Water Quality Standards; Establishment of Numeric Criteria for Priority Toxic Pollutants; States' ComplianceRevision of Polychlorinated Biphenyls (PCBs) Criteria

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[ FRL-5989-8]

Water Quality Standards; Establishment of Numeric Criteria for

Priority Toxic Pollutants; States' Compliance--Revision of

Polychlorinated Biphenyls (PCBs) Criteria

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Clean Water Act (CWA) requires states to adopt numeric

criteria for those priority toxic pollutants for which EPA has

published criteria guidance and whose discharge or presence could

reasonably be expected to interfere with designated uses of states'

waters. In 1992, EPA promulgated the National Toxics Rule (NTR)

establishing numeric water quality criteria for toxic pollutants in

fourteen states and jurisdictions to protect human health and aquatic

life. These states and jurisdictions had not adopted sufficient

chemical-specific, numeric criteria for toxic pollutants necessary to

comply with the Clean Water Act.

Among the criteria promulgated in the NTR were human health and

aquatic life water quality criteria for polychlorinated biphenyls

(PCBs). Today, EPA is proposing revisions to the human health water

quality criteria for PCBs in the NTR, based on the Agency's

reassessment of the cancer potency of PCBs.

DATES: Written comments must be submitted by midnight June 1, 1998.

ADDRESSES: Send written comments to W-98-06, WQS-PCBs Comment Clerk,

Water Docket, MC 4101, US EPA, 401 M Street, S.W., Washington, D.C.

20460. Comments may also be submitted electronically to OW-

D[email protected]. The record is available for inspection from

9:00 to 4:00 p.m., Monday through Friday, excluding legal holidays at

the Water Docket, East Tower Basement, USEPA, 401 M St., S.W.,

Washington, D.C. For

[[Page 16183]]

access to docket materials, please call (202) 260-3027 to schedule an

appointment.

FOR FURTHER INFORMATION CONTACT: Cindy Roberts, Health and Ecological

Criteria Division (4304), Office of Science and Technology, Office of

Water, U.S. Environmental Protection Agency, 401 M Street, S.W.,

Washington, D.C. 20460, (202) 260-2787.

SUPPLEMENTARY INFORMATION:

A. Potentially Affected Entities

B. Water Docket Information

C. Background

D. Proposed Revisions of Human Health Criteria for PCBs

E. Response to Issues Identified in Partial Settlement Agreement

F. Regulatory Assessment Requirements

A. Potentially Affected Entities

States authorized to implement the National Pollutant Discharge

Elimination System (NPDES) Permit Program will need to ensure that

permits they issue include any limitations on discharges necessary to

comply with the standards established by the final rule. In doing so,

the States will have a number of discretionary choices associated with

permit writing. Entities discharging pollutants to waters of the United

States in NTR states could be affected by this rulemaking. These

entities may be affected since water quality criteria are part of water

quality standards that in turn are used in developing NPDES permit

limits. Categories and entities that may ultimately be affected

include:

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Examples of potentially

Category affected entities

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State and Jurisdictional Governments...... NPDES Authorized states and

jurisdictions.

Industry.................................. Industries discharging to

waters in NTR states and

jurisdictions.

Municipalities............................ Publicly-owned treatment

works discharging to waters

of NTR states and

jurisdictions.

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This table is not intended to be exhaustive, but rather provides a

guide for readers regarding entities likely to be affected by this

action. This table lists the types of entities that EPA is now aware

could potentially be affected by this action. Other types of entities

not listed in the table could also be affected. To determine whether

your organization or facility may be affected by this action, you

should carefully examine the applicability criteria in Sec. 131.36 (d)

of title 40 of the Code of Federal Regulations as amended by this

action. If you have questions regarding the applicability of this

action to a particular entity, consult the person listed in the

preceding FOR FURTHER INFORMATION CONTACT section.

B. Water Docket Information

The record for this rulemaking has been established under docket

number W-98-06 and includes supporting documentation. When submitting

written comments to the Water Docket, (see ADDRESSES section above)

please reference docket number W-98-06 and submit an original and three

copies of your comments and enclosures (including references). Comments

must be received or postmarked by midnight June 1, 1998. Commenters who

want EPA to acknowledge receipt of their comments should enclose a

self-addressed, stamped envelope. No facsimiles (faxes) will be

accepted.

Electronic comments may also be submitted to the Water Docket (see

ADDRESSES section above). Electronic comments must be submitted as an

ASCII file or a WordPerfect file avoiding the use of special characters

and any form of encryption. Electronic comments must be identified by

the docket number, W-98-06, and be received by midnight of June 1,

1998. Comments and data will also be accepted on disks in WP5.1 format

or ASCII file format. No confidential business information (CBI) should

be sent via e-mail.

C. Background

In 1992, EPA promulgated numeric water quality criteria for

priority toxic pollutants in twelve states (Rhode Island, Vermont, New

Jersey, Florida, Michigan, Arkansas, Kansas, California, Nevada,

Alaska, Idaho, Washington), Puerto Rico, and the District of Columbia

(National Toxics Rule or NTR, 57 FR 60848, December 22, 1992, codified

in the Code of Federal Regulations at 40 CFR 131.36). These states and

jurisdictions had not adopted sufficient chemical-specific, numeric

criteria for toxic pollutants necessary to comply with section

303(c)(2)(B) of the Clean Water Act. Among the criteria promulgated in

the NTR were human health criteria for PCBs. The human health criteria

were based on methodology issued in 1980 (``Guidelines and Methodology

Used in the Preparation of Health Effects Assessment Chapters of the

Consent Decree Water Criteria Documents,'' 45 FR 79347, November 28,

1980 or ``Human Health Guidelines'').

General Electric Company and the American Forest and Paper

Association, Inc. challenged a number of aspects of the NTR, including

the human health water quality criteria for PCBs. See American Forest

and Paper Ass'n. Inc. et al. v. U.S. EPA (Consolidated Case No. 93-0694

(RMU) D.D.C.). In particular, the plaintiffs objected to EPA's

application of its cancer risk assessment methodology to its evaluation

of the carcinogenicity of PCBs and the Agency's evaluation of various

scientific studies relevant to the cancer risk posed by PCBs. EPA had

underway a number of activities related to these objections, including

reassessment of the cancer potency of PCBs (the ``cancer

reassessment''), revision of the methodology to derive human health

water quality criteria, and revision of the cancer guidelines, that

could lead the Agency to decide to amend the human health water quality

criteria for PCBs in the NTR. EPA and the plaintiffs entered into a

partial settlement agreement in which EPA, among other things, agreed

to a schedule for completing the final cancer reassessment. See

``Partial Settlement Agreement,'' Consolidated Case No. 93-0694 RMU,

D.D.C, signed November 7, 1995.

EPA also agreed that within l8 months of the issuance of the final

cancer reassessment, the Agency would propose a revision to the NTR

human health criteria for PCBs, or publish a Federal Register notice

explaining why it was not revising the NTR criteria. EPA completed the

reassessment in September 1996. See ``PCBs: Cancer Dose-Response

Assessment and Applications to Environmental Mixtures'' (EPA/600/P-96/

001F). In today's Notice, EPA is proposing an amendment to the PCBs

human health criteria in the NTR that reflects the reassessment. In the

settlement agreement, EPA also agreed to consider several issues

identified by the Plaintiffs; those issues are discussed in section E

of this document.

D. Proposed Revisions of Human Health Criteria for PCBs

1. Reassessment of Cancer Potency of PCBs

Background

Manufactured PCBs are mixtures of forms (congeners) of the PCB

molecule that differ in their chlorine content. Different mixtures can

take on forms ranging from oily liquids to waxy solids. Although their

chemical properties vary widely, different mixtures have many common

PCB congeners. Because of their flame retardant properties, chemical

stability, and insulating properties, commercial PCB mixtures

[[Page 16184]]

were used in many industrial applications. These chemical properties,

however, also contribute to the persistence of PCBs after they are

released into the environment. Because of evidence of persistence and

harmful effects, domestic manufacture of commercial mixtures was

stopped in 1977; existing PCBs, however, continue in use, primarily in

electrical capacitors and transformers.

In the environment, PCBs also occur as mixtures of congeners, but

their composition differs from the commercial mixtures. This is because

after release into the environment, the composition of PCB mixtures

changes over time, through partitioning, chemical transformation and

preferential bioaccumulation of certain congeners. Some PCB congeners

can accumulate selectively in living organisms. PCBs are widespread in

the environment because of past contaminations, and humans are exposed

through multiple pathways: ambient air, drinking water, and diet.

For the purpose of issuing PCBs criteria in the NTR, EPA used a

single dose-response slope (7.7 per mg/kg-d average lifetime exposure);

this was the value included in EPA's Integrated Risk Information System

(IRIS) at that time. This value was derived from a rat feeding study by

Norback and Weltman (1985), one of several studies of Aroclor 1260.

With no agreed upon basis for reflecting differences among

environmental mixtures, EPA used this slope factor for all PCBs.

Accordingly, the 7.7 per mg/kg-d slope factor was used for all PCBs and

PCB mixtures. General Electric Company challenged EPA's use of this

slope factor to calculate the NTR human health criteria for PCBs on

several grounds, including that the Norback and Weltman study had been

reevaluated. GE argued that if the reevaluated results had been used,

the cancer potency factor would have been significantly lower. EPA and

General Electric entered into a settlement agreement providing that EPA

would complete a reassessment of the cancer potency factor for PCBs .

Reassessment

EPA considered a number of different approaches for its

reassessment, and adopted an approach that distinguishes among PCB

mixtures by using information on environmental processes. Environmental

processes have effects that can decrease or increase toxicity, so

potency of an environmental mixture may differ from the original

commercial mixture. EPA's new assessment considered all cancer studies

(which used commercial mixtures only) including a new study of four

Aroclors that strengthens the case that all PCBs cause cancer. EPA used

this information to develop a range of dose response slopes, changing

the single-dose cancer potency factor of 7.7 per mg/kg-d to a slope

which ranges from 0.07 per mg/kg-d (lowest risk and persistence) to 2.0

per mg/kg-d (high risk and persistence). It is noteworthy that

bioaccumulated PCBs appear to be more toxic than commercial PCBs and

appear to be more persistent in the body. The reassessment uses

information on environmental processes to provide guidance on choosing

an appropriate slope for representative classes of environmental

mixtures and different exposure pathways.

The reassessment methodology determines cancer potency by using a

tiered approach based on exposure pathways (such as food chain) to

choose the appropriate slope values from the range. In this

methodology, exposure through the food chain is associated with higher

risks than other exposures. Specifically, preferential bioaccumulation

through the food chain tends to concentrate certain highly chlorinated

congeners which are often among the most toxic and persistent.

Persistence in the body can enhance the opportunity for PCB congeners

to express tumor promoting activity. Recent multimedia studies indicate

that the major pathway of exposure to persistent toxic substances such

as PCBs is through food (i.e., contaminated fish and shellfish

consumption). Consumption of contaminated fish was considered to be the

dominant source of PCB exposure. On this basis, EPA chose a cancer

potency factor of 2 per mg/kg-d, the upper bound potency factor

reflecting high risk and persistence, to calculate the revised human

health criteria for PCBs. This upper bound slope factor of 2 per mg/kg-

d is also used to assess increased risks associated with early life

exposure to PCBs.

2. Calculation of Revised Human Health Criteria for PCBs

Using the cancer potency factor of 2 per mg/kg-d EPA calculated the

revised human health criterion (HHC) for organism and water consumption

as follows:

[GRAPHIC] [TIFF OMITTED] TP02AP98.002

Where:

RF=Risk Factor=1 x 10 (-6)

BW=Body Weight=70 kg

q1*=Cancer slope factor=2 per mg/kg-d

WC=Water Consumption=2 l/day

FC=Fish and Shellfish Consumption=0.0065 kg/day

BCF=Bioconcentration Factor=31,200

the HHC (g/l)=0.00017 g/l (rounded to two significant

digits).

Following is the calculation of the human health criterion for

organism only consumption:

[GRAPHIC] [TIFF OMITTED] TP02AP98.003

Where:

RF=Risk Factor=1 x 10 (-6)

BW=Body Weight=70 kg q1

*=Cancer slope factor=2 per mg/kg-d

FC=Total Fish and Shellfish Consumption per Day=0.0065 kg/day

BCF=Bioconcentration Factor=31,200

the HHC (g/l)=0.00017 g/l (rounded to two significant

digits).

The criteria are both equal to 0.00017 g/l and apply to

the total PCBs or congener or isomer analyses. See PCBs: Cancer Dose

Response Assessment and Application to Environmental Mixtures (EPA/600/

9-96-001F). For a discussion of the body weight and water consumption

factors see the Human Health Guidelines (``Guidelines and Methodology

Used in the Preparation of Health Effects Assessment Chapters of the

Consent Decree Water Criteria Documents,'' 45 FR 79347, November 28,

1980). For a discussion of the BCF, see the 304(a) criteria guidance

document for PCBs (``Ambient Water Quality Criteria for Polychlorinated

Biphenyls'', EPA 440/5-80-068) (1980).

While EPA established ambient water quality criteria for PCBs based

on bioaccumulation factors (BAFs) in the Great Lakes Water Quality

Initiative, these BAFs were not used to derive national ambient water

quality criteria because they did not address conditions outside the

Great Lakes System (e.g., consumption weighted lipid content, freely

dissolved fraction). The Great Lakes Water Quality Initiative also used

a fish consumption value specific to the Great Lakes region; the 15

grams per day value represents the mean consumption rate of regional

fish caught and consumed by the Great Lakes sport fishing population.

3. Criteria Expressed as Total of All Aroclors

In addition to the proposed revision of the numeric human health

criteria for PCBs, EPA is proposing that the human health criterion be

expressed as a total of all Aroclors. This proposal differs from the

current NTR where criteria are expressed for each Arocolor. It is the

Agency's view that expressing the criterion in terms of total rather

than

[[Page 16185]]

single Aroclors better reflects current scientific thought (see also

the proposed PCBs criteria in the California Toxics Rule, 62 FR 42160,

August 5, 1997).

EPA's change of approach from one where each Aroclor has its own

criterion to one where a single criterion applies to the sum of all

Aroclors does not result in more stringent criteria. The proposed human

health criterion specifies concentration limits of 0.00017 g/L

for total PCBs, in contrast to the old criteria of 0.000044 g/

L and 0.000045 g/L for each of seven different Aroclors.

Although the old criteria would, in theory, have allowed 0.000308

g/L and 0.000315 g/L total PCBs, respectively, if

each of the seven Aroclors were at its limit, the new criterion is not

more stringent than the old.

First, several of these Aroclors are not prevalent in commerce or

in the environment. Aroclor 1242 alone accounted for 52 percent of U.S.

PCB production, and Aroclors 1016, 1242, 1254, and 1260 together

account for over 90 percent. It is, therefore, highly unlikely that the

seven Aroclors would be present in similar concentrations. Second, from

what we know about how PCBs degrade and partition into different

environmental media and bioaccumulate in living organisms, it is

unlikely that an environmental sample characterized in terms of

Aroclors would resemble original Aroclor in any definable way. For

example, PCBs in fish or sediment would likely contain PCB congeners of

high chlorine content and, consequently, be characterized as ``like''

Aroclor 1254 or 1260, while PCBs present in water would likely contain

PCB congeners of lower chlorine content and, thus, be characterized as

``like'' one or two Aroclors of lower chlorine content. Third, when

environmental samples have been characterized in terms of Aroclor

mixtures, experience shows that no more than two or three Aroclors are

used. For these reasons, it is unlikely that an environmental sample

could be characterized in terms of similar concentrations of the seven

different Aroclors.

More importantly, it is not consistent with current scientific

knowledge to characterize environmental PCBs as if they were Aroclors.

Environmental processes can profoundly alter the composition of PCB

mixtures through partitioning, chemical transformation, and

preferential bioaccumulation.

E. Response to Issues Identified in Partial Settlement Agreement

As noted above, in the Partial Settlement Agreement EPA agreed to

consider specific issues identified by the plaintiffs in developing the

proposed rule.

1. The effect that the reduction in PCB concentrations in fish due

to cooking and cleaning has on the human intake of PCBs through fish

consumption.

In determining the PCB criteria proposed here, EPA used the 1980

methodology consumption rate of 6.5 grams/person/day representing the

estimated mean per capita freshwater/estuarine finfish and shellfish

consumption rate for the U.S. population.

In methodology to be proposed for public comment in 1998, EPA

expects to recommend the use of ``as consumed'' intake rates, that

should reflect the potential exposure from fish consumption better than

using uncooked weights. States would have the flexibility to consider

raw fish consumption if they believe that the population that they are

targeting are consumers of raw fish if data are limited to uncooked

weights (provided an adjustment for cooking loss is made). EPA is

considering several issues regarding whether to use cooked or uncooked

weights when estimating the fish consumption rates. One issue concerns

the fact that weight loss in cooking is typically about 20 percent. If

the mass of a toxicant in the fish tissue remains constant, then the

concentration in the fish tissue will increase (the weight of the fish

tissue decreased). However, if the mass of toxicant in the fish tissue

decreases, the concentration in the fish tissue may decrease (Zabik, et

al., 1993). This issue is complicated as different chemicals accumulate

in different parts of the fish. Therefore, the method of preparation

and cooking can greatly affect the potential intake of the contaminant.

In addition, there is the relatively unexplored area of how the cooking

process may change the ``parent'' compound to a by-product, or form a

different compound altogether. EPA will solicit public comment on these

issues when it solicits comment on the revised methodology. Until these

issues relating to fish consumption are further considered, EPA does

not believe it should change the current fish consumption value for

this rule.

2. Statistical analysis, including Monte Carlo analysis, of studies

to determine average daily human fish consumption.

In determining the PCB criteria proposed here, EPA used the 1980

methodology consumption rate of 6.5 grams/person/day representing the

estimated mean per capita freshwater/estuarine finfish and shellfish

consumption rate for the U.S. population. The source of the 6.5 grams/

person/day was a fish consumption survey conducted in 1973 and 1974 by

the National Purchase Diaries (NPD), a market research and consulting

firm specializing in the analysis of consumer purchasing behavior.

Among the anticipated proposed changes to the 1980 methodology,

default fish and shellfish consumption values will be presented for the

general population, for sport fishers, and for subsistence fishers,

replacing the single value of 6.5 grams/day used in the 1980 Human

Health guidance. For contaminants that may cause effects resulting from

acute exposures, default rates will be provided for children and for

women of childbearing age. The proposed revision to the 1980

methodology is expected to encourage States to use fish and shellfish

intake levels derived from local data on fish and shellfish consumption

in place of the default values provided. However, EPA's proposal is

expected to recommend that the fish and shellfish intake level chosen

be protective of highly exposed populations. EPA will solicit public

comment on the proposed change when it solicits comment on the revised

methodology.

3. The impact of biodegradation of PCBs in the environment in

determining an appropriate water quality criterion for PCBs.

As previously mentioned, EPA has completed its reassessment of the

cancer potency of PCBs. The PCB criteria proposed today were developed

after finalizing the cancer reassessment document.

After release into the environment, PCB mixtures change through

partitioning, biodegradation, transformation, and bioaccumulation,

differing considerably from commercial mixtures. USEPA has devoted an

entire section in the PCBs' Reassessment (1996) (4.1. APPLICATION TO

PCB MIXTURES IN THE ENVIRONMENT, pp. 39-43) to the question of how

toxicity values for commercial mixtures can be applied to mixtures in

the environment.

4. The scientific basis of proposed models for establishing

bioaccumulation factors (BAFs), including: (a) the extent to which such

models account for the sources of PCBs to fish tissue, including the

water column and various strate of sediment, and dissolved,

undissolved, and adsorbed PCBs; and (b) the variability of field-

calculated BAFs for PCBs among various water bodies and the reasons for

such variations.

In determining the PCB criteria proposed here, EPA used the same

[[Page 16186]]

bioconcentration factor, 31,200 L/kg, as used in the 1980 criteria

guidance document.

In the revised human health methodology, EPA expects to recommend

the use of bioaccumulation factors (BAF) in place of BCFs. The revised

methodology would incorporate specific characteristics and behavior of

bioaccumulative chemicals. For certain chemicals where uptake from

exposure to multiple media is important, the revised methodology would

emphasize the assessment of bioaccumulation (i.e., uptake from water,

food, sediments) over bioconcentration (i.e., uptake from water).

As an alternative to expressing ambient water quality criteria as a

water concentration, under the revised human health methodology,

criteria may also be expressed in terms of fish tissue concentration.

For some substances, particularly those that are expected to exhibit

substantial bioaccumulation, the ambient water quality criteria derived

may have extremely low values, possibly below the practical limits for

detecting and quantifying the substance in the water column. It may be

more practical and meaningful in these cases to focus on the

concentration of those substances in fish tissue, since fish ingestion

would be the predominant source of exposure for these substances that

bioaccumulate.

It should be noted that the changes outlined above may result in

significant numeric changes in the ambient water quality criteria. EPA

will continue to rely on existing criteria as the basis for regulatory

and non-regulatory decisions, until EPA revises and reissues those

criteria using the revised final human health criteria methodology. The

existing criteria are still viewed as scientifically acceptable by EPA.

The intention of the methodology revisions is to present the latest

scientific advancements in the areas of risk and exposure assessment in

order to incrementally improve the already sound toxicological and

exposure bases for these criteria. Revisiting all existing criteria

would require considerable time and resources. Given these

circumstances, EPA intends to propose a process for revising these

criteria as part of the overall revisions to the methodology for

deriving human health criteria that is expected to be published in the

Federal Register in 1998.

F. Regulatory Assessment Requirements

1. Executive Order (E.O.) 12866, Regulatory Planning and Review

Under Executive Order 12866, (58 FR 51,735 (October 4, 1993)) the

Agency 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 (E.O.) 12866 and

is therefore not subject to OMB review.

2. The Unfunded Mandates Reform Act of 1995

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 promulgating an EPA 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 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.

Today's Rule contains no Federal mandates (under the regulatory

provisions of Title II of the UMRA) for State, local, or Tribal

governments or the private sector. The proposed rule imposes no

enforceable duty on any State, local or Tribal governments or the

private sector. This rule proposes revised ambient water quality

criteria which, when combined with State-adopted designated uses

constitute water quality standards for those water bodies with adopted

uses. Therefore, the proposed rule is not subject to the requirements

of sections 202 and 205 of the UMRA.

EPA has determined that this proposed rule contains no regulatory

requirements that might significantly or uniquely affect small

governments. As stated above, the rule imposes no enforceable

requirements on any party, including small governments. Moreover, any

water quality standards, including those proposed here apply broadly to

waters in the States and may potentially affect any discharger to such

waters and, therefore, will not uniquely affect small governments.

Additionally, the proposed rule results in ambient water quality

criteria for human health that are less stringent than those currently

in the NTR and therefore any effects on small governments should be

reduced by adoption, and future implementation by the States. Thus,

this proposed rule is not subject to the requirements of section 203 of

UMRA.

3. Executive Order 12875, Enhancing the Intergovernmental Partnership

Under Executive Order 12875, EPA may not issue a regulation that is

not required by statute and that creates a mandate upon a State, local

or Tribal government unless the Federal Government provides the

necessary funds to pay the direct costs incurred by the State, local or

Tribal government or EPA provides the Office of Management and Budget a

description of the extent of the Agency's's prior consultation and

written communications with representatives of affected State, local

and Tribal governments, the nature of

[[Page 16187]]

their concerns, and an Agency statement supporting the need to issue

the regulation. In addition, Executive Order 12875 requires EPA to

develop an effective process permitting elected officials and other

representatives of State, local and Tribal governments ``to provide

meaningful and timely input in the development of regulatory proposals

containing significant unfunded mandates.''

For the same reasons as stated above in section E.2, EPA has

determined this proposed rule does not impose federal mandates on

State, local or Tribal governments. Thus, today's proposed rule is not

subject to E.O. 12875.

4. The Regulatory Flexibility Act (RFA) as Amended by the Small

Business Regulatory Enforcement Fairness Act (SBREFA) of 1996

Under the RFA, (5 U.S.C. 601 et seq.), as amended by SBREFA, EPA

generally is required to conduct an initial regulatory flexibility

analysis (IRFA) describing the impact of the regulatory action on small

entities as part of proposed rulemaking. However, under section 605(b)

of the RFA, if the Administrator for the Agency certifies that the

proposed rule will not have a significant economic impact on a

substantial number of small entities, EPA is not required to prepare an

IRFA. Pursuant to section 605(b) of the RFA, 5 U.S.C. 605(b), the

Administrator certifies that this proposed rule will not have a

significant economic impact on a substantial number of small entities.

Therefore, the Agency did not prepare an initial regulatory flexibility

analysis.

The RFA requires analysis of the impacts of a rule on the small

entities subject to the rule's requirements. See United Dates

Distribution Companies v. FERC, 88 F.3d 1105, 1170 (D.C. Cir. 1996).

Today's rule establishes no requirements applicable to small entities,

and so is not susceptible to regulatory flexibility analysis as

prescribed by the RFA . (``[N]o [regulatory flexibility] analysis is

necessary when an agency determines that the rule will not have a

significant economic impact on a substantial number of small entities

that are subject to the requirements of the rule, ``United Distribution

at 1170, quoting Mid-Tex Elec. Co-op v. FERC, 773 F.2d 327, 342 (D.C.

Cir. 1985) (emphasis added by United Distribution court)). The Agency

is thus certifying that today's rule will not have a significant

economic impact on a substantial number of small entities, within the

meaning of the RFA.

EPA has authority to promulgate criteria or standards in any case

where the Administrator determines that a revised or new standard is

necessary to meet the requirements of the Act. EPA-promulgated

standards are implemented through various water quality control

programs including the National Pollutant Discharge Elimination System

(NPDES) program that limits discharges to navigable waters except in

compliance with an EPA permit or permit issued under an approved state

program. The CWA requires that all NPDES permits must include any

limits on discharges that are necessary to meet state water quality

standards. The States have discretion in deciding how to meet the water

quality standards and in developing discharge limits as needed to meet

the standards. While State implementation of federally-promulgated

water quality criteria or standards may result in new or revised

discharge limits being placed on small entities, the criteria or

standards themselves do not apply to any discharger, including small

entities.

Today's proposed rule as explained above, does not itself establish

any requirements that are applicable to small entities. As a result of

this action, the States will need to ensure that permits they issue

include any limitations on dischargers necessary to comply with the

water quality standards established by the criteria in today's proposed

rule. In so doing, States will have a number of discretionary choices

associated with permit writing. While implementation of today's rule

may ultimately result in some new or revised permit conditions for some

dischargers, including small entities, EPA's action today does not

impose any of these as yet unknown requirements on small entities.

Furthermore, today's proposed rule results in ambient water quality

criteria for human health that are less stringent than those currently

in the NTR. Consequently, the economic effect of today's proposed rule

should be positive in States subject to the NTR. Any adverse economic

impact on small entities associated with measures taken to implement

the current PCB criteria of the NTR should be reduced by adoption of

the proposed revision.

5. The Paperwork Reduction Act

This proposed rule requires no new or additional information

collection activities subject to the Paperwork Reduction Act, (44

U.S.C. 3501 et seq.) Therefore, no Information Collection Request will

be submitted to the Office of Management and Budget for review.

6. National Technology Transfer and Advancement Act (NTTAA)

Under Section 12(d) of the National Technology Transfer and

Advancement Act (NTTAA), the Agency is required 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, business practices,

etc.) that are developed or adopted by voluntary consensus standards

bodies. Where available and potentially applicable voluntary consensus

standards are not used by EPA, the Act requires the Agency to provide

Congress, through the Office of Management and Budget, an explanation

of the reasons for not using such standards.

The Agency does not believe that this proposed rule addresses any

technical standards subject to the NTTAA. A commenter who disagrees

with this conclusion should indicate how today's notice is subject to

the NTTAA and identify any potentially applicable voluntary consensus

standards.

7. EO 13045--Protection of Children From Environmental Health Risks and

Safety Risks

On April 21, 1997, the President issued Executive Order 13045

entitled Protection of Children From Environmental Health Risks and

Safety Risks (62 FR 19883). Under section 5 of the Order, a federal

agency submitting a ``covered regulatory action'' to OMB for review

under Executive Order 12866 must provide information regarding the

environmental health or safety affects of the planned regulation on

children. A ``covered regulatory action'' is defined in section 2-202

as a substantive action in a rulemaking, initiated after the date of

this order or for which a Notice of Proposal rulemaking is published 1

year after the date of this order, that is likely to result in a rule

that may: be ``economically significant'' under Executive Order 12866

and concern an environmental health risk or safety risk that any agency

has reason to believe may disproportionally affect children. As

discussed below, this final rule is not a ``covered regulatory action''

as defined in the Order and accordingly is not subject to section 5 of

the Order.

This proposed rule does not meet the threshold requirement for a

``covered regulatory action.'' This Notice of Proposed Rulemaking will

be published prior to April 21, 1998, and, as discussed in paragraph

E.1 above, is not a significant rule under Executive Order

[[Page 16188]]

12866. While this proposal is not subject to E.O.13045, we note that

this proposed water quality criteria is selected to be protective of

sensitive subpopulations, including children.

List of Subjects in 40 CFR Part 131

Environmental protection, Water pollution control, Water quality

standards, Toxic pollutants.

Dated: March 27, 1998.

Carol M. Browner,

Administrator.

For the reasons set out in the preamble title 40, chapter I part

131 of the Code of Federal Regulations is proposed to be amended as

follows:

PART 131--WATER QUALITY STANDARDS

1. The authority citation for part 131 continues to read as

follows:

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

2. Section 131.36 is amended:

a. The table in paragraph (b)(1) is amended by revising the entries

for 119, 120, 121, 122, 123, 124, 125, by adding an entry and revising

the total number of criteria at the end of the table, and adding

footnote q. (Footnotes d, and g are republished for the convenience of

the reader.)

b. Paragraph (d)(3)(ii) is amended by revising entries ``B2'' and

``C2'' under the heading ``Applicable Criteria''.

c. Paragraph (d)(9)(ii) is amended by revising entry ``B2'' under

the heading ``Applicable Criteria'' to read as follows:

Sec. 131.36 Toxics criteria for those states not complying with Clean

Water Act Section 303(c)(2)(B).

* * * * *

(b)(1) * *

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

A B Freshwater C Saltwater D Human health (106 risk for

------------------------------------------------------------------------------------------------------------------------- carcinogens for consumption

of:

Criterion Criterion Criterion Criterion -------------------------------

maximum conc. continuous maximum conc. continuous Water &

(No.) Compound CAS No. d (g/ conc. d d (g/ conc. d organism Organisms only

L) B1 (g/L) L) C1 (zg/ (g/L) (g/L)

B2 L) C2 D1 D2

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

* * * * * * *

119 PCB-1242........................... 53469219 .............. 0.014 g .............. 0.03 g .............. ..............

120 PCB-1254........................... 11097691 .............. 0.014 g .............. 0.03 g .............. ..............

121 PCB-1221........................... 11104282 .............. 0.014 g .............. 0.03 g .............. ..............

122 PCB-1232........................... 11141165 .............. 0.014 g .............. 0.03 g .............. ..............

123 PCB-1248........................... 12672296 .............. 0.014 g .............. 0.03 g .............. ..............

124 PCB-1260........................... 11096825 .............. 0.014 g .............. 0.03 g .............. ..............

125a PCB-1016.......................... 12674112 .............. 0.014 g .............. 0.03 g .............. ..............

125b Polychlorinated biphenyls (PCBs).. .............. .............. 0.014 g .............. 0.03 g 0.00017 q 0.00017 q

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

Total No. of Criteria (h)=........ .............. 24 29 23 27 85 84

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

Footnotes:

* * * * * * *

d. Criteria Maximum Concentration (CMC) = the highest concentration of a pollutant to which aquatic life can be exposed for a short period of time (1-

hour average) without deleterious effects. Criteria Continuous Concentration (CCC) = the highest concentration of a pollutant to which aquatic life

can be exposed for an extended period of time (4 days) without deleterious effects. g/L = micrograms per liter.

* * * * * * *

g. Aquatic life criteria for these compounds were issued in 1980 utilizing the 1980 Guidelines for criteria development. The acute values shown are

final acute values (FAV) which by the 1980 Guidelines are instantaneous values as contrasted with a CMC which is a one-hour average.

* * * * * * *

q. This criterion applies to total PCBs (i.e., the sum of all congener or all isomer analyses).

* * * * * * *

(d) * * *

(3) * * *

(ii) * * *

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

Use classification Applicable criteria

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

* * * * *

Column B2--all except #105,

107, 108, 111, 112, 113,

115, 117, 118, 119, 120,

121, 122, 123, 124, and

125a.

* * * * *

Column C2--all except #105,

107, 108, 111, 112, 113,

115, 117, 118, 119, 120,

121, 122, 123, 124, and

125a.

* * * * *

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

(9) * * *

(ii) * * *

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

Use classification Applicable criteria

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

* * * * *

Column B2--all except #9,

13, 105, 107, 108, 111-113,

115, 117, 119-125a and 126;

and

* * * * *

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

[FR Doc. 98-8644 Filed 4-1-98; 8:45 am]

BILLING CODE 6560-50-P