[Federal Register Volume 63, Number 63 (Thursday, April 2, 1998)]
[Proposed Rules]
[Pages 16182-16188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8644]


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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:

------------------------------------------------------------------------
                                               Examples of potentially  
                 Category                         affected entities     
------------------------------------------------------------------------
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.             
------------------------------------------------------------------------

    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