# Modification of Secondary Treatment Requirements for Discharges Into Marine Waters

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## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** August 9, 1994

## Text

SUMMARY: EPA is promulgating final amendments to the regulations
contained in 40 CFR part 125, subpart G, which implement section 301(h)
of the Clean Water Act (``CWA'' or ``Act''), 33 U.S.C. section 1311(h).
Section 301(h) provides for modifications of secondary treatment
requirements for discharges into marine waters by publicly owned
treatment works (POTWs) that demonstrate their compliance with the
section 301(h) criteria. These regulatory revisions are being
promulgated to respond to the amendments to section 301(h) contained in
section 303 of the Water Quality Act of 1987 (``WQA'') and to reflect
program experience. These amendments revise portions of the existing
part 125, subpart G, regulations and simplify and revise the
application requirements contained in Appendices A and B of subpart G.

DATES: Effective Date: These regulations take effect on September 8,
1994.
Promulgation Date: In accordance with 40 CFR 23.2, the
Administrator's promulgation occurs at 1:00 p.m. EDT on August 23,
1994.

ADDRESSES: Copies of comments submitted and the docket for this
rulemaking are available for review at EPA's Water Docket; Room L-102,
401 M St., SW., Washington, DC 20460. For access to the Docket
materials, call (202) 260-3027 between 9 a.m. and 3:30 p.m. for an
appointment.

FOR FURTHER INFORMATION CONTACT: Virginia Fox-Norse, Oceans and Coastal
Protection Division (4504F), U.S. Environmental Protection Agency, 401
M Street, SW, Washington, DC 20460, (202) 260-8448. An amended
Technical Support Document (TSD) has been prepared to provide guidance
for preparing applications and complying with provisions of the
regulations. This amended TSD completely supersedes the 1982 revised
section 301(h) TSD, and will be available soon after these regulations
are published in the Federal Register. Requests for the amended TSD
should be made to Virginia Fox-Norse at the address given in this
section.

SUPPLEMENTARY INFORMATION:

Preamble Outline

I. Background
A. History of the section 301(h) Program
B. Water Quality Act Amendments of 1987
C. Overview of Public Comments
D. Summary of Changes Made from the 1991 Proposal
II. Section by Section Analysis
III. Supporting Documentation
A. Regulatory Flexibility Act Analysis
B. Executive Order 12291
C. Paperwork Reduction Act

I. Background

A. History of the Section 301(h) Program

Under section 301(b)(1)(B) of the Clean Water Act of 1972
(hereinafter CWA or Act) (33 U.S.C. Sec. 1311(b)(1)(B)), POTWs were
required to achieve secondary treatment by July 1, 1977. The secondary
treatment requirements establish technology-based effluent limitations
for biochemical oxygen demand (BOD), suspended solids (SS), and pH. See
40 CFR part 133. Some municipalities with POTWs that discharged into
marine waters argued that secondary treatment might not be necessary to
protect certain marine waters where deeper waters with large tides and
currents can allow for greater dilution and dispersion than discharges
into fresh waters. As a result, Congress amended the CWA in 1977 to add
section 301(h), 33 U.S.C. 1311(h), to allow the Administrator, upon
application by a POTW and with the concurrence of the State, to issue a
National Pollutant Discharge Elimination System (NPDES) permit that
modifies the secondary treatment requirements of section 301(b)(1)(B).
In order to obtain a section 301(h) waiver, the applicant must
demonstrate to the satisfaction of the Administrator that the proposed
discharge complies with a set of criteria intended to protect the
marine environment. In addition, section 301(j)(1)(A) of the Act
established a deadline for filing a section 301(h) application. EPA
regulations and an accompanying technical support document (TSD) to
implement the section 301(h) program were issued in 1979. (44 FR 34784,
June 15, 1979.)
Section 301(h) was later amended by the Municipal Wastewater
Treatment Construction Grants Amendments (MWTCGA) of 1981 (Pub. L. 97-
117, 95 Stat. 1623). The MWTCGA extended the deadline for filing
section 301(h) applications to December 29, 1982, and modified
applicant eligibility requirements. In response to the MWTCGA and
program experience, the section 301(h) regulations and the TSD were
revised in 1982. (See 47 FR 24918, June 8, 1982, and 47 FR 53666,
November 26, 1982.)

B. Water Quality Act Amendments of 1987

On February 4, 1987, Congress passed the Water Quality Act of 1987
(Pub. L. 100-4, hereinafter WQA), further amending section 301(h) of
the CWA. Section 303 of the WQA, which contains the amendments to
section 301(h), made the following changes to section 301(h) of the
CWA:
(1) The discharge of pollutants, in accordance with modified
requirements, cannot interfere, alone or in combination with pollutants
from other sources, with the attainment or maintenance of water quality
which assures the protection of the resources and uses listed in CWA
section 301(h)(2).
(2) The scope of required monitoring is limited to only those
scientific investigations necessary to study the effects of the
proposed discharge.
(3) For POTWs serving a population of 50,000 or more, with respect
to any toxic pollutant introduced by an industrial source for which
pollutant there is no applicable pretreatment requirement in effect,
the applicant must demonstrate that sources introducing waste into the
POTW are in compliance with all applicable pretreatment requirements,
the applicant will enforce those requirements, and the applicant has in
effect a pretreatment program which, in combination with the treatment
of discharges from the POTW, removes the same amount of such toxic
pollutant as would be removed if the POTW were to apply secondary
treatment and had no pretreatment program for such pollutant. (For
purposes of this preamble, this requirement will be referred to as the
``urban area pretreatment requirement'').
(4) At the time the section 301(h) modification becomes effective,
the applicant will be discharging effluent which has received at least
primary or equivalent treatment and which meets water quality criteria
established under CWA section 304(a)(1) after initial mixing in the
waters surrounding or adjacent to the point at which the effluent is
discharged. The statutory amendments define primary or equivalent
treatment as treatment by screening, sedimentation, and skimming
adequate to remove at least 30 percent each of BOD and of SS, and
disinfection, where appropriate.
(5) No modification may be issued for a discharge into marine
waters unless those waters exhibit characteristics assuring that water
providing dilution does not contain significant amounts of previously
discharged effluent from the POTW.
(6) No section 301(h) modified permit may be issued authorizing the
discharge of any pollutant into saline estuarine waters which at the
time of the application exhibit certain stressed conditions specified
in the statute, without regard to the presence or absence of a causal
relationship between those conditions and the applicant's current or
proposed discharge.
(7) No permits may be issued for section 301(h) modified discharges
into the New York Bight Apex.
(8) Any POTW that had a contractual agreement before December 31,
1982, to use an outfall operated by another POTW which has applied for
or received a section 301(h) modified permit may apply for a section
301(h) permit in its own right within 30 days of WQA enactment.
(9) Certain provisions of the WQA amendments do not apply to
applications which received final or tentative approval before
enactment of the WQA. These permits will, however, be subject to the
new section 301(h) requirements upon permit renewal.

C. Overview of Public Comments

EPA proposed regulations on January 24, 1991, responding to the
requirements of the WQA and program experience (56 FR 2814). The
preamble to the proposed regulations explains the proposed changes in
the regulations in response to the WQA. On March 7, 1991, EPA held a
public hearing in Washington, DC, to receive comment on the proposal.
The public comment period was open for 60 days and closed on March 25,
1991. Although some comments were not received until April 8, 1991, EPA
has elected to consider all comments received in developing this final
rule. EPA received both written comments and comments at the public
hearing on the proposed rule from a total of 17 commenters: eight
section 301(h) applicants, two State governments, four independent
consultants, and three environmental/public interest groups.
Although the comments received addressed many of the proposed
changes, the principal areas of concern to commenters focused on
primary or equivalent treatment requirements, urban area pretreatment,
and the water quality criteria requirements. A brief summary of the
comments on these areas is set out below, and a more detailed
discussion of all comments received is set out later in the section-by-
section analysis of this preamble.
Comments regarding primary treatment raised issues related to the
30 percent removal requirement for BOD, the cost to small communities
of complying, and the time limit to meet the primary treatment
requirement. Comments on urban area pretreatment raised issues about
use of the pilot plant approach to demonstrate secondary removal
equivalency for toxics, development of local pretreatment limits, which
pollutants are subject to this requirement, the time limit to meet this
requirement, and the cost of compliance. Comments regarding the section
304(a)(1) water quality criteria focused on setting risk levels for
carcinogens, determining mixing zones for evaluating compliance with
State water quality standards, and the role of the section 304(a)(1)
water quality criteria in cases where the State has adopted a different
water quality standard under CWA section 303.

D. Summary of Changes Made From the 1991 Proposal

For the convenience of the reader, the following discussion
provides a brief overview of the sections and subject areas in which
today's final rule makes changes from the January 24, 1991, proposal.
Table 1 of the preamble also provides a summary of those changes. A
full discussion of the changes made in the regulations and proposal is
set out later in the section-by-section analysis of today's preamble.
Today's final rule would make a clarifying change from the 1991
proposal in Sec. 125.58(n), which defines the term ``ocean waters.''
This change is intended to clarify the distinction between ``saline
estuarine waters'' and ``ocean waters,'' a distinction important to the
application of the WQA provisions prohibiting section 301(h) discharges
into stressed saline estuarine waters.
Today's final rule makes a change from the 1991 proposal in
Sec. 125.59, which addresses general application requirements. The
proposal allowed the granting of tentative approvals if the applicant
demonstrated good faith to come into compliance with all the
requirements of this subpart, based on a schedule in accordance with
Sec. 125.59(f)(3)(ii). EPA received a comment asking that this section
be clarified. The commenter stated that because Sec. 125.59(f)(3)(ii)
only applies to primary treatment and urban area pretreatment
requirements, the section could be interpreted as allowing compliance
schedules only for those requirements and not for all requirements.
Section 125.59(h) has been amended to allow compliance schedules for
all requirements.
This change merely clarifies EPA's original intent.
Today's final rule makes a change from the 1991 proposal in
Sec. 125.60, which addresses the WQA requirements for compliance with
primary or equivalent treatment. The proposal specified a monthly
averaging period for determining compliance with the 30 percent BOD
removal requirement for BOD and SS established by the WQA. In response
to comments on this issue, the final rule adds the opportunity under
certain special circumstances for applicants unable to meet the 30
percent removal requirement for BOD on the basis of a monthly average
to request a longer averaging period (up to annual) in order to provide
needed flexibility in calculating compliance. This averaging basis is
not available for those POTWs that have already shown a consistent
ability to meet the 30-percent removal requirement for BOD on a monthly
basis. Because no comments were received indicating a need for
flexibility in the monthly averaging period for determining compliance
with the 30 percent suspended solids removal requirement, this change
applies only to the BOD removal requirements.
The final rule makes a change to the proposed regulatory language
of Sec. 125.62 with regard to determining compliance with State water
quality standards. Comments were received on the issue of mixing zones,
and in evaluating these comments, EPA noted that the proposal had
inadvertently omitted language contained in the existing 1982 section
301(h) regulations on meeting applicable water quality standards at and
beyond the zone of initial dilution. The final rule promulgated today
would retain that language so that the original requirement of the 1982
regulations for meeting State water quality standards at the edge of
the zone of initial dilution remains in effect.
The final rule also makes a change from the 1991 proposal in
Sec. 125.63, which addresses section 301(h) monitoring programs. While
implied, the proposal did not include explicit regulatory language
requiring monitoring to determine compliance with the primary treatment
requirements. It also did not include, under general requirements, an
explicit requirement to have a monitoring program to demonstrate
compliance with water quality criteria as well as water quality
standards, as applicable. The final rule adds these requirements to
Sec. 125.63 (a)(1) and (d)(2) in order to ensure that applicants
provide data on their compliance with these requirements over the life
of the permit.
In addition, in response to comments, the final rule makes several
clarifying changes to Sec. 125.65, which addresses the urban area
pretreatment requirements. The changes are intended to provide
additional guidance on implementation of this section with regard to
the development of pretreatment requirements and secondary equivalency
for toxics removal.
Some conforming and organizational changes were made to the
application questionnaire contained in the Appendix to these
regulations. These changes address amendments made in the final rule
and simplify its use by applicants and the Agency to determine
compliance with the 301(h) requirements.
The remaining sections of the rule (Secs. 125.56, 125.57, 125.61,
125.64, 125.66-125.68) remain unchanged from the 1991 proposal.

Table 1
----------------------------------------------------------------------------------------------------------------
Final subpart
G Contents Changes from 1991 Proposal
----------------------------------------------------------------------------------------------------------------
125.56 Scope and Purpose............................. Unchanged.
125.57 Law governing issuance of a modified permit... Unchanged.
125.58 Definitions................................... Clarified ocean water definition.
125.59 General....................................... Clarified requirements for compliance schedules.
125.60 Primary or equivalent treatment requirements.. Change to BOD removal averaging period under
certain circumstances.
125.61 Existence of and compliance with applicable Unchanged.
water quality standards.
125.62 Attainment or maintenance of water quality Change to mixing zone provisions.
which assures protection of water supplies,
and the protection and propagation of a
balanced, indigenous population of shellfish,
fish and wildlife, and allows recreational
activities.
125.63 Establishment of a monitoring program......... Monitoring provisions regarding primary
treatment compliance added.
125.64 Effect of discharge on other point and Unchanged.
nonpoint sources.
125.65 Urban area pretreatment program............... Clarifying language added.
125.66 Toxics control program........................ Unchanged.
125.67 Increase in effluent volume or amount of Unchanged.
pollutants discharged.
125.68 Special conditions for section 301(h) modified Unchanged.
permits.
Appendix Applicant questionnaire for modification of Conforming and Organizational changes made.
secondary treatment requirements.
----------------------------------------------------------------------------------------------------------------

II. Section-by-Section Analysis

This section provides a description of each section in the
regulation and discusses the public comments received. Citations to
sections of the part 125, subpart G, regulations in the discussion
below refer to the section numbers of the regulations as numbered under
today's rule.
Although portions of the section 301(h) regulations that were not
proposed for change are being reprinted with today's action, this has
been done for the convenience of the reader. EPA did not reconsider
those existing portions of the regulations and they are not subject to
challenge as part of this final rulemaking.
Section 125.56: This section establishes the general scope and
purpose of the regulations. EPA did not propose to revise this section,
and no comments were received. This section remains unchanged.
Section 125.57: This section sets forth the statutory language
applicable to section 301(h) modified permits. No comments were
received, and this section remains unchanged from the proposed rule.
Section 125.58: This section sets forth the definitions applicable
to the subpart G regulations. As a result of section 303 of the WQA,
the 1991 proposal added definitions of ``primary or equivalent
treatment,'' ``pretreatment,'' ``categorical pretreatment standard,''
``secondary removal equivalency,'' ``water quality criteria,''
``permittee,'' and ``New York Bight Apex.'' In addition, the proposal
made changes to existing definitions for ``industrial source,'' ``ocean
waters,'' and ``stressed waters.'' EPA received significant comments on
two aspects of the primary or equivalent treatment requirements and the
definition of saline estuarine waters.

Definition of Primary Treatment

Section 125.58(r) of the proposed rule defined ``primary or
equivalent treatment'' as treatment by screening, sedimentation, and
skimming adequate to remove at least 30 percent of the biochemical
oxygen demanding (BOD) material and of the suspended solids (SS) in the
treatment works influent, and disinfection, where appropriate. This
definition was taken directly from the language of section 303(d) of
the WQA. The preamble to the proposed rule further explained that the
terms ``sedimentation'' and ``skimming'' could include a range of
treatment techniques such as coagulation and precipitation (physical
adjuncts to sedimentation), and flotation and subsequent removal by
skimming, in order to achieve the required 30 percent removal of BOD
and SS. (56 FR 2818). Although certain types of treatment are specified
in the statutory definition (i.e., screening, sedimentation, and
skimming), EPA believes the principal intent of the statutory
definition is to ensure compliance with the 30 percent BOD and SS
removal requirements, rather than specifying the exact methods used to
achieve such removal rates. For example, chemical addition,
coagulation, and precipitation might be necessary in addition to the
specific treatment processes listed in the definition in order to
achieve the mandated 30 percent removal, and this would be allowable.
Several commenters sought a change to the definition due to
concerns with the requirement to achieve 30 percent BOD removal. As
discussed below in more detail, the commenters' concerns centered on
the practical difficulties in achieving 30 percent BOD removal by the
physical processes of primary treatment. Some noted that from an
engineering standpoint, technologies for primary treatment are aimed at
removing solids, rather than soluble BOD.
Some commenters stated that their review of the legislative history
of the WQA amendments to section 301(h) shows that Congress did not
articulate any rationale for defining primary treatment as 30 percent
removal of BOD. The commenters argued that Congress' intent was to stop
the discharge of untreated sewage from waiver recipients. They also
pointed out that Congress defined primary treatment as consisting only
of skimming, screening, and sedimentation, and did not include more
sophisticated technologies, such as coagulation and precipitation.
Therefore, they state, EPA must adopt that literal definition and
acknowledge that skimming, screening and sedimentation might not be
enough to achieve 30 percent removal of BOD. Commenters sought a change
to the definition of primary treatment to reflect only the physical
processes and not the 30-percent removal requirements.
Another commenter disagreed and argued that the advantages of using
clear, uniform 30-percent standards in the statute and regulations are
obvious, and that the fact that these advantages and other plausible
rationales were not stated explicitly in the legislative history is
insufficient grounds for ignoring the plain and unambiguous statutory
requirements.
Some commenters noted that primary treatment generally is intended
to remove settleable solids and floating materials rather than BOD and
therefore inclusion of 30 percent BOD removal as part of the definition
of primary treatment is technically inappropriate. In support, several
commenters cited the literature of wastewater engineering and stated
that BOD reductions achieved by primary treatment are the result of
insoluble (solid form) BOD being removed along with the settleable or
floatable materials. The commenters pointed out that soluble BOD would
not be removed by the physical processes of screening, skimming, and
sedimentation, and that the BOD removal rates achievable by primary
treatment would therefore vary depending upon the relative amounts of
soluble and insoluble BOD. Commenters also cited situations where
pretreatment of discharges by industrial dischargers that removes much
of the insoluble BOD (e.g., fish processors removing settleable fish
wastes) results in a high proportion of soluble to insoluble BOD. One
commenter noted that the key statutory term in section 303(d)(2) of the
WQA is ``material,'' implying that Congress intended that 30 percent
removal refers to insoluble BOD, not total BOD. Section 303(d)(2)
states that ``primary or equivalent treatment means the removal of at
least * * * 30 percent of the biological oxygen demanding material * *
*'' (emphasis added). The commenters therefore sought a change to the
regulations' definition of primary treatment to require 30 percent
removal of insoluble BOD, with soluble BOD being excluded from the 30
percent removal requirement.
Some commenters were concerned that they might have difficulty in
achieving 30 percent BOD removal by the physical processes of primary
treatment because their influent BOD levels were very dilute, that is,
relatively low concentrations of BOD in the raw wastewater would make
30 percent removal hard to achieve. These commenters pointed to a
number of factors leading to such dilute wastewater and difficulties in
achieving removal efficiencies such as (1) cold climates which result
in freeze/thaw problems including inflow and infiltration from snow
melt and cracked or broken pipes with attendant dilution of the
influent by the resulting influx of fresh water; (2) insufficient
industrial or commercial sources with high concentrations of BOD in the
wastewater discharges to the municipal sewage system to offset
otherwise dilute influents with low BOD concentrations; (3) cold
wastewater temperatures resulting in relatively less efficient
treatment; and (4) extremely high tides and high precipitation. These
commenters recommended that EPA not require 30 percent removal during
periods of extremely dilute and clean inflows.
After considering these comments, EPA made no changes to the
definition of primary or equivalent treatment in Sec. 125.58(r).
However, as discussed below in the section-by-section analysis for
Sec. 125.60, the Agency is making changes to how compliance with the 30
percent removal requirement is calculated for BOD. Specifically, EPA is
allowing the demonstration of compliance with the 30 percent BOD
removal requirement to be averaged over a longer time period than
proposed, in some circumstances. This added flexibility should provide
some of the relief sought by commenters.
Although EPA recognizes that from a technical or engineering
perspective, primary treatment is generally thought of as physical
processes to remove solids, the statutory definition of primary
treatment adopted by Congress for purposes of section 301(h) is
unambiguous in requiring 30 percent BOD removal. In addition, EPA
disagrees with the commenters who stated that the statutory definition
precludes the use of additional treatment processes such as chemical
addition to enhance primary treatment's physical processes (e.g.,
chemical addition, coagulation, and precipitation) in order to achieve
the required 30 percent removal of BOD.
With regard to the commenters' suggestions that the definition be
revised to define BOD as insoluble BOD only, EPA recognizes that
removal of BOD in primary treatment normally is associated with the
removal of settleable (i.e., insoluble) materials. While the literature
cited by the commenters indicates that BOD removals for traditional
primary treatment range from about 20 to 40 percent, the reported range
is a result of many factors including treatment plant design,
subsequent additional treatment and influent qualities such as the
presence of soluble versus non-soluble BOD. Furthermore, Congress set
the BOD removal standard without incorporating such a distinction. Both
soluble and insoluble BOD exert the similar effect of depressing
dissolved oxygen levels in the receiving waters. Limiting the required
removal to only insoluble BOD ignores this fact and also would be
inconsistent with the existing approach of the Agency's secondary
treatment regulations, which do not distinguish between removal of
soluble and insoluble BOD. EPA disagrees that the use of the term
``material'' in section 303(d)(2) indicates that Congress intended that
30 percent removal refer only to insoluble BOD. See, e.g., 40 CFR part
133.
The definition in today's regulations comports with the express
statutory language, and if an applicant does have difficulty meeting
the 30 percent BOD removal requirement with treatment by screening,
sedimentation, and skimming, for such reasons as dilute influent, cold
temperatures, or soluble-to-insoluble BOD ratios, applicants can
increase BOD removal efficiencies through the application of treatment
processes which may include physical processes enhanced by chemical
processes. Accordingly, given the unambiguous statutory language on
percent removal and the ability to use enhanced treatment processes
when necessary, EPA believes the definition should not be amended to
allow for less than 30 percent removal of BOD or to exclude soluble BOD
from the removal requirements established by Congress. Compliance with
the 30 percent removal requirement, which may require enhanced or
additional technologies, is more appropriate than limiting treatment
strictly to the three technologies listed in the statute and not
achieving 30 percent in some cases. The term material, EPA believes,
does not imply insoluble, and, as explained above, such an
interpretation makes little sense, given that soluble and insoluble BOD
exert similar effects in the receiving waters.
Other commenters requested that the definition be changed to
require that the combined average of both BOD and SS percent removal be
at least 30 percent. EPA considered this option but did not deem it
acceptable for two reasons. First, the statute states that primary
treatment requires the removal of at least 30 percent of the biological
oxygen demanding material and of the suspended solids. Combining the
BOD and SS removal requirements into an overall 30 percent average, in
EPA's view, would not satisfy the statutory language or intent. Second,
after considering both information submitted by commenters and EPA's
own assessment of primary treatment removal data from POTWs (See
Technical Review of the Influent/Effluent Characteristics of POTWs,
June 1994), EPA concludes that most POTWs are removing greater than 30
percent of SS, and some are removing greater than 60 percent of SS.
Adopting the suggested change thus would allow for an actual relaxing
of both BOD and SS removal even for applicants capable of meeting the
30 percent removal of BOD and 30 percent removal of SS. There is no
indication that Congress intended this result. Moreover, properly run
primary treatment plants should be able to meet 30 percent SS removal
and no comments or data were received that indicate otherwise. EPA
believes one objective of the primary treatment provision is to ensure
the proper design and operation of treatment plants, and this objective
would not be met under the commenters' suggested interpretation.
Similar to the above comments, some commenters requested the
definition be changed to require that the combined average of both BOD
and SS percent removal be greater than 60 percent. As stated above, EPA
does not believe that the statutory language and intent are consistent
with combining BOD and SS removals to meet the 30-percent removal
requirement. Using a standard of 60 percent would stray even further
from the plain meaning of the statute. Moreover, if Congress had
intended to provide a 60 percent removal requirement it could easily
have so specified in the statute, however, the statute makes no
reference to a 60 percent removal of BOD and SS. Finally, as with the
previous comment, this interpretation could allow for even greater
relaxing of treatment efficiencies for BOD removal (or SS), leading to
less efficient plant operations than applicants are currently
achieving.
Some commenters suggested that the requirement for 30 percent
removal should reflect a ``credit system,'' under which the removal
efficiency for BOD would be calculated based on a combination of the
BOD removal by industrial dischargers' pretreatment, plus the removal
achieved by treatment processes at the POTW. This approach is
inconsistent with the plain statutory language and thus cannot be
adopted. The statute unambiguously specifies that the 30 percent
removal rate is to be achieved with respect to the applicant's
influent. Such influent would already have been subject to industrial
dischargers' pretreatment, and because the statute requires that the 30
percent removal rate be achieved for the influent to the POTW, credit
cannot be given for upstream treatment by industrial dischargers.
In contrast to the above comments seeking a change in the
definition of primary treatment, other comments supported the
definition of primary treatment as 30 percent removal of BOD and of SS
as proposed. These commenters noted that this definition is consistent
with the plain, unambiguous definition specified by Congress in the WQA
as discussed above, and these commenters agree with EPA that the
suggested changes to the definition that EPA has rejected would be
inappropriate.
Definitions of Saline Estuarine Waters and Ocean Waters
Under section 303(e) of the WQA, section 301(h) modified discharges
are prohibited into saline estuarine waters exhibiting certain signs of
stress (i.e., degradation to water quality) specified in the statute.
In contrast, this flat prohibition does not apply to ``ocean waters.''
As a result, in the proposed rule, EPA amended the term ``ocean
waters'' in Sec. 125.58(n) to clarify that ocean waters are distinct
from saline estuarine waters because discharges to saline estuaries are
now subject to additional regulatory criteria not applicable to
discharges to oceans.
Although the existing definition of saline estuarine waters was not
proposed for amendment, some commenters expressed the view that it is
too broad and thus might give the prohibition on section 301(h)
discharges to stressed saline estuarine waters greater scope than
intended. These commenters sought a definition giving more precise
boundaries to saline estuarine waters.
The narrative definition of saline estuarine waters has remained
unchanged since its original 1979 promulgation in the section 301(h)
regulations, and the section 301(h) regulations have always placed
additional restrictions on discharges to saline estuarine waters
compared to ocean waters. Section 125.61(c)(4) (1982) places additional
limits on impacts within the zone of initial dilution for saline
estuarine discharges. EPA's experience with the use of a general
narrative definition of saline estuarine waters for purposes of making
regulatory distinctions is that this approach is workable. EPA believes
that it is not feasible for the purposes of the section 301(h)
regulations to develop a definition establishing fixed boundaries
between ocean and estuarine waters, but that all relevant local
circumstances should be considered and the distinction should be made
on the basis of the site-specific circumstances.
The commenters' concern appears to center on the meaning of the
term ``semi-enclosed waters'' in the definition of saline estuarine
waters. In this regard it is important to note that under
Sec. 125.58(v), not all semi-enclosed coastal waters are treated as
saline estuaries. Under the section 301(h) regulations, while some
embayments and other indentations along the coastline lie inside the
baseline from which the territorial sea begins, they are treated for
purposes of section 301(h) as being ocean waters. See preamble to 1979
section 301(h) regulations (44 FR 34784, 34795, June 15, 1979). As
noted in the preamble to the 1979 section 301(h) regulations (44 FR
34795), it is the presence of fresh water inflows that is the
distinguishing characteristic of estuaries. EPA notes today that saline
estuarine waters typically are waters lying inside the baseline in
which the salinity is diluted by fresh water inflows. In contrast,
embayments or indentations along the coastline that are not influenced
by such fresh water inflows are not estuaries. To further clarify that
ocean waters and saline estuarine waters are distinct and mutually
exclusive terms for purposes of section 301(h), the final rule, as in
the proposal, amends the definition of ``ocean waters'' to note that
this term specifically excludes saline estuarine waters.
Commenters also inquired about situations where an outfall crosses
through estuarine waters, but the actual discharge is into offshore
waters. Because both the statute and the implementing regulations make
clear that the prohibition applies to discharges of pollutants into
saline estuarine waters, the statute and implementing regulations
already adequately address this case.
Section 125.59: This section describes the general requirements for
section 301(h) applications, including filing procedures and deadlines,
procedures for revising applications, and procedures for State
determinations. EPA proposed to make several changes to this section.
In the proposed rule, EPA added procedures for permit renewal,
clarified language regarding State determinations, and added provisions
for the submission of additional information to demonstrate compliance
with the urban area pretreatment program and primary or equivalent
treatment requirements. EPA also proposed to amend the regulations in
accordance with section 303(g) of the WQA to exclude certain applicants
from the water quality criteria provisions of Sec. 125.62(a), primary
or equivalent treatment program requirements (Sec. 125.60) and urban
area pretreatment program requirements (Sec. 125.65) until permit
renewal. As provided by the WQA, and explained later on in this
preamble, these grandfathering provisions in today's final rule apply
only to those section 301(h) applications that received tentative or
final section 301(h) modified permit approvals prior to enactment of
the WQA.
The new requirements for submitting additional information are
found in Sec. 125.59(e) and (f). Under those provisions, permittees and
applicants to whom EPA has issued a final or tentative decision,
including those that have been grandfathered under WQA section 303(g),
must submit a letter of intent explaining how the permittee or
applicant will meet the primary treatment and urban area pretreatment
requirements. Under Sec. 125.59(f)(3), applicants that are not
grandfathered have two years from publication of the regulation to
comply with the primary treatment and urban area pretreatment
requirements; applicants that are grandfathered have until permit
renewal or two years from date of publication of these regulations,
whichever is later. Under Sec. 125.59(e), the letters of intent must
contain a project plan, including a schedule, to ensure that timely
implementation of the requirements is accomplished.
Some commenters expressed the view that two years from the date of
promulgation of the regulations is not sufficient time to enable
compliance with the primary treatment and urban area pretreatment
requirements. One of these commenters expressed concern over the impact
of such a deadline on a consent decree schedule it has entered into for
development of a pretreatment program. Further, this commenter was
concerned that the time would not be sufficient to develop pretreatment
limits for all 126 toxic priority pollutants. Another commenter
expressed concern that two years was not sufficient given their short
construction season and reliance on obtaining funds from a State
legislature whose timing is not in the commenter's control. Other
commenters expressed the view that two years is a reasonable timeframe.
Another commenter expressed the view that two years is an excessive
timeframe and in fact should not apply to requirements which were
either (1) in effect prior to the 1987 amendments or (2) clear on the
face of the 1987 amendments (e.g., 30 percent BOD/suspended solids
removal standards).
With regard to requirements in effect prior to the 1987 WQA, the
two-year time frame is not applicable. The two-year time frame applies
only to the urban area pretreatment program and primary or equivalent
treatment requirements, both of which were added by the WQA.
EPA recognizes that for some applicants, compliance with a two-year
deadline from the date of promulgation of the regulations may be more
difficult than for others, for example, those who may have to obtain
funding to design and build an upgraded facility to meet the primary
treatment requirements. However, none of the commenters opposing the
two-year deadline provided persuasive information demonstrating why
this deadline could not be met. One commenter subject to court-ordered
deadlines and consent decree time-lines asked how to reconcile these
deadlines with the consent decree time-lines. That commenter also noted
that there are a number of different activities that need to be
performed to establish a local limit, such as gathering data,
developing computer models, and obtaining government approvals. That
commenter, however, provided no information supporting why these
activities cannot be accomplished within the time established in the
regulation. EPA notes that several of these activities can be performed
simultaneously. In response, the commenter will have to comply with the
deadlines included in the consent decree. This comment is moot because
of the time that has elapsed between the proposed rule and today. The
deadlines in the rule should not affect the dates in consent decree. In
addition, the commenter has been on notice for several years. EPA
continues to believe that the two-year time frame for compliance
provides sufficient time to achieve compliance. It should also be noted
that the requirement to develop local pretreatment limits does not
necessarily apply to all 126 priority pollutants, but only those that
are known or suspected to be introduced to the plant by industry, as
discussed later in this preamble. The Agency notes that the statutory
provisions giving rise to these requirements were enacted in 1987, and
that the proposed regulations and draft technical support document were
issued in 1991. In addition, the Agency has had other final guidance on
the development of pretreatment programs in place for several years.
Even in cases where commenters claim they have large numbers of
dischargers and large numbers of pollutants will need to be addressed,
EPA continues to believe that sufficient time and notice has been given
to achieve compliance. EPA agrees with the commenter who noted that
applicants have been on notice of the need to comply with the primary
treatment and urban area pretreatment requirements for quite some time,
and could have already initiated work on the planning and development
of measures to achieve compliance. The Agency also recognizes that in
the absence of final regulations on these issues, applicants should not
be expected to have completely developed and implemented final plans.
Given this situation, and in the absence of supporting information to
show that the two-year time frame of the proposal is inappropriate, the
Agency is retaining the proposal's two-year time frame from the date of
publication of the final regulations in the Federal Register to achieve
compliance. This date, August 9, 1996, is inserted in the regulatory
text of this rule.
One commenter asked for additional time to comply with the urban
area pretreatment and primary treatment equivalency requirements for a
plant that has not yet been constructed. In response, these applicants
will have to demonstrate compliance with these requirements based on a
predictive analysis of their flows. The applicant must base their
prediction on potential industrial sources and pollutants, and, to the
best of their ability, support such predictions within the two-year
time frame.
In proposed Sec. 125.59(h), EPA added language to clarify that the
Agency may tentatively approve a section 301(h) permit modification
where an applicant has demonstrated a good faith effort to come into
compliance with all requirements of the section 301(h) regulations,
based upon a schedule approved by the Agency for meeting any
outstanding section 301(h) requirements. This provision is consistent
with the existing regulations and practice and was proposed for
addition only as a clarifying change. In addition, the proposal made no
changes to the existing requirement that in order to receive a final
section 301(h) modification, applicants must demonstrate actual
compliance with all of the part 125, subpart G, requirements before EPA
will issue a final section 301(h) modified permit. See 40 CFR
Sec. 125.59(g)(1) (1982).
One commenter supported the approach taken by EPA on tentatively
approving an application based on a schedule with respect to
outstanding requirements if an applicant has demonstrated a good faith
effort to come into compliance. However, the commenter is concerned
that Sec. 125.59(h) creates an ambiguity regarding the permissible
scope of the schedules for meeting 301(h) requirements. Section
Sec. 125.59(h) allows EPA to tentatively approve an application if the
applicant is making a good faith effort to comply with ``all
requirements of this subpart.'' (emphasis added) The section continues
on, however, to require that the schedule for meeting these
requirements must be ``approved by the Administrator in accordance with
Sec. 125.59(f)(3)(ii), which refers only to schedules of compliance
with Sec. 125.60 (primary or equivalent treatment) and Sec. 125.65
(urban area pretreatment).
EPA agrees with the commenter and is clarifying Sec. 125.59(h) to
allow schedules for satisfying the 301(h) requirements for all
requirements. It was not the Agency's intent to limit compliance
schedules to the requirements of Secs. 125.60 and 125.65. The Agency's
intent was that the limitations of Sec. 125.59(f)(3)(ii) apply only to
compliance schedules for meeting the Secs. 125.60 and 125.65
requirements. Therefore, we are adding a phrase to
Sec. 125.59(f)(3)(ii) that reflects the Agency's intent.
Some commenters expressed the view that EPA should not grant
tentative approvals before all the section 301(h) requirements are met.
Additionally, one of these commenters felt that if a tentative approval
is granted prior to such compliance, the applicant may be encouraged to
relax its effort to comply.
Based on its past experience with this approach, EPA believes that
the provisions of the proposed regulation are appropriate and contain
adequate safeguards to prevent abuse. The regulatory provision
specifically requires that applicants must be making a good faith
effort to achieve compliance and requires that EPA establish a schedule
for achieving compliance. In addition, this approach provides an
opportunity for EPA, through the tentative decision document, to put
the public and applicants on notice of specific deficiencies and the
steps and time frame required to correct such deficiencies. Rather than
creating a disincentive to timely compliance, the regulatory provision
requires that a schedule for compliance be established. In addition,
EPA believes that by advising applicants that they may receive a final
section 301(h) waiver if the identified deficiencies are corrected as
required, the provision provides an added incentive for applicants to
achieve timely compliance. Finally, by addressing such deficiencies
through the tentative approval, the more lengthy process of tentative
denial followed by application revision is avoided. For these reasons,
EPA believes that the regulatory provision is reasonable and is
promulgating that provision today as proposed with the clarification
noted above.
One commenter recommended that the EPA regional office issue a
letter to the applicant stating that its permit has been
administratively extended in accordance with Sec. 122.6. In response,
EPA notes that this is a procedural issue governed by the NPDES
regulations. It is not a subject of this rulemaking.
EPA notes in reviewing this section that Sec. 125.59(d)(5) might be
misinterpreted to mean there is no opportunity to present new
information on applications for permit renewal. Paragraph (d)(5) is
referring to the one-time revisions allowed in Sec. 125.59(d)(1) and
(d)(2). Applicants who are authorized or requested to submit additional
information under Sec. 125.59(g) may still do so.
Section 125.60: The proposal added Sec. 125.60 to the regulations
to implement the primary or equivalent treatment provision in section
303(d) of the WQA. Issues related to the definition of primary
treatment have been previously dealt with in the discussion of
Sec. 125.58.
Proposed Sec. 125.60 required an applicant's discharge, at the time
the waiver becomes effective, to have received at least primary or
equivalent treatment. Additionally, under the proposal, applicants were
to comply with this treatment requirement based on the monthly average
results of the monitoring for SS and BOD.
A number of commenters recommended that EPA consider lengthening
the period of time over which monitoring data are averaged to determine
compliance with the 30 percent BOD removal requirement. These
commenters presented information on the difficulties with achieving the
30 percent removal because of such factors as dilute wastewaters, cold
climates that impact treatment design parameters (e.g., settling
rates), and proportionately low amounts of insoluble BOD. One of the
options identified by these commenters was to change from monthly
averaging of monitoring data to annual averaging (or some period in
between). Commenters pointed out that this was a reasonable approach
which was necessary to account for variations in influent quality or
other factors affecting removal rates that might occur over a year's
time. Other commenters supported meeting the primary treatment removal
requirements on a monthly average basis.
The Agency believes that the proposed period for averaging
monitoring results (i.e., monthly) to determine compliance with the 30
percent BOD removal requirement will be appropriate for most
applicants. However, as noted in the discussion for the primary
treatment definition in Sec. 125.58, the Agency also recognizes that
the 30 percent removal rate for BOD may be difficult to achieve on a
monthly average basis in certain cases, e.g., dilute wastewater or
proportionately low concentrations of insoluble BOD. Because of this,
the final rule has been modified to provide flexibility in certain
instances by allowing compliance monitoring to be averaged for a period
longer than monthly, up to annually.
EPA anticipates that compliance monitoring requirements established
for longer than monthly average periods will be the exception, not the
general practice. An applicant who has demonstrated a consistent
ability to achieve 30 percent removal of BOD on a monthly average basis
over one year prior to the publication date of these regulations will
not be eligible for the longer than monthly averaging period. The
longer period will be available only to those applicants who have some
historical data on BOD removal, and not for newly constructed
facilities. Eligibility for the longer period is limited to those who,
based on circumstances listed below, and subject to the qualifications
listed below, truly cannot achieve 30 percent removal on a monthly
average.
It is the Regional Administrator's decision whether to allow the
longer averaging period. The Regional Administrator will judge each
eligible case on its individual circumstances, taking into account
climatic, seasonal, or other factors beyond the applicant's control
which cause significant fluctuations in influent characteristics that
could impact BOD removal efficiencies. Appropriate circumstances may
include:
Seasonally dilute influent BOD concentrations due to
relatively high (although nonexcessive) inflow and infiltration;
Relatively high soluble to insoluble BOD ratios on a
fluctuating basis; or
Cold climates resulting in cold influent.
The longer period must be requested by the applicant, and the
burden of justifying a longer averaging period will be on the
applicant. In addition to justifying the application on conditions
listed above, to qualify for the longer averaging period the applicant
will have to demonstrate to the satisfaction of the Regional
Administrator that the treatment facility is properly designed and
operated; that the applicant will be able to meet all section 301(h)
requirements with the longer averaging basis; and because of
circumstances beyond the applicant's control (examples listed above),
the applicant cannot achieve the 30 percent removal requirement for BOD
on a monthly averaging basis. The final rule also requires that inflow
and infiltration (I/I) is nonexcessive in order to ensure that
applicants have corrected, as feasible, deficiencies in their
collection system that result in extremely dilute wastewater. The
definition of excessive I/I in 40 CFR 35.2005(b)(16) will be used to
determine whether the I/I is excessive, plus the additional criterion
that inflow is nonexcessive if the total flow to the primary treatment
plant is less than 275 gallons per capita per day, consistent with 40
CFR 133.103(d) of the secondary treatment regulations.
It should be noted that permit writers can still incorporate
interim limits into the permit. When compliance determinations with
interim limits indicate that the ability to achieve 30 percent removal
of BOD for the designated period is compromised, action to determine
and, if possible, fix the problem should be taken. Monitoring
frequencies for BOD should remain the same as they would be if the
compliance determination for BOD removal was on a monthly average
basis. For enforcement purposes, there is the potential that allowing
longer averaging periods may prove more costly to the POTW in
violation. POTWs should note that if a longer period is granted, they
should be aware of the risk that a violation of an annual average limit
may result in 365 days of violation.
Other commenters requested that EPA set a baseline level of BOD in
the treatment works influent above which 30 percent removal would be
required, with 30 percent removal not required for influent cleaner
than that threshold level. This option relies on a level of BOD in the
influent that hypothetically represents a typical BOD influent
concentration. The statute specifies 30 percent removal and does not
tie this requirement to some specific concentration in the influent.
The Agency believes that making the statutory 30 percent removal
requirement dependent on a hypothetical influent baseline concentration
would not meet the statute's intent.
One commenter stated that the approach to section 301(h) waivers
should be based on water quality effects and not on any
``equivalencies,'' e.g., primary treatment and secondary removal
equivalency. In response to this general comment, EPA reiterates that
it is promulgating these regulations to implement the new provisions of
the WQA which mandate primary or equivalent treatment. Today's
regulatory scheme is fully consistent with the new WQA amendments.
Some commenters raised concerns about the financial impact on some
individual dischargers if additional capital improvements are needed to
meet the 30 percent BOD removal requirement. They see the costs of
meeting the new primary treatment requirements as having a
disproportionate impact on small communities. For example, one
commenter stated that this requirement would result in a 20 percent
rate increase; that polymers alone would cost $100,000. Others
commented that cost should not be a factor in justifying a lower
removal efficiency and that EPA should not guarantee a cap on sewage
treatment costs.
As part of this rulemaking EPA has prepared an economic analysis of
the impacts of the regulations. Although some communities may need to
make improvements to their plants to meet the primary treatment
requirements, the statute does not authorize any waiver of those
requirements on the basis of financial hardship. In addition, EPA
believes that as shown in the economic analysis, the final regulations'
requirements do not unduly impact small communities in terms of overall
cost of compliance. Specifically, none of the small communities,
including the community that indicated in its comments a 20 percent
increase in rates, will end up spending more than 1 percent of median
household income on wastewater treatment. Municipal financial impact
models used by EPA assume that ratios of wastewater treatment costs to
median household income of less than 1 are not expected to create
economic hardship for households. Moreover, although current treatment
costs may increase, small communities will still realize an overall
cost savings if less-than-secondary treatment is approved through the
section 301(h) process. Finally, as discussed above, the Agency in
today's rule has provided the opportunity for adjusting the averaging
period for calculating compliance with the primary treatment
requirement for BOD under certain circumstances. This added flexibility
should further serve to reduce any potential adverse financial impacts.
The new flexibility may allow POTWs with dilute influent, provided it
is not excessive I&I to qualify with less cost to achieve compliance.
The cost of improving collection systems to fix excessive I&I would
impact small communities, but is not a cost of this rule. In response
to a comment that the need for this flexibility results from future
increases in treatment capacity due to population growth, EPA agrees
that this is not an appropriate reason, and has not based its decision
to allow flexibility on costs of additional treatment due to future
growth. There are other more appropriate and legitimate reasons, as
spelled out earlier in this preamble, for some measure of flexibility.
Section 125.61: No changes to this section were proposed or are
promulgated today. This section addresses the existence of, and
compliance with, water quality standards for the pollutant for which
the modification is requested. No comments were received.
Section 125.62: This section contains requirements for the
attainment or maintenance of water quality which assures protection of
public water supplies, the protection and propagation of a balanced,
indigenous population of shellfish, fish, and wildlife, and allows
recreational activities. In response to the requirement of WQA section
303(d) for discharges to meet CWA section 304(a)(1) water quality
criteria, EPA proposed language at Sec. 125.62(a)(1)(i)-(iii) and
125.62(a)(2) and (3) to implement that additional requirement. The
proposal also amended Sec. 125.62(f) to implement requirements of WQA
section 303(a) regarding combined impacts of section 301(h) discharges
and made a conforming change in light of the WQA prohibition on section
301(h) discharges to stressed estuaries to clarify that the
regulations' stressed waters test applies only to ocean waters.
Comments on this section addressed issues related to water quality
criteria, including human health carcinogenic risk levels, mixing
zones, combined impacts, and stressed waters.
Water Quality Criteria
Under the proposal to implement the WQA requirement that discharges
meet EPA section 304(a)(1) water quality criteria, EPA would first
determine whether there is an EPA-approved State water quality standard
that directly corresponds to the EPA section 304(a)(1) water quality
criterion for the specific pollutant. If there is, EPA would apply this
directly corresponding State standard. In the absence of such a State
standard, the section 304(a)(1) water quality criterion would be
applied instead. Under the proposal, an EPA-approved State water
quality standard would be deemed to ``directly correspond'' if (a) the
State water quality standard addresses the same pollutant as EPA's
water quality criterion; and (b) the State water quality standard
specifies a numeric criterion for that pollutant, or an objective
methodology for deriving such a pollutant-specific criterion. The
preamble to the proposed rule discusses this subject in more detail (56
FR 2818-2819).
A commenter felt that the regulations should require compliance
with the CWA section 304(a)(1) criteria at a minimum, and that
compliance with a directly corresponding State standard that may be
less stringent instead was unacceptable. The commenter argued that
Congress was aware of State water quality standards, and had Congress
intended that an applicant's discharge meet State water quality
standards, then Congress would have provided language so mandating. The
commenter also asserted that 301(h) waiver requirements should be
strictly construed in favor of water quality because 301(h) waivers
represent an exception to the general requirement to meet secondary
treatment. Other commenters supported the proposal to defer to EPA-
approved State water quality standards. The commenters believed that
this approach appropriately recognizes the State's discretion to set
its own standards.
EPA continues to believe that compliance with the EPA-approved,
directly corresponding State water quality standard in lieu of the EPA
section 304(a)(1) water quality criterion is appropriate. EPA water
quality criteria are national criteria, primarily issued to serve as
guidance for the States to use in establishing their water quality
standards under CWA section 303.
Under the CWA, States may develop water quality standards based on
the section 304(a)(1) criteria, as modified to reflect site-specific
conditions, or they may use other scientifically defensible methods for
developing water quality standards. State standards are subject to EPA
review and approval. They are developed by the States to protect the
types of biota in, and beneficial uses of, their local waters, and thus
represent scientifically appropriate standards for each State's
specific situation. EPA does not believe that, in amending section
301(h), Congress intended to interfere with this statutory scheme, nor
require compliance with the national guidance contained in the section
304(a)(1) criteria when the CWA section 303 standard-setting process
results in adoption of different standards to reflect local conditions
and those standards have been subject to EPA review and approval.
Rather, EPA believes that the intent of this provision was to ensure
compliance with the national section 304(a)(1) criteria in those cases
where the States have not adopted a directly corresponding State
standard and EPA has not itself promulgated a standard in light of such
State inaction. Today's final rule therefore retains the proposal's
approach. In the absence of an EPA-approved State water quality
standard that directly corresponds to the section 304(a)(1) water
quality criteria, the final rule requires compliance with the section
304(a)(1) water quality criteria.
For carcinogens, the EPA section 304(a)(1) criteria provide a range
of risk levels and corresponding criterion for each specific risk
level. In the proposal, EPA did not establish a specific risk level for
use in the section 301(h) program. As explained in the preamble (56 FR
2819, 2820), EPA instead would consider all relevant information in
determining the pollutant concentration that represents an appropriate
risk level for a specific carcinogen. This information would include
evidence that the State has consistently used a particular risk level
when establishing its water quality standards for other carcinogens. In
the absence of such a consistent State policy, EPA would consider a
State recommendation of a particular risk level if the State
demonstrates to the satisfaction of EPA that the particular risk level
is justified. The State demonstration would need to account for the
relevant exposure and uncertainty factors, show adequate public
participation in the selection of the risk level, and show that use of
the selected risk level is adequately protective of human health. In
cases where there is no consistent State policy or satisfactory State
demonstration on which to base a risk level, under the proposal, EPA
would set a specific risk level (for example, 10-6) based on the
circumstances of each case. See preamble to the proposed rule, 56 FR
2818-2820, for a detailed explanation of a satisfactory State
demonstration of a recommended risk level and EPA's approach to setting
risk levels.
EPA received a number of comments addressing the issue of whether
to set a specific risk level by regulation as opposed to allowing it to
be set on a case-by-case basis. A commenter stated that rather than
assuming that a zero discharge level is unattainable for any known
carcinogen, EPA should require the discharger to prove that, in fact,
zero discharge in a particular situation either would create severe
economic hardship or is not technologically feasible. These commenters
also stated that under no circumstances involving carcinogenic
pollutants should the allowable discharge exceed a 10-6 risk level
or the applicable State standard, whichever is more stringent. Other
public comments received on the issue of water quality criteria for
carcinogens also said the regulations should specify a human health
risk level that is no less protective than the 10-6 incremental
cancer risk and asserted that EPA had done so in other national
programs. One commenter stated that there should not be a flexible,
case-by-case approach toward establishing risk levels for carcinogens.
Instead, the commenter suggested that EPA establish a minimum risk
level, the least protective risk level that is acceptable, (and
corresponding maximum permissible discharge concentration) but allow
for flexibility to choose a more stringent risk level based upon a
given State's past practice.
With regard to the zero-risk level, as mentioned in the preamble to
the proposed rule, EPA believes that a zero effluent concentration is
essentially unattainable. Therefore, EPA has approved numeric State
water quality standards for carcinogens under CWA section 303 that
correspond to risk levels above zero. The approach adopted in the
proposed rule provides consideration of the State's views on an
appropriate risk level, or in the absence of such State input, provides
for EPA to consider all relevant information in setting a risk level.
EPA believes that establishing a presumption in favor of a zero risk
level would be inappropriate because even apart from questions of
achievability, compliance could not be demonstrated due to limitations
in analytical methods. Further, the commenter provided no basis to
refute EPA's belief that zero risk levels are not achievable. EPA thus
is not amending the regulations to establish a presumptive zero risk
level.
With regard to whether the section 301(h) regulations should
establish a single uniform risk level for use in the section 301(h)
program, the establishment of risk levels is a national issue which is
not limited to the section 301(h) program. As noted in the preamble to
the proposed rule (56 FR 2819), EPA expected that many or most coastal
States already had established or soon would establish one or more EPA-
approved water quality standards for toxic carcinogenic pollutants,
pursuant to section 303(c)(2)(B) of the CWA.
Subsequent to the proposal of these revised section 301(h)
regulations, EPA applied risk levels in the National Toxics Rule, which
sets water quality standards for priority pollutants in States that did
not have approved standards, pursuant to Sections 303(c)(2)(B) and
303(c)(4) of the CWA (57 FR 60848, December 22, 1992). More
specifically, the National Toxics Rule establishes water quality
standards pollutant-by-pollutant for fourteen States that did not have
an EPA-approved standard for the toxic pollutant in question where
section 304(a)(1) water quality criteria have been developed. EPA set
legally enforceable water quality standards with incremental cancer
risk levels for carcinogens and corresponding numeric values based on
specific exposure and other modeling assumptions. It should be noted
that EPA did not adopt a uniform nationwide 10-6 risk level in
other contexts, e.g., the National Toxics Rule, as suggested by a
commenter, who advocated that as a minimum level of protection.
In each State covered by the National Toxics Rule, the carcinogenic
risk level used to set the State's standard(s) was based on the best
information available to the Agency regarding that State's policy or
practice for risk levels used or that should be used in regulating
carcinogens in surface waters. For most of the affected States, the
risk level is based on a State-adopted or formally proposed risk level.
For some, the risk level is based on an expressed State policy
preference. With the National Toxics Rule, all States are now in
compliance with section 303(c)(2)(B). Hence, for purposes of
implementing Sec. 125.62, EPA will now look to the guidance contained
in the preamble and regulations of the National Toxics Rule to
establish the appropriate human health risk level and numeric value in
the absence of a directly corresponding State standard for any section
304(a)(1) criterion later established.
EPA believes that the carcinogenic risk provisions of proposed
Sec. 125.62(a)(2)(ii) are consistent with the National Toxics Rule, 40
CFR Sec. 131.36, and the guidance provided in the preamble to the rule
(57 FR 60848). Accordingly, today's rule at Sec. 125.62(a)(ii) is
promulgated as proposed, with a minor editorial change. In the absence
of an EPA-approved State water quality standard for a carcinogenic
pollutant, the Administrator will consider a consistently used, or
State-adopted or formally proposed risk level recommendation with a
satisfactory demonstration that the level is adequately protective of
human health in light of exposure and uncertainty factors and
population exposed. Exposure factors would include, for example, local
patterns of fish consumption, cumulative effects of multiple
contaminants and local population sensitivities. Factors related to
uncertainty would include, for example, the weight of scientific
evidence concerning exposures and health effects and the reliability of
exposure data.
One commenter noted that determinations of compliance with water
quality criteria will be dependent on the frequency and types of
sampling methods used and the effects industrial users' pretreatment
programs have on effluent quality. The commenter urged a flexible
approach in determining compliance because of these variables. EPA
notes, in response, that the regulations do not specify rigid sampling
requirements and frequencies, and thus already allow for consideration
in designing sampling programs to adequately characterize effluent
quality for purposes of evaluating compliance with water quality
criteria.
New section 301(h)(9) of the CWA requires that the discharge meet
the section 304(a)(1) water quality criteria ``after initial mixing in
the waters surrounding or adjacent to the point at which [the] effluent
is discharged.'' The zone of initial dilution (ZID) is defined in
existing Sec. 125.58(w) as ``the region of initial mixing surrounding
or adjacent to the end of the outfall pipe or diffuser ports, provided
that the ZID may not be larger than allowed by mixing zone restrictions
in applicable water quality standards.'' The existing 1982 regulations
required that all applicable State water quality standards adopted
under section 303 of the CWA be met at and beyond the boundary of the
ZID.
New language was proposed in Sec. 125.62(a)(1)(i) to implement the
requirement of new section 301(h)(9) to comply with the section
304(a)(1) water quality criteria or the directly corresponding State
water quality standards, but inadvertently omitted those State water
quality standards that do not directly correspond to the section
304(a)(1) water quality criteria. In so doing, EPA inadvertently
omitted the existing requirement that all applicable State water
quality standards, including those that do not directly correspond,
must still be met at and beyond the ZID. This requirement has been
retained in the final regulation. For purposes of this discussion,
there are three categories of water quality requirements: State water
quality standards that directly correspond to water quality criteria,
State water quality standards that do not directly correspond to water
quality criteria, and water quality criteria. It is the second
category, those State water quality standards that do not directly
correspond to water quality criteria, that was inadvertently left out
of the proposed regulation.
Two commenters questioned whether the proposed rule, by referring
to the ZID for purposes of calculating compliance with section 303
State water quality standards, raised a potential conflict with State-
specified mixing zones adopted as part of the section 303 standard-
setting process. One of these commenters requested that the regulations
be clarified to specify that compliance with State water quality
standards is to be determined under the methods and conditions
specified by the State in its standards.
EPA agrees that the proposed language could create confusion.
Today's final rule includes the existing requirement of the 1982
regulations that all applicable State water quality standards adopted
under section 303 of the CWA be met at and beyond the boundary of the
ZID and promulgates as proposed the new section 301(h)(9) requirement.
The effect of today's rule is to retain the existing practice of the
section 301(h) program in determining compliance with State water
quality standards. As stated in the preamble to the proposed rule,
EPA's purpose in promulgating these revisions to the regulations on
this issue was to implement the new requirements of the WQA. EPA did
not intend to change existing regulatory requirements not affected by
the WQA. As promulgated today, Sec. 125.62(a)(1) reflects the existing
regulations with the additional requirements of section 301(h)(9) of
the CWA, and EPA intends no changes to how determinations of compliance
with State water quality standards are made.
One commenter pointed to inconsistencies between language in the
technical support document (TSD) on ZID size and the actual definition
of the ZID as contained in Sec. 125.58(dd) of the regulations and
requested that this be addressed by amending the ZID definition. The
ZID definition was not proposed for amendment in the 1991 proposal and
is not being changed today. EPA responded to the comment by adding a
clarification to the final TSD on the technical issues regarding
calculation of the ZID size.
Combined Impacts of Discharge
Section 303(a) of the WQA requires an applicant to demonstrate that
the section 301(h) modified discharge will not interfere, alone or in
combination with pollutants from other sources, with the attainment or
maintenance of water quality to protect the uses specified in section
301(h)(2). As noted in the preamble to the proposed rule (56 FR 2816),
although EPA believes this requirement is consistent with the existing
1982 regulations, EPA added language in proposed Sec. 125.62(f) to
clarify this point. Proposed Sec. 125.62(f) requires an applicant to
demonstrate that its modified discharge meets Sec. 125.62 (a) through
(e), both alone, and taking into account the discharge in combination
with pollutants from other sources.
One commenter noted that cumulative impact assessments would need
to be performed to demonstrate that the POTW is not causing impact
alone or in combination with other dischargers and that the information
needed to make the assessment may not be available. The commenter
recommends that EPA provide sufficient guidance on performing the
needed cumulative impact assessments, including information on regional
waste load allocations, nonpoint source information, beneficial use
quantification, and regional water quality monitoring data. EPA agrees
that such information would be useful in making the required
demonstration of compliance. The availability of such site-specific
information will vary depending on local circumstances. Applicants
should work closely with their EPA Region and State water agencies to
identify possible sources of such information. EPA considered this
comment and made changes to the final TSD for the regulations in order
to provide additional guidance on this issue.
Stressed Waters
EPA received comments on two related aspects of the statutory
requirements and regulatory provisions regarding stressed waters: (1)
Demonstrating that no causal relationship exists between stressed
conditions and the applicant's discharge, and (2) prohibitions on
301(h) modified discharges to stressed saline estuaries. One commenter
on Sec. 125.62(f) (1) through (3) (the ``stressed waters test'')
requested that EPA state that an applicant can still make the
demonstration required by Sec. 125.62(f) (1) through (3) by showing
that no causal relationship exists between the stressed conditions and
the applicant's discharge. Other commenters supported the continued
requirement to demonstrate that no causal relationship exists between
the stressed conditions and the proposed section 301(h) modified
discharge. As previously noted, paragraphs (f) (1) through (3) are the
same as provisions contained in the existing 1982 section 301(h)
regulations, and applicants must demonstrate an absence of a causal
relationship between their discharge and stressed conditions as
specified in those paragraphs. The three substantive requirements for
such a demonstration were not proposed for change. As in the past,
applicants invoking this provision may avoid the need to demonstrate
compliance with paragraphs (a) through (e) by demonstrating that the
modified discharge does not:
(1) Contribute to, increase or perpetuate stressed conditions;
(2) Contribute to further degradation; and
(3) Retard recovery if perturbations from other sources decrease.
To reiterate, despite the addition of the word ``entirely,'' an
applicant still can make the demonstration required by Sec. 125.62(f)
(1) through (3) by showing that no causal relationship exists between
the stressed conditions and its proposed discharge.
Prior to the 1987 WQA, section 301(h) and the 1982 implementing
regulations allowed section 301(h) modified discharges to stressed
waters only under certain limited conditions, with no distinction made
between stressed saline estuaries and stressed ocean waters. The 1987
WQA amendments tighten this restriction with respect to saline
estuaries by prohibiting section 301(h) modified discharges altogether
to saline estuaries that are stressed (i.e., that exhibit certain
characteristics specified in the statute). The amendments also specify
that this prohibition applies without regard to whether it is the
applicant's discharge that is causing or would cause the stressed water
quality conditions. To implement this new statutory prohibition, EPA
proposed a change to the existing regulations regarding stressed
waters. EPA proposed adding this new prohibition to Sec. 125.59(b)(4),
and making conforming changes to Sec. 125.62(f) to prohibit section
301(h) waivers where stressed saline estuaries are involved. Section
125.62(f) is the provision that allows discharges to stressed waters
under certain conditions. The proposal altered this provision so that
such discharges would be allowed only with respect to stressed ocean
waters and not saline estuarine waters.
Commenters expressed the view that Congress did not intend to make
section 301(h) waivers available for any severely degraded waters,
whether in estuaries or oceans, and recommended limiting the reach of
the stressed waters exception to those locations where severe
environmental degradation has not occurred. The commenters noted that
if an exception must be available to POTWs discharging to stressed
waters, the commenters supported the approach taken in proposed
Sec. 125.62(f). In response to this comment, EPA notes that the 1987
WQA flatly prohibits section 301(h) modifications with respect to
stressed estuaries only. In contrast, applicants can satisfy 301(h)(2)
by showing that their discharges will not ``interfere, alone or in
combination,'' with certain water quality objectives. EPA continues to
believe that Sec. 125.62(f) fully meets this statutory directive. There
is no basis for the suggestion that Congress intended categorically to
prohibit waivers with respect to all stressed waters. Indeed, the
legislative history cited by the commenter does not lead to a contrary
opinion. EPA believes that the provisions adopted in today's final
regulations to implement the WQA prohibition on discharges to stressed
estuaries are fully consistent with the statute and that extending this
prohibition to ocean waters would be inconsistent with the plain
statutory language. Accordingly, the stressed waters provision in this
section is promulgated as proposed.
Section 125.63: This section outlines the general requirements for
monitoring programs required under section 301(h)(3) of the CWA. In the
proposal, EPA added language to this section to respond to section
303(b) of the WQA, which restricts the required scope of section 301(h)
biological monitoring programs to those scientific investigations
necessary to study the effects of the proposed discharge. EPA also
noted in the preamble to the proposed rule that the requirements of
such monitoring programs under the existing regulations are in fact
already focused on the effects of the discharge. The proposal also
added a requirement that applicants monitor their discharges to ensure
compliance with water quality criteria (if applicable under
Sec. 125.62(a)), in addition to water quality standards based on the
provision of section 301(h)(9).
EPA received one comment regarding monitoring. The commenter
requested that EPA add a provision for amending monitoring programs in
existing permits, including permits administratively extended beyond
their expiration dates, when the changes are technically justified. EPA
appreciates that changes to section 301(h) monitoring programs during
the life of the permit may be appropriate. EPA notes that this is a
procedural issue governed by the NPDES regulations and is not the
subject of this rulemaking. See 40 CFR 122.6.
Monitoring for Removal Efficiency Requirements
Some commenters suggested that the demonstration of removal
efficiency (defined as removal of 30 percent of BOD and TSS) should be
made throughout the year, and not simply at the time the modification
becomes effective. Other comments suggested that EPA require a
demonstration of removal efficiency of BOD as an initial threshold
determination only, that is, a one-time demonstration. In response, EPA
believes that demonstration of the removal efficiency should be an
ongoing requirement, and Sec. 125.60(b) requires that compliance be
demonstrated based on monthly averaging, as proposed (subject to the
exceptions discussed above). In addition, the statute does not state a
one-time requirement but instead envisions an ongoing requirement that
the applicant ``will be'' discharging effluent that has received
primary treatment. Given the statutory requirement for primary
treatment, it would make little sense to require a one-time
demonstration of removal efficiency, with the possible result that
less-than-primary treatment could occur during the course of the
section 301(h) modified permit and go undetected.
To ensure that data are available for purposes of section 301(h)
permit renewals, ongoing monitoring of compliance with the removal
efficiency requirement is necessary. EPA thus continues to believe that
section 301(h) permittees should monitor for compliance with the
primary treatment requirement over the life of the permit at the
frequency required in Sec. 125.60 (i.e., monthly, unless a less
frequent monitoring period is specified). Although already required in
Sec. 125.60(b), to clarify this point the final rule adds a new
paragraph, Sec. 125.63(d)(2), to ensure that the permit monitoring
requirements provide adequate data for demonstrating compliance with
the removal efficiency requirement over the life of the permit.
EPA is also making a conforming change to Sec. 125.63(a)(1)(i) to
clarify that monitoring programs must be designed to evaluate water
quality criteria, as well as water quality standards. This conforms to
the proposed change in Sec. 125.63(c), reflecting WQA language.
Changes to Monitoring Requirements
Some commenters requested that EPA identify the practical impact
the new limitation on the scope of monitoring will have on current
monitoring programs. As previously discussed, EPA does not believe that
WQA language limiting section 301(h) biological monitoring to
investigations necessary to evaluate the discharge effects represents a
substantial change in the program. The purpose of the required
monitoring programs has always been to evaluate discharge effects.
Since the monitoring program was already focused on evaluating
discharge effects, the new statutory and regulatory language should not
result in substantial changes to existing monitoring programs.
Other commenters expressed concern over potentially increased
monitoring costs. The additional monitoring requirements to ensure
compliance with the WQA's water quality criteria and primary or
equivalent treatment requirements are a necessary and reasonable
outgrowth of those new statutory requirements. Given those substantive
requirements and the need for data to evaluate continued compliance and
to support future requests for permit renewal, EPA believes it is
necessary to require monitoring in these areas. As with other section
301(h) monitoring requirements, the exact nature and frequency of such
monitoring by a particular applicant would be set on a permit-by-permit
basis in order to reflect individual circumstances. Burdens associated
with these monitoring requirements were addressed in the supporting
documentation for the information collection request accompanying the
regulations. Although some extra costs may be incurred, many of these
are one-time costs, and are not excessive, especially in light of the
economic benefits to the discharger receiving a section 301(h) waiver.
Section 125.64: This section contains criteria related to the
impacts of the modified discharge on other point and nonpoint sources
and implements section 301(h)(4) of the CWA. There were no proposed
changes to this section and no comments were received. This section
remains unchanged.
Section 125.65: This new section sets forth the urban area
pretreatment program requirements of section 303(c) of the WQA (CWA
section 301(h)(6)). These requirements apply to POTWs serving a
population of 50,000 or more, with respect to any toxic pollutant as
defined by Sec. 125.58(aa) introduced into the POTW by an industrial
source. Applicants subject to this provision must demonstrate that
industrial sources are in compliance with all applicable pretreatment
requirements, and that the applicant will enforce those requirements.
Also, for each toxic pollutant for which there is no applicable
pretreatment requirement in effect, the applicant must have in effect a
pretreatment program which, in combination with the treatment of
discharges from the POTW, removes the same amount of such pollutant as
would be removed if the POTW were to apply secondary treatment and had
no pretreatment program for such pollutant.
To implement these provisions, the proposed rule added Sec. 125.65
and added or revised certain definitions in Sec. 125.58. Proposed
Sec. 125.65(a)(2) clarified that the requirements of Sec. 125.65 are to
apply in addition to any applicable pretreatment requirements contained
in 40 CFR part 403 and that nothing in Sec. 125.65 is intended to waive
or relax the 40 CFR part 403 requirements.
Section 125.65 provides two methods for satisfying the urban area
pretreatment requirements. For each toxic pollutant introduced by an
industrial discharger, the applicant must demonstrate that it either
(1) has an ``applicable pretreatment requirement in effect'' or (2) has
in effect a program that achieves ``secondary removal equivalency.''
EPA received a number of comments requesting clarification of this
provision, as well as comments related to pretreatment requirements,
which toxic pollutants should be subject to urban area pretreatment
requirements, demonstration of secondary equivalency, and enforcement
of pretreatment requirements.
Scope of Pollutants to be Addressed
Some commenters believe that the urban area pretreatment program
requirements should apply only to ``pollutants of concern,'' rather
than applying to all priority pollutants introduced by industrial
dischargers. Commenters were concerned that the requirements might be
interpreted to apply to all 126 priority pollutants, whether or not
these are known or suspected to be discharged to the POTW by industry.
They believe the urban area pretreatment requirements should be limited
to those priority pollutants that are specifically known to pose a
threat or potential threat to human health, safety, or environmental
quality. These commenters stated that pollutants of concern should not
include pollutants that do not pose such a risk and provided several
options for identifying pollutants of concern, i.e., by excluding from
coverage pollutants (1) only discharged in small amounts by one
industry; (2) meeting water quality standards at the boundary of
initial mixing; (3) discharged in effluent at a threshold level percent
of an applicable water quality standard, criterion, or permit limit;
(4) discharged in low concentrations; (5) which do not interfere or
threaten to interfere with the attainment or maintenance of water
quality objectives as found in Sec. 125.62; or (6) not detected in the
effluent of the POTW. These commenters felt that developing local
limits for all toxic pollutants would be difficult and overly
burdensome. The commenters further stated that a distinction should be
made between significant and insignificant industrial dischargers.
EPA has not adopted these suggested changes in today's rule. The
statute clearly states that the urban area pretreatment requirement
applies to any toxic pollutant introduced into the POTW by an
industrial discharger. Therefore, EPA believes the regulations should
address all such toxic pollutants. However, this means only those toxic
pollutants known or suspected to be introduced to the POTW by an
industrial discharger. Thus, if all 126 priority pollutants are not
discharged to a given POTW, not all 126 priority pollutants will need
an applicable pretreatment requirement, e.g., categorical standard or
local limit. EPA notes, however, that the industrial user's survey must
be comprehensive, addressing all non-domestic sources, to assure that
the POTW takes all toxics from industrial sources into account.
Guidance is provided in the TSD to help identify toxics known or
suspected to be discharged from several industries not subject to
categorical pretreatment regulations.
One commenter asserted that receiving waters should be the focus of
this requirement; that is, it is inappropriate to have technology-based
requirements when receiving waters do not warrant them. The commenter
further stated that the requirement should focus on whole effluent
toxicity. In response, EPA notes that the statutory provision is
technology-based, and refers to each toxic pollutant introduced by
industrial sources. Other Clean Water Act provisions address whole
effluent toxicity and this has been taken into account.
Applicable Pretreatment Requirements
As specified in Sec. 125.65(c) of the proposed regulations,
applicable pretreatment requirements could take the form of federal
categorical pretreatment standards promulgated by EPA under section 307
of the CWA, local limits developed in accordance with 40 CFR part 403,
or a combination of both. As proposed, therefore, applicable
pretreatment requirements consist of the following as stated in
Sec. 125.65(c):
(i) for each industrial source discharging to the applicant's
treatment works for which there is no applicable categorical
pretreatment standard for the toxic pollutant, a local limit or limits
on the toxic pollutant satisfying the requirements of 40 CFR part 403
and Sec. 125.62;
(ii) for each industrial source discharging to the applicant's
treatment works that is subject to a categorical pretreatment standard
for the toxic pollutant, the categorical standard plus a local limit or
limits as necessary to satisfy the requirements of 40 CFR part 403 and
Sec. 125.62.
One commenter stated that ``applicable pretreatment requirements''
should be developed to ensure compliance with 40 CFR part 403 and not
also to ensure compliance with requirements in Sec. 125.62, which
addresses protection of a balanced indigenous population (BIP). This
commenter pointed out that the requirements to achieve a BIP already
must be satisfied under Sec. 125.62 if the section 301(h) permit
modification is to be granted. Further, it is unnecessarily restrictive
to specify that the BIP requirements be met by applying local limits
rather than through other means.
EPA agrees and has clarified this provision in the final rule by
deleting the reference to Sec. 125.62 from Sec. 125.65 (c)(1) (i), (ii)
and (2). Any section 301(h) discharge must comply with the BIP
requirements of the regulations, but how this is achieved, whether by
local pretreatment standards or other toxics control measures, is at
the discretion of the applicant. The Agency never intended to require
that local limits alone must be shown to independently protect a BIP.
The intent was that local limits would be developed to meet 40 CFR part
403 and Sec. 125.65 and would be at least one aspect of overall toxic
control efforts by the applicant that would contribute as a whole to
meeting the requirements of a BIP. It should be noted, however, that
conditions necessary to achieve and perpetuate a BIP may be used as a
basis for setting a local limit.
Because the regulations already require compliance with
Sec. 125.62, and in light of the concerns raised over linkage of local
limits to the Sec. 125.62 requirement, EPA is making this change to the
final regulations. This change does not alter the requirement to meet
all other section 301(h) provisions.
Some commenters believe that provisions should be included for
local limits to consider sludge quality and the potential for air toxic
emissions. Under the Agency's existing local limit program under 40 CFR
part 403, and sewage sludge regulations at 40 CFR parts 257, 403 and
503, local limits may be required where necessary to protect sludge
quality so as not to interfere with its management and ultimate
disposal or beneficial use, and where necessary to protect plant
workers. The pretreatment regulations address air toxic emissions
within the POTW to protect worker health and safety. The commenters'
concerns regarding sludge quality and incineration, and resultant air
emissions are addressed by the Agency's pretreatment regulations,
sewage sludge regulations and regulations under the Clean Air Act. The
Agency has begun to address standards for air toxic emissions from
POTWs.
The comments taken as a whole show some confusion about how EPA
expects the ``applicable pretreatment requirement in effect'' provision
of the urban area pretreatment program to be implemented. Commenters
were concerned that these requirements were overly burdensome and
sought flexibility. Commenters pointed out that requirements for every
industrial user are unnecessary for ensuring an adequate local limit
for the toxic pollutant. After considering these comments, EPA has
revised its approach as follows. First, the POTW need not apply a
specific local limit to each and every industrial source of each toxic
pollutant. Instead, after conducting a local limits analysis, the POTW
may apportion the allocation to industrial sources of the toxic in the
way that the POTW deems most appropriate, subject to the approval of
the Regional Administrator. This could include not imposing any limit
for the pollutant on certain industrial users. This modification should
achieve the same end result as the proposal, that is, to attain the
same level of toxic pollutant reduction, while providing flexibility to
the POTW to implement the provision. The Guidance Manual on the
Development and Implementation of Local Discharge Limitations under the
Pretreatment Program discusses how to allocate local limits among
industrial sources for all POTWs, not just 301(h) applicants. EPA
believes that the approach of POTWs under 301(h)(6) should be
consistent with that guidance. This approach is less burdensome to
implement while still achieving equivalent reductions in toxics.
Second, the applicant can show an ``applicable pretreatment
requirement in effect'' for those toxic pollutants for which there is
no applicable categorical pretreatment standard, and for which the
applicant determines, based on the 40 CFR part 403 analyses, that a
local limit is not necessary. The permit in these cases will require
the applicant to demonstrate on an annual basis over the permit term,
that a local limit is not necessary and, where appropriate, will
require the applicant to institute industrial management practices
plans.
The following steps are intended to clarify how EPA will implement
the ``applicable pretreatment requirement in effect'' provision for
toxic pollutants:
(1) The applicant must conduct an industrial user survey as
required by 40 CFR part 403 and Sec. 125.66;
(2) The applicant must conduct representative sampling and analysis
of the POTW's influent, effluent, and sludge for toxic pollutants;
(3) The applicant must implement the national categorical standards
for each industrial source subject to categorical standards;
(4) For those toxic pollutants known or suspected to be introduced
by an industrial source, the applicant must conduct an analysis under
40 CFR part 403 to assess the need for local limits;
(5) For those toxic pollutants for which the applicant determines,
based on the 40 CFR part 403 analysis, a need for local limits, the
applicant must set local limits;
(6) For those toxic pollutants for which the applicant determines,
based on the 40 CFR part 403 analysis, that local limits are not
necessary, the applicant must continue to monitor the POTW influent and
effluent during the term of the permit and/or conduct technical reviews
of data on discharges from industrial sources during the term of the
permit, and where appropriate require industrial users to institute
industrial management practices plans (IMPs) and other pollution
prevention activities, to reduce or control the levels of these toxic
pollutants from industrial sources. These plans and activities could
include Best Management Practices (BMPs). See TSD and EPA Guidance
Manual on the Development and Implementation of Local Discharge
Limitations under the Pretreatment Program (1987 and 1991). For these
toxic pollutants, applicants would be required to assure EPA on an
annual basis that these particular toxic pollutants do not result in
levels that warrant development of local limits. If such monitoring and
technical review of data indicate that a local limit is needed, the
POTW shall establish and implement a local limit.
The basic philosophy of instituting industrial management practice
plans (IMPs) is to minimize the discharge of toxic or hazardous
pollutants to the sewer, or reduce the impact of toxic/hazardous
pollutant discharges by avoiding short-term, high concentration
discharges. IMPs can be applied to all classes of industrial users,
e.g., major and minor industrial users. Examples of appropriate uses of
IMPs include control of chemical spills and sludge discharges to the
POTW through formal chemical or waste management plans (including
BMPs), solvent management plans, batch discharge policies, waste
recycling and waste minimization. It would also be appropriate to
consider IMPs in cases where the POTW does not include biological
treatment processes, or provides less treatment, e.g., primary
treatment.
In these cases, IMPs can be tailored for industrial sources of
toxic pollutants that might otherwise interfere with biological
treatment or would be degraded or removed through additional treatment.
EPA has added this information to the regulations in response to
comments. The intent of these steps is to set forth a process that is
not overly burdensome for applicants but that assures that applicable
pretreatment requirements are in effect for each toxic pollutant.
Secondary Removal Equivalency
Under section 301(h)(6) and Sec. 125.65, where there is no
applicable pretreatment requirement as described above for a toxic
pollutant known or suspected to be introduced by an industrial
discharger, the applicant must demonstrate that it has in effect a
pretreatment program which, in combination with the POTW's own
treatment of discharges, removes the same amount of the pollutant as
would be removed if the POTW were to apply secondary treatment to
discharges and if such works had no pretreatment program with respect
to the pollutant.
EPA has termed this the ``secondary removal equivalency''
requirement and the proposed rule added this term to the definitions in
Sec. 125.58(w). To meet the ``secondary removal equivalency''
requirement, the applicant must demonstrate that the combination of its
own treatment plus pretreatment by industrial dischargers achieves
``secondary removal equivalency.''
Under today's final rule, to demonstrate secondary removal
equivalency, an applicant would need to use a secondary treatment pilot
plant. By diverting part of its waste stream to the pilot plant after
primary treatment, the applicant would empirically determine the amount
of a toxic pollutant that would be removed from the waste stream if the
applicant were to apply full-scale secondary treatment. The applicant
would then need to demonstrate to EPA that it has a pretreatment
program in effect which, in combination with its own treatment
processes, removes at least that total amount of toxic pollutant from
the POTW's discharge, achieved through concentration- and mass
emissions-based effluent limits. If at least that amount is not
removed, then further reductions of the pollutant would be required.
The NPDES permit will include concentration and/or mass emissions
effluent limits based on the data from the secondary equivalency
demonstration when those values are more stringent than effluent limits
based on State water quality standards or water quality criteria, if
applicable, and to assure that all of the Sec. 301(h) criteria are met.
Once such effluent limits are established in an NPDES permit, the POTW
may either establish local limits or perform additional treatment at
the POTW, or combine the two to achieve the permit limit.
Some commenters thought that they would be penalized for having an
existing pretreatment program if they used pretreated waste to
determine secondary equivalency, because of the undetermined removals
by current industrial pretreatment. They urged the use of procedures
for determining pre-existing (prior to source control) conditions to
take into account existing toxic pollutant reductions and commented on
the difficulty of obtaining ``unpretreated'' industrial wastewaters.
Other commenters thought that the secondary removal equivalency
demonstration should be made with all other pretreatment requirements
required by section 301(h)(5) in place, because they reasoned that the
section 301(h) program does not provide waivers from the toxics
requirements.
EPA agrees that the section 301(h) program does not provide a
waiver from toxics control requirements, and the existing section
301(h) program already has toxics control requirements, including
industrial pretreatment, in effect. However, the secondary removal
equivalency provision of section 301(h)(6) addresses only those toxic
pollutants that do not have applicable pretreatment requirements in
effect, and that are being introduced by industrial sources to POTWs
serving urban areas.
POTWs will not be penalized for having an applicable pretreatment
requirement in effect for a particular toxic pollutant. If the POTW has
an applicable pretreatment requirement in effect for a specific toxic
pollutant, as described in Sec. 125.65, it will be in compliance with
Sec. 125.65 with respect to that pollutant, and the POTW will not need
to comply with the ``secondary removal equivalency'' requirement for
that pollutant.
There may, however, be reduced levels of other toxics that are
discharged to the POTW owing to incidental removals from applicable
pretreatment requirements targeted to remove specific toxic pollutants.
Likewise, there may be reduced levels of a specific toxic pollutant
discharged to the POTW from categorical pretreatment for that toxic
pollutant that may not satisfy the conditions of an applicable
pretreatment requirement in effect. Because neither of these two above
situations satisfy the requirements of ``applicable pretreatment
requirement in effect'' with respect to these toxic pollutants, the
applicant would need to demonstrate secondary removal equivalency for
them. It may be true that the cumulative removal will be lower if
pretreated influent is used. EPA does not expect this situation to
occur often because if an applicable pretreatment requirement exists
for a particular toxic pollutant, then a secondary removal equivalency
demonstration is not needed for that toxic pollutant. This situation is
only likely if some pretreatment occurs for other pollutants.
One commenter asserted that secondary treatment removal equivalency
is highly impractical and appears to resurrect EPA's discredited
``removal credit'' system. In response, the statute focuses on the
levels of toxic pollutants that are removed through a combination of
pretreatment and POTW treatment processes, regardless of where the
removal occurs.
Some commenters felt that the term ``removals'' should not include
removals obtained by air volatilization and through sludge because this
is simply a transfer of a pollution problem between media. EPA notes
that removals obtained by a secondary pilot plant are used simply to
determine the amount of additional pretreatment and/or POTW treatment
if any, that would be needed to meet secondary removal equivalency. For
purposes of achieving removals through a combination of a POTW's
treatment and pretreatment, EPA will not consider pollutants that
remain in sludge or are volatilized as removed, except those removals
that are consistent with sludge and pretreatment regulations. As noted
in the discussion on ``applicable pretreatment requirements,'' EPA's
pretreatment and sludge regulations do apply in any case to any POTW
treatment processes and sludge produced from the POTW.
Some commenters suggested that EPA identify technology-based limits
for demonstrating secondary removal equivalency, citing EPA's Fate of
Priority Pollutants in Publicly Owned Treatment Works, Vol. I (Sept.
1982) and Vol. II (Sept. 1982) as a basis for establishing such limits.
In response, in EPA's judgement, the above cited studies demonstrate
that each POTW's influent is unique based on a variety of factors.
Secondary treatment removes toxics incidental to the technology for
reducing BOD and SS, and results in great variability in the levels of
toxic and non-conventional pollutants in effluent and sludge. The Act
clearly puts the burden on the applicant to demonstrate and not on EPA
to develop uniform technology-based standards. In any event, developing
uniform technology-based standards would be very difficult because of
the variability of influents, pretreatment levels, and other site-
specific conditions. Therefore, EPA has not developed technology-based
limits representing characteristic removal of toxic pollutants from
secondary treatment.
Commenters also asked EPA to address the costs of the pilot plant
approach. These costs are addressed in the Economic Impact Analysis.
In summary, for those toxic pollutants for which there is no
applicable pretreatment requirement in effect, the POTW must either (1)
develop and implement an applicable pretreatment requirement or (2)
demonstrate, through a combination of pretreatment by industry and the
POTW's own treatment processes, that it removes at least as much of the
toxic pollutant as would be removed by a POTW that applies secondary
treatment and that has no pretreatment program for the pollutant.
Guidance is provided in the TSD.
Compliance Determination
Several commenters stated that EPA needs to address how a POTW will
demonstrate that all of its industrial dischargers are in compliance
with the pretreatment requirements and that EPA would allow less than
100 percent compliance. Some suggested that EPA should allow POTWs to
demonstrate compliance with all applicable pretreatment requirements by
taking all appropriate legal and administrative enforcement actions to
enforce pretreatment requirements. Others thought that accommodating
less than 100 percent compliance would introduce considerable
uncertainty concerning the level of compliance EPA will deem to be
adequate and the regulations should identify a definite standard by
which to gauge compliance with this new standard. In addition,
commenters have provided examples of when less than full compliance
will be considered acceptable, such as instances of trivial or isolated
violations.
For urban area POTWs with significant numbers of industrial users,
at any given time, it is reasonable to expect that at least one or more
of those users might be out of compliance. EPA intends to determine a
POTW's continuing eligibility for a 301(h) waiver under section
301(h)(6) by measuring industrial user compliance and POTW enforcement
activities against existing criteria in the Agency's National
Pretreatment Program. In the proposed rule, EPA explained that it would
consider the issue of compliance with the pretreatment requirements on
a case-by-case basis, taking into account the number and nature of non-
compliances. In 1989, EPA established criteria for determining POTW
compliance with pretreatment implementation obligations. One element of
these criteria is the level of significant noncompliance of the POTW's
industrial users. The General Pretreatment Regulations (part 403)
identify the circumstances when industrial user noncompliance is
significant. The industrial user significant noncompliance (SNC)
criteria are set out in 40 CFR 403.8(f)(2)(vii) and address both
effluent and reporting violations. This policy is consistent with the
approach in the proposed rule. The General Pretreatment Regulations,
however, are more explicit. In response to public comments, EPA has
changed the approach in today's final rule to be consistent with Agency
enforcement policy and to remove uncertainty.
For pretreatment purposes, a POTW's enforcement program is
considered adequate if no more than 15 percent of its industrial users
meet the SNC criteria in a single year. A similar level of industrial
user SNC rate will generally be applicable to POTWs with 301(h)
waivers, but will be subject to facility-specific conditions. In
addition, a POTW is also considered in SNC if it fails to take formal
appropriate and timely enforcement action against any industrial user,
the wastewater from which passes through the POTW or interferes with
the POTW operations.
In enforcing the pretreatment programs, POTWs are expected to
respond to industrial user noncompliance using local enforcement
authorities in accordance with an approved enforcement response plan
(ERP) which is required of all approved pretreatment programs (see 40
CFR 403.5). POTWs, including 301(h) POTWs, with greater than 15 percent
of their users in SNC, or which fail to enforce appropriately against
any single industrial user causing pass through or interference, are
deemed to be failing to enforce their pretreatment program.
EPA will base its determination on data collected during site
visits to the POTW and from the POTW's pretreatment program performance
report required by 40 CFR 403.12(i). These reports include compliance
information on industrial users gathered by the POTW as well as a
description of the enforcement activities of the POTW. EPA believes
that the combination of industrial user compliance and POTW enforcement
provides an appropriate measurement of the POTW's eligibility for the
301(h) waiver under section 301(h)(6).
This interpretation is consistent with the directives in a Senate
Report on an earlier version of the bill (see S. Rep. No. 1128, 99th
Cong., 1st Sess. 14 (1985)) as discussed in the proposal (56 FR 2817).
EPA notes that approval of the 301(h) waiver, which requires that the
POTW applicant demonstrate that its industrial users are in compliance
with their applicable pretreatment requirements, provides a substantial
incentive to the POTW to assure that its industrial users are in
compliance with all applicable pretreatment requirements. EPA believes
that an approach relying on a determination of SNC is preferable to
focusing on trivial or isolated violations, or other suggested methods,
because it gives clear guidelines and is consistent with the
enforcement approach in the pretreatment program.
Section 125.66: This section includes provisions for industrial
pretreatment and control of toxic pollutants from nonindustrial
sources. To update compliance deadlines, the proposal made a minor
change in Sec. 125.66 (c)(1)) regarding deadlines by which applicants
were required to develop approved pretreatment programs. No comments
were received on this section and it is being promulgated as proposed.
Section 125.67: This section discusses the criteria related to
increased discharges and implements section 301(h)(8) of the CWA. No
changes were proposed for this section, and no comments were received.
It remains unchanged.
Section 125.68: This section sets forth special permit conditions
to be included in section 301(h) modified NPDES permits. No changes
were proposed for this section, and no comments were received. It
remains unchanged.
Application questionnaires: Under the section 301(h) regulations
promulgated in 1982, there are two application questionnaires
(questionnaire is defined in Sec. 125.58), one for use by small
applicants and one for use by large applicants. The proposal merged
these into a single questionnaire and added questions as necessary to
respond to the new requirements of the WQA. No comments were received
on the proposed changes, and they are promulgated today as proposed.

Other Issues and Comments

EPA received several technical and minor comments on the draft
amended TSD guidance document and some comments that addressed the
regulations or 301(h) program in general. EPA responded to many
comments by making changes to the TSD as appropriate. The changes are
not discussed here. Below are responses to comments for which no change
was made in the TSD, and responses to the general comments.
One commenter suggested that it is important that significant
flexibility be provided in making determinations regarding the impacts
of other sources on water quality until more definitive information is
available for nonpoint and other source categories. The commenter also
states that this section appears to be in conflict with Sec. 125.63(b)
which limits the monitoring program to only those scientific
investigations necessary to study the effects of the proposed
discharge. In response, the regulations already address the cumulative
impacts of a discharge as an integral piece of information necessary to
analyze the balanced indigenous population requirements of 301(h). It
is not in conflict with Sec. 125.63(b). The effects of the proposed
discharge are evaluated in the context of the receiving water
environment, alone and in combination with other sources of pollutants.
Another comment recommended that the guidance document be changed
to require that a date and approval sequence between the State and EPA
Region be mutually agreed-upon, rather than requiring compliance with
Sec. 125.59(f)(4), which requires State determinations to be due to the
regions no later than 90 days after an application is submitted to EPA.
In response, the TSD simply reflects the regulatory language, which was
not proposed for change and is not a subject of this rulemaking.
Another commenter asked that the guidance better define what is
meant by ``significant ecological change.'' This comment is beyond the
scope of this rulemaking. The approach to defining a balanced
indigenous population (BIP) was not proposed for change and EPA is not
considering redefining the BIP.
A commenter suggested that the approach to 301(h) waivers should be
based on water quality effects and not on any ``equivalencies.''
Another commenter suggested that if high BOD levels are allowed for
industrial dischargers under effluent guidelines for certain
industries, why do we require the 30% removal of BOD and SS for
municipal effluents? In response to both these comments, the statute
does not provide us leeway on these issues. The statute is clear on its
face in requiring equivalency testing and the removal of 30% of BOD and
SS.
One commenter requested that strong consideration be given to
centralizing the evaluation of waiver requests. While this comment is
beyond the scope of this rulemaking, we recognize the consistency and
efficiency this might suggest. However, 301(h) waiver applications are
handled case by case, based on site-specific circumstances. Although
there is national oversight on the implementation of the program,
regional evaluation provides the ability to apply regional expertise on
regional and local circumstances surrounding 301(h) applications.
EPA also received requests from commenters for additional time to
comment. EPA accommodated these requests and considered all comments
received in developing this final rule. Others requested that EPA
notify industrial users of the proposal. In response, EPA gave a 60 day
public comment period, which EPA believes to be adequate notice for all
affected parties.

III. Supporting Documentation

A. Regulatory Flexibility Act

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et
seq.), federal agencies must, when developing regulations, consider the
impact of the regulations on small entities (small businesses, small
government jurisdictions, and small organizations). To evaluate whether
this rule will have a significant economic impact on a substantial
number of small entities, the Agency has prepared an Economic Impact
Analysis (EIA). The Agency has concluded, based on the EIA, that this
rule does not unduly impact on small communities in terms of overall
cost of compliance. Specifically, none of the small communities will
end up spending more than 1 percent of median household income on
wastewater treatment. Moreover, although current treatment costs may
increase, small communities will still realize an overall cost savings
if less than secondary treatment is approved through the section 301(h)
process.
There were 51 applicants or permittees in the section 301(h) permit
program at the time of the economic analysis. Out of these 51
applicants or permittees, only six are both expected to incur
additional costs due to the primary or equivalent treatment
requirements and meet the Small Business Administration (SBA)
definition of a small entity (a service area with a population of less
than 50,000). All those applicants or permittees subject to and
expected to incur additional costs due to the urban area pretreatment
requirements and one of the permittees expected to incur additional
costs due to the primary or equivalent treatment requirements have
service area populations of greater than 50,000, and thus are not small
entities. On a national level, the total estimated capital cost of
meeting the primary or equivalent treatment requirements for the six
small entities amounts to less than $7.2 million, with an associated
operations and maintenance cost of $465,000 per year. Assuming a 20-
year repayment schedule, the total annualized cost, for the six small
entities, equals approximately $675,000 a year. After compliance with
the primary or equivalent treatment requirements, the total annual
sewer fee charged by these ten small entities is less than 1 percent of
the community's median household income. Consequently, none of the
small entities affected by this rule are expected to incur significant
economic impacts, especially in light of the overall savings garnered
by these communities from not having to comply with secondary treatment
requirements.
In summary, I certify that this rule will not have a significant
economic impact on a substantial number of entities.

B. Executive Order 12866

Under Executive Order 12866, [58 Federal Register 51735 (October 4,
1993)] the Agency must determine whether the regulatory action is
``significant'' and therefore subject to 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, comp

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-19058. Public record. Not legal advice.
