provision was constrained by analytical method 
detection levels (MDLs) used for compliance purposes at that time and 
did not account for improvements in MDLs in the future. While this 
analysis accurately predicted the impact of the BCC mixing zone 
provision based on 1995 MDLs, it may have resulted in an underestimate 
of compliance costs associated with the BCC mixing zone provision if 
MDLs improved to criteria levels in the future and ``hidden'' loadings 
of BCCs are discovered and removed. For this proposal, EPA assumed that 
analytical detection methods would improve so that all BCCs can be 
quantified at the applicable water quality criteria level. This is 
significantly different than the evaluation performed in 1995 for the 
BCC mixing zone provision.
    Employing this assumption, EPA made a new estimate of the pollutant 
load that would need to be reduced if this proposed rule were 
promulgated, based on the difference between implementing the Guidance 
as presently codified at 40 CFR Part 132 (with no special BCC mixing 
zone provisions) and implementing the Guidance if amended by today's 
proposal (prohibiting mixing zones for BCCs). That is, the increment 
evaluated is just the impact of prohibiting BCC mixing zones and does 
not include the total cost of implementing the Guidance.
    Apart from these differences, EPA's method for establishing costs 
followed the methodology used for the 1995 Guidance and the sensitivity 
analysis for the future impact of detection levels. See ``Assessment of 
Compliance Costs Resulting from Implementation of the Final Great Lakes 
Water Quality Guidance'' (March 1995). For a sample of 50 facilities 
representing 588 major municipal and nonmunicipal dischargers, EPA 
calculated projected limits based on the 1995 Guidance and allowed 
mixing zones for BCCs (i.e., reflecting the requirements as currently 
codified at 40 CFR Part 132). This was the baseline. EPA then compared 
these limits to projected limits based on the 1995 Guidance as amended 
by today's proposed rule (i.e., prohibiting mixing zones for BCCs). In 
developing the limits associated with the proposed rule, EPA used the 
two sets of data described above. The comparison of the limits under 
the baseline and the proposed rule produced an incremental pollutant 
load reduction attributable to the proposed rule. EPA then determined 
the cost of reducing this pollutant load based on the estimated cost 
per pound of toxic pollutant removed (including BCCs) established for 
the 1995 Guidance.
    The cost per pound to remove toxic pollutants reflects EPA's higher 
cost estimate for the 1995 Guidance (updated to January 1999 dollars). 
As described in the ``Regulatory Impact Analysis of the Final Great 
Lakes Water Quality Guidance'' (March 1995), for EPA's higher cost 
estimate, capital and operation and maintenance (O&M) costs related to 
the installation of treatment technologies accounted for over 90 
percent of the total annual costs. Further, EPA assumed that the 
regulatory flexibility available to existing BCC discharges based on 
economic and technical considerations (as set forth in the 1995 
Guidance and, now, in this proposal), was used only under exceptional 
circumstances.
    Based on the pre-1995 data updated with new information from nine 
POTWs (Scenario 1), EPA estimates annual compliance costs to be 
approximately $12 million (January 1999 dollars) and BCC load 
reductions to be just over 225,000 toxic pound-equivalents per year. 
Pound-equivalents are calculated by multiplying pounds of each 
pollutant removed by the toxic weight (based on the toxicity of copper) 
for that pollutant. Under this scenario, POTWs and indirect dischargers 
to POTWs are expected to incur almost 92 percent of the total annual 
costs. Nonmunicipal facility categories account for the remaining 8 
percent of the total costs. Controls for 2,3,7,8-TCDD, mercury, 
lindane, and toxaphene account for nearly 97 percent of the estimated 
annual costs.
    Based exclusively on pre-1995 data (Scenario 2), EPA estimates the 
annual compliance costs to be approximately $35 million. This estimate 
is based on expected BCC load reductions of approximately 668,000 toxic 
pound-equivalents per year. Under this scenario, the majority of 
estimated costs are associated with POTWs and indirect dischargers to 
POTWs (accounting for just over 97 percent of the total annual costs). 
Nonmunicipal facility categories account for just under 3 percent of 
the total costs. Mercury, lindane, 2,3,7,8-TCDD, pentachlorobenzene, 
and toxaphene account for almost 80 percent of the estimated annual 
costs. In either scenario, mercury and 2,3,7,8-TCDD account for over 50 
percent of all costs.
    The costs and loadings reductions were lower for Scenario 1 than 
for Scenario 2 because Scenario 1 employed more recent effluent data 
(based on high-resolution/super-clean methods for detecting pollutants) 
for the nine sample POTWs that indicated the infrequent presence and 
relatively low concentrations of BCCs in effluents. EPA expects that 
Scenario 1 better approximates the estimated total annual costs and BCC 
load reductions attributable to this proposal because use and/or 
production of many BCCs are already banned (e.g., PCBs and DDT) or are 
severely restricted by regulation (e.g., dieldrin and toxaphene) and 
are not expected to be present in effluents above criteria levels.

D. Factors That May Result in Lower Cost Impacts

    As previously acknowledged in EPA's 1995 analyses of the BCC mixing 
zone provisions in the 1995 Guidance, estimating treatment costs for 
WQBELs below current minimum levels (MLs) of quantification, and most 
likely below MDLs, is inherently speculative. The ML is the level at 
which the analytical system or method gives recognizable

[[Page 53641]]

signals and an acceptable calibration point. In other words, it is the 
minimum level at which a pollutant's concentration in the effluent can 
be reliably quantified. The MDL, in turn, is the minimum level at which 
the pollutant can even be reliably detected (never mind quantified). 
This means that EPA cannot reliably quantify BCC loadings in effluents 
below the MLs for the BCCs in question or predict the effectiveness of 
control strategies needed to reduce them to achieve WQBELs based on 
criteria end-of-pipe. This makes it very difficult for EPA to provide a 
meaningful estimate of the economic impact of this proposed rule on new 
discharges (which would be subject to its prohibitions within two years 
of the publication date of the final rule). The same uncertainties 
interfere with cost estimates applicable to existing discharges, which 
under the proposal would have ten years from the publication date of 
the final rule to phase-out their BCC mixing zones. EPA expects that 
WQBELs for many BCCs will remain well below MLs and possibly MDLs even 
beyond the time the mixing zone phase-out is fully implemented for 
existing discharges of BCCs because criteria for many of these 
pollutants are still far below quantitation levels for the most 
advanced analytical methods currently being evaluated by the Agency. In 
any case, even if EPA were confident today that the relevant analytical 
methods would become more stringent in the next years, it is difficult 
for EPA to speculate today what the new MLs would be. Equally 
speculative would be EPA's assumptions regarding dischargers' treatment 
or pollution prevention response to any future changes in analytical 
methods, or the States' response to what additional controls would be 
considered technically and economically feasible. For these reasons, 
potential economic effects on dischargers in the Great Lakes Basin 
resulting from prohibiting mixing zones for BCCs are speculative.
    For some BCCs, notably mercury, the applicable analytical method 
used for compliance purposes has a minimum level that is lower than the 
WQBELs based on criteria end-of-pipe (i.e., the WQBEL that would be 
calculated if no mixing zone is available). Even in this situation, 
however, estimating costs associated with that projected WQBEL would be 
speculative using the new method, which was published by EPA in June of 
1999, 64 FR 30417 (June 8, 1999), because the method has not been in 
use long enough to demonstrate the effectiveness of pollution 
prevention/waste minimization control strategies, including source 
controls, or the effectiveness of existing or new and innovative 
treatment technologies that could be used to reduce mercury to levels 
needed to achieve WQBELs based on criteria end-of-pipe. In addition, as 
stated above and discussed in more detail below about Ohio's mercury 
variance, there is considerable uncertainty in how the technical and 
economic feasibility exception provision in today's proposal will be 
implemented by the Great Lakes States.
    Notwithstanding the speculative nature of potential future costs on 
BCC dischargers, however, there are several factors that could 
ultimately lower the potential cost impacts from today's proposed rule. 
Some of these factors are discussed below.
1. Lower BCC Levels Than Anticipated
    While developing the 1995 Guidance, EPA received numerous comments 
asserting that, because of the ubiquitous nature of BCCs in the 
environment, many BCCs will be detected above permitted limits and 
significantly above criteria in wastewater discharges as improvements 
to analytical methods are made.
    As a result, EPA attempted to determine the potential presence of 
BCCs in treated wastewater discharges to the Great Lakes Basin using 
the most sensitive, state-of-the-art analytical methods available to 
the Agency. Particularly, EPA performed limited sampling of treated 
wastewater discharges from the nine major POTWs that the Agency had 
randomly selected as its sample to estimate compliance costs for the 
Guidance. EPA concentrated its BCC sampling efforts on POTWs because 
although BCCs could potentially be present in non-POTW discharges, the 
presence and control of BCCs for non-POTWs are in most cases highly 
dependent upon the manufacturing processes and raw materials utilized 
by a facility. In contrast, EPA assumed BCCs to be more ubiquitous at 
major POTWs, which have less control of the potential sources of BCCs 
being discharged to their collection systems.
    As a result of the sampling effort, EPA found BCCs or suspected 
BCCs to be present only infrequently in POTW effluent (25 detected 
analytes or congener mixtures in 288 possible observations, 
approximately nine percent of all analytes and congener mixtures) and, 
in those samples, in relatively low concentrations (11 detected 
concentrations above criteria, less than four percent of all analytes 
and congener mixtures). Of the pollutants detected in EPA's sampling 
effort, mercury was detected at each of the POTWs (either as total 
mercury or in the methyl mercury form). The concentrations of mercury 
found in POTW effluents exceeded the most stringent Guidance criteria 
for mercury in only five of the nine POTWs. Other BCCs with Tier I 
criteria that were detected include lindane (found in seven of nine 
POTWs, none above the Guidance criteria), hexachlorobenzene (found in 
four out of nine POTWs, three of which were above the Guidance 
criteria), and dioxins (found in two out of nine POTWs, both above 
criteria expressed as a toxicity equivalent factor of 2,3,7,8-TCDD). 
Coplanar PCBs (treated as a mixture), a suspected BCC without a Tier I 
criterion, were found in one POTW above the expected Tier II value. 
Pentachlorobenzene, another BCC without Tier I criterion, was also 
detected in two of the nine POTWs at levels EPA expects to be below 
Tier II values established in accordance with Tier II procedures 
contained in the Guidance.
2. Availability of Lower Cost Control Options
    Commenters also expressed concern related to the controls that will 
be necessary to ensure compliance with associated WQBELs for BCCs once 
they are detected in wastewater discharges. EPA's estimates of the 
potential cost of today's proposed rule are based on the cost per 
pound-equivalent removed that was associated with EPA's higher cost 
estimate from its analysis of the 1995 Guidance. In 1995, EPA developed 
the high end estimate of potential compliance costs under the 
assumption that needed pollutant reductions would largely be met 
through installation of end-of-pipe treatment.
    However, EPA believes that a facility, when faced with the 
challenge to achieve compliance with WQBELs for BCCs after mixing zones 
are eliminated, will select the most cost-effective controls. The 
controls to be applied for a facility, and the effectiveness of those 
controls, will vary depending upon many factors including, for example, 
volume of discharge, type of manufacturing processes, raw materials, 
number and types of BCCs present in the discharge, etc. However, EPA 
believes that, prior to design and installation of a treatment system, 
a facility would evaluate whether lower-cost options, such as 
modernizing certain unit operations and processes within the facility 
or implementing other waste minimization or pollution prevention 
techniques, are feasible.

[[Page 53642]]

    For example, there are several documented instances in the Great 
Lakes Basin and elsewhere where the development and implementation of 
aggressive source control programs have resulted in the virtual 
elimination of pollutants, including BCCs. For example, the Western 
Lake Superior Sanitary District (WLSSD), which after evaluating the 
costs involved to meet more stringent WQBELs for mercury with end-of-
pipe treatment, concluded that pollution prevention techniques were the 
preferable control strategy. As a result, WLSSD published a Blueprint 
for Mercury Elimination, which is a guide designed to ``assist 
wastewater treatment plant staff with creating and implementing their 
own mercury reduction projects.'' As a result of the efforts of WLSSD, 
effluent mercury levels decreased significantly in the wastewater 
effluent.
    EPA understands that lower-cost alternatives may not be feasible or 
available for all facilities, and that some may require the 
installation of new or expanded treatment systems when mixing zones are 
eliminated for BCCs. Depending upon the circumstances of the 
discharger, the installation of these treatment systems could be 
expensive and not cost-effective. However, except for mercury which was 
discussed earlier, because criteria for many of the BCCs covered by the 
1995 Guidance and today's proposal are well below quantification levels 
(MLs), the actual quantity of BCC loads that would need to be removed 
from a wastestream would be unknown using current Part 136 analytical 
methods. As such, it is uncertain whether a facility would actually 
incur the capital costs associated with the construction of new or 
expanded treatment systems.
3. Availability of Regulatory Alternatives
    There are several regulatory alternatives that are available to 
dischargers of BCCs that could provide some relief in the event that 
EPA promulgates the proposed restrictions on BCC mixing zones.
    a. Variance from Water Quality Standards--The Guidance allows 
States and Tribes to provide existing Great Lakes dischargers relief 
from a water quality standard in the form of a variance to the 
standard. See 40 CFR Part 132, Appendix F, Procedure 2. Variances are 
available for BCCs. The variance, in effect, provides a substitute 
standard for the point source; water quality-based effluent limits 
would be based on that substitute standard. The intent of the variance 
provision is to: (1) Provide a mechanism by which permits can be 
written to meet a modified standard where compliance with the 
underlying water quality standard is demonstrated to be infeasible; (2) 
encourage States to maintain original standards as goals rather than to 
provide relief to point sources by removing uses; (3) identify 
conditions under which such variances may be granted; (4) identify the 
requirements for variance applications; and (5) ensure the highest 
level of water quality achievable while the variance is in effect.
    Variances may be available for certain dischargers where the intake 
water contains a ubiquitous pollutant that is found in almost all water 
bodies in a watershed at about the same concentration due to watershed-
wide contributions from nonpoint sources and where removing the 
pollutant would cause a substantial and widespread social and economic 
impact. The State or Tribe may renew the variance every 5 years, or at 
the time of permit reissuance, whichever is less, by recertifying the 
eligibility of the discharger. Procedure 2 of Appendix F of the 
Guidance identifies the terms and conditions that must be met if a 
State or Tribe wants to grant a variance.
    Traditionally, variances are chemical-specific and facility-
specific. For situations where a number of dischargers are located in 
the same watershed and the circumstances for granting a variance are 
the same, a State or Tribe may wish to process a multiple-source 
variance for a group of dischargers at one time. The State or Tribe 
would need to make a showing that all of the individual facilities in a 
group meet the terms and conditions described in Procedure 2. After the 
multiple source variance is approved for the initial group of 
facilities, additional facilities could be included in the multiple 
source variance, provided they met the terms and conditions of 
Procedure 2. As with individual variances, a multiple source variance 
would be subject to review and approval by EPA; however, individual 
agreements between the States or Tribes and their respective EPA 
Regional offices could be developed to streamline such review and 
approval.
    In addition to the specific requirements of Procedure 2, a State or 
Tribe must make a showing that each of the individual facilities in a 
specific group meets the criteria for granting a variance and must:
    1. Identify the facilities proposed for coverage under the 
variance;
    2. Identify the geographic area of the watershed impacted by the 
variance;
    3. Evaluate the geographic area for the existence of any endangered 
or threatened species listed under section 4 of the Endangered Species 
Act; and
    4. Recertify the eligibility of individual facilities at a minimum 
of every 5 years, or at the time of permit reissuance, whichever is 
less.
    New and recommencing dischargers are not eligible for variances. As 
with any variance granted under Procedure 2, dischargers must continue 
to implement all applicable technology-based treatment and pretreatment 
requirements of CWA sections 301, 302, 304, 306, 307, 401 and 402 and 
WQBELs not affected by the variance.
    b. Site-specific Criteria--Procedure 1 of Appendix F of the 1995 
Guidance provides for changing the criteria to account for site-
specific environmental conditions that affect the stringency of the 
criteria (e.g., toxicity to indigenous species). EPA recommends that 
States and Tribes develop site-specific modifications to human health, 
wildlife and aquatic life Tier I criteria or Tier II values to reflect 
local physical, chemical, biological and/or hydrological conditions, 
especially in situations where such modifications improve the cost-
effectiveness of treatment or other control alternatives. Further, 
site-specific modifications to criteria and values should take into 
consideration differences in species sensitivity; bioaccumulation 
factors (BAFs) including food chain multipliers; particulate organic 
carbon and dissolved organic carbon concentrations; fish lipid content; 
and fish consumption rate.
    An important component of a site-specific modification is the 
definition of the site to which the modification is applicable. A site 
may range from being a portion of a watershed to the entire part of the 
Great Lakes System under the jurisdiction of the State or Tribe 
proposing the modification. EPA encourages States and Tribes to work 
with permittees to modify criteria and values, where appropriate, on as 
large an area as practical to avoid duplication of effort and to 
conserve resources. However, EPA notes that it could be more cost-
effective to develop a site-specific criteria for a very small area as 
well.
    c. Exceptions to the BCC Mixing Zone Prohibitions for Existing 
Discharges--As described earlier in section III.B. of this preamble, 
today's proposed rule would provide for limited exceptions for existing 
discharges of BCCs to the Great Lakes System. First, today's proposed 
rule would allow an exception with respect to existing discharges for 
facilities implementing water conservation measures. In order to be 
granted this exception, the discharger must show that the failure to 
grant a

[[Page 53643]]

mixing zone would preclude the use of water conservation measures that 
would lead to overall load reductions of BCCs even though BCCs would 
consequently appear in higher concentrations.
    Second, the proposal would allow for the granting of mixing zones 
for existing discharges of BCCs after the phase-out period because of 
technical and economic considerations. In order to authorize a mixing 
zone for an existing discharge of BCCs, the permitting authority must 
determine that: (1) The discharger is in compliance with existing 
technology-based and water quality-based effluent limitations for the 
BCC for which a mixing zone is requested; and (2) the discharger has 
reduced and will continue to reduce the loading of the BCC for which a 
mixing zone is requested to the maximum extent possible, such that any 
additional controls or pollution prevention measures to reduce or 
ultimately eliminate the BCC would result in unreasonable economic 
effects on the discharger or the affected community because the 
technology is not feasible or cost-effective.
    In addition to the possible alternatives provided for by EPA in the 
1995 Guidance and today's proposed rule, States within the Great Lakes 
Basin can also provide some additional limited relief to dischargers 
when faced with complying with the phase-out of mixing zones for BCCs. 
For example, the State of Ohio's water quality standards adopted in 
compliance with the Guidance contain a variance provision for mercury 
that relieves dischargers from constructing end-of-pipe treatment for 
mercury once detection levels improve. The basis for the mercury 
variance provision was a Statewide analysis that showed that it was not 
cost-effective to install end-of-pipe treatment to reduce mercury from 
Ohio's pre-Guidance standard of 12 nanograms per liter (ng/L) to its 
post-Guidance mercury criteria of 3.1 and 1.3 ng/L for the protection 
of human health and wildlife, respectively. In exchange for relief from 
installation of end-of-pipe treatment, a facility is required to 
implement a pollutant minimization program and must demonstrate that it 
can, or projects that it can, achieve an average annual mercury 
effluent concentration of 12 ng/L or less. EPA expects that Great Lakes 
States will use an analysis similar to the one performed by Ohio on a 
facility-by-facility basis to support an exception to the mixing zone 
prohibition for existing discharges of BCCs in those cases where it 
would be technically or economically infeasible to achieve criteria-
based WQBELs for BCCs absent a mixing zone.

VI. Administrative Requirements

A. Regulatory Planning and Review (Executive Order 12866)

    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, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that this rule is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to OMB review.

B. Regulatory Flexibility Act, as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996

    The Regulatory Flexibility Act (RFA), as amended by the Small 
Business Regulatory Enforcement Fairness Act, generally requires an 
agency to prepare a regulatory flexibility analysis for any rule 
subject to notice and comment rulemaking requirements under the 
Administrative Procedure Act or any other statute unless the agency 
certifies that the rule will not have a significant economic impact on 
a substantial number of small entities. Under section 605(b) of the 
RFA, however, if the head of an agency certifies that a rule will not 
have a significant economic impact on a substantial number of small 
entities, the statute does not require the agency to prepare a 
regulatory flexibility analysis. Pursuant to section 605(b), the 
Administrator certifies that this proposal, if adopted, will not have a 
significant economic impact on a substantial number of small entities 
for the reasons explained below. Consequently, EPA has not prepared a 
regulatory flexibility analysis.
    This proposal would amend the Water Quality Guidance for the Great 
Lakes System to establish requirements that apply in the first instance 
to Great Lakes States and Tribes. These requirements would restrict the 
current discretion of States and Tribes, in establishing water quality-
based effluent limitations for dischargers discharging BCCs, to allow 
for mixing zones for BCCs. The proposed changes would do two things. 
First, in the case of NPDES permits issued to new dischargers, States 
and Tribes would need to ensure that new discharges of BCCs achieve 
limits equal to the water quality criteria for those BCCs. Second, in 
the case of existing discharges, while States and Tribes would retain 
some discretion to authorize mixing zones for BCCs in limited 
circumstances, by and large, dischargers of BCCs would also need to 
achieve limits equal to water quality criteria for those pollutants.
    The RFA only requires analysis of the economic impacts of a rule on 
the small entities that are subject to the requirements of a rule. 
United Distribution Cos. v. FERC, 88 F.3d 1105 at 1170 (D.C. Cir. 
1996), quoting Mid-Tex Elec. Co-op v. FERC, 773 F.2d 327, 342 (D.C. 
Cir. 1985). Today's proposal applies to States and Tribes in the Great 
Lakes System when issuing NPDES permits. It would establish 
requirements that States and Tribes must adopt and apply to all new and 
virtually all existing dischargers, including small entities. The 
universe of dischargers affected by the rule, if adopted, is certain 
and States and Tribes have no discretion in implementing the rule with 
respect to new dischargers and only limited authority to modify the 
requirements with respect to existing dischargers. In this sense, the 
proposal would impose requirements on new and existing dischargers in 
the Great Lakes System.
    The proposal would impose requirements on dischargers in much the 
same way that, for example, effluent limitations guideline regulations 
do. The guideline regulations do not become binding requirements on 
dischargers until the guideline discharge limitations are included as 
conditions in an NPDES permit issued to the discharger. These guideline 
limitations, however, must be included by NPDES permitting authorities 
as permit conditions when the permitting authority issues or reissues 
permits to dischargers in the guideline industry point source category. 
Based on this consideration, EPA has concluded that small entities will 
be subject to the proposed regulation for purposes of the RFA and EPA 
has accordingly evaluated

[[Page 53644]]

the impact of the proposal on small entities. Based on its assessment, 
the Agency concludes that the proposal would not have a significant 
economic impact on a substantial number of small entities for the 
reasons explained below.
    EPA prepared a screening analysis to evaluate the potential impact 
to existing small entity dischargers that would be subject to the 
requirements of the rule, if it is promulgated as proposed (i.e., NPDES 
permit holders that may discharge BCCs). EPA identified existing small 
dischargers potentially affected by the mixing zone provisions using 
the definitions of small businesses, small governmental jurisdictions, 
and small nonprofit organizations established by the RFA. For this 
analysis, EPA considered the potential effect of this proposed rule 
only on direct dischargers. Under these assumptions, EPA estimated that 
there are approximately 2,329 small entities that potentially would be 
subject to the requirements of the proposed rule, if promulgated (61.4 
percent of the 3,795 total NPDES permit holders that may discharge BCCs 
to the Great Lakes Basin), consisting of ``small businesses'' and 
``small governmental jurisdictions.'' EPA does not expect any existing 
small nonprofit organization to be potentially subject to the 
requirements of today's proposed rule.
    EPA's screening analysis compared annualized facility-level 
compliance costs (estimated as described above in section V) with (1) 
total sales for nonmunicipal establishments, and (2) total government 
revenues for municipal owners of industrial establishments or domestic 
wastewater treatment plants. EPA compared the costs of compliance under 
two different assumptions. EPA's assessment showed that under neither 
assumption would the proposal have a significant economic impact on a 
substantial number of small entities.
    Under Scenario 1, the cost to comply with the proposal would 
represent greater than 3 percent of estimated revenues for only 7 (or 
0.7 percent) small municipalities, 0 small businesses, and 0 small 
nonprofit organizations. In aggregate, the cost to comply with the 
proposal would represent greater than 3 percent of estimated revenues 
for 7 (or 0.3 percent) small entities.
    Under Scenario 2, compliance costs would represent greater than 3 
percent of estimated revenues for 43 (or 4.4 percent) small 
municipalities, 0 small businesses, and 0 small nonprofit 
organizations. In aggregate, the cost to comply with the proposal would 
represent greater than 3 percent of estimated revenues for 43 (or 1.9 
percent) small entities. Thus, under either scenario, fewer than 100 
small entities would experience an economic impact of 3 percent or 
greater on their revenues.
    Moreover, the number of small entities for which compliance costs 
would represent greater than 1 percent of estimated revenues is 39 (4.0 
percent) for small municipalities and 0 for small businesses under 
Scenario 1. In aggregate, the number is 39 (1.7 percent) small entities 
under Scenario 1. The number of small entities for which compliance 
costs would represent greater than 1 percent of estimated revenues is 
127 (12.9 percent) for small municipalities and 0 for small businesses 
under Scenario 2. In aggregate, the number is 127 (5.5 percent) small 
entities under Scenario 2. EPA concludes that these estimates are not a 
significant economic impact on a substantial number of small entities. 
EPA's screening analysis is discussed in greater detail in ``RFA/SBREFA 
Screening Analysis for the Proposal to Amend the Final Water Quality 
Guidance for the Great Lakes System to Prohibit Mixing Zones for 
Bioaccumulative Chemicals of Concern'' (August 1999).
    EPA's analysis was based on the projected impact of the rule on 
existing small entities. However, the proposed rule may also affect 
small entities that do not yet exist or that do not discharge BCCs at 
this time but may choose to do so in the future. EPA does not expect 
that new small entities discharging to the Great Lakes will experience 
significant economic impacts because in EPA's view, it is highly 
unlikely that any new discharger would discharge BCCs in quantities to 
be affected by the proposed mixing zone prohibition. First, most BCCs 
are already banned from use and/or production or are severely 
restricted in use. Therefore, EPA does not expect them to be present in 
a new discharger's effluent above criteria levels. Second, for the few 
remaining BCCs that may be contaminating effluent as a result of 
household products or products and chemicals used in production, 
municipalities and commercial and industrial users of those products 
should be able to substitute away from these products, rely on cleaner 
technologies that do not require their use or that do not produce BCCs 
as a by-product, or employ source controls to reduce releases of BCCs 
to acceptable levels. These pollution prevention alternatives often are 
significantly more cost-effective than the end-of-pipe treatment 
technologies that could be used in their place.
    In other words, while EPA expects that implementation of today's 
proposed rule would ultimately result in some new or revised permit 
conditions for small entities, for the reasons set forth above EPA 
expects that neither new nor existing small entities will actually 
experience estimated economic impacts as great as those quantified 
under Scenario 2. In addition, for existing discharges, there is some 
flexibility and discretion in how the proposed rule would be 
implemented by States and Tribes within the NPDES permit program.
    The Agency thus is certifying that today's proposed rule would not 
have a significant economic impact on a substantial number of small 
entities, within the meaning of the RFA.

C. Paperwork Reduction Act

    An agency may not consider or sponsor a collection of information, 
and a person is not required to respond to a collection of information 
unless it displays a currently valid OMB control number under the 
Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Once this proposed rule 
is promulgated, the Great Lakes States and Tribes must adopt and submit 
to EPA provisions that are as protective as this amendment. See 40 CFR 
132.1 and 132.5(a). EPA has already received approval from OMB for that 
information collection as part of the 1995 rulemaking. The OMB control 
number is 2040-0180.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and Tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal Mandates'' that 
may result in expenditures to State, local, and Tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before EPA promulgates a rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and to 
adopt the least costly, most cost-effective or least burdensome 
alternative that achieves the objectives of the rule. The provisions of 
section 205 do not apply when they are inconsistent with applicable 
law. Moreover, section 205 allows EPA to adopt an alternative other 
than the least costly, most cost-effective

[[Page 53645]]

or least burdensome alternative if the Administrator publishes with the 
rule an explanation why that alternative was not adopted.
    Before EPA establishes any regulatory requirements that may 
significantly or uniquely affect small governments, including Tribal 
governments, it must have developed under section 203 of the UMRA a 
small government agency plan. The plan must provide for notifying 
potentially affected small governments, enabling officials of the 
affected small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    As noted above, this proposed rule would amend Part 132 to prohibit 
mixing zones for BCCs in the Great Lakes System. EPA has determined 
that this proposed rule does not contain a Federal mandate that may 
result in expenditures of $100 million or more for State, local, and 
Tribal governments, in the aggregate, or the private sector in any one 
year. The total annual impact of this rule on State, local, and Tribal 
governments and the private sector is not expected to exceed $12 
million to $35 million. Thus, today's proposal to amend Part 132 to 
prohibit mixing zones for BCCs in the Great Lakes System is not subject 
to the requirements of sections 202 and 205 of the UMRA.
    EPA has determined that this proposed rule contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. As described above, EPA does not expect that small 
governments, including Tribal governments with responsibility for 
implementing this rule, and small governments operating POTWs 
discharging to the Great Lakes, will experience significant economic 
impacts because most BCCs are already banned from use or are severely 
restricted in use. In those rare instances where the few remaining BCCs 
(i.e., BCCs that are not already banned or severely restricted) are 
found contaminating effluent to unacceptable levels as a result of 
household products or products and chemicals used in production, 
municipalities and commercial and industrial users of those products 
should be able to substitute away from these products, rely on cleaner 
technologies that do not require their use or that do not produce BCCs 
as a by-product, or employ source controls to reduce releases of BCCs 
to acceptable levels. In addition, for existing discharges, there is 
some flexibility and discretion in how the proposed rule would be 
implemented by States and Tribes within the NPDES permit program. Thus, 
today's rule is not subject to the requirements of section 203 of UMRA.

E. Executive Orders on Federalism

    Under Executive Order 12875, EPA may not issue a regulation that is 
not required by statute and that creates a mandate upon a State, local 
or Tribal government unless the Federal Government provides the funds 
necessary to pay the direct compliance costs incurred by those 
governments or to provide to the Office of Management and Budget a 
description of the extent of EPA's prior consultation with 
representatives of affected State, local and Tribal governments, the 
nature of their concerns, any written communications from the 
governments and a statement supporting the need to issue the 
regulation. In addition, Executive Order 12875 requires EPA to develop 
an effective process allowing elected officials and other 
representatives of State, local and Tribal governments ``to provide 
meaningful and timely input in the development of regulatory proposals 
containing significant unfunded mandates.''
    In compliance with Executive Order 12875, EPA has extensively 
involved Great Lakes State, Tribal and local governments in the 
development of this proposed amendment, notably during the process of 
developing the 1995 Guidance, which contained the original version of 
this proposed rule. The rulemaking that promulgated the Guidance in 
1995 was subject to Executive Order 12875. The process used to develop 
the Guidance marked the first time that EPA had developed a major 
rulemaking effort in the water quality standards program through a 
regional public forum. The public process, which lasted over a seven 
year period and involved Great Lakes States, EPA, and other Federal 
agencies in open dialogue with citizens, Tribal and local governments, 
and industry in the Great Lakes Basin, is described further in the 
preamble to the Guidance. See 60 FR 15383-15384 (March 23, 1995).
    As described above, today's action by EPA proposes to reinstate a 
provision nearly identical to the provision in the 1995 Guidance that 
was vacated by the Court in AISI. It thus reflects the State, local and 
Tribal government input EPA received during the 1995 Guidance 
rulemaking.
    On August 4, 1999, President Clinton issued a new executive order 
on federalism, Executive Order 13132, see 64 FR 43255 (August 10, 
1999), which will take effect on November 2, 1999. In the interim, the 
current Executive Order 12612, see 52 FR 41685 (October 30, 1987), on 
federalism still applies. This rule, if promulgated as proposed, will 
not have a substantial direct effect on States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 12612. Today's proposed rule simply 
would require the Great Lakes States to add one discrete provision to 
the regulations and policies they have already adopted as part of the 
Great Lakes Water Quality Initiative, 60 FR 15366 (March 23, 1995). 
Similarly, this proposed rule would not have a substantial direct 
effect upon the distribution of power and responsibilities among the 
various levels of government because the Great Lakes States retain 
primary responsibility for administering their NPDES permit programs, 
through which this proposed rule would be implemented. It would 
authorize EPA to promulgate these mixing zone provisions only if a 
State or Tribe has failed to act. Accordingly, these provisions will 
not have a substantial direct effect on States or on intergovernmental 
relationships or responsibilities.

F. Executive Order 13084: Consultation and Coordination With Indian 
Tribal Governments

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to provide to the Office of Management and Budget, in a 
separately identified section of the preamble to the rule, a 
description of the extent of EPA's prior consultation with 
representatives of affected tribal governments, a summary of the nature 
of their concerns, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 13084 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of Indian tribal governments ``to provide meaningful 
and timely input in the development of regulatory policies on matters 
that

[[Page 53646]]

significantly or uniquely affect their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments or impose substantial direct 
compliance costs on them. Therefore, the requirements of section 3(b) 
of Executive Order 13084 do not apply to this rule. Nonetheless, in 
compliance with Executive Order 12875, EPA has extensively involved 
Great Lakes State, Tribal and local governments in the development of 
this proposed amendment, notably during the process of developing the 
1995 Guidance, which contained the original version of this proposed 
rule. Today's action by EPA proposes to reinstate a provision nearly 
identical to the provision in the 1995 Guidance that was vacated by the 
Court in AISI. It thus reflects the State, local and Tribal government 
input EPA received during the 1995 Guidance rulemaking.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies 
to any rule that: (1) Is determined to be ``economically significant'' 
as defined under Executive Order 12866, and (2) concerns an 
environmental health or safety risk that EPA has reason to believe may 
have a disproportionate effect on children. If the regulatory action 
meets both criteria, the Agency must evaluate the environmental health 
or safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    This proposed rule is not subject to the Executive Order because it 
is not economically significant as defined in E.O. 12866. Further, EPA 
interprets E.O. 13045 as applying only to those regulatory actions that 
are based on health or safety risks, such that the analysis required 
under section 5-501 of the Order has the potential to influence the 
regulation. This rule is not subject to E.O. 13045 because it does not 
establish an environmental standard intended to mitigate health or 
safety risks. However, as noted earlier, children may be a greater risk 
to BCCs than adults. If they are at greater risk, they will benefit the 
most from this rule to prohibit mixing zones for BCCs.
    The public is invited to submit or identify peer-reviewed studies 
and data, of which the agency may not be aware, that assessed results 
of early life exposure to BCCs.

H. Endangered Species Act

    Section 7 of the Endangered Species Act (ESA) requires federal 
agencies, in consultation with the U.S. Fish and Wildlife Service (FWS) 
and National Marine Fisheries Service (NMFS), to ensure their actions 
are not likely to jeopardize the continued existence of any listed 
species or result in the destruction or adverse modification of habitat 
of such species which have been designated as ``critical.'' 
Consultation is designed to assist federal agencies in complying with 
the requirements of section 7 by supplying a process within which FWS 
and NMFS provide such agencies with advice on whether an action 
complies with the substantive requirements of ESA.
    In accordance with these requirements, EPA completed consultation 
with the FWS on the 1995 Guidance, and the FWS issued a biological 
opinion concluding that the Guidance was not likely to jeopardize the 
continued existence of listed species or result in the destruction or 
adverse modification of species' critical habitat. As explained above, 
today's proposal essentially reinstates, with some clarification, the 
BCC mixing zone provisions of the 1995 Guidance. Since the substance of 
today's proposal has already been the subject of section 7 
consultation, the effects of today's proposal have been addressed by 
the Services' prior biological opinion.

I. National Technology Transfer and Advancement Act

    Under section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (``NTTAA''), Pub. L. No. 104-113, section 12(d) 
(15 U.S.C. 272 note) directs EPA to use voluntary consensus standards 
in its regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through the Office and Management and Budget, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.
    The proposed rulemaking does not involve technical standards. 
Therefore, EPA is not considering the use of any voluntary consensus 
standards. EPA welcomes comments on this aspect of the proposed 
rulemaking and, specifically, invites the public to identify 
potentially-applicable voluntary consensus standards and to explain why 
such standards should be used in this regulation.

VII. References

Beattie, M.K., S. Gerstenberger, R. Hoffman and J.A. Dellinger. 
1996. Rodent neurotoxicity bioassays for screening contaminated 
Great Lakes fish. Environmental Toxicology and Chemistry, Vol. 15, 
pp. 313-318.
Driver, C.J., M.W. Ligotke, P. Van Voris, B.D. McVeety, B.J. 
Greenspan and D.B. Drown. 1991. Routes of uptake and their relative 
contribution to the toxicologic response of northern bobwhite 
(Colinus virginianus) to an organophosphate pesticide. Environmental 
Toxicology and Chemistry, Vol. 10, pp. 21-33.
Elliot, J.E., R.J. Norstrom, A. Lorenzen, L.E. Hart, H. Philibert, 
S.W. Kennedy, J.J. Stegeman, G.D. Bellward and K.M. Cheng. 1996. 
Biological effects of polychlorinated dibenzo-p-dioxins, 
dibenzofurans, and biphenyls in bald eagle (Haliaeetus 
leucocephalus) chicks. Environmental Toxicology and Chemistry, Vol. 
15, pp. 782-793.
Landrum, P.F., B.J. Eadie and W.R. Faust. 1991. Toxicokinetics and 
toxicity of a mixture of sediment-associated polycyclic aromatic 
hydrocarbons to the amphipod Diporeia sp. Environmental Toxicology 
and Chemistry, Vol. 10, pp. 35-46.
Larson, J.M., W.H Karasov, L. Sileo, K.L. Stromborg, B.A. Habidge, 
J.P. Giesy, P.D. Jones, D.E. Tillitt, and D.A. Verbrugge. 1996. 
Reproductive success, developmental anomalies, and environmental 
contaminants in double-crested cormorants (Phalacrocorax auritus). 
Environmental Toxicology and Chemistry, Vol. 15, pp. 553-559.
Palace, V.P., J.F. Klaverkamp, W.L. Lockhart, D.A. Metner, D.C.G. 
Muir and S.B. Brown. 1996. Mixed-function oxidase enzyme activity 
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3,3',4,4',5-pentacholorbiphenyl (PCB-126). Environmental Toxicology 
and Chemistry, Vol. 15, pp. 995-960.
Sasson-Brickson, G. and G.A. Burton, Jr. 1991. In situ and 
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Environmental Toxicology and Chemistry, Vol. 12, pp. 115-125.
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[[Page 53647]]

List of Subjects in 40 CFR Part 132

    Environmental protection, Administrative practice and procedure, 
Great Lakes, Indians-lands, Intergovernmental relations, Reporting and 
recordkeeping requirements, Water pollution control.

    Dated: September 24, 1999.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I, part 
132 of the Code of Federal Regulations is proposed to be amended as 
follows:

PART 132--WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM

    1. The authority citation for Part 132 continues to read as 
follows:

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

    2. Section 132.5 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec. 132.5  Procedures for adoption and EPA review.

    (a) Except as provided herein and 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. With 
respect to procedure 3.C of appendix F of this part, the Great Lakes 
States and Tribes shall make its submission to EPA no later than 18 
months after the publication date of the final rule to prohibit mixing 
zones for BCCs.
* * * * *
    (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, or, for procedure 3.C. of 
appendix F of this part, no later than 2 years after the publication 
date of the final rule to prohibit mixing zones for BCCs.
* * * * *
    3. Appendix F of Part 132 is amended by adding Procedure 3.C. to 
read as follows:

Appendix F of Part 132--Great Lakes Water Quality Initiative 
Implementation Procedures

* * * * *
    Procedure 3: * * *
    C. Mixing Zones for Bioaccumulative Chemicals of Concern (BCCs). 
The following requirements shall be applied in establishing TMDLs, 
WLAs in the absence of TMDLs, and preliminary WLAs for purposes of 
determining the need for WQBELs under procedure 5 of appendix F, for 
BCCs:
    1. There shall be no mixing zones available for new discharges 
of BCCs to the Great Lakes System. WLAs established through TMDLs, 
WLAs in the absence of TMDLs, and preliminary WLAs for purposes of 
determining the need for WQBELs for new discharges of BCCs shall be 
set equal to the most stringent applicable water quality criteria or 
values for the BCCs in question. This prohibition takes effect for a 
State or Tribe on the date EPA approves the State's or Tribe's 
submission of such prohibition or publishes a notice under 40 CFR 
132.5(f) identifying that prohibition as applying to discharges 
within the State or Federal Tribal reservation.
    2. For purposes of section C of procedure 3 of appendix F, new 
discharges are defined as: (1) A ``discharge of pollutants'' (as 
defined in 40 CFR 122.2) to the Great Lakes System from a building, 
structure, facility, or installation, the construction of which 
commences after the date the prohibition in section C.1 takes effect 
in that State or Tribe; (2) a new discharge from an existing Great 
Lakes discharger that commences after the date the prohibition in 
section C.1 takes effect in that State or Tribe; or (3) an expanded 
discharge from an existing Great Lakes discharger that commences 
after the date the prohibition in section C.1 takes effect in that 
State or Tribe, except for those expanded discharges resulting from 
changes in loadings of any BCC within the existing capacity and 
processes (e.g., normal operational variability, changes in intake 
water pollutants, increasing the production hours of the facility or 
adding additional shifts, or increasing the rate of production), and 
that are covered by the existing applicable control document. All 
other discharges of BCCs are defined as existing discharges.
    3. Up until 10 years from the publication date of the final BCC 
mixing zone rule, mixing zones for BCCs may be allowed for existing 
discharges to the Great Lakes System pursuant to the procedures 
specified in sections D and E of this procedure.
    4. Except as provided in sections C.5 and C.6 of this procedure, 
permits issued on or after the publication date of the final BCC 
mixing zone rule shall not authorize mixing zones for existing 
discharges of BCCs to the Great Lakes System 10 years after the 
publication date of the final BCC mixing zone rule. After 10 years 
from the publication date of the final BCC mixing zone rule, WLAs 
established through TMDLs, WLAs established in the absence of TMDLs, 
and preliminary WLAs for purposes of determining the need for WQBELs 
under procedure 5 of appendix F for existing discharges of BCCs to 
the Great Lakes System shall be set equal to the most stringent 
applicable water quality criteria or values for the BCCs in 
question.
    5. Exception for Water Conservation. States and Tribes may grant 
mixing zones for any existing discharge of BCCs to the Great Lakes 
System beyond the date specified in section C.4 of this procedure 
where it can be demonstrated, on a case-by-case basis, that failure 
to grant a mixing zone would preclude water conservation measures 
that would lead to overall load reductions in BCCs, even though 
higher concentrations of BCCs occur in the effluent. Such mixing 
zones must also be consistent with sections D and E of this 
procedure.
    6. Exception for Technical and Economic Considerations. States 
and Tribes may grant mixing zones beyond the date specified in 
section C.4 of this procedure for any existing discharges of a BCC 
to the Great Lakes System upon the request of a discharger subject 
to the limited circumstances specified in sections C.6.a through 
C.6.c below.
    a. The State or Tribe must determine that:
    i. The discharger is in compliance with and will continue to 
implement, for the BCC in question, all applicable requirements of 
Clean Water Act sections 118, 301, 302, 303, 304, 306, 307, 401, and 
402, including existing National Pollutant Discharge Elimination 
System (NPDES) water-quality based effluent limitations; and
    ii. The discharger has reduced and will continue to reduce the 
loading of the BCC for which a mixing zone is requested to the 
maximum extent possible such that any additional controls or 
pollution prevention measures to reduce or ultimately eliminate the 
BCC would result in unreasonable economic effects on the discharger 
or the affected community because the controls or measures are not 
feasible or cost-effective.
    b. Any exceptions granted pursuant to this section shall:
    i. Not result in any less stringent limitations than those 
existing prior to the publication date of the final BCC mixing zone 
rule;
    ii. Reflect all information relevant to ensure that the mixing 
zone is no larger than necessary to account for the technical 
constraints and economic effects identified pursuant to paragraph 
C.6.a above;
    iii. Meet all applicable acute and chronic aquatic life, 
wildlife and human health criteria and values within and at the edge 
of the mixing zone or be consistent with the applicable TMDL or 
assessment and remediation plan authorized under procedure 3.A.
    iv. As appropriate, require the discharger to implement an 
ambient monitoring plan to ensure compliance with water quality 
standards and consistency with any applicable TMDL or such other 
strategy consistent with section A of this procedure, including the 
evaluation of alternative means for reducing BCCs elsewhere in the 
watershed; and
    v. Be limited to one permit term unless the permitting authority 
makes a new determination in accordance with this section for each 
successive permit application in which a mixing zone for the BCC(s) 
is sought.
    c. For each draft NPDES permit that would allow a mixing zone 
for one or more BCCs 10 years after the publication date of the 
final BCC mixing zone rule, the fact sheet or statement of basis for 
the draft permit that is required to be made available through 
public notice under 40 CFR 124.6(e) shall:
    i. Specify the mixing provisions used in calculating the permit 
limits; and

[[Page 53648]]

    ii. Identify each BCC for which a mixing zone is proposed.
    7. Any mixing zone authorized under section C.3, C.5 or C.6 must 
be consistent with sections D and E of this procedure, as 
applicable.
* * * * *
[FR Doc. 99-25436 Filed 10-1-99; 8:45 am]
BILLING CODE 6560-50-P