[Federal Register Volume 75, Number 120 (Wednesday, June 23, 2010)]
[Proposed Rules]
[Pages 35712-35720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15254]
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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.
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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: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected]. 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
http://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 http://www.regulations.gov or e-mail. The http://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 http://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 http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the http://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 http://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:
[email protected].
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.
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\1\ Where the term ``pollutant'' is used, it refers to both
pollutants and pollutant parameters.
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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.
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\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
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Category Examples of potentially affected entities
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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.
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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
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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
EPA-approved methods, including some methods that have greater
sensitivities and lower minimum levels than the others.
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\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.
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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\
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\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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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 http://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
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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 http://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 http://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 http://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 http://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.
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\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 http://www.epa.gov/waterscience/criteria/methylmercury/mercury.2010.pdf).
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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.
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\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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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.
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\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 http://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]
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