[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-
Docket@epamail.epa.gov. 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
