National Pollutant Discharge Elimination System (NPDES): Use of Sufficiently Sensitive Test Methods for Permit Applications and Reporting, 35712-35720 [2010-15254]
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Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Proposed Rules
Executive Order 12866—Regulatory
Planning and Review
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
Executive Order classifies a ‘‘significant
regulatory action,’’ requiring review by
the Office of Management and Budget
(OMB) unless OMB waives such review,
as any regulatory action that is likely to
result in a rule that may: (1) Have an
annual effect on the economy of $100
million or more or adversely affect in a
material way the economy, a sector of
the economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities; (2) create
a serious inconsistency or otherwise
interfere with an action taken or
planned by another agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
The economic, interagency,
budgetary, legal, and policy
implications of this proposed rule have
been examined, and it has been
determined not to be a significant
regulatory action under Executive Order
12866 because it is unlikely to result in
a rule that may raise novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
principles set forth in the Executive
Order.
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Unfunded Mandates
The Unfunded Mandates Reform Act
of 1995 requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of
anticipated costs and benefits before
issuing any rule that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation) in any
1 year. This proposed rule would have
no such effect on State, local, and tribal
governments, or on the private sector.
Catalog of Federal Domestic Assistance
Numbers and Titles
The Catalog of Federal Domestic
Assistance program numbers and titles
for this proposal are 64.104, Pension for
Non-Service-Connected Disability for
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Veterans, and 64.109, Veterans
Compensation for Service-Connected
Disability.
Signing Authority
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 122 and 136
[EPA–HQ–OW–2009–1019; FRL–9166–7]
The Secretary of Veterans Affairs, or
designee, approved this document and
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs. John
R. Gingrich, Chief of Staff, Department
of Veterans Affairs approved this
document on June 17, 2010 for
publication.
RIN 2040–AC84
National Pollutant Discharge
Elimination System (NPDES): Use of
Sufficiently Sensitive Test Methods for
Permit Applications and Reporting
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: The Environmental Protection
Agency (EPA) is proposing minor
List of Subjects in 38 CFR Part 4
amendments to its Clean Water Act
(CWA) regulations to codify that under
Disability benefits, Pensions,
the National Pollutant Discharge
Veterans.
Elimination System (NPDES) program,
Dated: June 18, 2010.
only ‘‘sufficiently sensitive’’ analytical
William F. Russo,
test methods can be used when
Director of Regulations Management, Office
completing an NPDES permit
of the General Counsel.
application and when performing
sampling and analysis pursuant to
For the reasons set out in the
monitoring requirements in an NPDES
preamble, 38 CFR part 4, subpart B, is
permit.
proposed to be amended as set forth
This proposal is based on
below:
requirements in the CWA and existing
EPA regulations. It also would codify
PART 4—SCHEDULE FOR RATING
existing EPA guidance on the use of
DISABILITIES
‘‘sufficiently sensitive’’ analytical
methods with respect to measurement of
1. The authority citation for part 4
mercury and extend the approach
continues to read as follows:
outlined in that guidance to the NPDES
Authority: 38 U.S.C. 1155, unless
program more generally. Specifically,
otherwise noted.
EPA is proposing to clarify the existing
NPDES application, compliance
Subpart B—Disability Ratings
monitoring, and analytical methods
regulations. The amendments in this
2. In § 4.124a, revise diagnostic code
proposed rulemaking affect only
8017 to read as follows:
chemical-specific methods; they do not
§ 4.124a Schedule of ratings—neurological apply to the Whole Effluent Toxicity
(WET) methods or their use.
conditions and convulsive disorders.
DATES: Comments on this action must be
Rating
received or postmarked on or before
midnight August 9, 2010.
ADDRESSES: You may submit comments,
*
*
*
*
*
identified by EPA–HQ–OW–2009–1019,
8017 Amyotrophic lateral sclerosis .............................................
100 by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
Note: Consider the need for special
instructions for submitting comments.
monthly compensation.
• E-mail: ow-docket@epa.gov. Include
EPA–HQ–OW–2009–1019 in the subject
*
*
*
*
*
line of the message.
[FR Doc. 2010–15169 Filed 6–22–10; 8:45 am]
• Mail: Send the original and three
BILLING CODE 8320–01–P
copies of your comments to: Water
Docket, Environmental Protection
Agency, Mail Code 2822T, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460, Attention:
Docket ID No. EPA–HQ–OW–2009–
1019.
• Hand Delivery/Courier: Deliver
your comments to EPA Docket Center,
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EPA West, Room 3334, 1301
Constitution Avenue, NW., Washington,
DC, Attention Docket ID No. EPA–HQ–
OW–2009–1019. Such deliveries are
accepted only during the Docket’s
normal hours of operation, which are
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
Special arrangements should be made
for deliveries of boxed information. The
telephone number for the Water Docket
is 202–566–2426.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OW–2009–
1019. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identify
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA might not be
able to consider your comment. Avoid
the use of special characters and any
form of encryption, and ensure that
electronic files are free of any defects or
viruses. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Some
information, however, is not publicly
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is publicly
available only in hard copy. Publicly
available docket materials are available
electronically in https://
www.regulations.gov or in hard copy at
the Water Docket, EPA Docket Center,
EPA West, Room 3334, 1301
Constitution Avenue, NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is 202–566–1744,
and the telephone number for the Water
Docket is 202–566–2426.
FOR FURTHER INFORMATION CONTACT: For
additional information, contact Kathryn
Kelley, Water Permits Division, Office of
Wastewater Management (4203M),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: 202–564–
7004, e-mail address:
kelley.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
1 Where the term ‘‘pollutant’’ is used, it refers to
both pollutants and pollutant parameters.
2 The term ‘‘Director’’ refers to the permitting
authority. Per 40 CFR 122.2, ‘‘Director’’ means the
Regional Administrator or the State Director, as the
context requires, or an authorized representative.
When there is no ‘‘approved State program’’’ and
there is an EPA-administered program, ‘‘Director’’
means the Regional Administrator. When there is
an approved State program, ‘‘Director’’ normally
means the State Director. In some circumstances,
however, EPA retains the authority to take certain
actions even when there is an approved State
program. (For example, when EPA has issued an
NPDES permit prior to the approval of a State
program, EPA may retain jurisdiction over that
permit after program approval; see 40 CFR 123.1.)
In such cases, the term ‘‘Director’’ means the
Regional Administrator and not the State Director.
3 Although terms such as ‘‘authorities,’’
‘‘applicants,’’ and ‘‘permittees’’ imply individuals,
EPA uses these terms to refer to entities. For
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I. General Information
A. Potentially Affected Parties
B. Legal Authority
II. Background
III. Scope and Rationale of the Proposed Rule
IV. Impacts
V. Compliance Dates
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer and
Advancement Act
J. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations
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I. General Information
A. Potentially Affected Parties
In the NPDES program, point source
dischargers obtain permits that are
issued by EPA regions and authorized
NPDES States, Territories, and Indian
Tribes (collectively referred to as
‘‘permitting authorities’’). These point
source dischargers include publicly
owned treatment works (POTWs) and
various industrial and commercial
facilities (collectively referred to as
‘‘NPDES applicants or permittees’’).
Permitting authorities issue NPDES
permits after analyzing the information
contained in the application or in the
case of a general permit, the information
submitted to demonstrate eligibility for
coverage. The NPDES permit prescribes
the conditions under which the facility
is allowed to discharge pollutants and
that will ensure the facilities’
compliance with the CWA’s technologybased and water quality-based
requirements. NPDES permits typically
include restrictions on the mass and/or
concentration of pollutants 1 that a
permittee may discharge and require the
permittee to conduct routine sampling
and reporting of various parameters
measured in the permitted discharge. In
general, NPDES applicants and
permittees are required to use EPAapproved, pollutant-specific test
procedures (or approved alternative test
procedures) when measuring the
pollutants in their discharges.
The purpose of today’s proposal is to
clarify that NPDES applicants and
permittees must use sufficiently
sensitive analytical methods when
quantifying the presence of pollutants in
a discharge, and the Director 2 must
require and accept only such data. The
broad universe of entities‘‘ 3 that would
be affected by this proposal includes
NPDES permitting authorities and
municipal and industrial applicants and
permittees (Table I–1). The impact of
this proposal, however, would only
affect those entities that use or allow the
use of any EPA-approved analytical
methods (for one or more parameters)
that are not ‘‘sufficiently sensitive’’ to
detect pollutants being measured in the
discharge.
example, EPA uses the term ‘‘NPDES permitting
authorities’’ to mean the EPA Regions, States,
Territories, and Indian Tribes granted authority to
implement and manage the NPDES program. EPA
uses the term ‘‘NPDES applicants’’ or ‘‘NPDES
permittees’’ to mean facilities that have applied for,
sought coverage under, or been issued an NPDES
individual or general permit.
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TABLE I–1—ENTITIES POTENTIALLY REGULATED BY THIS RULE
Category
Examples of potentially affected entities
State, Territorial, and Indian Tribal Governments ....................................................
States, Territories, and Indian Tribes authorized to administer
the NPDES permitting program; States, Territories, and Indian Tribes that provide certification under section 401 of
the CWA.
POTWs required to apply for or seek coverage under an
NPDES individual or general permit and to perform routine
monitoring as a condition of any issued NPDES permit.
Facilities required to apply for or seek coverage under an
NPDES individual or general permit and to perform routine
monitoring as a condition of any issued NPDES permit.
Municipalities ............................................................................................................
Industry .....................................................................................................................
If you have any questions regarding
the applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
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B. Legal Authority
EPA would promulgate the rule being
proposed today pursuant to the
authority of sections 301, 304(h), 308,
402(a), and 501(a) of the CWA [33
U.S.C. 1311, 1314(h), 1316, 1318,
1342(a), 1343, and 1361(a)]. Section
501(a) of the CWA authorizes the
Administrator of EPA to prescribe such
regulations as are necessary to carry out
the act. Section 301(a) of the CWA
prohibits the discharge of any pollutant
into navigable waters unless the
discharge complies with an NPDES
permit issued under section 402 of the
act. Section 402(a) of the CWA
authorizes the Administrator to issue
permits that require a discharger to meet
all the applicable requirements under
sections 301, 302, 306, 307, 308, and
403. Section 301(b) of the CWA further
requires that NPDES permits include
effluent limitations that implement
technology-based standards of
performance and, where necessary,
water quality-based effluent limitations
(WQBELs) that are as stringent as
necessary to meet water quality
standards. With respect to the
protection of water quality, NPDES
permits must include limitations to
control all pollutants that the NPDES
permitting authority determines are or
might be discharged at a level that ‘‘will
cause, have the ‘reasonable potential’ to
cause, or contribute to an excursion
above any State water quality standard,’’
including both narrative and numeric
criteria [40 CFR 122.44(d)(1)(i)]. If the
Director determines that a discharge
causes, or has the reasonable potential
to cause or contribute to, such an
excursion, the permit must contain
WQBELs for the pollutant [40 CFR
122.44(d)(1)(iii)]. Section 402(a)(2) of
the CWA requires EPA to prescribe
permit conditions to ensure compliance
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with requirements, ‘‘* * * including
conditions on data and information
collection, reporting and such other
requirements as [the Administrator]
deems appropriate.’’ Thus, a prospective
permittee might need to measure
various pollutants in its effluent at two
stages: First, at the permit application
stage so that the Director can determine
what pollutants are present in the
applicant’s discharge and the amount of
each pollutant present and, second, to
quantify the levels of each pollutant
limited in the permit to determine
whether the discharge is in compliance
with the applicable limits and
conditions.
Section 304(h) of the CWA requires
the Administrator of EPA to ‘‘* * *
promulgate guidelines establishing test
procedures for the analysis of pollutants
that shall include the factors which
must be provided in any certification
pursuant to [section 401of this Act] or
permit application pursuant to [section
402 of this Act].’’ Section 501(a) of the
act authorizes the Administrator to
‘‘* * * prescribe such regulations as are
necessary to carry out this function
under [the act].’’ EPA generally has
codified its test procedure regulations
(including analysis and sampling
requirements) for CWA programs at 40
CFR 136, although some requirements
are codified in other parts (e.g., 40 CFR
chapter I, subchapters N and O).
The Director is authorized under 40
CFR 122.21(e) to determine when an
NPDES permit application is complete.
Moreover, the Director shall not begin
processing a permit until the applicant
has fully complied with the application
requirements for that permit [40 CFR
124.3(a)(2)]. Under 40 CFR
122.21(g)(13), applicants are required to
provide to the Director, upon request,
such other information as the Director
may reasonably require to assess the
discharge. Under 40 CFR 122.28(b)(2),
dischargers (or treatment works treating
domestic sewage) seeking coverage
under a general permit must submit to
the Director a written NOI to be covered
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by the general permit (with some
exceptions set forth elsewhere in 40
CFR 122.28(b)(2)). The contents of the
NOI must be specified in the general
permit, and they must require the
submission of information necessary for
adequate program implementation.
Finally, 40 CFR 122.41(j)(1) requires
NPDES permits to specify that sampling
and measurements taken for the
purposes of monitoring shall be
‘‘representative of the monitored
activity.’’
Among other things, section 308 of
the CWA authorizes EPA to require
owners or operators of point sources to
establish records, conduct monitoring
activities, and make reports to enable
the permitting authority to determine
whether there is a violation of any
prohibition or any requirement
established under provisions including
section 402 of the CWA. Under sections
308(c) and 402(b)(2)(A), a State’s
authorized NPDES program must have
authorities for inspection, monitoring,
and issuing permits that are applicable
to at least the same extent as those
under section 308.
As summarized above, the legal
requirements and authorities exist for
EPA to require NPDES applicants and
permittees to use sufficiently sensitive
analytical methods when quantifying
the presence of pollutants in a discharge
and to require the Director to require
and accept only such data.
II. Background
Multiple analytical test methods exist
for many pollutants regulated under the
CWA. Therefore, EPA has generally
approved multiple methods for CWA
pollutants under 40 CFR 136 and 40
CFR chapter I, subchapters N and O.
Some of the approved analytical test
methods have greater sensitivities and
lower minimum levels 4 5 or method
4 The term ‘‘minimum level’’ refers to either the
lowest calibration point in a method or a multiple
of the method detection limit (MDL), whichever is
higher. Minimum levels may be obtained in several
ways: They may be published in a method; they
may be the lowest acceptable calibration point used
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detection limits (MDLs) 6 than other
approved methods for the same
pollutant. This situation often occurs
because of advances having been made
in instrumentation and in the analytical
protocols themselves. Many metals and
toxic compounds (for example,
mercury) have an array of EPAapproved methods, including some
methods that have greater sensitivities
and lower minimum levels than the
others.
EPA and State permitting authorities
use data from the permit application to
determine whether pollutants are
present in an applicant’s discharge and
to quantify the levels of all detected
pollutants. These pollutant data are then
used to determine whether technologyor water quality-based effluent limits are
needed in the facility’s NPDES permit.
It is critical, therefore, that applicants
provide data that have been measured
with precision and accuracy so that they
will be meaningful to the decisionmaking process. Among other things,
data must be provided at a level that
will enable the Director to make a
sound, reasonable potential
determination and, if necessary,
establish appropriate water qualitybased permit limits. The same holds
true for monitoring and reporting
relative to permit limits established for
regulated parameters. The aim is for
applicants and permittees to use
analytical methods that are capable of
detecting and measuring the pollutants
at, or below, the respective water quality
criteria or permit limits.7
For example, in 2002 and 2007 EPA
published two new analytical methods
for mercury that were several orders of
by a laboratory; or they may be calculated by
multiplying the MDL in a method, or the MDL
determined by a lab, by a factor. [See: (A) 40 CFR
136, appendix A, footnotes to table 2 of EPA
Method 1624 and table 3 of EPA Method 1625 (49
FR 43234, October 26, 1984); (B) 40 CFR 136,
section 17.12 of EPA Method 1631E (67 FR 65876–
65888, October 29, 2002); (C) 61 FR 21, January 31,
1996; (D) ‘‘Analytical Method Guidance for the
Pharmaceutical Manufacturing Point Source
Category,’’ EPA 821–B–99–003, August 1999; and
(E) ‘‘EPA Region 10 Guidance For WQBELs Below
Analytical Detection/Quantitation Level,’’ EPA
Region 10, March 22, 1996.]
5 For the purposes of this rulemaking, EPA is
considering the following terms to be synonymous:
‘‘quantitation limit,’’ ‘‘reporting limit,’’ and
‘‘minimum level.’’
6 The MDL is determined using the procedure at
40 CFR 136, appendix B. It is defined as the
minimum concentration of a substance that can be
measured and reported with 99 percent confidence
that the analyte concentration is greater than zero
and is determined from analysis of a sample in a
given matrix containing the analyte.
7 To address this situation some State permitting
authorities have developed a list of monitored
parameters and prescribed a required minimum
level that must be achieved for each parameter as
a part of their State regulations or policy.
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magnitude more sensitive than
previously available methods. In
addition, a number of States have set
water quality criteria for mercury that
are below the detection levels of the
older methods for mercury that EPA
approved prior to 2002. Unlike the
previous methods, the new methods are
capable of measuring whether effluent
samples are above or below the current
water quality criteria. In 2007 EPA
addressed this issue with respect to
mercury in a memorandum titled
‘‘Analytical Methods for Mercury in
NPDES Permits,’’ from James A. Hanlon,
Director of EPA’s Office of Wastewater
Management, to the Regional Water
Division Directors. This memorandum
is available at https://www.epa.gov/
npdes/pubs/
mercurymemo_analyticalmethods.pdf.
The memorandum explains EPA’s
expectation that ‘‘All facilities with the
potential to discharge mercury will
provide with their NPDES permit
applications monitoring data for
mercury using Method 1631E or another
sufficiently sensitive EPA-approved
method. * * * Accordingly, EPA
strongly recommends that the
permitting authority determine that a
permit application that lacks effluent
data analyzed with a sufficiently
sensitive EPA-approved method such as
Method 1631E, is incomplete unless and
until the facility supplements the
original application with data analyzed
with such a method.’’
Following issuance of the 2007
memorandum, EPA determined that the
NPDES permit application regulations at
40 CFR 122.21 and the NPDES permit
monitoring requirements at 40 CFR
122.44 should be clarified to ensure that
applicants and permittees use
sufficiently sensitive analytical methods
for all pollutants, not just mercury. EPA
is proposing to incorporate language in
the regulations that extends the
requirement to use sufficiently sensitive
test methods to all pollutants. EPA is
also proposing to codify the definition
of ‘‘sufficiently sensitive’’ to include an
additional criterion that was not part of
the 2007 memorandum, as described
below.
III. Scope and Rationale of the
Proposed Rule
This proposed rule clarifies that
NPDES applicants and permittees must
use sufficiently sensitive analytical test
methods when submitting information
characterizing the discharge in an
NPDES permit application and when
performing sampling and analysis
pursuant to monitoring requirements in
an NPDES permit. In addition, the
proposed rule clarifies that the Director
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must require NPDES applicants and
permittees to use sufficiently sensitive
analytical test methods and accept only
data analyzed by such methods. EPA
proposes adding or modifying language
to define ‘‘sufficiently sensitive’’ at 40
CFR 122.21(e)(3) and 122.44(i)(1)(iv).
EPA also proposes providing a crossreference to these changes at 40 CFR
136.1(c). For the purposes of this
rulemaking, if monitoring requirements
are included as a condition of the
general permit, these requirements
would be subject to the provisions
established in 122.44(i)(1)(iv).
As discussed earlier, it is critical that
the Director make permitting decisions
based on accurate data and, thus, sound
science. The use of imprecise analytical
methods could lead the Director to make
assumptions regarding the presence or
absence of a pollutant in an applicant’s
discharge. These assumptions, in turn,
could result in the Director’s making an
incorrect permitting decision (e.g., the
decision not to include a limit in a
permit when, in fact, a waste stream
concentration of a pollutant will cause,
have the reasonable potential to cause,
or contribute to an excursion above an
applicable water quality criterion).
Moreover, if the Director were to
include imprecise analytical methods in
permits for compliance monitoring
purposes, the use of such methods
could result in undetected exceedances
of permit limits.
Although EPA has approved multiple
analytical methods for individual
pollutants under 40 CFR 136, the
Agency has historically expected that
applicants and permittees would select
from the array of available methods a
specific analytical method that is
sufficiently sensitive to quantify the
presence of a pollutant in a given
discharge. EPA has not expected that
NPDES permit applicants would select
a method with insufficient sensitivity,
thereby masking the presence of a
pollutant in their discharge, when an
EPA-approved sufficiently sensitive
method is available. This proposed rule,
therefore, would clarify that NPDES
applicants and permittees must use
sufficiently sensitive analytical methods
when quantifying the presence of
pollutants in a discharge and that the
Director must require and accept only
such data.
EPA proposes defining the term
‘‘sufficiently sensitive’’ in two sections
of the Federal NPDES regulations––at 40
CFR 122.21(e) (Permit Application
Completeness) as a new subsection (3)
and at 40 CFR 122.44(i)(1)(iv)
(Monitoring Requirements). EPA also
proposes modifying 40 CFR 136.1
(Applicability) by adding a new
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subsection (c), which is simply a crossreference to the changes proposed for 40
CFR 122.21(e)(3) and 40 CFR
122.44(i)(1)(iv). The regulatory changes
proposed are open to comment. EPA,
however, is not reopening or taking
comment on any other existing
requirement in the regulations.
A. The new and revised sections indicate
that a method is sufficiently sensitive where:
i. The method minimum level is at or
below the level of the applicable water
quality criterion or permit limitation for the
measured pollutant or pollutant parameter;
or
ii. The method minimum level is above the
applicable water quality criterion or permit
limitation, but the amount of the pollutant or
pollutant parameter in a facility’s discharge
is high enough that the method detects and
quantifies the level of the pollutant or
pollutant parameter in the discharge; or
iii. The method has the lowest minimum
level of the analytical methods approved
under 40 CFR 136.
B. When no analytical method is approved
under 40 CFR 136, required under
subchapter N or O, or otherwise required by
the Director, an NPDES applicant may use
any suitable sufficiently sensitive method;
however, the applicant shall provide a
description of the method, including
documentation of the minimum level.8
The first two criteria in the
sufficiently sensitive definition are
aimed at addressing situations in which
EPA has approved multiple methods
under 40 CFR 136 for a pollutant and
some of those approved methods have
greater sensitivities and lower minimum
levels than others.
The third criterion of the definition is
included to address situations in which
none of the approved 40 CFR 136
methods for a pollutant are sufficiently
sensitive to achieve the minimum levels
necessary to assess reasonable potential
with a water quality criterion or to
monitor compliance with a permit limit.
In these situations, EPA proposes that
applicants or permittees use the ‘‘most
sensitive’’ of the approved methods for
the pollutant. This practice has long
been the Agency’s policy, and it is
consistent with the CWA and with the
EPA regulations at 40 CFR 122.44(d)
requiring that limits be protective of
water quality standards.9 EPA
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8 This
provision is adopted from existing
language in 40 CFR 122.21(g)(7).
9 EPA’s Office of Water issued Final Guidance on
Section 304(1), ‘‘Listing and Permitting of Pulp and
Paper Mills’’ (referred to as the 304(l) Guidance,
March 15, 1989, available at https://www.epa.gov/
npdes/pubs/owm0360.pdf). The guidance
recommended that where WQBELs are less than the
detection level for the specified analytical method,
the calculated WQBEL should be included as a
requirement of the permit. EPA again addressed the
issue of detection levels in its May 21, 1990,
‘‘Strategy for the Regulation of Discharges of PCDDs
and PCDFs from Pulp and Paper Mills to Waters of
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acknowledges that a laboratory might
achieve MDLs and minimum levels
lower than those published when the
promulgated method was developed.10
Thus, the Director should not rely solely
on MDLs or minimum levels in
published methods because they give
only an upper, not a lower, bound on
the lab’s MDL and minimum level.
Flexibility is provided at 40 CFR 136.6,
which allows a laboratory to
demonstrate performance better than the
MDL or minimum level published in a
method.
The final provision is intended to
address situations where no approved
analytical method exists under part 136,
is required under subchapter N or O, or
is otherwise required by the Director. In
such situations, an applicant may use
any suitable sufficiently sensitive
method but shall provide a description
of the method that includes
documentation of the minimum level.
Where an EPA-approved analytical
method is nonexistent under part 136 or
is not required under subchapter N or O
for a pollutant limited in an NPDES
permit, the Director must specify a
sufficiently sensitive analytical method
as a condition of the NPDES permit,
consistent with the criteria established
in this proposed rulemaking at 40 CFR
122.44(i)(1)(iv)(A)–(B).
Under the CWA, authorized NPDES
States, Territories, and Indian Tribes
must have in place legal authorities that
are at least as stringent as the
requirements in certain parts of the EPA
regulations. See 40 CFR 123.25. The
requirements of sections 122.21(e) and
122.44(i), which are the subject of this
proposal, are among those that States
must include within their own
programs. Therefore, once the revised
regulations that EPA is proposing today
are finalized, States will need to amend
their own legal authorities, where
necessary, to ensure that only
sufficiently sensitive methods are used
to produce data for permit applications
and for monitoring under a permit. See
40 CFR 123.62(e).
In some cases, States currently have
State statutes or regulations that require
the United States’’ (the Dioxin Strategy, available at
https://www.epa.gov/npdes/pubs/owm0286.pdf).
This strategy modified the 304(l) Guidance by
recommending that permit writers specify the
minimum level in permits that limit dioxin. In
March 1991, EPA further expanded its guidance on
detection levels in the ‘‘Technical Support
Document for Water Quality-based Toxics Control’’
by applying the concepts contained in the Dioxin
Strategy to analytical detection levels for all
pollutants (EPA Office of Water, EPA/505/2–90–
001, PB91–127415; available at https://www.epa.gov/
waterscience/methods/det/faca/mtg20051208/
excerpt-detectionlimits.html).
10 See Content Notes 4–6.
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NPDES applicants to use a specific
analytical method or achieve a specific
minimum level for a particular pollutant
(or they have a State policy or guidance
that recommends a specific method or
minimum level). A problem would arise
if the State currently requires a
particular method or minimum level
that is not ‘‘sufficiently sensitive’’ as
defined in new EPA regulations. In
these situations, EPA would expect
States to revise their statutes or
regulations so that if they require the
use of a particular method or minimum
level, it is one that is sufficiently
sensitive. States would need to revise
any policy guidances as well. (No
problem would arise, however, if the
method or minimum level currently
required by the State does qualify as
‘‘sufficiently sensitive.’’) EPA will
provide regular updates on its Web site
at https://www.epa.gov/waterscience/
methods to keep permitting authorities
and permittees informed of method
updates and revised water quality
criteria to better enable the permitting
authorities to determine that their
requirements for applicants and
permittees remain sufficiently sensitive.
The following example is provided to
help clarify the importance of using
sufficiently sensitive test methods in the
NPDES program:
Example III–1—Mercury
Measurements included with an
NPDES permit application and with
reports required to be submitted under
the NPDES permit must generally be
made using analytical methods
approved by EPA under 40 CFR 136.
(See 40 CFR 136.1, 136.4, 136.5,
122.21(g)(7), and 122.41(j).) EPA has
four approved methods for mercury
under 40 CFR 136––EPA Methods
245.1, 245.2, 1631E, and 245.7. The first
two methods, approved by EPA in 1974,
can achieve measurement of mercury
down to 200 parts per trillion (ppt). EPA
approved Method 1631 Revision E in
2002. Method 1631E has a minimum
level of 0.5 ppt, making it 400 times
more sensitive than EPA Methods 245.1
and 245.2. In fact, the sensitivity of
Methods 245.1 and 245.2 when last
updated in 1994 and 1979, respectively,
was well above the water quality criteria
now adopted in most States, as well as
the criteria included by EPA in its final
‘‘Water Quality Guidance for the Great
Lakes System’’ for the protection of
aquatic life and human health, which
generally fall in the range of 1 to 50
ppt.11 In contrast, Method 1631E, with
11 Many States have adopted mercury water
quality criteria of 12 parts per trillion (ppt) for the
protection of aquatic life and 50 ppt for the
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a minimum level of 0.5 ppt, supports
the measurement of mercury at these
low levels.
On March 12, 2007, EPA published
the Methods Update Rule, or MUR (72
FR 11200), under which the Agency
approved Method 245.7 for mercury and
also modified versions of other EPAapproved methods for the parameter.
This method change applies to the
implementation of both water column
criteria and fish tissue criteria in
permits. Method 245.7 has a minimum
level of 5.0 ppt, making it 40 times more
sensitive than Methods 245.1 and 245.2.
Methods 245.1 and 245.2 may be
modified to achieve lower minimum
levels.12 Modifications to an EPAapproved method for mercury that meet
the method performance requirements
of 40 CFR 136.6 are considered to be
approved methods and require no
further EPA approval. (See 72 FR
11239–40, March 12, 2007.) For
analytical method modifications that do
not fall within the flexibility of 40 CFR
136.6, the modified methods may be
approved under the alternate test
procedure program, as defined at 40
CFR 136.4 and 136.5.
As noted, most States have adopted
water quality criteria for the protection
of aquatic life and human health that
fall in the range of 1 to 50 ppt. If an
applicant or permittee used Methods
245.1 and 245.2, ‘‘the absence of a
quantitative result’’ would show only
that mercury levels are below 200 ppt
(based on a minimum level of 200 ppt)
but would not establish that the
discharge is at or below the applicable
water quality criterion. In such a
circumstance, a permit writer would
possibly lack the information needed to
make a reasonable potential
determination. Use of an insufficiently
sensitive method when performing
routine monitoring under an NPDES
permit could also yield data that would
not be adequate for the Director to
assess compliance. In contrast, if the
applicant used Method 1631E (or 245.7),
which can detect and quantify mercury
concentrations at or below the low
water quality criteria levels, the permit
writer would have adequate information
to make a reasonable potential
determination. Therefore, EPA proposes
to clarify in the regulations that the
Director must consider an NPDES
permit application incomplete until the
applicant submits analytical data using
a sufficiently sensitive method as that
term is defined in this rulemaking, and
when specifying in a permit which
analytical methods the permittee may
35717
use, the Director may only specify
sufficiently sensitive methods.
IV. Impacts
Entities that discharge to waters of the
United States vary in terms of the
quantity of their discharges, the
potential constituents contained in their
discharges, and their operation and
maintenance practices. Consequently,
the Director’s NPDES application
requirements vary depending on
applicant type. For example, Form 2A
for municipalities requires minimal
screening for POTWs with design flows
under 100,000 gallons per day; however,
for POTWs with design flows above 1
million gallons per day (MGD), multiple
priority pollutant scans are required.
Similarly, existing industrial and
commercial facilities that complete
Form 2C are required to test for toxic
pollutants based on the nature of their
manufacturing operation. To assist
permitting authorities (EPA regions,
States, and Tribes), EPA developed
several NPDES permit application
forms. Table IV–1 provides a list of
these forms and the discharger type(s)
for which they are intended. Permitting
authorities may use EPA’s forms or
comparable forms of their own.
TABLE IV–1—EPA NPDES PERMIT APPLICATION FORMS BY APPLICANT TYPE
Form or request
Applicant type
1 ......
Form 1 ..................................................................................................................
2 ......
3 ......
Form 2A ...............................................................................................................
Form 2B ...............................................................................................................
4 ......
5 ......
6 ......
Form 2C ...............................................................................................................
Form 2D ...............................................................................................................
Form 2E ...............................................................................................................
7 ......
8 ......
Form 2F ................................................................................................................
40 CFR 122.21(r) and 122.22(d) .........................................................................
9 ......
Form 2S ...............................................................................................................
New and existing applicants, except POTWs and treatment works treating domestic sewage.
New and existing POTWs (i.e., municipal facilities).
New and existing concentrated animal feeding operations (CAFOs) and aquatic animal production facilities.
Existing industries discharging process wastewater.
New industries discharging process wastewater.
New and existing industries discharging non-process
wastewater only.
New and existing industries discharging stormwater.
New and existing industries with cooling water intake
structures.
New and existing POTWs and other treatment works
treating domestic sewage (covers sludge).
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As noted earlier, permitting
authorities issue and develop effluent
limitations for individual NPDES
permits after analyzing the data
contained in each permittee’s
application. The NPDES permit
prescribes the conditions under which
the facility is allowed to discharge to
ensure the facility’s compliance with
the CWA’s technology-based and water
quality-based requirements. NPDES
permits typically include restrictions on
the quantity of pollutants that a
permittee may discharge and require the
permittee to conduct routine
measurements of, and report on, a
number of parameters using EPAapproved, pollutant-specific test
protection of human health; for discharges to the
Great Lakes Basin, the applicable water quality
criteria for mercury are 1.3 ppt for the protection
of wildlife and 1.8 ppt for the protection of human
health. In 2001, EPA issued new recommended
water quality criteria guidance for the protection of
human health. This new guidance recommends
adoption of a methylmercury water quality criterion
of 0.3 milligrams of methylmercury per kilogram
(mg/kg) in fish tissue. EPA published final guidance
in April 2010 to assist States in implementing the
methylmercury criterion (‘‘Guidance for
Implementing the January 2001 Methylmercury
Water Quality Criterion,’’ EPA–823–F–10–001). It is
available at https://www.epa.gov/waterscience/
criteria/methylmercury/mercury.2010.pdf).
12 Examples of such modification may include
changes in the sample preparation digestion
procedures such as the use of reagents similar in
properties to ones used in the approved method,
changes in the equipment operating parameters
such as the use of an alternate more sensitive
wavelength, adjusting the sample volume to
optimize method performance, and changes in the
calibration ranges (provided that the modified range
covers any relevant regulatory limit).
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procedures (or approved alternative test
procedures).
In 2008 EPA submitted an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB) that, in part, updated the
Agency’s burden estimates for
applicants to complete Forms 1, 2A, 2C–
2F, and 2S and for permitting
authorities to review and process such
forms.13 The renewal ICR did not
include updated estimates for Form 2B
or for forms associated with cooling
water intake structures (Item 8 in Table
IV–1). Updated estimates to complete
those forms were contained in separate
ICRs.14 The existing ICRs include
annual burden estimates for completing
NPDES permit applications and for
conducting ongoing compliance
monitoring for both new and existing
NPDES permittees. EPA’s expectation is
that permit applicants and permittees
will use a range of methods based on a
need to appropriately quantify
pollutants in their discharge. To
calculate cost and burden, the ICRs use
an average cost for analytical methods,
which is then translated into burden
hours.
To assess the impact of this proposed
rule, EPA also assessed the cost
information for 40 CFR 136 methods
found in the National Environmental
Methods Index (NEMI) at https://
www.nemi.gov. The NEMI site describes
the ‘‘relative cost’’ as the cost per
procedure of a typical analytical
measurement using the specified
methods (i.e., the cost of analyzing a
single sample). Additional
considerations affect total project costs
(e.g., labor and equipment/supplies for
a typical sample preparation, quality
assurance/quality control requirements
to validate results reported, number of
samples being analyzed). EPA’s review
of the cost ranges provided in NEMI
indicated that there was generally little
13 USEPA. ‘‘Information Collection Request (ICR)
for National Pollutant Discharge Elimination
System (NPDES) Program (Renewal),’’ OMB Control
No. 2040–0004, EPA ICR No. 0229.19, December
2008.
14 USEPA. ‘‘Supporting Statement for the
Information Collection Request for the NPDES
Regulation and Effluent Limitation Guidelines and
Standards for Concentrated Animal Feeding
Operations,’’ OMB Control No. 2040–0250, EPA ICR
No. 1989.04, June 2006.
USEPA, ‘‘Information Collection Request (ICR) for
Cooling Water Intake Structures at Phase III
Facilities (Final Rule),’’ OMB Control No. 2040–
0268, EPA ICR No. 2169.02, February 2009.
USEPA, ‘‘Information Collection Request (ICR) for
Cooling Water Intake Structures Phase II Existing
Facilities (Renewal),’’ OMB Control No. 2040–0257,
EPA ICR No. 2060.03, May 2007.
USEPA, ‘‘Information Collection Request (ICR) for
Cooling Water Intake Structures New Facility Rule
(Renewal),’’ OMB Control No. 2040–0241, EPA ICR
No. 1973.04, June 2008.
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difference in the cost ranges across the
EPA-approved analytical methods for a
particular pollutant. A table with the
NEMI cost ranges is included in the
record. We request comment on this
assessment of the cost range for the
various EPA-approved methods. While
we acknowledge that there are cost
differentials for some facilities based on
case-specific situations, on the basis of
the analytical cost ranges provided in
NEMI, and the assumptions used in the
current ICRs (i.e., that applicants and
permittees will use a range of available
approved methods), the proposed rule is
expected to result in little or no new or
increased burden to applicants or
permittees. We request comment on the
burden estimate resulting from this
proposal.
The existing ICRs also account for the
ongoing burden to permitting
authorities to review applications and to
issue NPDES permits annually. They
also account for the ongoing burden
associated with reviewing discharge
monitoring and other reports for
compliance assessment purposes.
Finally, the existing ICRs account for
program revisions where they are
necessary because the controlling
Federal statutes or regulations were
modified.
V. Compliance Dates
Following issuance of this rule,
authorized States have up to one year to
revise, as necessary, their NPDES
regulations to adopt the requirements of
this rule, or two years if statutory
changes are needed, as provided at 40
CFR 123.62.
VI. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
This rule is not a ‘‘significant
regulatory action’’ under the terms of
Executive Order 12866 (58 FR 51735,
October 4, 1993) and is therefore not
subject to review under the EO.
B. Paperwork Reduction Act
This action does not impose any new
information collection burden. This
proposed rulemaking merely clarifies
testing procedures under the NPDES
program based on existing legal
requirements and authorities. The
proposed rulemaking requires the use of
sufficiently sensitive analytical test
methods when applying for an NPDES
permit and when performing sampling
and analysis pursuant to monitoring
requirements in an NPDES permit.
However, the Office of Management and
Budget (OMB) has previously approved
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the information collection requirements
contained in the existing regulations
(which cover all potential NPDES
applicants) under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned OMB
control numbers, as summarized in
section IV (Impacts) of this preamble.
The OMB control numbers for EPA’s
regulations in 40 CFR are listed in 40
CFR part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
For purposes of assessing the impacts
of this proposed rule on small entities,
‘‘small entity’’ is defined as (1) a small
business based on the Small Business
Administration regulations at 13 CFR
121.201; (2) a small governmental
jurisdiction that is a government of a
city, county, town, school district, or
special district with a population of less
than 50,000; or (3) a small organization
that is any not-for-profit enterprise
which is independently owned and
operated and is not dominant in its
field.
After considering the economic
impacts of this proposed rule on small
entities, I certify that this action will not
have a significant economic impact on
a substantial number of small entities.
Because EPA is simply clarifying, based
on existing legal requirements and
authorities, that sufficiently sensitive
analytical test methods must be used
when applying for an NPDES permit
and when performing sampling and
analysis pursuant to monitoring
requirements in an NPDES permit, this
proposed action will not impose any
new legally binding requirements or
burden on EPA, States, or the regulated
community, and specifically, any
burden on any small entity. EPA
continues to be interested in the
potential impacts of the proposed rule
on small entities and welcomes
comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
This proposed rule does not contain
a Federal mandate that might result in
expenditures of $100 million or more
for State, local, and Tribal governments,
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in the aggregate, or the private sector in
any one year. EPA is proposing to
clarify under existing legal requirements
and authorities that sufficiently
sensitive analytical test methods may be
used when applying for an NPDES
permit and when performing sampling
and analysis pursuant to monitoring
requirements in an NPDES permit. The
rulemaking will not impose any new
legally binding requirements on EPA,
States, or the regulated community.
Thus, this proposed rule is not subject
to the requirements of sections 202 and
205 of the UMRA. For the same reason,
EPA has determined that this rule
contains no regulatory requirements that
might significantly or uniquely affect
small governments. Thus, this proposed
rule is not subject to the requirements
of section 203 of UMRA.
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E. Executive Order 13132: Federalism
This proposed rule does not have
federalism implications. If promulgated,
it will not have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, as
specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This
proposed rule does not change the
relationship between the national
government and the States or change
their roles and responsibilities. Rather,
this proposed rulemaking would
confirm Agency policy, which is based
on existing legal requirements and
authorities, that sufficiently sensitive
analytical test methods must be used
when applying for an NPDES permit
and when performing sampling and
analysis pursuant to monitoring
requirements in an NPDES permit. EPA
does not expect this proposed rule to
have any impact on local governments.
Furthermore, the revised regulations
would not alter the basic State-Federal
scheme established in the CWA, under
which EPA authorizes States to carry
out the NPDES permitting program. EPA
expects the revised regulations to have
little effect on the relationship between,
or the distribution of power and
responsibilities among, the Federal and
State governments. In the spirit of
Executive Order 13132, and consistent
with EPA policy to promote
communications between EPA and State
and local governments, EPA specifically
solicits comment on this proposed
action from State and local officials.
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F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This proposed rule does not have
Tribal implications, as specified in
Executive Order 13175, ‘‘Consultation
and Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000). It will not have substantial
direct effects on Tribal governments, on
the relationship between the Federal
Government and Indian Tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian Tribes, as
specified in Executive Order 13175. The
proposed rule, which is based on
existing legal requirements and
authorities, clarifies that sufficiently
sensitive analytical test methods must
be used when applying for an NPDES
permit and when performing sampling
and analysis pursuant to monitoring
requirements in an NPDES permit.
Nothing in this proposed rule would
prevent an Indian Tribe from exercising
its own organic authority to deal with
such matters. EPA specifically solicits
additional comment on this proposed
action from Tribal officials.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
The proposed rule is not subject to
Executive Order 13045, ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), because it is not
economically significant and the
Agency does not believe that the
environmental health and safety risks
addressed by this action present a
disproportionate risk to children. This
proposed rule only interprets existing
legal requirements and authorities and
clarifies Agency policy that sufficiently
sensitive analytical test methods must
be used when applying for an NPDES
permit and when performing sampling
and analysis pursuant to monitoring
requirements in an NPDES permit.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This rulemaking is not subject to
Executive Order 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001), because it is not a significant
regulatory action under Executive Order
12866.
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35719
I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act (NTTAA) of 1995 (Pub. L. 104–113,
section 12(d), 15 U.S.C. 272 note)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standard bodies.
The NTTAA directs EPA to provide
explanations to Congress, through OMB,
when the Agency decides not to use
available and applicable voluntary
consensus standards. This proposed
rulemaking does not involve technical
standards. The proposed rulemaking
does, however, clarify Agency policy
based on existing regulations and
authorities that sufficiently sensitive
analytical test methods must be used
when applying for an NPDES permit
and when performing sampling and
analysis pursuant to monitoring
requirements in an NPDES permit.
J. Executive Order 12898 (Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations)
Executive Order (EO) 12898 (59 FR
7629 (Feb. 16, 1994)) establishes Federal
executive policy on environmental
justice. Its main provision directs
Federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
EPA has determined that this
proposed rule will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations
because it does not affect the level of
protection provided to human health or
the environment. As explained above,
the Agency does not have reason to
believe that the rule addresses
environmental health and safety risks
that present a disproportionate risk to
minority populations and low-income
populations. This proposed rule only
interprets existing legal requirements
and authorities and clarifies Agency
policy as stated above.
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List of Subjects
40 CFR Part 122
Administrative practice and
procedure, Confidential business
information, Environmental protection,
Hazardous substances, Reporting and
recordkeeping requirements, Water
pollution control.
40 CFR Part 136
Environmental protection,
Incorporation by reference, Reporting
and recordkeeping requirements, Water
pollution control.
For the reasons set out in the
preamble, title 40, chapter I, of the Code
of Federal Regulations is proposed to be
amended as follows:
PART 122—EPA ADMINISTERED
PERMIT PROGRAMS: THE NATIONAL
POLLUTANT DISCHARGE
ELIMINATION SYSTEM
1. The authority citation for part 122
continues to read as follows:
Authority: The Clean Water Act, 33 U.S.C.
1251 et seq.
2. Section 122.21, is amended by
adding a new paragraph (e)(3), to read
as follows:
§ 122.21 Application for a permit
(applicable to State programs, see § 123.25).
erowe on DSK5CLS3C1PROD with PROPOSALS-1
*
*
*
*
*
(e) * * *
(3) A permit application shall not be
considered complete unless all required
quantitative data are collected in
accordance with sufficiently sensitive
analytical methods approved under 40
CFR part 136 or in accordance with
another method required under 40 CFR
chapter I, subchapter N or O.
(i) For the purposes of this
requirement, a method approved under
40 CFR part 136 is ‘‘sufficiently
sensitive’’ when:
(A) The method minimum level (ML)
is at or below the level of the applicable
water quality criterion for the measured
pollutant or pollutant parameter;
(B) The method ML is above the
applicable water quality criterion, but
the amount of the pollutant or pollutant
parameter in a facility’s discharge is
high enough that the method detects
and quantifies the level of the pollutant
or pollutant parameter in the discharge;
(C) The method has the lowest ML of
the analytical methods approved under
40 CFR part 136.
(ii) When there is no analytical
method that has been approved under
15:05 Jun 22, 2010
§ 136.1
Applicability.
*
*
*
*
*
(c) For the purposes of the NPDES,
when more than one test procedure is
available under this part for the analysis
of a pollutant or pollutant parameter,
the test procedure selected shall be
sufficiently sensitive as defined at 40
CFR 122.21(e)(3) and 122.44(i)(1)(iv).
[FR Doc. 2010–15254 Filed 6–22–10; 8:45 am]
BILLING CODE 6560–50–P
Jkt 220001
§ 122.44 Establishing limitations,
standards, and other permit conditions
(applicable to State NPDES programs, see
§ 123.25).
ENVIRONMENTAL PROTECTION
AGENCY
*
Dated: June 16, 2010.
Lisa P. Jackson,
Administrator.
VerDate Mar<15>2010
40 CFR part 136, required under 40 CFR
chapter I, subchapter N or O, or
otherwise required by the Director, the
applicant may use any suitable,
sufficiently sensitive method but shall
provide a description of the method that
includes documentation of the ML.
*
*
*
*
*
3. Section 122.44 is amended by
revising paragraph (i)(1)(iv) to read as
follows:
40 CFR Part 271
*
*
*
*
(i) * * *
(1) * * *
(iv) According to sufficiently sensitive
test procedures (i.e., methods) approved
under 40 CFR part 136 for the analysis
of pollutants or pollutant parameters or
in accordance with another method
required under 40 CFR chapter I,
subchapter N or O.
(A) For the purposes of this
paragraph, a method is ‘‘sufficiently
sensitive’’ when:
(1) The method minimum level (ML)
is at or below the level of the effluent
limit established in the permit;
(2) The method ML is above the level
of the effluent limit in the permit, but
the amount of the pollutant or pollutant
parameter in a facility’s discharge is
high enough that the method detects
and quantifies the amount of the
pollutant or pollutant parameter in the
discharge;
(3) The method has the lowest ML of
the analytical methods approved under
40 CFR part 136.
(B) In the case of pollutants or
pollutant parameters for which there are
no approved methods under 40 CFR
part 136 or methods are not otherwise
required under 40 CFR chapter I,
subchapter N or O, monitoring shall be
conducted according to a sufficiently
sensitive test procedure specified in the
permit for such pollutants or pollutant
parameters.
*
*
*
*
*
PART 136—GUIDELINES
ESTABLISHING TEST PROCEDURES
FOR THE ANALYSIS OF POLLUTANTS
4. The authority citation for part 136
continues to read as follows:
Authority: Secs. 301, 304(h), 307, and
501(a) Pub. L. 95–217, 91 Stat. 1566, et seq.
(33 U.S.C. 1251 et seq.) (The Federal Water
Pollution Control Act Amendments of 1972
as amended by the Clean Water Act of 1977.)
5. Section 136.1 is amended by
adding a new paragraph (c) to read as
follows:
PO 00000
Frm 00035
Fmt 4702
Sfmt 4702
[EPA–R01–RCRA–2010–0468; FRL–9166–6]
Massachusetts: Final Authorization of
State Hazardous Waste Management
Program Revisions
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: The Commonwealth of
Massachusetts has applied to EPA for
final authorization of changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). EPA proposes to grant final
authorization to Massachusetts. EPA has
determined that these changes satisfy all
requirements needed to qualify for final
authorization, and is authorizing the
State’s changes through an immediate
final action.
DATES: Comments must be received on
or before July 23, 2010.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R01–
RCRA–2010–0468, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail: biscaia.robin@epa.gov.
• Fax: (617) 918–0642, to the
attention of Robin Biscaia.
• Mail: Robin Biscaia, RCRA Waste
Management Section, Office of Site
Remediation and Restoration (OSRR 07–
1), EPA New England—Region 1, 5 Post
Office Square, Suite 100, Boston, MA
02109–3912.
• Hand Delivery or Courier: Deliver
your comments to: Robin Biscaia, RCRA
Waste Management Section, Office of
Site Restoration and Remediation
(OSRR 07–1), EPA New England—
Region 1, 5 Post Office Square, Suite
100, Boston, MA 02109–3912. Such
deliveries are only accepted during the
Office’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
E:\FR\FM\23JNP1.SGM
23JNP1
]]>Agencies
[Federal Register Volume 75, Number 120 (Wednesday, June 23, 2010)]
[Proposed Rules]
[Pages 35712-35720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15254]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 122 and 136
[EPA-HQ-OW-2009-1019; FRL-9166-7]
RIN 2040-AC84
National Pollutant Discharge Elimination System (NPDES): Use of
Sufficiently Sensitive Test Methods for Permit Applications and
Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is proposing minor
amendments to its Clean Water Act (CWA) regulations to codify that
under the National Pollutant Discharge Elimination System (NPDES)
program, only ``sufficiently sensitive'' analytical test methods can be
used when completing an NPDES permit application and when performing
sampling and analysis pursuant to monitoring requirements in an NPDES
permit.
This proposal is based on requirements in the CWA and existing EPA
regulations. It also would codify existing EPA guidance on the use of
``sufficiently sensitive'' analytical methods with respect to
measurement of mercury and extend the approach outlined in that
guidance to the NPDES program more generally. Specifically, EPA is
proposing to clarify the existing NPDES application, compliance
monitoring, and analytical methods regulations. The amendments in this
proposed rulemaking affect only chemical-specific methods; they do not
apply to the Whole Effluent Toxicity (WET) methods or their use.
DATES: Comments on this action must be received or postmarked on or
before midnight August 9, 2010.
ADDRESSES: You may submit comments, identified by EPA-HQ-OW-2009-1019,
by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: ow-docket@epa.gov. Include EPA-HQ-OW-2009-1019 in
the subject line of the message.
Mail: Send the original and three copies of your comments
to: Water Docket, Environmental Protection Agency, Mail Code 2822T,
1200 Pennsylvania Avenue, NW., Washington, DC 20460, Attention: Docket
ID No. EPA-HQ-OW-2009-1019.
Hand Delivery/Courier: Deliver your comments to EPA Docket
Center,
[[Page 35713]]
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC,
Attention Docket ID No. EPA-HQ-OW-2009-1019. Such deliveries are
accepted only during the Docket's normal hours of operation, which are
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. Special arrangements should be made for deliveries of boxed
information. The telephone number for the Water Docket is 202-566-2426.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2009-
1019. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov or e-mail. The https://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identify or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through https://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
might not be able to consider your comment. Avoid the use of special
characters and any form of encryption, and ensure that electronic files
are free of any defects or viruses. For additional information about
EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the https://www.regulations.gov index. Some information, however, is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is publicly available only in hard copy. Publicly available
docket materials are available electronically in https://www.regulations.gov or in hard copy at the Water Docket, EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington,
DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is 202-566-1744, and the telephone number for the
Water Docket is 202-566-2426.
FOR FURTHER INFORMATION CONTACT: For additional information, contact
Kathryn Kelley, Water Permits Division, Office of Wastewater Management
(4203M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 202-564-7004, e-mail address:
kelley.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Potentially Affected Parties
B. Legal Authority
II. Background
III. Scope and Rationale of the Proposed Rule
IV. Impacts
V. Compliance Dates
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
I. General Information
A. Potentially Affected Parties
In the NPDES program, point source dischargers obtain permits that
are issued by EPA regions and authorized NPDES States, Territories, and
Indian Tribes (collectively referred to as ``permitting authorities'').
These point source dischargers include publicly owned treatment works
(POTWs) and various industrial and commercial facilities (collectively
referred to as ``NPDES applicants or permittees''). Permitting
authorities issue NPDES permits after analyzing the information
contained in the application or in the case of a general permit, the
information submitted to demonstrate eligibility for coverage. The
NPDES permit prescribes the conditions under which the facility is
allowed to discharge pollutants and that will ensure the facilities'
compliance with the CWA's technology-based and water quality-based
requirements. NPDES permits typically include restrictions on the mass
and/or concentration of pollutants \1\ that a permittee may discharge
and require the permittee to conduct routine sampling and reporting of
various parameters measured in the permitted discharge. In general,
NPDES applicants and permittees are required to use EPA-approved,
pollutant-specific test procedures (or approved alternative test
procedures) when measuring the pollutants in their discharges.
---------------------------------------------------------------------------
\1\ Where the term ``pollutant'' is used, it refers to both
pollutants and pollutant parameters.
---------------------------------------------------------------------------
The purpose of today's proposal is to clarify that NPDES applicants
and permittees must use sufficiently sensitive analytical methods when
quantifying the presence of pollutants in a discharge, and the Director
\2\ must require and accept only such data. The broad universe of
entities`` \3\ that would be affected by this proposal includes NPDES
permitting authorities and municipal and industrial applicants and
permittees (Table I-1). The impact of this proposal, however, would
only affect those entities that use or allow the use of any EPA-
approved analytical methods (for one or more parameters) that are not
``sufficiently sensitive'' to detect pollutants being measured in the
discharge.
---------------------------------------------------------------------------
\2\ The term ``Director'' refers to the permitting authority.
Per 40 CFR 122.2, ``Director'' means the Regional Administrator or
the State Director, as the context requires, or an authorized
representative. When there is no ``approved State program''' and
there is an EPA-administered program, ``Director'' means the
Regional Administrator. When there is an approved State program,
``Director'' normally means the State Director. In some
circumstances, however, EPA retains the authority to take certain
actions even when there is an approved State program. (For example,
when EPA has issued an NPDES permit prior to the approval of a State
program, EPA may retain jurisdiction over that permit after program
approval; see 40 CFR 123.1.) In such cases, the term ``Director''
means the Regional Administrator and not the State Director.
\3\ Although terms such as ``authorities,'' ``applicants,'' and
``permittees'' imply individuals, EPA uses these terms to refer to
entities. For example, EPA uses the term ``NPDES permitting
authorities'' to mean the EPA Regions, States, Territories, and
Indian Tribes granted authority to implement and manage the NPDES
program. EPA uses the term ``NPDES applicants'' or ``NPDES
permittees'' to mean facilities that have applied for, sought
coverage under, or been issued an NPDES individual or general
permit.
[[Page 35714]]
Table I-1--Entities Potentially Regulated by This Rule
----------------------------------------------------------------------------------------------------------------
Category Examples of potentially affected entities
----------------------------------------------------------------------------------------------------------------
State, Territorial, and Indian States, Territories, and Indian Tribes authorized to administer the NPDES
Tribal Governments. permitting program; States, Territories, and Indian Tribes that provide
certification under section 401 of the CWA.
Municipalities................... POTWs required to apply for or seek coverage under an NPDES individual or
general permit and to perform routine monitoring as a condition of any
issued NPDES permit.
Industry......................... Facilities required to apply for or seek coverage under an NPDES individual
or general permit and to perform routine monitoring as a condition of any
issued NPDES permit.
----------------------------------------------------------------------------------------------------------------
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. Legal Authority
EPA would promulgate the rule being proposed today pursuant to the
authority of sections 301, 304(h), 308, 402(a), and 501(a) of the CWA
[33 U.S.C. 1311, 1314(h), 1316, 1318, 1342(a), 1343, and 1361(a)].
Section 501(a) of the CWA authorizes the Administrator of EPA to
prescribe such regulations as are necessary to carry out the act.
Section 301(a) of the CWA prohibits the discharge of any pollutant into
navigable waters unless the discharge complies with an NPDES permit
issued under section 402 of the act. Section 402(a) of the CWA
authorizes the Administrator to issue permits that require a discharger
to meet all the applicable requirements under sections 301, 302, 306,
307, 308, and 403. Section 301(b) of the CWA further requires that
NPDES permits include effluent limitations that implement technology-
based standards of performance and, where necessary, water quality-
based effluent limitations (WQBELs) that are as stringent as necessary
to meet water quality standards. With respect to the protection of
water quality, NPDES permits must include limitations to control all
pollutants that the NPDES permitting authority determines are or might
be discharged at a level that ``will cause, have the `reasonable
potential' to cause, or contribute to an excursion above any State
water quality standard,'' including both narrative and numeric criteria
[40 CFR 122.44(d)(1)(i)]. If the Director determines that a discharge
causes, or has the reasonable potential to cause or contribute to, such
an excursion, the permit must contain WQBELs for the pollutant [40 CFR
122.44(d)(1)(iii)]. Section 402(a)(2) of the CWA requires EPA to
prescribe permit conditions to ensure compliance with requirements, ``*
* * including conditions on data and information collection, reporting
and such other requirements as [the Administrator] deems appropriate.''
Thus, a prospective permittee might need to measure various pollutants
in its effluent at two stages: First, at the permit application stage
so that the Director can determine what pollutants are present in the
applicant's discharge and the amount of each pollutant present and,
second, to quantify the levels of each pollutant limited in the permit
to determine whether the discharge is in compliance with the applicable
limits and conditions.
Section 304(h) of the CWA requires the Administrator of EPA to ``*
* * promulgate guidelines establishing test procedures for the analysis
of pollutants that shall include the factors which must be provided in
any certification pursuant to [section 401of this Act] or permit
application pursuant to [section 402 of this Act].'' Section 501(a) of
the act authorizes the Administrator to ``* * * prescribe such
regulations as are necessary to carry out this function under [the
act].'' EPA generally has codified its test procedure regulations
(including analysis and sampling requirements) for CWA programs at 40
CFR 136, although some requirements are codified in other parts (e.g.,
40 CFR chapter I, subchapters N and O).
The Director is authorized under 40 CFR 122.21(e) to determine when
an NPDES permit application is complete. Moreover, the Director shall
not begin processing a permit until the applicant has fully complied
with the application requirements for that permit [40 CFR 124.3(a)(2)].
Under 40 CFR 122.21(g)(13), applicants are required to provide to the
Director, upon request, such other information as the Director may
reasonably require to assess the discharge. Under 40 CFR 122.28(b)(2),
dischargers (or treatment works treating domestic sewage) seeking
coverage under a general permit must submit to the Director a written
NOI to be covered by the general permit (with some exceptions set forth
elsewhere in 40 CFR 122.28(b)(2)). The contents of the NOI must be
specified in the general permit, and they must require the submission
of information necessary for adequate program implementation. Finally,
40 CFR 122.41(j)(1) requires NPDES permits to specify that sampling and
measurements taken for the purposes of monitoring shall be
``representative of the monitored activity.''
Among other things, section 308 of the CWA authorizes EPA to
require owners or operators of point sources to establish records,
conduct monitoring activities, and make reports to enable the
permitting authority to determine whether there is a violation of any
prohibition or any requirement established under provisions including
section 402 of the CWA. Under sections 308(c) and 402(b)(2)(A), a
State's authorized NPDES program must have authorities for inspection,
monitoring, and issuing permits that are applicable to at least the
same extent as those under section 308.
As summarized above, the legal requirements and authorities exist
for EPA to require NPDES applicants and permittees to use sufficiently
sensitive analytical methods when quantifying the presence of
pollutants in a discharge and to require the Director to require and
accept only such data.
II. Background
Multiple analytical test methods exist for many pollutants
regulated under the CWA. Therefore, EPA has generally approved multiple
methods for CWA pollutants under 40 CFR 136 and 40 CFR chapter I,
subchapters N and O. Some of the approved analytical test methods have
greater sensitivities and lower minimum levels \4\ \5\ or method
[[Page 35715]]
detection limits (MDLs) \6\ than other approved methods for the same
pollutant. This situation often occurs because of advances having been
made in instrumentation and in the analytical protocols themselves.
Many metals and toxic compounds (for example, mercury) have an array of
EPA-approved methods, including some methods that have greater
sensitivities and lower minimum levels than the others.
---------------------------------------------------------------------------
\4\ The term ``minimum level'' refers to either the lowest
calibration point in a method or a multiple of the method detection
limit (MDL), whichever is higher. Minimum levels may be obtained in
several ways: They may be published in a method; they may be the
lowest acceptable calibration point used by a laboratory; or they
may be calculated by multiplying the MDL in a method, or the MDL
determined by a lab, by a factor. [See: (A) 40 CFR 136, appendix A,
footnotes to table 2 of EPA Method 1624 and table 3 of EPA Method
1625 (49 FR 43234, October 26, 1984); (B) 40 CFR 136, section 17.12
of EPA Method 1631E (67 FR 65876-65888, October 29, 2002); (C) 61 FR
21, January 31, 1996; (D) ``Analytical Method Guidance for the
Pharmaceutical Manufacturing Point Source Category,'' EPA 821-B-99-
003, August 1999; and (E) ``EPA Region 10 Guidance For WQBELs Below
Analytical Detection/Quantitation Level,'' EPA Region 10, March 22,
1996.]
\5\ For the purposes of this rulemaking, EPA is considering the
following terms to be synonymous: ``quantitation limit,''
``reporting limit,'' and ``minimum level.''
\6\ The MDL is determined using the procedure at 40 CFR 136,
appendix B. It is defined as the minimum concentration of a
substance that can be measured and reported with 99 percent
confidence that the analyte concentration is greater than zero and
is determined from analysis of a sample in a given matrix containing
the analyte.
---------------------------------------------------------------------------
EPA and State permitting authorities use data from the permit
application to determine whether pollutants are present in an
applicant's discharge and to quantify the levels of all detected
pollutants. These pollutant data are then used to determine whether
technology- or water quality-based effluent limits are needed in the
facility's NPDES permit. It is critical, therefore, that applicants
provide data that have been measured with precision and accuracy so
that they will be meaningful to the decision-making process. Among
other things, data must be provided at a level that will enable the
Director to make a sound, reasonable potential determination and, if
necessary, establish appropriate water quality-based permit limits. The
same holds true for monitoring and reporting relative to permit limits
established for regulated parameters. The aim is for applicants and
permittees to use analytical methods that are capable of detecting and
measuring the pollutants at, or below, the respective water quality
criteria or permit limits.\7\
---------------------------------------------------------------------------
\7\ To address this situation some State permitting authorities
have developed a list of monitored parameters and prescribed a
required minimum level that must be achieved for each parameter as a
part of their State regulations or policy.
---------------------------------------------------------------------------
For example, in 2002 and 2007 EPA published two new analytical
methods for mercury that were several orders of magnitude more
sensitive than previously available methods. In addition, a number of
States have set water quality criteria for mercury that are below the
detection levels of the older methods for mercury that EPA approved
prior to 2002. Unlike the previous methods, the new methods are capable
of measuring whether effluent samples are above or below the current
water quality criteria. In 2007 EPA addressed this issue with respect
to mercury in a memorandum titled ``Analytical Methods for Mercury in
NPDES Permits,'' from James A. Hanlon, Director of EPA's Office of
Wastewater Management, to the Regional Water Division Directors. This
memorandum is available at https://www.epa.gov/npdes/pubs/mercurymemo_analyticalmethods.pdf. The memorandum explains EPA's expectation that
``All facilities with the potential to discharge mercury will provide
with their NPDES permit applications monitoring data for mercury using
Method 1631E or another sufficiently sensitive EPA-approved method. * *
* Accordingly, EPA strongly recommends that the permitting authority
determine that a permit application that lacks effluent data analyzed
with a sufficiently sensitive EPA-approved method such as Method 1631E,
is incomplete unless and until the facility supplements the original
application with data analyzed with such a method.''
Following issuance of the 2007 memorandum, EPA determined that the
NPDES permit application regulations at 40 CFR 122.21 and the NPDES
permit monitoring requirements at 40 CFR 122.44 should be clarified to
ensure that applicants and permittees use sufficiently sensitive
analytical methods for all pollutants, not just mercury. EPA is
proposing to incorporate language in the regulations that extends the
requirement to use sufficiently sensitive test methods to all
pollutants. EPA is also proposing to codify the definition of
``sufficiently sensitive'' to include an additional criterion that was
not part of the 2007 memorandum, as described below.
III. Scope and Rationale of the Proposed Rule
This proposed rule clarifies that NPDES applicants and permittees
must use sufficiently sensitive analytical test methods when submitting
information characterizing the discharge in an NPDES permit application
and when performing sampling and analysis pursuant to monitoring
requirements in an NPDES permit. In addition, the proposed rule
clarifies that the Director must require NPDES applicants and
permittees to use sufficiently sensitive analytical test methods and
accept only data analyzed by such methods. EPA proposes adding or
modifying language to define ``sufficiently sensitive'' at 40 CFR
122.21(e)(3) and 122.44(i)(1)(iv). EPA also proposes providing a cross-
reference to these changes at 40 CFR 136.1(c). For the purposes of this
rulemaking, if monitoring requirements are included as a condition of
the general permit, these requirements would be subject to the
provisions established in 122.44(i)(1)(iv).
As discussed earlier, it is critical that the Director make
permitting decisions based on accurate data and, thus, sound science.
The use of imprecise analytical methods could lead the Director to make
assumptions regarding the presence or absence of a pollutant in an
applicant's discharge. These assumptions, in turn, could result in the
Director's making an incorrect permitting decision (e.g., the decision
not to include a limit in a permit when, in fact, a waste stream
concentration of a pollutant will cause, have the reasonable potential
to cause, or contribute to an excursion above an applicable water
quality criterion). Moreover, if the Director were to include imprecise
analytical methods in permits for compliance monitoring purposes, the
use of such methods could result in undetected exceedances of permit
limits.
Although EPA has approved multiple analytical methods for
individual pollutants under 40 CFR 136, the Agency has historically
expected that applicants and permittees would select from the array of
available methods a specific analytical method that is sufficiently
sensitive to quantify the presence of a pollutant in a given discharge.
EPA has not expected that NPDES permit applicants would select a method
with insufficient sensitivity, thereby masking the presence of a
pollutant in their discharge, when an EPA-approved sufficiently
sensitive method is available. This proposed rule, therefore, would
clarify that NPDES applicants and permittees must use sufficiently
sensitive analytical methods when quantifying the presence of
pollutants in a discharge and that the Director must require and accept
only such data.
EPA proposes defining the term ``sufficiently sensitive'' in two
sections of the Federal NPDES regulations--at 40 CFR 122.21(e) (Permit
Application Completeness) as a new subsection (3) and at 40 CFR
122.44(i)(1)(iv) (Monitoring Requirements). EPA also proposes modifying
40 CFR 136.1 (Applicability) by adding a new
[[Page 35716]]
subsection (c), which is simply a cross-reference to the changes
proposed for 40 CFR 122.21(e)(3) and 40 CFR 122.44(i)(1)(iv). The
regulatory changes proposed are open to comment. EPA, however, is not
reopening or taking comment on any other existing requirement in the
regulations.
A. The new and revised sections indicate that a method is
sufficiently sensitive where:
i. The method minimum level is at or below the level of the
applicable water quality criterion or permit limitation for the
measured pollutant or pollutant parameter; or
ii. The method minimum level is above the applicable water
quality criterion or permit limitation, but the amount of the
pollutant or pollutant parameter in a facility's discharge is high
enough that the method detects and quantifies the level of the
pollutant or pollutant parameter in the discharge; or
iii. The method has the lowest minimum level of the analytical
methods approved under 40 CFR 136.
B. When no analytical method is approved under 40 CFR 136,
required under subchapter N or O, or otherwise required by the
Director, an NPDES applicant may use any suitable sufficiently
sensitive method; however, the applicant shall provide a description
of the method, including documentation of the minimum level.\8\
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\8\ This provision is adopted from existing language in 40 CFR
122.21(g)(7).
The first two criteria in the sufficiently sensitive definition are
aimed at addressing situations in which EPA has approved multiple
methods under 40 CFR 136 for a pollutant and some of those approved
methods have greater sensitivities and lower minimum levels than
others.
The third criterion of the definition is included to address
situations in which none of the approved 40 CFR 136 methods for a
pollutant are sufficiently sensitive to achieve the minimum levels
necessary to assess reasonable potential with a water quality criterion
or to monitor compliance with a permit limit. In these situations, EPA
proposes that applicants or permittees use the ``most sensitive'' of
the approved methods for the pollutant. This practice has long been the
Agency's policy, and it is consistent with the CWA and with the EPA
regulations at 40 CFR 122.44(d) requiring that limits be protective of
water quality standards.\9\ EPA acknowledges that a laboratory might
achieve MDLs and minimum levels lower than those published when the
promulgated method was developed.\10\ Thus, the Director should not
rely solely on MDLs or minimum levels in published methods because they
give only an upper, not a lower, bound on the lab's MDL and minimum
level. Flexibility is provided at 40 CFR 136.6, which allows a
laboratory to demonstrate performance better than the MDL or minimum
level published in a method.
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\9\ EPA's Office of Water issued Final Guidance on Section
304(1), ``Listing and Permitting of Pulp and Paper Mills'' (referred
to as the 304(l) Guidance, March 15, 1989, available at https://www.epa.gov/npdes/pubs/owm0360.pdf). The guidance recommended that
where WQBELs are less than the detection level for the specified
analytical method, the calculated WQBEL should be included as a
requirement of the permit. EPA again addressed the issue of
detection levels in its May 21, 1990, ``Strategy for the Regulation
of Discharges of PCDDs and PCDFs from Pulp and Paper Mills to Waters
of the United States'' (the Dioxin Strategy, available at https://www.epa.gov/npdes/pubs/owm0286.pdf). This strategy modified the
304(l) Guidance by recommending that permit writers specify the
minimum level in permits that limit dioxin. In March 1991, EPA
further expanded its guidance on detection levels in the ``Technical
Support Document for Water Quality-based Toxics Control'' by
applying the concepts contained in the Dioxin Strategy to analytical
detection levels for all pollutants (EPA Office of Water, EPA/505/2-
90-001, PB91-127415; available at https://www.epa.gov/waterscience/methods/det/faca/mtg20051208/excerpt-detectionlimits.html).
\10\ See Content Notes 4-6.
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The final provision is intended to address situations where no
approved analytical method exists under part 136, is required under
subchapter N or O, or is otherwise required by the Director. In such
situations, an applicant may use any suitable sufficiently sensitive
method but shall provide a description of the method that includes
documentation of the minimum level. Where an EPA-approved analytical
method is nonexistent under part 136 or is not required under
subchapter N or O for a pollutant limited in an NPDES permit, the
Director must specify a sufficiently sensitive analytical method as a
condition of the NPDES permit, consistent with the criteria established
in this proposed rulemaking at 40 CFR 122.44(i)(1)(iv)(A)-(B).
Under the CWA, authorized NPDES States, Territories, and Indian
Tribes must have in place legal authorities that are at least as
stringent as the requirements in certain parts of the EPA regulations.
See 40 CFR 123.25. The requirements of sections 122.21(e) and
122.44(i), which are the subject of this proposal, are among those that
States must include within their own programs. Therefore, once the
revised regulations that EPA is proposing today are finalized, States
will need to amend their own legal authorities, where necessary, to
ensure that only sufficiently sensitive methods are used to produce
data for permit applications and for monitoring under a permit. See 40
CFR 123.62(e).
In some cases, States currently have State statutes or regulations
that require NPDES applicants to use a specific analytical method or
achieve a specific minimum level for a particular pollutant (or they
have a State policy or guidance that recommends a specific method or
minimum level). A problem would arise if the State currently requires a
particular method or minimum level that is not ``sufficiently
sensitive'' as defined in new EPA regulations. In these situations, EPA
would expect States to revise their statutes or regulations so that if
they require the use of a particular method or minimum level, it is one
that is sufficiently sensitive. States would need to revise any policy
guidances as well. (No problem would arise, however, if the method or
minimum level currently required by the State does qualify as
``sufficiently sensitive.'') EPA will provide regular updates on its
Web site at https://www.epa.gov/waterscience/methods to keep permitting
authorities and permittees informed of method updates and revised water
quality criteria to better enable the permitting authorities to
determine that their requirements for applicants and permittees remain
sufficiently sensitive.
The following example is provided to help clarify the importance of
using sufficiently sensitive test methods in the NPDES program:
Example III-1--Mercury
Measurements included with an NPDES permit application and with
reports required to be submitted under the NPDES permit must generally
be made using analytical methods approved by EPA under 40 CFR 136. (See
40 CFR 136.1, 136.4, 136.5, 122.21(g)(7), and 122.41(j).) EPA has four
approved methods for mercury under 40 CFR 136--EPA Methods 245.1,
245.2, 1631E, and 245.7. The first two methods, approved by EPA in
1974, can achieve measurement of mercury down to 200 parts per trillion
(ppt). EPA approved Method 1631 Revision E in 2002. Method 1631E has a
minimum level of 0.5 ppt, making it 400 times more sensitive than EPA
Methods 245.1 and 245.2. In fact, the sensitivity of Methods 245.1 and
245.2 when last updated in 1994 and 1979, respectively, was well above
the water quality criteria now adopted in most States, as well as the
criteria included by EPA in its final ``Water Quality Guidance for the
Great Lakes System'' for the protection of aquatic life and human
health, which generally fall in the range of 1 to 50 ppt.\11\ In
contrast, Method 1631E, with
[[Page 35717]]
a minimum level of 0.5 ppt, supports the measurement of mercury at
these low levels.
---------------------------------------------------------------------------
\11\ Many States have adopted mercury water quality criteria of
12 parts per trillion (ppt) for the protection of aquatic life and
50 ppt for the protection of human health; for discharges to the
Great Lakes Basin, the applicable water quality criteria for mercury
are 1.3 ppt for the protection of wildlife and 1.8 ppt for the
protection of human health. In 2001, EPA issued new recommended
water quality criteria guidance for the protection of human health.
This new guidance recommends adoption of a methylmercury water
quality criterion of 0.3 milligrams of methylmercury per kilogram
(mg/kg) in fish tissue. EPA published final guidance in April 2010
to assist States in implementing the methylmercury criterion
(``Guidance for Implementing the January 2001 Methylmercury Water
Quality Criterion,'' EPA-823-F-10-001). It is available at https://www.epa.gov/waterscience/criteria/methylmercury/mercury.2010.pdf).
---------------------------------------------------------------------------
On March 12, 2007, EPA published the Methods Update Rule, or MUR
(72 FR 11200), under which the Agency approved Method 245.7 for mercury
and also modified versions of other EPA-approved methods for the
parameter. This method change applies to the implementation of both
water column criteria and fish tissue criteria in permits. Method 245.7
has a minimum level of 5.0 ppt, making it 40 times more sensitive than
Methods 245.1 and 245.2. Methods 245.1 and 245.2 may be modified to
achieve lower minimum levels.\12\ Modifications to an EPA-approved
method for mercury that meet the method performance requirements of 40
CFR 136.6 are considered to be approved methods and require no further
EPA approval. (See 72 FR 11239-40, March 12, 2007.) For analytical
method modifications that do not fall within the flexibility of 40 CFR
136.6, the modified methods may be approved under the alternate test
procedure program, as defined at 40 CFR 136.4 and 136.5.
---------------------------------------------------------------------------
\12\ Examples of such modification may include changes in the
sample preparation digestion procedures such as the use of reagents
similar in properties to ones used in the approved method, changes
in the equipment operating parameters such as the use of an
alternate more sensitive wavelength, adjusting the sample volume to
optimize method performance, and changes in the calibration ranges
(provided that the modified range covers any relevant regulatory
limit).
---------------------------------------------------------------------------
As noted, most States have adopted water quality criteria for the
protection of aquatic life and human health that fall in the range of 1
to 50 ppt. If an applicant or permittee used Methods 245.1 and 245.2,
``the absence of a quantitative result'' would show only that mercury
levels are below 200 ppt (based on a minimum level of 200 ppt) but
would not establish that the discharge is at or below the applicable
water quality criterion. In such a circumstance, a permit writer would
possibly lack the information needed to make a reasonable potential
determination. Use of an insufficiently sensitive method when
performing routine monitoring under an NPDES permit could also yield
data that would not be adequate for the Director to assess compliance.
In contrast, if the applicant used Method 1631E (or 245.7), which can
detect and quantify mercury concentrations at or below the low water
quality criteria levels, the permit writer would have adequate
information to make a reasonable potential determination. Therefore,
EPA proposes to clarify in the regulations that the Director must
consider an NPDES permit application incomplete until the applicant
submits analytical data using a sufficiently sensitive method as that
term is defined in this rulemaking, and when specifying in a permit
which analytical methods the permittee may use, the Director may only
specify sufficiently sensitive methods.
IV. Impacts
Entities that discharge to waters of the United States vary in
terms of the quantity of their discharges, the potential constituents
contained in their discharges, and their operation and maintenance
practices. Consequently, the Director's NPDES application requirements
vary depending on applicant type. For example, Form 2A for
municipalities requires minimal screening for POTWs with design flows
under 100,000 gallons per day; however, for POTWs with design flows
above 1 million gallons per day (MGD), multiple priority pollutant
scans are required. Similarly, existing industrial and commercial
facilities that complete Form 2C are required to test for toxic
pollutants based on the nature of their manufacturing operation. To
assist permitting authorities (EPA regions, States, and Tribes), EPA
developed several NPDES permit application forms. Table IV-1 provides a
list of these forms and the discharger type(s) for which they are
intended. Permitting authorities may use EPA's forms or comparable
forms of their own.
Table IV-1--EPA NPDES Permit Application Forms by Applicant Type
----------------------------------------------------------------------------------------------------------------
Form or request Applicant type
----------------------------------------------------------------------------------------------------------------
1........... Form 1................... New and existing applicants, except POTWs and treatment works treating
domestic sewage.
2........... Form 2A.................. New and existing POTWs (i.e., municipal facilities).
3........... Form 2B.................. New and existing concentrated animal feeding operations (CAFOs) and
aquatic animal production facilities.
4........... Form 2C.................. Existing industries discharging process wastewater.
5........... Form 2D.................. New industries discharging process wastewater.
6........... Form 2E.................. New and existing industries discharging non-process wastewater only.
7........... Form 2F.................. New and existing industries discharging stormwater.
8........... 40 CFR 122.21(r) and New and existing industries with cooling water intake structures.
122.22(d).
9........... Form 2S.................. New and existing POTWs and other treatment works treating domestic
sewage (covers sludge).
----------------------------------------------------------------------------------------------------------------
As noted earlier, permitting authorities issue and develop effluent
limitations for individual NPDES permits after analyzing the data
contained in each permittee's application. The NPDES permit prescribes
the conditions under which the facility is allowed to discharge to
ensure the facility's compliance with the CWA's technology-based and
water quality-based requirements. NPDES permits typically include
restrictions on the quantity of pollutants that a permittee may
discharge and require the permittee to conduct routine measurements of,
and report on, a number of parameters using EPA-approved, pollutant-
specific test
[[Page 35718]]
procedures (or approved alternative test procedures).
In 2008 EPA submitted an Information Collection Request (ICR) to
the Office of Management and Budget (OMB) that, in part, updated the
Agency's burden estimates for applicants to complete Forms 1, 2A, 2C-
2F, and 2S and for permitting authorities to review and process such
forms.\13\ The renewal ICR did not include updated estimates for Form
2B or for forms associated with cooling water intake structures (Item 8
in Table IV-1). Updated estimates to complete those forms were
contained in separate ICRs.\14\ The existing ICRs include annual burden
estimates for completing NPDES permit applications and for conducting
ongoing compliance monitoring for both new and existing NPDES
permittees. EPA's expectation is that permit applicants and permittees
will use a range of methods based on a need to appropriately quantify
pollutants in their discharge. To calculate cost and burden, the ICRs
use an average cost for analytical methods, which is then translated
into burden hours.
---------------------------------------------------------------------------
\13\ USEPA. ``Information Collection Request (ICR) for National
Pollutant Discharge Elimination System (NPDES) Program (Renewal),''
OMB Control No. 2040-0004, EPA ICR No. 0229.19, December 2008.
\14\ USEPA. ``Supporting Statement for the Information
Collection Request for the NPDES Regulation and Effluent Limitation
Guidelines and Standards for Concentrated Animal Feeding
Operations,'' OMB Control No. 2040-0250, EPA ICR No. 1989.04, June
2006.
USEPA, ``Information Collection Request (ICR) for Cooling Water
Intake Structures at Phase III Facilities (Final Rule),'' OMB
Control No. 2040-0268, EPA ICR No. 2169.02, February 2009.
USEPA, ``Information Collection Request (ICR) for Cooling Water
Intake Structures Phase II Existing Facilities (Renewal),'' OMB
Control No. 2040-0257, EPA ICR No. 2060.03, May 2007.
USEPA, ``Information Collection Request (ICR) for Cooling Water
Intake Structures New Facility Rule (Renewal),'' OMB Control No.
2040-0241, EPA ICR No. 1973.04, June 2008.
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To assess the impact of this proposed rule, EPA also assessed the
cost information for 40 CFR 136 methods found in the National
Environmental Methods Index (NEMI) at https://www.nemi.gov. The NEMI
site describes the ``relative cost'' as the cost per procedure of a
typical analytical measurement using the specified methods (i.e., the
cost of analyzing a single sample). Additional considerations affect
total project costs (e.g., labor and equipment/supplies for a typical
sample preparation, quality assurance/quality control requirements to
validate results reported, number of samples being analyzed). EPA's
review of the cost ranges provided in NEMI indicated that there was
generally little difference in the cost ranges across the EPA-approved
analytical methods for a particular pollutant. A table with the NEMI
cost ranges is included in the record. We request comment on this
assessment of the cost range for the various EPA-approved methods.
While we acknowledge that there are cost differentials for some
facilities based on case-specific situations, on the basis of the
analytical cost ranges provided in NEMI, and the assumptions used in
the current ICRs (i.e., that applicants and permittees will use a range
of available approved methods), the proposed rule is expected to result
in little or no new or increased burden to applicants or permittees. We
request comment on the burden estimate resulting from this proposal.
The existing ICRs also account for the ongoing burden to permitting
authorities to review applications and to issue NPDES permits annually.
They also account for the ongoing burden associated with reviewing
discharge monitoring and other reports for compliance assessment
purposes. Finally, the existing ICRs account for program revisions
where they are necessary because the controlling Federal statutes or
regulations were modified.
V. Compliance Dates
Following issuance of this rule, authorized States have up to one
year to revise, as necessary, their NPDES regulations to adopt the
requirements of this rule, or two years if statutory changes are
needed, as provided at 40 CFR 123.62.
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This rule is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the EO.
B. Paperwork Reduction Act
This action does not impose any new information collection burden.
This proposed rulemaking merely clarifies testing procedures under the
NPDES program based on existing legal requirements and authorities. The
proposed rulemaking requires the use of sufficiently sensitive
analytical test methods when applying for an NPDES permit and when
performing sampling and analysis pursuant to monitoring requirements in
an NPDES permit. However, the Office of Management and Budget (OMB) has
previously approved the information collection requirements contained
in the existing regulations (which cover all potential NPDES
applicants) under the provisions of the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. and has assigned OMB control numbers, as summarized
in section IV (Impacts) of this preamble. The OMB control numbers for
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of this proposed rule on
small entities, ``small entity'' is defined as (1) a small business
based on the Small Business Administration regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district, or special district with a
population of less than 50,000; or (3) a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field.
After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Because EPA
is simply clarifying, based on existing legal requirements and
authorities, that sufficiently sensitive analytical test methods must
be used when applying for an NPDES permit and when performing sampling
and analysis pursuant to monitoring requirements in an NPDES permit,
this proposed action will not impose any new legally binding
requirements or burden on EPA, States, or the regulated community, and
specifically, any burden on any small entity. EPA continues to be
interested in the potential impacts of the proposed rule on small
entities and welcomes comments on issues related to such impacts.
D. Unfunded Mandates Reform Act
This proposed rule does not contain a Federal mandate that might
result in expenditures of $100 million or more for State, local, and
Tribal governments,
[[Page 35719]]
in the aggregate, or the private sector in any one year. EPA is
proposing to clarify under existing legal requirements and authorities
that sufficiently sensitive analytical test methods may be used when
applying for an NPDES permit and when performing sampling and analysis
pursuant to monitoring requirements in an NPDES permit. The rulemaking
will not impose any new legally binding requirements on EPA, States, or
the regulated community. Thus, this proposed rule is not subject to the
requirements of sections 202 and 205 of the UMRA. For the same reason,
EPA has determined that this rule contains no regulatory requirements
that might significantly or uniquely affect small governments. Thus,
this proposed rule is not subject to the requirements of section 203 of
UMRA.
E. Executive Order 13132: Federalism
This proposed rule does not have federalism implications. If
promulgated, it will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999). This proposed rule does not change the
relationship between the national government and the States or change
their roles and responsibilities. Rather, this proposed rulemaking
would confirm Agency policy, which is based on existing legal
requirements and authorities, that sufficiently sensitive analytical
test methods must be used when applying for an NPDES permit and when
performing sampling and analysis pursuant to monitoring requirements in
an NPDES permit. EPA does not expect this proposed rule to have any
impact on local governments.
Furthermore, the revised regulations would not alter the basic
State-Federal scheme established in the CWA, under which EPA authorizes
States to carry out the NPDES permitting program. EPA expects the
revised regulations to have little effect on the relationship between,
or the distribution of power and responsibilities among, the Federal
and State governments. In the spirit of Executive Order 13132, and
consistent with EPA policy to promote communications between EPA and
State and local governments, EPA specifically solicits comment on this
proposed action from State and local officials.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This proposed rule does not have Tribal implications, as specified
in Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments'' (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal Government and Indian Tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes, as specified in Executive Order 13175.
The proposed rule, which is based on existing legal requirements and
authorities, clarifies that sufficiently sensitive analytical test
methods must be used when applying for an NPDES permit and when
performing sampling and analysis pursuant to monitoring requirements in
an NPDES permit. Nothing in this proposed rule would prevent an Indian
Tribe from exercising its own organic authority to deal with such
matters. EPA specifically solicits additional comment on this proposed
action from Tribal officials.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
The proposed rule is not subject to Executive Order 13045,
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant and the Agency does not believe that the environmental
health and safety risks addressed by this action present a
disproportionate risk to children. This proposed rule only interprets
existing legal requirements and authorities and clarifies Agency policy
that sufficiently sensitive analytical test methods must be used when
applying for an NPDES permit and when performing sampling and analysis
pursuant to monitoring requirements in an NPDES permit.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This rulemaking is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001), because it is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) of 1995 (Pub. L. 104-113, section 12(d), 15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standard bodies. The NTTAA directs EPA
to provide explanations to Congress, through OMB, when the Agency
decides not to use available and applicable voluntary consensus
standards. This proposed rulemaking does not involve technical
standards. The proposed rulemaking does, however, clarify Agency policy
based on existing regulations and authorities that sufficiently
sensitive analytical test methods must be used when applying for an
NPDES permit and when performing sampling and analysis pursuant to
monitoring requirements in an NPDES permit.
J. Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations)
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. As explained above, the Agency does not have reason to
believe that the rule addresses environmental health and safety risks
that present a disproportionate risk to minority populations and low-
income populations. This proposed rule only interprets existing legal
requirements and authorities and clarifies Agency policy as stated
above.
[[Page 35720]]
List of Subjects
40 CFR Part 122
Administrative practice and procedure, Confidential business
information, Environmental protection, Hazardous substances, Reporting
and recordkeeping requirements, Water pollution control.
40 CFR Part 136
Environmental protection, Incorporation by reference, Reporting and
recordkeeping requirements, Water pollution control.
Dated: June 16, 2010.
Lisa P. Jackson,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, of
the Code of Federal Regulations is proposed to be amended as follows:
PART 122--EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT
DISCHARGE ELIMINATION SYSTEM
1. The authority citation for part 122 continues to read as
follows:
Authority: The Clean Water Act, 33 U.S.C. 1251 et seq.
2. Section 122.21, is amended by adding a new paragraph (e)(3), to
read as follows:
Sec. 122.21 Application for a permit (applicable to State programs,
see Sec. 123.25).
* * * * *
(e) * * *
(3) A permit application shall not be considered complete unless
all required quantitative data are collected in accordance with
sufficiently sensitive analytical methods approved under 40 CFR part
136 or in accordance with another method required under 40 CFR chapter
I, subchapter N or O.
(i) For the purposes of this requirement, a method approved under
40 CFR part 136 is ``sufficiently sensitive'' when:
(A) The method minimum level (ML) is at or below the level of the
applicable water quality criterion for the measured pollutant or
pollutant parameter;
(B) The method ML is above the applicable water quality criterion,
but the amount of the pollutant or pollutant parameter in a facility's
discharge is high enough that the method detects and quantifies the
level of the pollutant or pollutant parameter in the discharge;
(C) The method has the lowest ML of the analytical methods approved
under 40 CFR part 136.
(ii) When there is no analytical method that has been approved
under 40 CFR part 136, required under 40 CFR chapter I, subchapter N or
O, or otherwise required by the Director, the applicant may use any
suitable, sufficiently sensitive method but shall provide a description
of the method that includes documentation of the ML.
* * * * *
3. Section 122.44 is amended by revising paragraph (i)(1)(iv) to
read as follows:
Sec. 122.44 Establishing limitations, standards, and other permit
conditions (applicable to State NPDES programs, see Sec. 123.25).
* * * * *
(i) * * *
(1) * * *
(iv) According to sufficiently sensitive test procedures (i.e.,
methods) approved under 40 CFR part 136 for the analysis of pollutants
or pollutant parameters or in accordance with another method required
under 40 CFR chapter I, subchapter N or O.
(A) For the purposes of this paragraph, a method is ``sufficiently
sensitive'' when:
(1) The method minimum level (ML) is at or below the level of the
effluent limit established in the permit;
(2) The method ML is above the level of the effluent limit in the
permit, but the amount of the pollutant or pollutant parameter in a
facility's discharge is high enough that the method detects and
quantifies the amount of the pollutant or pollutant parameter in the
discharge;
(3) The method has the lowest ML of the analytical methods approved
under 40 CFR part 136.
(B) In the case of pollutants or pollutant parameters for which
there are no approved methods under 40 CFR part 136 or methods are not
otherwise required under 40 CFR chapter I, subchapter N or O,
monitoring shall be conducted according to a sufficiently sensitive
test procedure specified in the permit for such pollutants or pollutant
parameters.
* * * * *
PART 136--GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS
OF POLLUTANTS
4. The authority citation for part 136 continues to read as
follows:
Authority: Secs. 301, 304(h), 307, and 501(a) Pub. L. 95-217, 91
Stat. 1566, et seq. (33 U.S.C. 1251 et seq.) (The Federal Water
Pollution Control Act Amendments of 1972 as amended by the Clean
Water Act of 1977.)
5. Section 136.1 is amended by adding a new paragraph (c) to read
as follows:
Sec. 136.1 Applicability.
* * * * *
(c) For the purposes of the NPDES, when more than one test
procedure is available under this part for the analysis of a pollutant
or pollutant parameter, the test procedure selected shall be
sufficiently sensitive as defined at 40 CFR 122.21(e)(3) and
122.44(i)(1)(iv).
[FR Doc. 2010-15254 Filed 6-22-10; 8:45 am]
BILLING CODE 6560-50-P
