67638 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

MICHIGAN—OZONE (1-HOUR STANDARD)

Designated areas

Designation Classification

Date1 Type Date1 Type

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Flint Area:

Genesee County .............................................................. January 16, 2001 ................... Attainment.

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Saginaw-Bay City-Midland Area:

Bay County ...................................................................... January 16, 2001 ................... Attainment.

Midland County ................................................................ January 16, 2001 ................... Attainment.

Saginaw County ............................................................... January 16, 2001 ................... Attainment.

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1This date is October 18, 2000, unless otherwise noted.

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[FR Doc. 00–28805 Filed 11–9–00; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 132

[FRL–6898–7]

RIN 2040–AD32

Final Rule 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: Final rule.

SUMMARY: Today EPA is promulgating

the final rule to amend the Final Water

Quality Guidance for the Great Lakes

System (Guidance) to prohibit mixing

zones for bioaccumulative chemicals of

concern (BCCs) in the Great Lakes

System, subject to certain exceptions for

existing discharges. For existing

discharges, the regulation prohibits

mixing zones for BCCs starting 10 years

after the publication date of the final

BCC mixing zone rule. New discharges

of BCCs are subject to the mixing zone

prohibition immediately upon

commencing discharge. EPA had

promulgated a mixing zone provision

similar to this regulation on March 23,

1995, as part of the Guidance 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. In response to the Court’s

remand, EPA published a proposal on

October 4, 1999, to amend the Guidance

to reinstate the provision to prohibit

mixing zones for BCCs (64 FR 53632).

EPA received many comments from

stakeholders throughout the United

States on its proposal to prohibit mixing

zones for BCCs in the Great Lakes Basin.

This final rule reflects EPA’s

reconsideration of the factual record in

response to the Court’s remand and

public comments received on its

proposal.

EFFECTIVE DATE: December 13, 2000.

ADDRESSES: 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 at (312) 886–3717.

FOR FURTHER INFORMATION CONTACT:

Mark Morris (4301), U.S. EPA, Ariel

Rios Building, 1200 Pennsylvania

Avenue, NW., Washington, DC 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 the

following:

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.

Category Examples of potentially

affected entities

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 is presented to

provide a guide for readers regarding

regulated entities likely to be affected by

this action. Listed in the table are 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 also could be affected. To

determine whether your facility is

affected by this action, you should

examine carefully 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 section titled FOR

FURTHER INFORMATION CONTACT.

I. Legal Authority

This regulation is promulgated under

the authority of sections 118, 301, 303,

402, and 501 of the Clean Water Act

(CWA).

II. Introduction

Section 118(c)(2) of the 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’’

(Guidance) in order to satisfy this

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67639

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

exceptions for existing discharges to

account for water conservation and

technical and economic considerations.

Great Lakes States and Tribes were

required to adopt water quality

standards, antidegradation policies, and

implementation procedures consistent

with the criteria methodologies,

policies, and implementation

procedures specified in the 1995

Guidance by March 23, 1997, and to

submit them to EPA for approval or

disapproval. See 40 CFR 132.5. In the

event EPA disapproves all or part of a

State’s or Tribe’s submission, EPA

would publish a final rule identifying

the provisions of part 132 that shall

apply to discharges in that State or

Tribal reservation. See 40 CFR

132.5(f)(2).

The 1995 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, 115

F.3d 979 (D.C. Cir. 1997)); however, the

Court vacated the provisions of the

Guidance that would have eliminated

mixing zones for BCCs (115 F.3d at 985).

The Court held that EPA had ‘‘failed to

address whether the measure is costjustified,’’ and remanded the provision

to EPA for an opportunity to address

this issue (115 F.3d at 997). In response

to the Court’s remand, EPA re-examined

the factual record, including its cost

analyses, and published the Proposal to

Amend the Final Water Quality

Guidance for the Great Lakes System to

Prohibit Mixing Zones for

Bioaccumulative Chemicals of Concern

in the Federal Register on October 4,

1999 (64 FR 53632). EPA received

numerous comments, data, and

information from commenters in

response to the proposal.

After reviewing and analyzing the

information in the rulemaking record,

including those comments, EPA has

developed the Final Rule to Amend the

Final Water Quality Guidance for the

Great Lakes System to Prohibit Mixing

Zones for Bioaccumulative Chemicals of

Concern, to be codified in appendix F,

procedure 3.C of 40 CFR part 132. This

preamble describes the background and

purpose of this final rule, briefly

summarizes the rule’s major provisions,

and summarizes the major issues in the

public comments received on the

proposal and EPA’s responses to them.

A detailed discussion of EPA’s analysis

of comments and issues, as well as its

reasons for issuing the final rule to

prohibit mixing zones for BCCs in the

Great Lakes Basin, are provided in

additional technical and supporting

documents, which are available in the

docket for this rulemaking. Copies of the

supporting documents also are available

from EPA in electronic format (see

section VIII of this preamble). For a

detailed discussion of the rule’s major

provisions, please see the preamble to

the proposed rule.

III. Summary of the Final Regulation

Today, EPA is promulgating the final

rule to amend 40 CFR part 132,

appendix F, procedure 3, to reinstate the

mixing zone provisions for BCCs. A

mixing zone is the area beyond a point

source outfall (e.g., a pipe) in which

concentrations of a particular pollutant

from a wastewater discharge mix with

receiving waters. The water is allowed

to exceed the water quality criterion for

that pollutant within the mixing zone.

Behind the theory of using mixing zones

is the belief that by mixing with the

receiving waters within the zone, the

discharge will become sufficiently

diluted to meet applicable water quality

criteria beyond the borders of that zone.

Today’s rulemaking prohibits or, for

existing discharges, phases out mixing

zones for BCCs in the Great Lakes

System subject to certain exceptions.

This means that NPDES permit

limitations for BCCs discharged to the

Great Lakes System must be set no

higher than water quality criteria. Under

today’s rule, the phase-out of mixing

zones is to occur, in most cases, by

November 15, 2010. EPA believes this is

a reasonable time frame because five out

of the eight Great Lakes States have

similar State-adopted BCC mixing zone

provisions and the remaining three

States have been aware since 1997 of

EPA’s intention to reinstate this

provision. See 63 FR 20107 (April 23,

1998). In addition, EPA has not chosen

to reduce the phase-out period to less

than 10 years (the time frame originally

promulgated in the 1995 Guidance), to

allow affected dischargers the same time

(approximately 10 years) they would

have had under the original BCC mixing

zone provision.

Under this amendment to Part 132,

the mixing zone prohibition would be

limited to BCCs—the pollutants of

primary concern in the Great Lakes

System. 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

(BAF) greater than 1000 (after

considering various specified factors),

and (2) has the potential upon entering

surface waters to cause adverse effects,

either by itself or in the form of its toxic

transformation product, as a result of

that accumulation. See 40 CFR 132.2.

The table below lists the BCCs subject

to today’s rule.

BIOACCUMULATIVE CHEMICALS OF

CONCERN (BCCS)

Lindane ..................... Mirex

Hexachlorocyclohexane (BHC)Hexachlorobenezene

alphaHexachlorocyclohexaneChlordane

betaHexachlorocyclohexaneDDD

deltaHexachlorocyclohexaneDDT

Hexachlorobutadiene DDE

Photomirex Octachlorostyrene

1,2,4,5-

Tetrachlorobenzene

PCBs

Toxaphene 2,3,7,8-TCDD

Pentachlorobenzene Mercury

1,2,3,4-

Tetrachlorobenzene

Dieldrin

There are two components of this

rule. First, today’s rule prohibits the

establishment of mixing zones for new

discharges of BCCs to the Great Lakes

67640 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

System. This prohibition takes effect as

soon as EPA has approved the State’s or

Tribe’s submission with respect to this

prohibition or publishes a notice

identifying that prohibition as applying

within the State’s or Tribe’s jurisdiction.

The definition of ‘‘new discharge’’ can

be found at procedure 3.C.2 of today’s

rule. All other discharges of BCCs are

defined as existing discharges.

Second, this regulation prohibits

mixing zones for existing discharges of

BCCs after November 15, 2010, subject

to two exceptions: (1) promotion of

water conservation; and (2) technical

and economic considerations. 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. Therefore,

the first exception would allow States

and Tribes to grant mixing zones for any

existing discharge of BCCs even after

November 15, 2010 in cases in which it

can be demonstrated 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

may occur in the effluent. This mixing

zone exception is virtually identical to

the provision promulgated in 1995.

Regarding the exception for technical

and economic considerations, a State or

Tribe could authorize a mixing zone for

existing discharges of BCCs after

November 15, 2010 if the State or Tribe

determines that (a) the discharger

complies with all applicable

requirements of CWA sections 118, 301,

302, 303, 304, 306, 307, 401, and 402

(including existing NPDES water

quality-based effluent limitations) for

the BCC for which the mixing zone is

requested, and (b) the discharger has

reduced and will continue to reduce—

to the maximum extent possible—its

discharge of the BCC for which the

mixing zone is requested. This

exception would not be available if costeffective pollution prevention and/or

other control and treatment strategies

exist that make it technically feasible 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 economic

effects in implementing such strategies.

EPA has modified the technical and

economic feasibility provision from the

1995 Guidance to clarify the importance

of implementing only those control

strategies determined to be costeffective. EPA expects that exceptions to

the BCC mixing zone provision will be

granted solely at the discretion of the

State or Tribe on a case-by-case basis.

See procedure 3.C.5 and 6 for more

information on exceptions to the

provisions contained herein. EPA

received no comments concerning any

aspects of either exception as proposed.

To date, the States of Illinois, Indiana,

Minnesota, Michigan, and Wisconsin

have adopted and submitted to EPA

requirements to eliminate or, for

existing discharges, to phase out mixing

zones for BCCs. If these requirements

are retained by the five States, and if

EPA determines that they are as

protective as today’s final rule, EPA will

approve those 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 in

today’s rule (e.g., New York, Ohio,

Pennsylvania) will need to adopt such

provisions and submit them to EPA for

approval or disapproval pursuant to 40

CFR 132.5 by May 13, 2002, see 40 CFR

132.5(a) and (c) (as amended by today’s

rule.). If a Great Lakes State or Tribe

fails to submit such provisions, or if

EPA disapproves the submission, EPA,

after giving the State or Tribe an

opportunity to make necessary changes,

will publish a final rule no later than

November 13, 2002 identifying the

provisions of today’s rule that shall

apply to discharges within that State’s

or Tribe’s jurisdiction. See 40 CFR

132.5(c), (d) and (f).

IV. Comments on the Proposed

Regulation

EPA solicited comments on the

intended amendment in the ‘‘Proposal

to Amend the Final Water Quality

Guidance for the Great Lakes System to

Prohibit Mixing Zones for

Bioaccumulative Chemicals of

Concern,’’ which was published in the

Federal Register on October 4, 1999 (64

FR 53632). The following sections

summarize comments received and

EPA’s responses.

A. Support for the Regulation

Some commenters on the proposal of

this rule support the elimination of

mixing zones for BCCs in the Great

Lakes System. The majority of these

comments address issues such as (1) the

consistency between the final rule, the

goals of the CWA, and the goals of the

Great Lakes Water Quality Agreement

(GLWQA), (2) the inappropriateness of

mixing zones for BCCs due to BCCs’

persistence in the environment, and (3)

the adverse health effects BCCs impose

on fish and other aquatic organisms,

wildlife, and humans. Commenters also

urged EPA to extend the proposed rule

so that it encompasses other national

waters, to apply the prohibition to

chemicals other than BCCs, and to

include chemicals with BAFs lower

than the current 1000 cutoff that was

established in the 1995 Guidance. These

issues and requests are discussed

throughout the remainder of this

section.

Phasing out existing mixing zones for

BCCs and prohibiting new mixing zones

for BCCs will ensure that the 1995

Guidance achieves the goals of the CWA

and the objectives of the GLWQA,

which is an international agreement

between the United States and Canada

to restore and maintain the

environmental integrity of the Great

Lakes ecosystem. Several commenters

pointed out that today’s rule is an

important and necessary step toward

achieving the GLWQA’s goals to

virtually eliminate persistent and

bioaccumulative toxics (Article II.a) and

to reduce mixing zones to the maximum

extent possible (Article IV.f). EPA

acknowledges the consistency between

today’s rulemaking and the objectives of

the GLWQA and is promulgating this

amendment in an effort to conform to

goals that work toward mending and

upholding the integrity of the Great

Lakes System.

As part of this effort, EPA has judged

that mixing zones for BCCs (even of the

limited size already authorized by 40

CFR part 132 under certain conditions)

for existing discharges should be

prohibited to the greatest extent

technically and economically possible.

A large number of scientists, policy

makers, and other stakeholders in the

Great Lakes and Canada agree on the

need to virtually eliminate BCCs from

the Great Lakes Basin and to reduce the

size of BCC mixing zones to the

maximum extent possible. This is

because BCCs, due to their persistent

and bioaccumulative nature, are

incompatible with mixing zones. By

definition, BCCs are chemicals that do

not degrade over time. These chemicals

accumulate in organisms living in the

water and become more concentrated as

they move up the food chain—from

biota to fish and wildlife to humans.

Because the effects of these chemicals

are not mitigated by dilution, using a

mixing zone to ‘‘dilute’’ BCC discharges

is not appropriate. Commenters pointed

out that dilution and dispersion are

inadequate substitutes for removing and

treating the BCCs before they are

discharged to the Great Lakes’ waters.

EPA agrees with these commenters

because it is the mass of BCCs that poses

a problem, not just the concentration.

Because dioxins, mercury,

polychlorinated biphenyls (PCBs) and

other BCCs degrade over long periods of

time or do not degrade at all, their

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67641

buildup in pockets of sediments creates

‘‘hot spots’’ in the environment in

which bioaccumulation of toxics in fish

and other aquatic organisms can occur

at levels that significantly exceed safe

levels for consumption by wildlife and

humans. The 1995 Guidance required 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. See 40 CFR

part 132, appendix F, procedure 3.D and

3.E. Larger mixing zones also are

allowed if a particular demonstration is

performed. See 40 CFR part 132,

appendix F, procedure 3.F. Thus, with

the currently allowable dilution, the

mass of BCCs discharged from point

sources to the Great Lakes System could

be reduced significantly—by a factor of

10 to 100 in certain circumstances—

when mixing zones for BCCs are

prohibited.

Commenters on EPA’s proposal

support today’s rule because of its

ability to help decrease the amount of

BCCs to which fish, wildlife, and

humans are exposed. The commenters

recognize the adverse effects BCCs have

on human health and wildlife and that

even small concentrations can increase

the risks of cancer, organ failure, and a

host of other maladies. One commenter

noted that contaminating any waterbody

with persistent toxic substances that

accumulate in the food chain is never

rational. Furthermore, it should not be

justifiable public policy.

Because the food web that

accumulates BCCs can be concentrated

in tributaries, bays, and other areas

where natural sinks exist—and where

fish species are more diverse and

productive—the elimination of mixing

zones will reduce the probability of

adverse effects on these organisms and

those that consume them. Fewer

pollutants entering the waters will

reduce the detrimental effects already

discovered in various fish species and

wildlife.

In aquatic organisms, effects of BCCs

range from death to impairment of

reproduction, development, and growth

(Sweeney et al., 1993). In wildlife, birds

exposed to BCCs have exhibited

biochemical dysfunction and metabolic

effects, behavioral/neurological

disorders, and reproductive impairment

(Elliott et al., 1996).

For humans, as is true for wildlife, the

main route of exposure to BCCs is

through the consumption of Great Lakes

fish, which have ‘‘uptaken’’ and

retained the pollutants from their

surrounding environment and food.

Potential adverse human health effects

resulting from the consumption of

contaminated fish include both the

increased risk of cancer and the

potential for systemic or noncancer risks

such as kidney damage (U.S. EPA,

1997). As affirmed by commenters who

support today’s rule, women who are

pregnant and children, in particular, are

at risk for being adversely affected by

BCCs (U.S. EPA, 1997). BCCs can

induce inheritable chromosomal

changes in women that 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. 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.

Children may be at greater risk than

adults. Because BCCs can accumulate in

human milk, women exposed to the

pollutants who breastfeed could

potentially pass the chemicals on to

their infants. Risks to infants and

children include central nervous system

effects, mortality, low IQ scores,

cataracts, congestive heart failure, skin

disorders, cancers, immune system

dysfunction and immunosuppression,

skeletal disorders, neurological/

behavioral effects, and endocrinological

disorders.

In addition to supporting EPA in its

rationale behind the rule, as

summarized in the above paragraphs,

many commenters strongly advised EPA

to expand the proposed rule so that the

regulations apply nationwide, not just

for the Great Lakes System, and that the

BCC mixing zone phase-out should

cover chemicals other than BCCs. One

commenter noted that, although lakes

lend themselves to the most easily

quantifiable demonstration of risk to a

particular subpopulation, the discharge

of BCCs into moving waterbodies is no

less problematic. EPA, under a separate

undertaking, is evaluating whether

mixing zones for BCCs should be

prohibited in other national waters and

for chemicals other than BCCs.

Commenters also urged EPA to

propose an amendment that would

address chemicals with a BAF that falls

short of the cutoff established by the

Guidance. These commenters claimed

that the risks to wildlife and humans

from chemicals with lower BAFs might

be just as severe as those chemicals with

BAFs of greater than 1000, particularly

when wildlife and humans are exposed

to a mix of chemicals found within fish.

In response, EPA believes that the

current BAFs are sufficient to protect

water quality and human health. The

Agency wishes to point out, however,

that 40 CFR 132.1(d) provides that the

methodologies for establishing BAFs

and criteria for pollutants, including

BCCs, will be evaluated and revised, as

appropriate, every three years.

In summary, these commenters stated

their support for today’s rule. Although

some hope to see an extension of the

mixing zone prohibition, many were

satisfied with the step forward that this

rule is making in helping to meet the

objectives of the CWA.

B. Benefits Associated With Phase-out

and Elimination of Mixing Zones for

BCCs

A few commenters asserted that the

proposed rule contained no evidence or

documentation that restrictions on

NPDES dischargers would produce any

measurable change in the levels of BCCs

in water, sediment, or fish tissue. Others

claimed that the proposal would yield

no benefits because five of the Great

Lakes States have already adopted a

similar prohibition on BCC mixing

zones and, to date, no mixing zone

credit exists for cases in which water

quality exceeds applicable water quality

standards. One commenter estimated

that annual benefits of the proposal

would amount to no more than $1.3 to

$4.1 million.

EPA disagrees with these claims. EPA

believes that the mixing zone

prohibition is necessary to protect the

integrity of the Great Lakes and that its

benefits derive from the minimization or

avoidance of the adverse effects

summarized in the preceding section.

The Court that struck down an earlier

version of this regulation noted that

EPA had adequately explained the

environmental importance of

eliminating mixing zones for BCCs. In

addition, numerous scientists, policy

makers, and other stakeholders in the

United States and Canada are urging

EPA to reduce the size of BCC mixing

zones to the maximum extent possible,

which would be a step forward in trying

to virtually eliminate BCCs from the

Great Lakes Basin as called for by the

GLWQA.

Because BCCs are harmful to the

environment, any discharge of BCCs—

even those discharges that are

equivalent to the applicable water

quality criteria-have the potential to

impair the integrity of the receiving

waterbody. Using mixing zones to

increase the amount of allowable

discharge exacerbates this situation

because the effects of BCCs are not

limited to the short term, or localized

zone of initial dilution, meaning that

adverse effects could occur far outside

the mixing zone and long after the BCC

discharge occurred.

67642 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

Since point sources affect waterbodies

and, hence, fish tissue on a site-specific

basis, removing fish advisories and

restoring waters requires a reduction in

the mass of BCCs that accumulate in

depositional areas of the Great Lakes.

The bottom levels of the food web

biomagnify BCCs that concentrate in

these sinks, affecting the higher levels of

species that tend to be more productive

in these areas. Prohibiting mixing zones

for BCCs in the Great Lakes System can

reduce the natural sink masses below

point source discharges by a factor of 10

to 100 in some circumstances.

EPA reiterates that one of the primary

purposes of the 1995 Guidance and, by

extension, today’s rule is to promote

pollution prevention. Approximately

one-third of the more than 360

hazardous pollutants in the Great Lakes

System could have acute or chronic

toxic effects on aquatic life, wildlife,

and human health. Had the Guidance’s

framework been in place 30 years ago

when the effects of PCBs from point

source discharges began to emerge,

States could have moved quickly to

control these pollutants, avoiding

millions of dollars in cleanup costs,

human health impacts, and other

environmental damage. Prompted by

today’s rule, dischargers can use

pollutant minimization to control

pollutants before new water quality

problems arise. With low concentrations

of new chemicals being introduced into

the environment every year, it would be

prudent to try to avoid future cleanup

costs now.

Although EPA was not able to

quantify all of these benefits in its

analysis of the final Guidance as

promulgated in March 1995, the Agency

believes today’s rule is an integral part

of the framework created by the

Guidance for the type of preventative

measures mentioned above. EPA

believes that these and other benefits

derived from the Guidance and today’s

rule are indeed significant and, further,

draws attention to the potential high

costs of future cleanup that, without the

help of the BCC mixing zone

prohibition, may someday need to be

addressed.

Some commenters asserted that the

proposed rule would yield no benefits

because some Great Lakes States have

already adopted a similar prohibition on

BCC mixing zones (e.g., Indiana). EPA

observes that these commenters do not

make the corresponding argument that

the rule has no costs in those States. As

noted above, the benefits and costs of

the rule are directly linked to reducing

the mass loading of BCCs to the

waterbody. EPA has chosen to assess

costs and benefits in these States

because EPA would be required to

impose these measures through a

Federal promulgation if those Great

Lakes States withdraw or fail to submit

such voluntarily adopted measures.

As for the claim that the annual

benefits of the prohibition will be

between $1.3 million and $4.1 million,

EPA believes that this is an

understatement and was made based on

a misconception of the methodology

EPA used in the Guidance. When EPA

developed the 1995 Guidance, EPA did

not estimate benefits for the entire Great

Lakes Basin; rather, EPA estimated

values for three case-study areas only.

An extrapolation to the whole Great

Lakes Basin from this small number of

case studies, as the commenter has

done, is inappropriate because EPA was

able to estimate basinwide benefits for

one benefit category only, and was not

able to quantify all categories of benefits

even for the three case-study areas (for

example, there is no methodology for

monetizing noncancer health effects

from pollutants like mercury). Nor was

EPA able to account for avoided future

contamination and cleanup in its

analysis of benefits. EPA believes that

any disparity between the

environmental justification for today’s

rule (which the Court found to be

adequately explained) and estimates of

monetary benefits is the result of not

being able to account for all potential

benefits in dollar values.

C. Source Controls, Pollution

Prevention, and Waste Minimization

A number of commenters expressed

the opinion that EPA, in its proposal,

failed to support its statement that

dischargers can comply with the

prohibition through product

substitution, cleaner technologies, and

source controls. These commenters

believe that it is unlikely that many

publicly-owned treatment works

(POTWs) would be able to achieve

additional pollutant reductions through

source controls alone, particularly for

mercury. Some commenters also

asserted that EPA did not evaluate the

cost impacts on indirect dischargers.

EPA disagrees with these comments.

The record shows that it will be

technically and economically feasible

for many dischargers, including POTWs,

to phase out mixing zones for BCCs

during the 10-year phase out period.

Although EPA acknowledges that at

present it may be difficult to identify

potential sources of pollutants within

POTW service areas, as analytical

methods continue to improve, so should

the POTWs’ abilities to identify and

control sources of BCCs and to educate

the public on how to prevent pollution

by avoiding household products that

contain high levels of BCCs or

substituting for those products ones that

are BCC-free or more environmentally

friendly. As discussed below, EPA also

considered the cost impact on indirect

dischargers.

Even though many facilities may face

challenges in achieving effluent

limitations derived from Great Lakes

standards for mercury, EPA’s record

shows that when facilities try to control

mercury they have been able to achieve

significant reductions in their discharge

levels. As described in more detail

below, in many cases these reductions

have been attained by source control,

not end-of-pipe treatment. These

approaches succeed for other BCCs as

well. Less costly than end-of-pipe

treatment, source controls have

included efforts to control more diffuse

sources of BCCs, such as households

using lindane-containing products and

have resulted in substantial increases in

the percentages of BCC removals (U.S.

EPA, 1999).

One commenter argued that all

POTWs will have a hard time meeting

effluent limits for mercury unless a

mixing zone is allowed. The two

primary reasons for this belief are (1)

that POTWs currently have high

concentrations of mercury in influents

from domestic sources alone (according

to the commenter an approximate

median of 110 ppt), and (2) that

pollution prevention is cost-effective for

industrial users only. The conclusion

reached by this commenter, then, is that

end-of-pipe treatment would need to be

added if stringent limitations based on

mercury water quality criteria (1.3 ng/L)

are to be met. EPA believes that both of

the reasons given overstate the issue and

that the conclusion is based on an

incorrect premise. EPA acknowledges

that many POTWs have high

concentrations of mercury in their

influent and agrees that these high

levels need to be significantly reduced

if POTWs are to meet the stringent

effluent limits contemplated by today’s

rule. The mere fact that high mercury

concentrations exist, however, does not

mean that they cannot be controlled at

the source, prior to the time they arrive

at the POTW. Indeed, EPA’s record

shows that source controls, pollution

prevention, and waste minimization

often are far more efficient and cost

effective than end-of-pipe treatment for

mercury. EPA does not agree that costeffective opportunities typically occur

for POTWs only when there are

industrial sources with high loading

rates. EPA acknowledges that if the great

majority of mercury in a POTW’s

influent is derived from one or two

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67643

sources, obviously it would be easier

and more cost-effective to control those

sources than it would be to control

other, more diverse sources.

Nonindustrial sources, however, such as

dental and medical facilities, often

discharge high concentrations of

mercury. These sources are usually

classified as ‘‘domestic’’ rather than

‘‘industrial’’ discharges. In those few

cases in which POTWs have seriously

attempted to reduce mercury from

domestic sources, significant measures

of success from control of commercial

facilities in ‘‘domestic’’ wastewater have

been achieved. While dental and

medical facilities tend to be more

widely distributed than ‘‘industrial’’

facilities, reductions in discharges can

be organized through a variety of

programs that include campaigns

directed toward dental and medical

practices and public education. In some

cases, dental and medical offices are

required to remove mercury prior to

discharging to sewers. The bottom line

is that the treatment of more

concentrated wastestreams at the source

or pollution prevention at the source is

more likely to be cost-effective than

treating diluted wastestreams at the

POTW.

EPA understands that the control of

mercury from ‘‘domestic’’ sources

would entail costs on the part of the

POTW, but such costs are likely to be

considerably smaller than those

required for end-of-pipe treatment. In

sum, the most cost-effective way in

which POTWs can substantially reduce

mercury discharges thus appears to be

pollution prevention and waste

minimization. These programs can focus

on high concentration high volume

industrial discharges to the collection

system as well as high concentration

low volume discharges, such as those

coming from medical and dental

facilities. As evidence, EPA provides the

example of the Western Lake Superior

Sanitary District (WLSSD), which, after

evaluating the costs involved in meeting

more stringent water quality-based

effluent limits for mercury with end-ofpipe treatment, concluded that

pollution prevention techniques were

the preferable control strategy. As of

1996, WLSSD had successfully reduced

mercury concentrations at the

wastewater treatment plant by more

than 74% from 1990 dry sludge levels

(from 4.50 ppm to 1.15 ppm) and by

more than 97% from 1990 effluent

levels (from 0.58 ppb to 0.015 ppb),

which brought WLSSD well into

compliance with its existing WQBEL.

Additional examples of source control

programs can be found in Overview of

P2 Approaches at POTWs, Draft, Office

of Science and Technology, March (U.S.

EPA, 1999). EPA believes that facilities

like WLSSD, with the use of super clean

analytical methods to better identify and

characterize sources of mercury, will be

able to advance their pollution

prevention efforts to further reduce the

levels of mercury in their sludge and

effluent as mixing zones are phased out

over the next 10 years.

Further, EPA believes that recent data

submitted by the Association of

Metropolitan Sewerage Agencies

(AMSA) support EPA’s position that

product substitution, cleaner

technologies, and source controls are

the most efficient and cost-effective

means of reducing BCCs. These data

indicate that POTWs are achieving, on

average, about 97 percent removal of

mercury from their influent with an

average effluent discharge concentration

of about 9 parts per trillion (ppt or ng/

L). Wastewater from industrial and

commercial establishments, however,

such as hospitals, medical waste

incinerators, industrial laundries,

medical/dental/clinical laboratories,

dental offices, and others, can be

discharged directly to the POTW’s

wastewater collection system virtually

unregulated at concentrations that

exceed 1 million ppt. Indeed, AMSA’s

data indicate that influent mercury

concentrations at the headworks of

POTWs range from 50 ppt to 1300 ppt.

What this means is that POTWs are

channeling a significant amount of

mercury into their sludge

(approximately 30 to 40 tons

nationally), which results in a release of

chemicals into the environment when

the sludge is disposed of through

incineration or land-application

practices. EPA estimates that between

0.6 and 1.9 tons of mercury are emitted

each year from sewage sludge

incinerators in the vicinity of the Great

Lakes Basin. In essence, pollutants are

merely being transferred from one

medium to another. Therefore, EPA

believes that the solution to controlling

mercury releases to the environment is

not to change the medium from the

POTW’s influent to its sludge and

effluent, but to either prevent mercury

from entering the wastewater collection

system at the source through product

substitution, waste minimization, or

process modification, or by removing

and recycling mercury at the source

(i.e., employing source controls) using

state-of-the-art technology. Such costeffective source controls, which will

prevent additional environmental

releases, provide an auxiliary

environmental benefit to today’s

rulemaking.

In conclusion, pollution prevention

(including product substitution by

households), waste minimization, and

source controls for high concentration

low volume industrial and commercial

discharges (as well as high

concentration high volume discharges)

to the POTW’s collection system, are the

most cost-effective approaches to

reducing overall environmental releases

to water, as well as to air and land. At

facilities in which these approaches

have been implemented, substantial

reductions in BCC concentrations,

including mercury concentrations in

POTW influents, sludges, and effluents,

have been achieved. Where these

reductions are insufficient to meet

WQBELs, POTWs can seek an exception

to the mixing zone prohibition. A

condition for eligibility is that the

facility has and will continue to

implement controls or pollution

prevention measures to reduce or

ultimately eliminate the BCC. Thus,

aggressive pollution prevention efforts

may well achieve the necessary

reductions to meet a WQBEL with no

mixing zone, but if not, will help the

facility to qualify for an exception.

With respect to costs, in 1995, EPA

estimated potential costs to indirect

dischargers of implementing the

Guidance with the mixing zone

provision to be between $6.6 million

and $19.9 million per year (in 1994

dollars). In addition, EPA’s estimate of

total costs to direct and indirect

dischargers to implement the Guidance

in 1995 (including the mixing zone

provision) of $60 million to $380

million per year included source control

costs for POTWs (i.e., costs to control

indirect discharges). EPA’s analysis of

today’s rule provides an estimate of the

portion of the $60 million to $380

million cost range that is attributable to

just the phase out and elimination of

mixing zones. By including costs for

source controls at POTWs, EPA’s cost

estimates reflect costs that could be

passed on to dischargers to POTWs.

EPA also conducted an analysis of

potential impacts on small entities.

Although this analysis looks at small

dischargers that are direct dischargers

(the Guidance only regulates direct

dischargers), EPA did not find a

significant impact on small entities. In

addition, an independent economic

analysis of the Guidance (including the

BCC mixing zone prohibition)

concluded that it would have an

imperceptible impact on the region’s

economy (DRI/McGraw-Hill, 1993).

Thus, EPA can only conclude that the

impacts on many industries discharging

to POTWs will not be significant.

67644 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

D. Other Cost Issues Related to

Rulemaking Implementation

A commenter from California

expressed concern that end-of-pipe

treatment would be necessary to meet

water quality-based effluent limitations

based on water quality criteria for BCCs

in the Great Lakes and that such

treatment would cost $2.45 billion to

implement in California alone.

Additional commenters cited an Ohio

study that reported that EPA’s cost

estimates were too low and that the

elimination of mixing zones for BCCs in

the Great Lakes will result in significant

costs for dischargers.

EPA disagrees with the claim that

today’s rule would force the

construction and operation of

extraordinary treatment. As discussed

earlier EPA believes that an aggressive

pollutant minimization program

consisting of source controls, pollution

prevention (e.g., product substitution or

process modification), and public

education, can attain effluent limits

based on achieving criteria end-of-pipe.

While there are new data showing that

mercury comes from a variety of sources

and products (e.g., industrial,

commercial, household), no one to date

has demonstrated that an aggressive

long-term pollutant minimization

program containing these features has

failed in this regard, or that, as a result,

the State or community had to force the

construction of extraordinary end-ofpipe treatment that was later

determined to be cost ‘‘ineffective’’ with

no environmental benefit. In addition,

the sampling results presented by

AMSA for mercury at POTWs in and out

of the Great Lakes Basin do not provide

evidence that Great Lakes standards for

BCCs cannot be met without end-of-pipe

treatment. EPA recognizes that

discharges from some facilities exceed

the mercury criterion, but, based on

results from facilities that have tried to

control mercury, significant reductions

in discharge levels have been achieved.

In many cases, these reductions have

been attained by source control, not

end-of-pipe treatment, demonstrating

the feasibility of this approach. (Refer to

section IV.C for more discussion on the

benefits of source controls). EPA also

notes that if, after ten years, it appears

that a pollution minimization program

at a facility will not achieve the

necessary BCC reductions, today’s rule

affords States and Tribes the flexibility

to authorize BCC mixing zones when

additional controls are not technically

feasible or cost-effective.

Even though the rule is only

applicable to the Great Lakes Basin, EPA

disagrees with the claim that

implementing the rule in California

would cost $2.45 billion. The cost tables

offered by the commenter to support

this estimate do not provide information

on the current levels of mercury or other

BCC concentrations in California

POTWs, the estimated reductions

needed to achieve revised standards for

BCCs, or the treatment already in place

at these facilities. Instead, the cost tables

provide only calculations of a worstcase estimate assuming all California

POTWs would need to implement lime

precipitation, carbon adsorption, and

reverse osmosis. A thorough facilitylevel analysis, which was not furnished

by the commenter, is essential if the

commenter wishes to provide

meaningful cost estimates. Further, EPA

has not seen impacts of the magnitude

indicated by the commenter in other

regions of the country that have

aggressive water quality standards

programs. Moreover, data for California

POTWs evaluated by EPA as part of

analysis of the California Toxics Rule do

not support the claim that all POTWs

would need end-of-pipe treatment to

meet criteria end-of-pipe for mercury

and other BCCs in California.

With respect to comments regarding

the Ohio mercury study, EPA believes

that Ohio’s alternative cost analysis for

mercury is not compelling here because

it assumes that end-of-pipe treatment is

necessary in cases when EPA would

conclude otherwise. EPA believes that

this is an artificial analysis of the

options required of dischargers. EPA’s

own estimates instead assume a

combination of end-of-pipe treatment

and lower cost alternatives such as

process modification, waste

minimization, pollution prevention,

source controls, and public education.

In addition, Ohio’s estimates are also

not comparable to EPA’s because they

reflect not only the costs of today’s

mixing zone rule but also costs

associated with the Guidance

promulgated in 1995. EPA’s estimates

for today’s rule reflect only the impact

of the BCC mixing zone provision, not

the impact of the entire 1995 Guidance.

Using this estimate, as well as

information on the contribution of air

sources to mercury water concentrations

in Ohio, Ohio adopted a variance

provision for mercury for point source

dischargers that requires dischargers, in

order to obtain the variance, to

implement a plan of study and pollutant

minimization plan for identifying and

reducing loadings of mercury. Thus,

Ohio variance provision employs much

the same control strategies

contemplated by EPA.

E. Point Source Loadings

Some commenters on EPA’s proposed

rule argued that point sources

contribute a relatively insignificant

amount of BCCs (mercury, in particular)

when compared to the total

accumulation of BCCs in the Great

Lakes caused by other sources, such as

atmospheric deposition.

EPA disagrees with the assertion that

point source loadings are insignificant

and believes that comparing the total

contribution of BCCs from point sources

and atmospheric sources to the entire

Great Lakes System often ignores the

nature of point source discharges and

their spatial impact on the environment.

Macro-scale analyses of the atmospheric

contribution of BCCs to the Great Lakes

System is not comparable with localized

point source studies because those

analyses assume that atmospheric

deposition is constant and uniform over

a significantly larger geographical area

like the Great Lakes Basin. The water

column concentrations from air

deposition derived from such

assumptions simply assume that the

Great Lakes Basin is one unique,

enormous, completely mixed system.

These assumptions are used by

researchers who study the fate and

transport of pollutants on a large-scale

system, not by researchers who address

localized impacts on a much smaller

scale, such as the ones created by point

source dischargers.

By their very nature, point source

discharges create ‘‘hot spots’’ within the

Great Lakes System where elevated

concentrations of BCCs have a potential

adverse impact on aquatic life, wildlife,

and human health. In other words, a

point source discharge does not disperse

and mix completely throughout the

entire Great Lakes System, as is

assumed for BCCs from atmospheric

deposition. Therefore, comparing

contributions from the two sources on

such a large scale conceals the real

impact of BCCs from point source

discharges. In fact, when assessing the

impact of a point source discharge,

water quality analysts do not perform a

mass balance on the entire lake system,

but rather on the specific zone of

influence of the point source discharge

where atmospheric deposition may be

insignificant and generally not taken

into account.

F. TMDLs and Other CWA Issues

Some commenters asserted that a BCC

mixing zone prohibition is inconsistent

with the Clean Water Act and

implementing regulations and they

argue that EPA erroneously concluded

that mixing zones are never permissible

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67645

in impaired waters. Others assert that

today’s rule would interfere with States’

abilities to control discharges through a

TMDL process. Other commenters

simply assert that BCC mixing zones

should be available wherever the area of

impact from the discharge is not

biologically significant.

With respect to the first assertion, the

question of when and whether mixing

zones (for any pollutant) are permissible

in impaired waters is outside the scope

of today’s rule. Today’s rule applies

only after the permitting authority has

determined that a mixing zone for BCCs

might otherwise be available in the

Great Lakes System under the Clean

Water Act and State and federal

implementing regulations and

standards. Today’s rule establishes

restrictions on the availability of such

mixing zones. In addition, the general

availability of mixing zones in impaired

waters was not relevant to EPA’s cost

estimates for today’s rule. Rather, EPA

estimated its costs for this rule based on

the perhaps over-broad assumption that

mixing zones for BCCs would be

available throughout the Great Lakes for

each discharger with known or

suspected BCC discharges.

EPA’s discussion in the preamble to

the proposed rule about the availability

of mixing zones in impaired waters

generated considerable concern that

EPA was announcing a new policy

banning mixing zones in impaired

waters. EPA does not have a general

policy on the availability of mixing

zones in impaired waters at this time

and generally defers to States on this

issue. What the preamble discussion

reflected was the application of

provisions in procedure 3 governing the

calculation of wasteload allocations in

various situations. Under procedure

3.B.c.3, background levels of the

pollutant must be accounted for in

determining wasteload allocations

(WLAs). When background levels of the

pollutant for which a mixing zone is

sought already exceed the applicable

criterion in the receiving water, there

may be no available dilution, despite

the availability of a mixing zone.

(Exceptions might be where there are no

currently available data for calculating

background values as provided in 3.B.9

or where anticipated loading reductions

would lower background levels (see

3.C.3.b.iii) and ‘‘free up’’ assimilative

capacity for use in calculating WLAs.)

Thus, the preamble discussion in the

proposal used the absence of a mixing

zone as a simplified way of discussing

other procedures that might have the

same effect when calculating WLAs for

discharges to impaired waters.

With respect to the second assertion,

EPA agrees that today’s rule limits the

discretion of Great Lakes States to use

a TMDL as a vehicle for establishing

mixing zones for BCCs in the Great

Lakes System. EPA believes that this

restriction is reasonable because of the

documented environmental and health

effects caused by BCCs in the Great

Lakes System. EPA notes, however, that

Great Lakes States are not absolutely

foreclosed from authorizing a mixing

zone for BCCs in the context of a TMDL.

For existing dischargers, today’s rule

provides for a 10-year phase-out period

that allows dischargers sufficient time to

develop and implement control

strategies to achieve WQBELs based on

meeting water quality criteria end-ofpipe. The rule also provides for

exceptions to the mixing zone

prohibition for existing discharges of

BCCs. In addition to the water

conservation exception, the rule

authorizes an exception to account for

technical and economic circumstances.

This exception could be employed, at

the discretion of the State, beyond the

10-year period (perhaps implemented

through a TMDL) if the State determines

that more aggressive controls aimed at

achieving criteria at the end of the pipe

would not be cost-effective or

economically or technically feasible for

the existing BCC discharge in question.

Finally, in response to the third

assertion, regarding the availability of

mixing zones when the impact is not

biologically significant, EPA is

particularly concerned with how

commenters are defining ‘‘not

biologically significant.’’ EPA does not

consider mixing zones an entitlement

and does not agree that it is reasonable

to not seek reduction of mass loadings

of BCCs to areas of the Great Lakes

System that no longer are considered

‘‘biologically significant.’’ In many

cases, these areas have been biologically

impacted because of the discharge of

these pollutants. That is no reason that

they should remain aquatic waste

dumps especially when improved water

quality is feasible. Further, one of the

basic tenets underlying the mixing zone

prohibition is that the adverse impacts

of BCC discharges can almost never be

limited to areas that are determined to

be biologically or otherwise

insignificant. If the receiving water is

connected to another waterbody, that

other waterbody would almost certainly

be affected adversely by BCC discharges.

States, nevertheless, have the flexibility

to allow a mixing zone under certain

exceptions, as noted above.

G. EPA’s Fulfillment of the Court

Remand

In 1997, the U.S. Court of Appeals for

the District of Columbia Circuit

remanded the provisions of the

Guidance to phase out and eliminate

mixing zones for BCCs. The Court found

that ‘‘[a]lthough the EPA appears to

have shown that eliminating mixing

zones is not without some

environmental benefit, the agency

simply failed to address whether the

measure is cost-justified. We remand the

matter in order to afford the EPA an

opportunity to do just that,’’ American

Iron & Steel Institute (AISI) v. EPA, 115

F.3d 979 (D.C. Cir. 1997). This finding

resulted because the Agency had

estimated the total cost of eliminating

BCC mixing zones at $200,000 yet did

not explain a comment estimating at

approximately $300,000 the cost to one

town of removing the BCC mercury from

its sewage discharge. Commenters on

the proposal for this rulemaking

asserted that EPA’s revised cost

estimates had been underestimated and

that EPA had not yet satisfied this order.

EPA’s 1995 sensitivity analysis on the

BCC mixing zone provisions of the

Guidance produced the $200,000

estimate because State derived permit

limits (based on State water quality

standards and mixing zone

requirements) and Guidance-based

permit limits (derived without a mixing

zone) were both below analytical

method detection levels. This provided

EPA with little information concerning

the effectiveness of possible pollution

control strategies that the Guidance

might impose over those that would be

required to achieve current State (i.e.,

pre-Guidance) permit limits. EPA

recognized at the time that its mixing

zone sensitivity analysis did not

produce a justifiable cost estimate and

supplemented it with a second analysis

that evaluated the possible cost impacts

of reducing potential hidden loadings of

BCCs as future analytical detection

methods improve. This analysis showed

that if hidden loadings exist and

analytical method detection levels

improve, significant costs impacts from

reducing BCCs could occur. However,

this analysis did not evaluate the impact

of the BCC mixing zone prohibition

alone.

As such, EPA has reevaluted the

comment from the City of Owosso on

the proposed Guidance in which they

asserted that it would cost $300,000 to

remove mercury from their sewage

discharge. EPA notes that the $300,000

estimate presented by the City of

Owosso is not comparable to the cost

that was estimated in 1995 for the

67646 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

elimination of mixing zones for BCCs

($200,000) nor is it comparable to the

costs estimated for today’s rule. This is

because the City’s cost is the total cost

estimated to be necessary to comply

with all of the requirements contained

in the 1995 Guidance (as proposed).

That is, the City did not distinguish

between the original BCC mixing zone

provision and the rest of the Guidance.

The $300,000 estimate does not

represent the incremental cost of

eliminating mixing zones for BCCs. Nor

did the City provide in its comment any

information regarding the State’s

mercury water quality standard for the

receiving water (Michigan’s mercury

standard that it has been using for over

15 years to protect human health and

wildlife is as stringent as the mercury

criteria promulgated in the 1995

Guidance, but less stringent than the

criteria in the proposed Guidance), or

the dilution and ambient background

data that is used by the State permitting

authority to evaluate reasonable

potential and calculate permit limits for

this facility when mixing zones are

allowed. Nonetheless, the City’s cost

estimate of $300,000 is within the

average cost range per municipal facility

that EPA calculated for its economic

analysis of the entire 1995 Guidance

(from $75,185 to $822,251 under the

low and high scenarios, respectively).

In addition, the City did not indicate

in its comment if it had previously

conducted any pollution prevention or

minimization efforts among its users.

Although the commenter describes the

industrial contribution to its headworks

as ‘‘light,’’ this is not a sufficient

argument to disregard, without further

assessment, the true impact of the

existing industrial discharges and the

applicability of pollution prevention to

control them. Most importantly, the City

did not indicate whether or not it had

conducted pollution prevention

assessments at any medical and dental

offices that it serves. Medical and dental

offices have been found, in many cases,

to significantly contribute to the

mercury levels in the influents to

POTWs but have controllable sources of

mercury that are readily amenable to

cost-effective pollution prevention

techniques.

Nonetheless, as discussed above, EPA

has revised its economic sensitivity

analysis of today’s BCC mixing zone

provision in response to the Court

remand. EPA’s estimated cost range for

the 1995 Guidance, which included the

1995 provision to prohibit mixing zones

for BCCs, was $60 million to $380

million per year. EPA estimates, based

on its revised analysis, that the portion

of that cost range attributable to today’s

rule to prohibit mixing zones for BCCs

is between $12 million and $35 million

per year (not $200,000 as was indicated

in 1995).

Not only does EPA believe that this

revised estimate is reasonable, it

believes that the upper estimate ($35

million annually) may be overstated.

This is because the upper estimate is

based on pre-1995 effluent data. When

EPA supplemented these data for

today’s rule using high-resolution and

super clean analytical techniques for

detecting BCCs in POTW effluents, it

obtained the $12 million per year

estimate. This lower estimate is due to

the fact that concentrations in BCCs in

POTW effluents were found to be

substantially lower than expected.

Complementing the Agency’s opinion

in this regard is DRI/McGraw-Hill’s

independent review of the analyses of

costs for the 1995 Guidance from which

the costs for the proposed rule were

derived. This review found EPA to be

‘‘conservative in the sense that, on the

whole, higher costs were adopted in

cases where assumptions were required

due to incomplete data’’ (DRI/McGrawHill, 1995). Thus, EPA expects that its

cost estimates overstate, rather than

underestimate, the costs associated with

the Guidance and, by extension, today’s

rule.

For these reasons and other reasons

set forth in the rulemaking record, EPA

believes that its revised economic

analysis provides a substantiated

estimate of the potential incremental

costs of the rule. EPA also believes that

today’s rule is ‘‘cost-justified.’’ That is,

EPA believes that the estimated costs

are reasonable in view of the benefits

derived from minimizing the adverse

effects of pollutants such as mercury in

the Great Lakes System as a result of

this rule. Today’s rule also complies

with the test articulated in the GLWQA,

which called for the reduction of BCC

mixing zones to the maximum extent

possible. EPA estimated that today’s

rule will result in a reduction of

between 225,000 and 668,000 toxicweighted pounds (or between 876 and

81,718 unweighted pounds) of

pollutants from the Great Lakes System

each year. This includes loadings of

chlordane, DDT, dieldrin,

hexachlorocyclohexane, alphahexachlorocyclohexane, betahexachlorocyclohexane,

hexachlorocyclohexane, lindane,

mercury, PCBs, pentachlorobenzene,

1,2,4,5-tetrachlorobenzene, 2,3,7,8-

TCDD, and toxaphene. As described

previously, this will reduce the

accumulation of BCCs in depositional

areas of the Great Lakes, reducing the

probability for bioaccumulation in the

food chain and adverse effects on fish,

wildlife, and humans. EPA believes that

these avoided effects justify the costs

even when the cost to remove a pound

of a specific pollutant may be relatively

high.

In addition, EPA has codified

exceptions to the mixing zone

prohibition to ensure that the BCC

reductions achieved under the rule are

both technically feasible and costeffective. Procedure 3.C.6.a.ii states that

dischargers must reduce the loadings of

BCCs to ‘‘the maximum extent possible

such than 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 costeffective.’’ As noted above in Section III,

EPA modified this provision from the

1995 Guidance to clarify the importance

of implementing only those control

strategies determined to be costeffective. For example, if the State

determined that the discharger or

affected community would face

unreasonable economic effects as a

result of implementing the rule, it could

grant the exception.

In relation to this topic, some

commenters alleged that the cost

justification required by the Court’s

remand necessitated a justification of

benefits. However, as several industry

commenters have observed in arguing

that EPA’s benefits analysis is

irrelevant, the AISI Court already has

held that EPA adequately explained the

environmental benefits of its BCC

mixing zone prohibition. Moreover, EPA

may have understated the resulting

benefits, because many benefits

categories are not amenable to

quantification (e.g., estimating the

number of noncancer human health

cases avoided from exposure to fish

contaminated with mercury and

monetizing those benefits) and can only

be discussed in qualitative terms. In

addition, EPA’s benefits estimates do

not account for the impact of pollution

prevention strategies with respect to the

environment as a whole; as a result of

today’s rule, not only will fewer BCCs

be discharged into the Great Lakes

System, but EPA expects that overall

release of BCCs to the environment will

be reduced as well, so that these

pollutants are not simply transferred to

the air or soil.

V. Special Provision for Certain New or

Expanded Discharges of BCCs from

Municipalities

In proposing today’s rule, EPA

requested comments on excluding from

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67647

the definition of ‘‘new discharge’’ any

new or expanded discharges of BCCs

from POTWs when such discharges are

necessary to prevent a public health

threat to the community. EPA did not

receive any comments directed at this

exclusion. The Agency is promulgating

this new exclusion because it believes

that it is a reasonable, common sense

policy that balances competing health

risks. As such, new or expanded

discharges to which this exclusion

applies will be treated as existing

discharges of BCCs for purposes of

today’s rule. See procedure 3.C.2 (2).

VI. Economic Analysis

As described above in Section IV,

EPA revised its analysis of the potential

costs associated with eliminating and,

for existing discharges, phasing out

mixing zones for BCCs from the analysis

that accompanied the Guidance in 1995.

EPA’s estimated cost range for the 1995

Guidance, which included the 1995

provision to prohibit mixing zones for

BCCs, was $60 million to $380 million

per year. EPA estimates, based on its

revised analysis, that the portion of that

cost range attributable to today’s rule

ranges from $12 million to $35 million

per year. This estimate, and EPA’s

methodology, are presented in the

proposal for today’s rulemaking (64 FR

53632, October 4, 1999).

VII. 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 therefore is 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. Small entities

include small businesses, small

organizations, and small governmental

jurisdictions.

For purposes of assessing the impacts

of today’s rule on small entities, small

entity is defined as: (1) A small business

based on Small Business Administration

size standards; (2) a small governmental

jurisdiction that is a government of a

city, county, town, school district or

special district with a population of less

than 50,000; and (3) a small

organization that is any not-for-profit

enterprise which is independently

owned and operated and is not

dominant in its field.

EPA prepared a screening analysis to

evaluate the financial impact on small

entity dischargers that would be subject

to the requirements of the rule (i.e.,

NPDES permit holders that may

discharge BCCs). EPA identified 2,329

of these small entities and estimated

that more than 96% of them would not

be significantly affected. EPA

determined that potential impacts

represent less than 1% of estimated

revenues for 2,290 small entity

dischargers under the low cost scenario

and 2,244 under the high cost scenario.

For small entities that may be affected

more, EPA estimates the impact on

small municipal dischargers to range

from 3% to 5% under the low cost

scenario for seven facilities, and from

3% to 14% under the high cost scenario

for 43 facilities, with a midpoint of 5%.

EPA determined that potential impacts

on nonmunicipal dischargers represent

less than 1% of estimated revenues.

EPA believes that its screening

analysis is conservative (erring on the

side of higher costs and greater impacts

on small entities than would normally

be expected) because Great Lakes States

and Tribes have flexibility to authorize

mixing zones for small entities under

certain technical and economic

circumstances and EPA’s screening

analysis did not take these

circumstances into consideration. EPA

further believes that as States and Tribes

exercise this flexibility for small

municipal dischargers that may be

affected by this rule the cost impact

realized would be near the low end of

the range. The screening analysis results

were presented in more detail in the

proposal for today’s final rulemaking

(64 FR 53632, October 4, 1999) and the

analytical method is described in a

document entitled 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 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 use substitutes for

these products, rely on cleaner

technologies that do not require their

use or that do not produce BCCs as a byproduct, 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.

After considering the economic

impacts of today’s final rule on small

entities, I certify that this action will not

have a significant economic impact on

a substantial number of small entities.

This rulemaking amends the 1995 Water

Quality Guidance for the Great Lakes

System to establish requirements that

apply in the first instance to Great Lakes

States and Tribes. Today’s rule restricts

the current discretion of States and

Tribes to allow mixing zones when

establishing water quality-based effluent

limitations for discharges of BCCs to the

67648 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

Great Lakes System. Great Lakes States

and Tribes (or EPA, if a State or Tribe

fails to do so) must adopt requirements

to ensure that all discharges of BCCs to

the Great Lakes System receive limits no

greater than the water quality criteria for

those BCCs. In the case of existing

discharges of BCCs, Great Lakes States

and Tribes need not require attainment

of such limitations until November 15,

2010. Great Lakes States and Tribes also

retain some discretion after that date to

authorize mixing zones for existing

discharges of BCCs in specified

circumstances.

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 MidTex Elec. Co-op v. FERC, 773 F.2d 327,

342 (D.C. Cir. 1985). Today’s rule

applies to States and Tribes in the Great

Lakes System when issuing NPDES

permits. It establishes requirements that

Great Lakes States and Tribes must

adopt and apply to all new and existing

discharges of BCCs in the Great Lakes

System, including discharges from small

entities. The universe of dischargers

affected by the rule is certain and Great

Lakes States and Tribes have no

discretion in implementing the rule

with respect to new BCC discharges and

only limited authority to modify the

requirements with respect to existing

BCC discharges. In this sense, the rule

imposes requirements on new and

existing dischargers in the Great Lakes

System.

The requirements in this rulemaking

do not become binding requirements on

direct dischargers until they are used to

derive effluent discharge limitations as

conditions in an NPDES permit issued

to the discharger. However, effluent

limitations based on today’s regulations

must be included by NPDES permitting

authorities as permit conditions when

the permitting authority issues or

reissues permits to direct dischargers

discharging BCCs to the Great Lakes

System. Based on this consideration,

EPA has concluded that small entities

will be subject to the regulation for

purposes of the RFA, and EPA has

accordingly evaluated the impact of the

rule on small entities. Based on its

assessment, the Agency concludes that

this rulemaking will not have a

significant economic impact on a

substantial number of small entities for

the reasons explained above.

Although this final rule will not have

a significant economic impact on a

substantial number of small entities,

EPA nonetheless has tried to reduce the

impact of today’s rule on small entities

by authorizing an exception, granted

solely at the discretion of the State or

Tribe on a case-by-case basis, under

certain circumstances. EPA believes that

small entity dischargers will have an

easier time meeting an economic

threshold that would qualify them for

the exception. Prior to promulgation of

the final 1995 Water Quality Guidance,

which contained the BCC mixing zone

prohibition, EPA received in excess of

23,000 pages of information and data

from over 6,000 respondents on its April

16, 1993, proposal. To stay abreast of

public expectations for the final

Guidance, EPA continued to meet with

State, Local, and Tribal government

officials, financial officials and coregulators, the regulated community and

environmental interests to listen and

openly discuss their concerns. During

the post-proposal process for the

Guidance, EPA participated in over 40

such meetings with over 1,000

stakeholder representatives including

small entities. The comments and issues

raised by the various stakeholders were

considered in EPA’s option selection

process and regulatory impact analysis

for developing the final Guidance. The

open public process resulted in

meaningful changes to the final

Guidance. Many of the provisions

outlined in the proposal were revised

for the final Guidance to increase

flexibility for State, local, and Tribal

implementation, and to reduce the

impact of the Guidance on large and

small entities. Today’s final rule builds

on that process.

C. Paperwork Reduction Act

An agency may not conduct or

sponsor 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.

The OMB control number for EPA’s

regulations are listed in 40 CFR part 9

and 48 CFR Chapter 15. Under this rule,

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

received approval from OMB for that

information collection as part of the

1995 rulemaking. OMB renewed its

approval in September 30, 1998. The

OMB control number is 2040–0180 and

is listed in 40 CFR part 9. EPA will

renew this information collection prior

to the date by which Great Lakes States

and Tribes must make submissions

consistent with today’s rule.

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,

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 rule amends part

132 to prohibit mixing zones for BCCs

in the Great Lakes System. EPA has

determined that this 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 to $35 million. Thus, today’s rule 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 rule

contains no regulatory requirements that

might significantly or uniquely affect

small governments. As described above,

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67649

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 use

substitutes for 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

rule is to 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 Order on Federalism

Executive Order 13132, entitled

‘‘Federalism’’ (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the 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.’’

This final rule does not have

federalism implications. It will not have

substantial direct effects on the 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 13132. Today’s rule

simply requires the Great Lakes States to

add one discrete provision to the

regulations and policies they were

already required to adopt pursuant to

the 1995 Guidance. EPA’s estimated

cost range for the 1995 Guidance, which

included the 1995 provision to prohibit

mixing zones for BCCs, was $60 million

to $380 million per year. EPA estimates

that only a small portion of that cost

range, $12 million to $35 million per

year, is attributable to today’s rule.

Similarly, this rule will not have a

substantial direct effect upon the

distribution of power and

responsibilities among the various

levels of government because the States

retain primary responsibility for

administering their NPDES permit

programs, through which this rule is

implemented. The rulemaking

authorizes EPA to promulgate these

mixing zone provisions only if an

authorized State has failed to act.

Accordingly, these provisions will not

have a substantial direct effect on States

or on intergovernmental relationships or

responsibilities. Thus, the requirements

of section 6 of the Executive Order do

not apply to this final rule.

Although section 6 of Executive Order

13132 does not apply to this rule, EPA

extensively involved State, local, and

Tribal government representatives in the

development of this amendment,

notably during the process of

developing the 1995 Guidance, which

contained the original version of today’s

rule. 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 (March 23,

1995). As described above, today’s

action by EPA reinstates 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.

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 unless 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

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. See section VII. D above for more

discussion. Therefore, the requirements

of section 3(b) of Executive Order 13084

do not apply to this rule. Nonetheless,

EPA has extensively involved Great

Lakes State, local, and Tribal

governments in the development of this

amendment, notably during the process

of developing the 1995 Guidance, which

contained the original version of this

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 rule is not subject to the

Executive Order because it is not

economically significant as defined in

Executive Order 12866. As noted earlier,

however, children may be at a greater

risk to BCCs than adults. If they are at

greater risk, then they will benefit the

most from this rule to prohibit mixing

zones for BCCs in the Great Lakes

System.

67650 Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations

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 that 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 rule

essentially reinstates, with some

clarification, the BCC mixing zone

provisions of the 1995 Guidance. Since

the substance of today’s rule has already

been the subject of section 7

consultation, the effects of today’s rule

have been addressed by the Services’

prior biological opinion.

I. National Technology Transfer and

Advancement Act

As noted in the proposed rule,

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Public Law 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 of

Management and Budget, explanations

when the Agency decides not to use

available and applicable voluntary

consensus standards.

Today’s rule does not involve

technical standards; therefore, EPA did

not consider using any voluntary

consensus standards. EPA received no

comments on this aspect of the

rulemaking and no commenter

identified any potentially applicable

voluntary consensus standards for use

in this regulation.

J. Submission to Congress and the

General Accounting Office

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This rule is not a major rule as defined

by 5 U.S.C. 804(2). This rule will be

effective December 13, 2000.

VIII. Supporting Documents

All documents that are referenced in

this preamble are available for

inspection and photocopying in the

docket of the 1995 Guidance and the

docket of this rulemaking at the address

listed at the beginning of this preamble.

A reasonable fee will be charged for

photocopies.

EPA is also making a number of

documents available in electronic

format at no incremental cost to users of

the Internet (http://www.epa.gov/ost/

GLI). These documents include the

contents of this Federal Register

document and several other supporting

documents and materials.

IX. References

Amyot, M., J.D. Lalonde, L. Poissant, and

D.R.S. Lean. 1999. Mercury in Lake Ontario

and the St. Lawrence River. Great Lakes

Research Review 4(2): 1–4.

DRI/McGraw-Hill. 1995. Great Lakes Water

Quality Initiative, Cost Effectiveness Update.

June.

Elliot, J.E., R.J. Norstrom, A. Lorenzen, L.E.

Hart, H. Philibert, S.W. Kennedy, J.J.

Stegeman, G.D. Bllward, 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 15: 782–93.

Mason, R.T., and K.A. Sullivan. 1997.

Mercury in Lake Michigan. Environmental

Science and Technology 31: 942–47.

Sweeney, B.W., D.H. Funk, and L.J.

Standley. 1993. Use of the stream mayfly

Cloeon triangulifer as a bioassay organism:

life history response and body burden

following exposure to technical chlordane.

Environmental Toxicology and Chemistry 12:

115–25.

U.S. EPA. 1995. Regulatory Impact

Analysis for the Final Great Lakes Water

Quality Guidance. U.S. Environmental

Protection Agency, Washington, D.C.

U.S. EPA. 1997. Guidance for Assessing

Chemical Data for Use in Fish Advisories.

Volume 2. Risk Assessment and Fish

Consumption Limits. EPA 823-B–97–009.

U.S. Environmental Protection Agency,

Washington, D.C.

U.S. EPA. 1999. Overview of Pollution

Prevention Approaches at POTWs. Draft.

Office of Science and Technology. U.S.

Environmental Protection Agency,

Washington, D.C.

List of Subjects in 40 CFR Part 132

Environmental protection,

administrative practice and procedure,

Great Lakes, Indian lands,

Intergovernmental relations, Reporting

and recordkeeping requirements, Water

pollution control.

Dated: November 2, 2000.

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

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:

§ 132.5 Procedures for adoption and EPA

review.

(a) Except as provided in paragraph

(c) of this section, the Great Lakes States

and Tribes shall adopt and submit for

EPA review and approval the criteria,

methodologies, policies, and procedures

developed pursuant to this part no later

than September 23, 1996. With respect

to procedure 3.C of appendix F of this

part, each Great Lakes State and Tribe

shall make its submission to EPA no

later than May 13, 2002.

* * * * *

(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 November

13, 2002.

* * * * *

Federal Register / Vol. 65, No. 219 / Monday, November 13, 2000 / Rules and Regulations 67651

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 no higher

than the most stringent applicable water

quality criteria or values for the BCCs in

question. This prohibition takes effect for a

Great Lakes 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. Not included

within the definition of ‘‘new discharge’’ are

new or expanded discharges of BCCs from a

publicly owned treatment works (POTW as

defined at 40 CFR 122.2) when such

discharges are necessary to prevent a public

health threat to the community (e.g., a

situation where a community with failing

septic systems is connected to a POTW to

avert a potential public health threat from

these failing systems). These and all other

discharges of BCCs are defined as existing

discharges.

3. Up until November 15, 2010, 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 this provision takes effect in a Great

Lakes State or Tribe shall not authorize

mixing zones for existing discharges of BCCs

to the Great Lakes System after November 15,

2010. After November 15, 2010, 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 equal to the most stringent

applicable water quality criteria or values for

the BCCs in question.

5. Exception for Water Conservation. Great

Lakes 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-bycase basis, that failure to grant a mixing zone

would preclude water conservation measures

that would lead to overall load reductions in

BCCs, even though higher concentrations of

BCCs occur in the effluent. Such mixing

zones must also be consistent with sections

D and E of this procedure.

6. Exception for Technical and Economic

Considerations. Great Lakes States and Tribes

may grant mixing zones beyond the date

specified in section C.4 of this procedure for

any existing discharge of a BCC to the Great

Lakes System upon the request of a

discharger, subject to 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 discharge 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 mixing zone established pursuant to

this section shall:

i. Not result in any less stringent

limitations than those existing prior to

November 13, 2000;

ii. Be no larger than necessary to account

for the technical constraints and economic

effects identified pursuant to paragraph

C.6.a.ii 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. Be accompanied, as appropriate, by a

permit condition requiring 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 the BCC from other sources 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 is sought.

c. For each draft NPDES permit that would

allow a mixing zone for one or more BCCs

after November 15, 2010, 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

ii. Identify each BCC for which a mixing

zone is proposed.

7. Any mixing zone authorized under

sections C.3, C.5 or C.6 must be consistent

with sections D and E of this procedure, as

applicable.

* * * * *

[FR Doc. 00–28709 Filed 11–9–00; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 63

[IB Docket No. 97–142, FCC 00–339]

Rules and Policies on Foreign

Participation in the U.S.

Telecommunications Market

AGENCY: Federal Communications

Commission.

ACTION: Final rule; announcement of

effective date.

SUMMARY: This document announces the

effective date of rules. The Commission

amended its rules regarding the prior

notifications of foreign affiliations, and

the rules contained information

collection requirements. These rules

become effective on November 9, 2000.

EFFECTIVE DATE: The amendments to 47

CFR 63.11 published at 65 FR 60113,

October 10, 2000, become effective on

November 9, 2000.

FOR FURTHER INFORMATION CONTACT:

Peggy Reitzel, Telecommunications

Division, International Bureau, (202)

418–1499.

SUPPLEMENTARY INFORMATION: On

September 12, 2000, the Commission

adopted an order clarifying and revising

rules regarding prior notifications of

foreign affiliations, a summary of which

was published in the Federal Register.

See 65 FR 60113, October 10, 2000.

Section 63.11 of the rules contained