Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations 49001 

1Where the term ‘‘pollutant’’ is used, it refers to 

both pollutants and pollutant parameters. 

2For purposes of this rule, the term ‘‘EPAapproved methods’’ refers to methods that have 

been approved under 40 CFR part 136 or are 

required under 40 CFR chapter I, subchapter N or 

O. This includes analytical methods for CWA 

pollutants developed by EPA, voluntary consensus 

standards bodies (VCSBs), and other government 

agencies (such as the U.S. Geological Survey), as 

well as Alternate Test Procedures (ATPs) developed 

by commercial method developers for nation-wide 

use. These methods have been reviewed by EPA 

and approved for use in compliance monitoring 

under the CWA. EPA publishes lists of the EPA, 

VCSB, and other agency methods as well as ATPs 

that it has found to be acceptable for such use at 

40 CFR Part 136, and at 40 CFR Chapter I, 

subchapters N and O. As a point of clarification, 

this includes approved ATPs as described in 40 

CFR 136.4 and 136.5. 

* * * * * 

[FR Doc. 2014–19557 Filed 8–18–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 122 and 136 

[EPA–HQ–OW–2009–1019; FRL–9915– 

18–OW] 

RIN 2040–AC84 

National Pollutant Discharge 

Elimination System (NPDES): Use of 

Sufficiently Sensitive Test Methods for 

Permit Applications and Reporting 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is finalizing minor 

amendments to its Clean Water Act 

(CWA) regulations to codify that under 

the National Pollutant Discharge 

Elimination System (NPDES) program, 

permit applicants must use ‘‘sufficiently 

sensitive’’ analytical test methods when 

completing an NPDES permit 

application and the Director must 

prescribe that only ‘‘sufficiently 

sensitive’’ methods be used for analyses 

of pollutants or pollutant parameters 

under an NPDES permit. 

The final rule is based on 

requirements in the CWA and clarifies 

existing EPA regulations. It also codifies 

existing EPA guidance on the use of 

‘‘sufficiently sensitive’’ analytical 

methods with respect to measurement of 

mercury and extends the approach 

outlined in that guidance to the NPDES 

program more generally. Specifically, 

EPA is modifying existing NPDES 

application, compliance monitoring, 

and analytical methods regulations. The 

amendments in this rulemaking affect 

only chemical-specific methods; they do 

not apply to the Whole Effluent Toxicity 

(WET) methods or their use. 

DATES: These final regulations are 

effective September 18, 2014. For 

judicial review purposes, this final rule 

is promulgated as of 1:00 p.m. Eastern 

Time, on September 2, 2014, as 

provided in 40 CFR 23.2. 

ADDRESSES: The record for this 

rulemaking is available for inspection 

and copying at the Water Docket, 

located at the EPA Docket Center (EPA/ 

DC), EPA West 1301 Constitution Ave. 

NW., Washington, DC 20004. The record 

is also available via EPA Dockets at 

http://www.regulations.gov under 

docket number EPA–HQ–OW–2009– 

1019. The rule and key supporting 

documents are also available 

electronically on the Internet at http:// 

cfpub.epa.gov/npdes/ssmethods.cfm. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Some information, however, is 

not publicly available, e.g., confidential 

business information (‘‘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 

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, email address: 

kelley.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Potentially Affected Parties 

B. Legal Authority 

II. Background 

III. Summary of Public Comments and EPA’s 

Response 

IV. The Final Rule 

V. Impacts 

VI. Compliance Dates 

VII. 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 

individual permits after analyzing the 

information contained in the 

application and making a determination 

that the application is ‘‘complete’’ under 

40 CFR 122.21(e). In the case of a 

general permit, authorization to be 

covered by the permit is given if the 

information submitted demonstrates 

eligibility for coverage under 40 CFR 

122.28. The NPDES permit prescribes 

the conditions under which the facility 

is allowed to discharge pollutants into 

waters of the United States and the 

conditions that will ensure the facility’s 

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 as well as 

requirements that the permittee 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 methods 2 when 

measuring the pollutants in their 

discharges. 

The purpose of today’s final rule is to 

codify that where EPA-approved 

methods exist, NPDES applicants must 

use sufficiently sensitive EPA-approved 

analytical methods when quantifying 

the presence of pollutants in a 


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3The term ‘‘Director’’ refers to the permitting 

authority. See definition at 40 CFR 122.2. 

4Although 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. 

discharge, and the Director 3 must 

prescribe that only sufficiently sensitive 

EPA-approved methods be used for 

analyses of pollutants or pollutant 

parameters under the permit. The broad 

universe of entities 4 that would be 

affected by this final action includes 

NPDES permitting authorities and 

municipal and industrial applicants and 

permittees (Table I–1). This rule does 

not apply to indirect dischargers as 

defined in 40 CFR 122.2. The impact of 

this action, 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. 

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. 

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 is issuing today’s final rule 

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 301(a) of the CWA prohibits the 

discharge of any pollutant except in 

compliance 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 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, has the reasonable potential to 

cause, or contributes 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 part 136, although some 

requirements are codified in other parts 

(e.g., 40 CFR chapter I, subchapters N 

and O). 

The Director is required under 40 CFR 

122.21(e) to determine when an NPDES 

permit application is complete. 

Moreover, the Director shall not begin 

processing an application for an 

individual 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. Finally, 40 CFR 122.41(j)(1) 

requires NPDES permits to include a 

standard condition specifying that 

‘‘samples and measurements taken for 

the purpose 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 to inspect, monitor, enter, 

and require reports to at least the same 

extent as required in section 308. 

As summarized above, the legal 

requirements and authorities exist for 

EPA to require NPDES applicants and 

permittees to use sufficiently sensitive 

EPA-approved 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 


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5The term ‘‘minimum level’’ refers to either the 

sample concentration equivalent to the lowest 

calibration point in a method or a multiple of the 

method detection limit (MDL). Minimum levels 

may be obtained in several ways: They may be 

published in a method; they may be sample 

concentrations equivalent to 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; and (D) ‘‘Analytical Method 

Guidance for the Pharmaceutical Manufacturing 

Point Source Category,’’ EPA 821–B–99–003, 

August 1999]. 

6For the purposes of this rulemaking, EPA is 

considering the following terms related to analytical 

method sensitivity to be synonymous: ‘‘quantitation 

limit,’’ ‘‘reporting limit,’’ ‘‘level of quantitation,’’ 

and ‘‘minimum level.’’ 

7The MDL is determined using the procedure at 

40 CFR Part 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. 

8To 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. 

approved multiple methods for CWA 

pollutants under 40 CFR part 136 and 

40 CFR chapter I, subchapters N and O. 

Some of the approved analytical test 

methods have greater sensitivities and 

lower minimum levels 5 6 or method 

detection limits (MDLs) 7 than other 

approved methods for the same 

pollutant. This situation often occurs 

because of advances 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. 

Although EPA has approved multiple 

analytical methods for individual 

pollutants, the Agency has historically 

expected that applicants 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. Further, EPA 

anticipated that NPDES permitting 

authorities would specify an EPAapproved method in an NPDES permit 

where the Director determined that a 

particular analytical method was 

needed to provide meaningful results 

relative to the permit limit. EPA 

believes that the authority to prescribe 

a specific analytical method in an 

NPDES permit exists under the current 

regulations. However, some state 

permitting authorities expressed 

concern that this authority was not 

explicit in current regulations, thus 

limiting states’ ability to prescribe an 

appropriate analytical method where 

needed to assess compliance with 

permit limits. This rule requires that, 

where EPA-approved methods exist, 

NPDES applicants must use sufficiently 

sensitive EPA-approved analytical 

methods when quantifying the presence 

of pollutants in a discharge and that the 

Director must prescribe that only 

sufficiently sensitive EPA-approved 

methods be used for analyses of 

pollutants or pollutant parameters 

under the permit. 

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 at 

levels that will be meaningful to the 

decision-making process. Among other 

things, data must be provided 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 intent 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.8

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 revised to ensure that, 

where EPA-approved methods exist, 

applicants use sufficiently sensitive 

EPA-approved analytical methods when 

quantifying the presence of pollutants in 

a discharge and that Directors prescribe 

that only sufficiently sensitive EPAapproved methods be used to perform 

sampling and analysis for all pollutants, 

not just mercury. Therefore, in this 

rulemaking, EPA is revising the 

regulations to extend the requirement to 

use sufficiently sensitive EPA-approved 

analytical test methods, where they 

exist, to all pollutants and establish 

criteria for what qualifies as a 

‘‘sufficiently sensitive’’ method. 

This final rule requires that NPDES 

applicants must use sufficiently 

sensitive EPA-approved analytical 

methods, where they exist, when 

submitting information required by a 

permit application quantifying the 

presence of pollutants in a discharge. If 

the applicant does not provide data 

using a sufficiently sensitive EPAapproved analytical method, the 

Director may determine that the 

application is ‘‘incomplete’’ per 40 CFR 

122.21(e).The Director may require that 

the applicant provide new screening 

data obtained using a sufficiently 

sensitive EPA-approved analytical 

method before making a completeness 

determination and moving forward with 

permit development. The final rule also 

requires that, as a condition of permit 

development, to assure compliance with 

permit limitations the permit shall 

include requirements to monitor 

according to sufficiently sensitive EPAapproved methods, where they exist. 


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Specifically, where an EPA-approved 

analytical method exists that would 

provide quantifiable results necessary to 

assess compliance with a permit limit 

and the permit allows monitoring to be 

conducted using different analytical 

methods that, although approved, 

would fail to produce data necessary to 

assess compliance, the permit would be 

inconsistent with the NPDES permitting 

requirements of 40 CFR 122.44(i). 

EPA is defining the term ‘‘sufficiently 

sensitive’’ in two sections of the NPDES 

regulations: At 40 CFR 122.21(e) 

(Completeness), as a new subsection (3), 

and at 40 CFR 122.44(i)(1)(iv) 

(Monitoring Requirements). EPA is also 

modifying 40 CFR 136.1 (Applicability) 

by adding a new paragraph (c), which is 

simply a cross-reference to the changes 

being promulgated in 40 CFR 

122.21(e)(3) and 40 CFR 122.44(i)(1)(iv). 

The new and revised sections indicate 

that an EPA-approved method is 

sufficiently sensitive where: 

A. 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 

B. In the case of permit applications, 

the method minimum level 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; 

or 

C. The method has the lowest 

minimum level of the EPA-approved 

analytical methods. 

The requirement to use a ‘‘sufficiently 

sensitive’’ EPA-approved method does 

not apply where no EPA-approved 

method exists. When no analytical 

method is approved under 40 CFR part 

136 or required under subchapter N or 

O, and a specific method is not 

otherwise required by the Director, an 

NPDES applicant may use any suitable 

method; however, the applicant shall 

provide a description of the method. 

The first two criteria, A and B, in the 

sufficiently sensitive definition address 

situations in which EPA has approved 

multiple methods for a pollutant and 

some of those approved methods have 

greater sensitivities and lower minimum 

levels than others. In this situation, the 

applicant or permitting authority may 

select a method based on the minimum 

level published in the EPA-approved 

method, where available, or using a 

derived minimum level. As noted in 

footnote 4, the minimum level may be 

explicitly listed in some EPA-approved 

methods. Where this is the case, the 

applicant may reference the published 

minimum level when determining 

whether a method selected to provide 

data for their permit application is 

sufficiently sensitive. Where EPA has 

included a minimum level for a 

pollutant in a specific method, it reflects 

the minimum level obtained in a multilaboratory study of the new method in 

a wide variety of matrices, many of 

which EPA selects due to their complex 

nature. EPA acknowledges that complex 

matrices exist and provides flexibility 

and suggestions for ways to mitigate 

interferences in such instances, often 

within the published method for a 

specific pollutant. EPA’s experience is 

that many laboratories find solutions to 

address difficult matrices and are able to 

achieve the published minimum level 

within the required quality assurance 

specifications. However, applicants 

have always had the option of 

calculating a matrix-specific method 

detection limit (MDL). Extreme matrices 

may necessitate the use of an elevated 

sample specific minimum level, in 

which case the laboratory should be 

able to show that a reasonable effort 

(e.g., published cleanup procedures) 

was attempted to achieve as low a 

minimum level as possible for those 

samples. The use of sample or matrix 

specific minimum levels rather than the 

published levels has always been an 

available option, and consistent with 

that flexibility, use of a matrix-specific 

minimum level may sometimes be 

necessary when determining which 

methods are sufficiently sensitive. 

For EPA-approved methods that do 

not explicitly list minimum levels, the 

applicant can derive the minimum level 

from either the concentration of the 

lowest calibration standard in methods 

that dictate the concentrations of such 

standards, or as a multiple of the MDL 

or similar statistically derived detection 

limit concept. When the method 

dictates, or recommends, the 

concentration of the lowest calibration 

standard, that concentration can be 

converted to a minimum level by 

considering the weights and/or volumes 

of the sample and all of the intermediate 

preparation and analysis steps in the 

method. If a method provides a 

literature MDL for the matrix of interest, 

that MDL value can be used to estimate 

the minimum level as 10 times the 

standard deviation of the replicate 

measurements used to determine the 

MDL according to 40 CFR part 136, 

appendix B. However, MDLs are 

inherently method- and laboratoryspecific, so whenever a permittee is 

contracting a laboratory for NPDES 

work, it is prudent to obtain that 

laboratory’s MDL and compare it to the 

published MDL to ensure that both their 

MDL and their minimum level are 

appropriate for the intended 

application. 

The third criterion, C, of the 

definition addresses situations in which 

none of the EPA-approved methods for 

a pollutant can achieve the minimum 

levels necessary to assess reasonable 

potential or to monitor compliance with 

a permit limit. In these situations, 

applicants or permittees must use the 

method with the lowest minimum level 

among the EPA-approved methods for 

the pollutant, and this method would 

meet the definition of sufficiently 

sensitive. 

As explained above, the requirement 

to use a ‘‘sufficiently sensitive’’ EPAapproved method does not apply where 

no EPA-approved methods exist. The 

final rule addresses these situations, for 

permit applicants, where no approved 

analytical method exists under 40 CFR 

part 136 or is required under subchapter 

N or O, and one is not otherwise 

required by the Director. In such 

situations, an applicant may use any 

suitable method but shall provide a 

description of the method. With respect 

to pollutant limits in permits, where an 

EPA-approved analytical method does 

not exist, monitoring shall be conducted 

in accordance with a test procedure 

specified in the permit. 

EPA recognizes that other factors 

beyond the minimum level or MDL can 

also be important in determining 

method performance, including a 

method’s resolution, accuracy, and 

precision. Where there are no EPAapproved methods, this rule does not 

affect how those other factors are 

considered in selecting a method. 

Rather, the rule notes that permit 

applicants may consider these other 

factors when selecting a suitable method 

where no EPA-approved method exists. 

For EPA-approved methods, however, 

these factors have already been 

considered during the method 

validation and approval process. As 

explained above, EPA evaluates method 

performance in a wide variety of 

wastewater matrices and approves those 

methods that have sensitivity, precision 

and accuracy that are appropriate for 

wastewater compliance monitoring. 40 

CFR 136.6 also allows flexibility to 

tailor approved methods to more 

challenging wastewater matrices or 

overcome methodological problems. 

Based on data and information provided 

to EPA by analytical laboratories, EPA 

finds that experienced laboratories are 

often capable of achieving minimum 

levels below those published with a 


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method while maintaining the precision 

and accuracy specified in the method. 

EPA acknowledges that while rare, 

methodological problems may exist that 

could affect the determination of a 

‘‘sufficiently sensitive’’ method. In such 

rare situations, the Director may 

consider additional technical factors 

when determining whether the method 

is still ‘‘sufficiently sensitive.’’ 

Specifically, where the permit applicant 

or permittees can demonstrate to the 

Director that despite a good faith effort 

to overcome these methodological 

problems due to challenging wastewater 

matrices, either (1) the method’s 

minimum level is higher than originally 

anticipated, or (2) the method results no 

longer meet the methods quality 

assurance/quality control (‘‘QA/QC’’) 

specification, the Director may take 

these factors into account when 

determining whether the permit 

applicant has met the requirements to 

use a ‘‘sufficiently sensitive’’ method or 

in prescribing a ‘‘sufficiently sensitive’’ 

method in the permit. In the first 

situation, the matrix or sample-specific 

minimum level should be used to 

evaluate which of the EPA-approved 

methods is ‘‘sufficiently sensitive.’’ In 

the second situation, if the method’s 

results are no longer consistent with the 

QA/QC specifications, then the method 

is not performing adequately and a 

‘‘sufficiently sensitive’’ method should 

be selected from the remaining EPAapproved methods. In either case, the 

permit applicant or permittee is 

responsible for demonstrating that a 

published minimum level is 

unachievable or a reasonable effort was 

applied to bring the original sufficiently 

sensitive method within the QA/QC 

specifications in the given matrix before 

selecting another EPA-approved method 

(e.g., cleanup procedures, dilution when 

appropriate, etc.). 

Additionally, where a technologybased requirement is specified as ‘‘zero 

discharge’’ or ‘‘no detect,’’ the 

permitting authority may take into 

account the sensitivity of the method 

used to establish the requirement when 

determining if a method is ‘‘sufficiently 

sensitive.’’ EPA recognizes that if a more 

sensitive method is approved after such 

a requirement has been established, its 

use may be inconsistent with the 

technological basis of the original 

requirement. In situations where a 

technology-based requirement reflects a 

technology that eliminates the discharge 

of the subject pollutant altogether, the 

newer sensitive method is appropriate. 

However, where a technology-based 

limit reflects a technology that may not 

achieve the minimum level of the newer 

more sensitive method, the Director may 

determine that the method on which the 

requirement was originally based is 

‘‘sufficiently sensitive’’ to determine 

compliance, as understood at the time 

the requirement was established. 

For both EPA-approved methods and 

non-EPA-approved methods, EPA’s 

understanding of standard practice is 

that if an applicant/permittee or 

laboratory has questions regarding the 

suitability of a specific method in a 

given situation, or has technical 

questions on its use, it will consult with 

its permitting authority. EPA has the 

same expectations in connection with 

today’s rulemaking for questions 

specifically about which methods are 

sufficiently sensitive. The permitting 

authority continues to have the ultimate 

responsibility for determining whether 

an NPDES application is complete (40 

CFR 122.21(e)) and establishing permit 

conditions, including monitoring and 

reporting requirements (40 CFR 

122.44(i)). 

The amendments in this rulemaking 

affect only chemical-specific methods; 

they do not apply to the Whole Effluent 

Toxicity (WET) methods or their use. 

Note that existing EPA regulations (40 

CFR 122.44(d)(1)(ii)) and policy require 

permit writers to take into account the 

sensitivity of the species to toxicity 

testing when evaluating whole effluent 

toxicity. EPA has interpreted this 

provision as directing the permitting 

authority to develop criteria and limits 

based upon the most sensitive test 

species to ensure that the most sensitive 

species and all less sensitive species 

will be protected. 

III. Summary of Public Comments and 

EPA’s Response 

On June 23, 2010, EPA proposed 

changes to the existing NPDES 

regulations (75 FR 35712) and requested 

comments from the public. EPA 

received 25 comment letters. The 

majority of the comments came from 

publicly owned treatment works and 

industry organizations, but EPA also 

received comments from laboratories, 

and state and federal agencies. The 

majority of comments covered the 

following categories: Implementation 

and technology; administration and 

timing; and burden. The complete list of 

comments and responses is available in 

the record of this rulemaking. 

A. Implementation 

1. Effect of the Rule on Current Practices 

EPA received several comments that 

indicated the approach outlined in the 

proposed rule would force applicants 

and permittees to make decisions 

regarding the selection of an appropriate 

method without adequate information 

upon which to base a decision. 

Specifically, commenters indicated that 

issues related to the definition of the 

method minimum level would make 

this rule difficult to implement and that 

method sensitivity should not be the 

sole factor in deciding which method 

should be used in the permitting 

process. They indicated that there are 

other factors including accuracy, 

precision, selectivity, and whether the 

method has been validated that should 

be considered. 

In response, EPA notes that applicants 

for NPDES permits have always needed 

to make decisions regarding which EPAapproved methods are the most 

appropriate for use when performing the 

screening analyses required under the 

various permit application regulations 

at 40 CFR 122.21. Similarly, NPDES 

permitting authorities, even before 

today’s rulemaking, have had to 

consider which of the EPA-approved 

methods are the most appropriate for 

permittees to use to meet their 

monitoring and reporting requirements 

under an NPDES permit. Today’s rule 

does not change the basic NPDES permit 

application or permit issuance process. 

Under 40 CFR 122.21, permittees 

seeking permit renewal or new 

applicants must provide the Director 

with adequate information to determine 

whether an NPDES application is 

complete. Once the Director makes this 

determination, the Director determines 

the applicable permit requirements, 

including any sampling or monitoring 

that must be taken that is 

‘‘representative of the monitored 

activity.’’ See 40 CFR 122.41(j)(1). The 

effect of today’s final rulemaking is to 

codify that where EPA-approved 

methods exist, only ‘‘sufficiently 

sensitive’’ EPA-approved methods may 

be used in connection with permit 

applications and to conduct monitoring 

and reporting under a permit. 

To determine whether an EPAapproved analytical method is 

‘‘sufficiently sensitive’’ in any particular 

case, NPDES applicants/permittees and 

permit authorities should use the best 

information available on what the 

minimum level is for the method, and 

EPA believes that in general a method’s 

accurate minimum level will be readily 

ascertainable. Where the minimum level 

is explicitly listed in the EPA-approved 

method, applicants may reference the 

published minimum level when 

determining whether a method selected 

to provide data for their permit 

application is sufficiently sensitive. 

Alternatively, applicants have always 

had the option of providing matrixspecific method detection limits and 


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minimum levels rather than the 

published minimum levels, and nothing 

in today’s rule changes that flexibility, 

including with respect to selecting a 

sufficiently sensitive EPA-approved 

method. For these cases the laboratory 

should be able to show that a reasonable 

effort (e.g., published cleanup 

procedures) was attempted to achieve as 

low a minimum level as possible for 

those samples. For EPA-approved 

methods that do not explicitly list 

minimum levels, the minimum level 

can be obtained or derived by the 

applicant or permitting authority. 

Indeed, many permitting authorities 

have developed guidance, policies or 

regulations that establish minimum 

levels for various methods, or specify 

specific methods to be used by 

applicants and permittees. Where 

applicable, these policies and 

regulations will continue to affect 

method selection, although at the same 

time, states must ensure that such 

policies and regulations conform with 

the criteria established in today’s 

rulemaking that, where they exist, only 

‘‘sufficiently sensitive’’ EPA-approved 

methods are being used when 

completing an NPDES permit 

application and when performing 

sampling and analysis pursuant to 

monitoring requirements in an NPDES 

permit. If the applicant does not provide 

data using a sufficiently sensitive EPAapproved analytical method where one 

exists, the Director may determine that 

the application is ‘‘incomplete’’ per 40 

CFR 122.21(e). The Director may require 

that the applicant provide new 

screening data obtained using a 

sufficiently sensitive EPA-approved 

analytical method before making a 

completeness determination and 

moving forward with permit 

development. Thus, to avoid having the 

permitting authority reject data 

provided in an application because the 

data were not collected by means of a 

‘‘sufficiently sensitive’’ method, the 

NPDES applicant should work closely 

with the permitting authority prior to 

conducting the required analyses. In 

addition, the permitting authority must 

ensure the permit includes a 

requirement to use a sufficiently 

sensitive EPA-approved analytical test 

method, where one exists, where 

necessary to perform sampling and 

analysis, consistent with 40 CFR 

122.41(j) and 122.44(i). 

2. Development of New or Alternate 

Test Procedures 

EPA received several comments that 

indicated the proposed rule would 

require the development of new 

analytical methods where no EPAapproved methods exist or where 

existing EPA-approved methods would 

not quantify the pollutant concentration 

at or below the level of the criterion or 

permit limit. Other commenters 

indicated that the rule would alter the 

existing requirements for developing 

Alternate Test Procedures under 40 CFR 

part 136. EPA has modified the proposal 

to address these comments, as explained 

below. 

EPA has modified the proposed 

language for this final rule so that it 

does not change existing regulatory 

requirements with respect to 

unapproved methods. Where no EPAapproved analytical methods exist, an 

applicant will need to select a method 

from another source of available 

analytical methods (e.g., Standard 

Methods for the Examination of Water 

and Wastewater) to measure that 

pollutant or pollutant parameter. 

Today’s final rule does not require the 

applicant to develop new methods. The 

situation in which there are no EPAapproved methods is uncommon 

because there are EPA-approved 

methods for most pollutants or pollutant 

parameters screened and regulated 

under the NPDES program. Under the 

existing regulations at 40 CFR 

122.21(g)(7), the NPDES applicant has 

the flexibility to use any suitable 

analytical method when no EPAapproved analytical method exists for 

that pollutant or pollutant parameter. 

Additionally, under the existing 

regulations at 40 CFR 122.44(i)(1)(iv), 

the NPDES permitting authority 

specifies a method in the permit when 

there is no EPA-approved method. 

Where EPA-approved methods exist, 

but none of the available methods will 

quantify the pollutant concentration at 

or below the level of the criterion or 

permit limit, today’s rulemaking does 

not require the development of any new 

analytical methods. However, in this 

situation, the rule will now require the 

use of the most sensitive of the EPAapproved methods. 

Finally, today’s rulemaking does not 

alter any of the existing requirements 

related to the development or approval 

of alternative test procedures under 40 

CFR 136.4 and 136.5. 

3. Consideration of Matrix Effects in 

Selecting a Sufficiently Sensitive 

Method 

EPA received several comments that 

indicated the approach outlined in the 

proposed rule would force applicants 

and permittees to make decisions 

regarding the selection of an appropriate 

method without adequate information 

upon which to base a decision. 

Specifically, commenters indicated that 

issues related to the definition of the 

method minimum level would make 

this rule difficult to implement and that 

method sensitivity should not be the 

sole factor in deciding which method 

should be used in the permit process. 

They believe there are other critical 

factors including accuracy, precision, 

selectivity, and whether the method has 

been validated. 

In response, as noted above, EPA has 

clarified that the requirement to use a 

‘‘sufficiently sensitive’’ EPA-approved 

method does not apply where no EPAapproved method exists. EPA agrees 

that other factors beyond the minimum 

level can also be important in 

determining method performance, 

including a method’s selectivity, 

resolution, accuracy, and precision. EPA 

has added language in the rule text that 

clarifies where no EPA-approved 

methods exist, permit applicants may 

consider these other factors, in 

conjunction with sensitivity, when 

selecting an appropriate method. 

For EPA-approved methods, however, 

these factors have already been 

considered during the method 

validation and approval process. As 

explained above, EPA evaluates method 

performance in a wide variety of 

wastewater matrices and approves those 

methods that have selectivity, 

sensitivity, precision and accuracy that 

are appropriate for wastewater 

compliance monitoring. 40 CFR 136.6 

also allows flexibility to tailor approved 

methods to more challenging 

wastewater matrices. EPA notes that 

applicants have always had the option 

of providing matrix or sample-specific 

minimum levels rather than the 

published levels and nothing in today’s 

rule changes that flexibility, including 

with respect to selecting a sufficiently 

sensitive EPA-approved method. For 

these cases the laboratory should be able 

to show that a reasonable effort (e.g., 

published cleanup procedures) was 

attempted to achieve as low a minimum 

level as possible for those samples. 

If the most sensitive method listed in 

40 CFR Part 136 is not performing 

adequately in a given wastewater matrix 

(e.g., with regard to sensitivity, 

accuracy, and precision), several 

options are available and should be 

pursued. Dilution is often a good option 

if it does not drive the sample specific 

minimum level above the permit 

requirements. Cleanup procedures 

included in the method can also be 

utilized. If those cleanups do not prove 

adequate for a particular matrix, the 

analyst should consult ‘‘Solutions to 

Analytical Chemistry Problems with 

Clean Water Act Methods,’’ EPA 821–R– 

07–002 (or more recent revisions) to 


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determine if another cleanup procedure 

may be appropriate. If a solution is still 

not apparent, the permittee should 

consult EPA or the permitting authority. 

Based on data and information 

provided to EPA by analytical 

laboratories, EPA finds that experienced 

laboratories are often capable of 

achieving minimum levels below those 

published with a method while 

maintaining the precision and accuracy 

specified in the method. However, EPA 

acknowledges that while rare, situations 

may exist where a method cannot 

perform adequately in a specific matrix. 

In such rare situations, the Director may 

consider additional technical factors 

when determining whether the method 

is still ‘‘sufficiently sensitive.’’ 

Specifically, where the permit applicant 

or permittees can demonstrate to the 

Director that despite a good faith effort 

to overcome these methodological 

problems due to challenging wastewater 

matrices, either (1) the method’s 

minimum level is higher than originally 

anticipated, or (2) the method results no 

longer meet the methods QA/QC 

specification, the Director may take 

these factors into account when 

determining whether the permit 

applicant has met the requirements to 

use a ‘‘sufficiently sensitive’’ method or 

in prescribing a ‘‘sufficiently sensitive’’ 

method in the permit. In the first 

situation, the matrix or sample-specific 

minimum level should be used to 

evaluate which EPA-approved method 

is ‘‘sufficiently sensitive.’’ In the second 

situation, if the method’s results are no 

longer consistent with the QA/QC 

specifications, then the method is not 

performing adequately and a 

‘‘sufficiently sensitive’’ method should 

be selected from the remaining EPAapproved methods. In either case, the 

permit applicant or permittee is 

responsible for demonstrating that a 

published minimum level is 

unachievable or a reasonable effort was 

applied to bring the original sufficiently 

sensitive method within the QA/QC 

specifications in the given matrix before 

selecting another EPA-approved method 

(e.g., cleanup procedures, dilution when 

appropriate, etc.). To illustrate the type 

of situations where this provision would 

be appropriate, EPA provides two 

examples below. 

EPA received comments about the 

situation where there are multiple EPAapproved methods for an organic 

pollutant and the methods employ 

different technologies (i.e., gas 

chromatography (GC) and gas 

chromatography/mass spectrometry 

(GC/MS)). These commenters raised 

concern that, in some instances, while 

the GC method may provide a lower 

detection limit, the GC/MS method 

provides a greater degree of confidence 

in the correct identification of the 

regulated parameter. As explained 

above, this is not an issue if the 

laboratory has demonstrated that it can 

achieve a minimum level for GC/MS 

that is lower than the NPDES permit 

limit for the regulated parameter, in 

which case GC/MS would be considered 

‘‘sufficiently sensitive.’’ EPA agrees that 

GC/MS is more selective than GC, but 

several options are available to remove 

the interferences from difficult matrices 

before using a dual-column GC method 

(e.g., solid-phase extraction as a cleanup 

procedure, Florisil cleanup, alumina 

cleanup, sulfur removal with copper or 

TBA sulfite, gel permeation 

chromatography, etc.). Generally, a 

result from a dual-column GC method 

would only be questioned if the 

chromatograms from the two columns 

did not yield similar numerical results 

or if the chromatograms contained many 

extraneous peaks that suggest 

interferences are present. If the permit 

applicant or permittee is still concerned 

that the peaks may be caused by a 

different contaminant, and the GC 

method provides a false positive result, 

the permit applicant or permittee could 

use a GC/MS to confirm the presence of 

the contaminant. However, since the 

GC/MS is less sensitive, it may not be 

able to confirm low-level dual column 

GC results. The more sensitive GC/MS 

method options (e.g., larger sample 

volume, smaller final extract volume, 

selected ion monitoring techniques, or 

high resolution GC/MS) may be 

necessary to prove whether the dual 

column GC result is a false positive. The 

permittee should also consult with EPA 

and/or its permitting authority for 

potential solutions. In this case, if the 

permittee has exhausted all practical 

options (e.g., solid-phase extraction as a 

cleanup procedure, Florisil cleanup, 

alumina cleanup, sulfur removal with 

copper or TBA sulfite, gel permeation 

chromatography, etc.) and has 

documentation to demonstrate that the 

dual-column GC creates false positive 

results for that specific matrix, then the 

Director would appropriately approve 

the selection of a different EPAapproved method that would then be 

considered a sufficiently sensitive 

method (e.g., GC/MS). 

As another example, EPA also 

received comments specific to Method 

1631 for mercury. These commenters 

noted that use of the ‘‘clean’’ sampling 

methods associated with this method to 

minimize potential contamination from 

the sampling technique itself is not 

possible in many industrial settings. 

They noted that EPA’s documentation of 

the sampling technique acknowledges it 

is not intended for treated and untreated 

discharges from industrial uses. EPA 

notes that since approval of this method 

and the associated clean sampling 

techniques, these techniques have been 

successfully used in some industrial 

settings. For example, sewage treatment 

plants accepting industrial wastewater 

have successfully eliminated permit 

exceedances for mercury as measured 

by Method 1631 by employing the clean 

sampling procedures. Where the 

permittee has documentation that clean 

sampling techniques cannot be adopted 

for the site-specific application, the 

Director would appropriately approve 

the selection of a different EPAapproved method that meets the 

definition of a sufficiently sensitive 

method (e.g., the one with the lowest 

minimum level of the remaining EPAapproved methods). If the ambient level 

of mercury contamination at the site is 

too high to use clean sampling methods, 

then using a less sensitive EPAapproved method can meet the 

definition of a sufficiently sensitive 

method. 

Another commenter raised concerns 

specific to Method 1631. They 

questioned the method’s suggestion to 

minimize laboratory contamination by 

soaking laboratory air filters in gold 

chloride solution so that mercury in 

incoming air will amalgamize with the 

filter’s gold. This commenter questioned 

whether or not it was EPA’s expectation 

that laboratories go to such lengths to 

employ such a sufficiently sensitive 

method where required under this rule. 

EPA notes the procedure described by 

the commenter is only a suggestion if 

laboratories are having problems with 

laboratory contamination. There are 

now many laboratories that perform 

Method 1631 without undue difficulty. 

In this case, where necessary to meet the 

definition of ‘‘sufficiently sensitive’’ in 

today’s final rule, EPA would expect 

that the permittee use Method 1631, 

since the permittee should send their 

sample to a laboratory that can 

demonstrate it has control over sources 

of mercury within its own environment. 

Finally, where a technology-based 

requirement is specified as ‘‘zero 

discharge’’ or ‘‘no detect,’’ the 

permitting authority may take into 

account the sensitivity of the method 

used to establish the requirement when 

determining if a method is ‘‘sufficiently 

sensitive.’’ EPA recognizes that if a more 

sensitive method is approved after such 

a requirement has been established, its 

use may be inconsistent with the 

technological basis of the original 

requirement. In situations where a 


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9Authorized NPDES states have up to one year 

following rule issuance to revise their own 

regulations to conform to the requirements of this 

rule. Authorized NPDES states have up to two years 

to conform to the rule’s requirements if they must 

make statutory changes. 

technology-based requirement reflects a 

technology that eliminates the discharge 

of the subject pollutant altogether, the 

newer sensitive method is appropriate. 

However, where a technology-based 

limit reflects a technology that may not 

achieve the minimum level of the newer 

more sensitive method, the Director may 

determine that the method on which the 

requirement was originally based is 

‘‘sufficiently sensitive’’ to determine 

compliance, as understood at the time 

the requirement was established. 

4. Report of the Federal Advisory 

Committee on Detection and 

Quantitation Approaches and Uses in 

Clean Water Act Programs 

EPA received a number of comments 

that identified concerns that the 

proposed rule uses terms, such as 

minimum level, that are not defined in 

new or existing regulations. 

Commenters also indicated that the 

proposed rule fails to address a variety 

of issues regarding detection and 

quantitation that were raised in the 

Report of the Federal Advisory 

Committee on Detection and 

Quantitation Approaches and Uses in 

Clean Water Act Programs. EPA agrees 

that there are a variety of related issues 

raised in the aforementioned report, yet 

notes that the members of the Federal 

Advisory Committee (FAC) were unable 

to reach consensus over several key 

issues in the report. While several of 

these issues, such as the definition of 

minimum level, are discussed in today’s 

rulemaking, applicants and permitting 

authorities must still, on a regular and 

ongoing basis, choose which of the 

available analytical methods are most 

appropriate for use when screening 

effluent for permit applications and as 

part of permit conditions. This has 

always been the case, regardless of 

today’s rulemaking. 

EPA believes that the requirements of 

the rule are adequately described and 

can be implemented without having to 

address the myriad of issues considered 

by the FAC. For today’s rulemaking, 

EPA is not redefining or establishing 

new method detection limits (MDLs) or 

minimum levels, developing new 

procedures for determining detection or 

quantitation, or maintaining a 

clearinghouse on detection and 

quantitation issues. EPA considers such 

issues to be outside the scope of today’s 

rulemaking. 

5. Other Factors Affecting Selection of 

Analytical Methods 

EPA received several comments that 

expressed concern that the rule would 

require the use of only the most 

sensitive available method, and that 

other factors such as geographical 

isolation or unique sample collection 

constraints might preclude the use of 

certain available methods. Some 

comments also expressed concerns 

regarding the availability of laboratories 

qualified to conduct some of the more 

sensitive analytical methods, 

particularly where the state requires 

applicants and permittees to use 

laboratories certified by the state to 

conduct analyses. 

EPA is not requiring the use of any 

specific analytical technology or 

practice over others; only that the 

selected EPA-approved method is 

sufficiently sensitive. EPA expects that, 

in general, factors such as geographical 

isolation, or unique sampling collection 

constraints would not preclude the 

selection of a sufficiently sensitive 

method. The definition does not require 

the use of the most sensitive EPAapproved method available, so long as a 

less sensitive approved method still 

meets the criteria for being ‘‘sufficiently 

sensitive.’’ In cases where factors 

beyond a facility’s control render the 

use of a particular method infeasible, 

such as extreme geographical isolation, 

the permitting authority could consider 

such factors in deciding which method 

best meets the definition of ‘‘sufficiently 

sensitive.’’ EPA expects such situations 

would be rare. 

Issues related to sampling procedures, 

such as holding times, are frequently 

prescribed by the test procedures in 40 

CFR Part 136, and may be contingent on 

the unique physical, chemical, and 

biological characteristics of the 

discharge. Standard practice has been 

and continues to be that if an applicant/ 

permittee or laboratory has questions 

regarding the appropriateness of using a 

specific method in a given situation, or 

has technical questions on its use, it 

should consult with its permitting 

authority prior to conducting 

monitoring. 

B. Administration and Timing 

EPA received a few comments 

regarding the effect of the rule on 

recordkeeping and reporting 

requirements. The rule does not change 

existing recordkeeping and reporting 

requirements at 40 CFR 122.21(p), 

122.41(j) and 122.48. The permitting 

authority, however, has discretionary 

authority to require its applicants or 

permittees to provide information under 

the latter two provisions. In addition, a 

few comments asked whether the rule 

alters the terms or conditions of existing 

permits. The rule itself does not modify 

the terms or conditions of existing 

NPDES permits. If, under the 

requirements of today’s rulemaking, a 

change needs to occur in the analytical 

methods specified in an existing permit, 

that change would occur at the time of 

permit renewal, or it could occur 

through a permit modification under the 

procedures of 40 CFR Part 124, if the 

permitting authority determined that 

such a modification was appropriate. 

EPA received a few comments 

regarding whether existing data, if 

collected using insufficiently sensitive 

methods, will be acceptable for 

submission with an application for 

permit renewal. NPDES application 

monitoring data that is collected after 

the effective date of the rule, or, if 

applicable, after an authorized state has 

revised its regulations to adopt the 

provisions of the rule,9 must be based 

on the use of sufficiently sensitive test 

methods. However, the rule does not 

negate the existing requirement for 

applicants to submit data from previous 

years, even where these data may have 

been collected using methods that did 

not conform to the sufficiently sensitive 

criteria established in this rule. Based 

on all of the data submitted with the 

permit application, the permitting 

authority will determine whether it has 

information adequate to develop an 

NPDES permit. Where the permitting 

authority determines that data was 

collected using insufficiently sensitive 

methods, it may choose to disregard this 

information and accept only data 

collected employing sufficiently 

sensitive EPA-approved methods. In 

addition, even prior to the effective date 

of today’s rulemaking, the permitting 

authority has the authority under the 

existing NPDES regulations to request 

additional data from applicants where 

insufficient data is provided with the 

application before considering an 

application complete. 

EPA received a few comments 

pertaining to the rule’s impact on 

indirect dischargers. The rule affects 

only direct dischargers (those applying 

for an individual NPDES permit) and 

state/EPA NPDES permitting 

authorities. The rule does not apply to 

indirect dischargers. POTWs with 

approved pretreatment programs may at 

their discretion (as authorized by their 

local ordinances and regulations) 

require their indirect dischargers to 

achieve specific minimum levels when 

performing analyses or may require the 

use of specific methods to enable them 

to better characterize contributions into 

their system. Where a state or EPA is the 


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pretreatment Control Authority, the 

specific requirements for analytical 

methods can be specified in the control 

mechanism issued to the indirect 

discharger. 

EPA received several comments that 

indicated that while the commenters 

supported the concept established in the 

proposed rule, they believed additional 

flexibility should be provided to 

account for instream dilution. 

Specifically, the commenters requested 

that the criteria defining sufficiently 

sensitive be revised such that the 

minimum level would be compared to 

either ‘‘the applicable water quality 

criterion, wasteload allocation, permit 

limit, or other critical regulatory value.’’ 

EPA believes that the final rule need 

only require comparison of a method’s 

minimum level with the applicable 

water quality criterion, as proposed, and 

that this language is sufficiently flexible 

to address the commenters’ concern. 

Under this language, the permitting 

authority has adequate discretion to 

determine whether the data provided 

with a permit application were collected 

with methods that are sufficiently 

sensitive to measure at the relevant 

regulatory value. For example, where a 

permitting authority has conducted a 

timely and relevant dilution analysis 

(including an evaluation of ambient 

pollutant concentrations) and 

documented this analysis in the permit 

record, the permitting authority could 

provide this information to the 

applicant prior to the applicant 

sampling for the permit application. The 

applicant would then only need to show 

that the method it has selected has a 

minimum level that is at least as 

sensitive as necessary to determine 

compliance with the water quality 

criterion, after accounting for allowable 

dilution. The water quality criterion as 

adjusted for allowable dilution would 

be the ‘‘applicable water quality 

criterion’’ in this case, and the method 

would be ‘‘sufficiently sensitive’’ if it 

measures at this level. EPA considers 

this approach consistent with the 

requirements established in today’s rule. 

For these reasons, EPA is not revising 

the regulatory text to incorporate the 

language suggested by the commenters. 

C. Burden 

EPA received a few comments 

indicating that site-specific situations 

might increase the implementation costs 

of the rule beyond those costs outlined 

in the proposed rule. Some of these 

commenters provided examples of when 

site-specific conditions might result in 

increased costs. EPA recognizes that the 

burden estimated is a national average 

and that the cost for an individual 

facility could be higher or lower than 

that average. However, EPA does not 

believe that the information provided by 

the commenters is representative of the 

impact for a typical facility affected by 

this rule, nor does it alter the Agency’s 

original burden estimates. 

EPA also recognizes that in some 

cases, use of a more sensitive method 

could have the practical effect of 

requiring a facility to adopt additional 

pollution control measures, even if the 

permit limit remained unchanged. This 

is because a more sensitive method may 

detect the presence of a pollutant that 

was previously undetected. EPA 

emphasizes that this rule would not be 

responsible for any change in stringency 

of the permit requirements in such a 

case, but acknowledges that a facility 

may incur additional pollution control 

costs if a previously undetected 

pollutant is later detected by the use of 

a sufficiently sensitive method, and 

additional treatment is required to meet 

the existing permit limit. In general, 

when EPA develops a cost analysis for 

a new regulation, there is an assumption 

made of full compliance with existing 

requirements. EPA does not have data 

that would allow it to predict in 

advance where or how often this 

situation might occur, or what a facility 

would be required to do to address it. 

Therefore, EPA has not attempted to 

quantify any such costs, as they are 

outside the scope of this rulemaking. 

As noted above, where a technologybased requirement is specified as ‘‘zero 

discharge’’ or ‘‘no detect,’’ the 

permitting authority may take into 

account the sensitivity of the method 

used to establish the requirement when 

determining if a method is ‘‘sufficiently 

sensitive.’’ EPA recognizes that if a more 

sensitive method is approved after such 

a requirement has been established, its 

use may be inconsistent with the 

technological basis of the original 

requirement. In situations where a 

technology-based requirement reflects a 

technology that eliminates the discharge 

of the subject pollutant altogether, the 

Agency included costs that reflect that 

technology, the newer sensitive method 

is appropriate, and the permittee would 

not incur additional costs. However, 

where a technology-based limit reflects 

a technology that may not achieve the 

minimum level of the newer more 

sensitive method, the Director may 

determine that the method on which the 

requirement was originally based is 

‘‘sufficiently sensitive’’ to determine 

compliance, as understood at the time 

the requirement was established, and 

there would thus be no additional 

control costs incurred by the facility. 

EPA received a few comments 

regarding compliance with requirements 

under the statutory and Executive Order 

reviews contained in the proposed rule. 

EPA believes that there was a 

misunderstanding on the part of the 

commenters regarding the intent of the 

rule that led the commenters to believe 

that the rule would result in a higher 

cost of implementation than that 

estimated by EPA. EPA believes that the 

Agency has met its responsibilities 

under the applicable statutory and 

Executive Orders. 

IV. The Final Rule 

The final rule adds a new 40 CFR 

122.21(e)(3) and revises 122.44(i)(1)(iv) 

to require that where EPA-approved 

methods exist, NPDES applicants use 

sufficiently sensitive EPA-approved 

analytical methods when submitting 

information quantifying the presence of 

pollutants in a discharge and that the 

Director must prescribe that only 

sufficiently sensitive EPA-approved 

analytical test methods be used for 

analyses of pollutants or pollutant 

parameters under the permit. EPA is 

also providing a cross-reference to these 

changes in a new 40 CFR 136.1(c). For 

the purposes of this rulemaking, if 

monitoring requirements are included 

as a condition of a general permit, those 

requirements are subject to the 

provisions established in 

122.44(i)(1)(iv). Only these specific 

parts of the regulations undergoing 

revision are subject to challenge under 

section 509(b) of the Clean Water Act. 

In addition, based on public 

comments, EPA made certain minor 

modifications to the final rule from the 

original proposal. Specifically, EPA 

amended 122.21(e)(3)(i)(B) and 

122.44(i)(1)(iv)(A)(1) to add the word 

‘‘or’’ when defining the term 

‘‘sufficiently sensitive,’’ which was 

unintentionally omitted in the proposed 

rule. In addition, EPA added ‘‘pollutant 

or pollutant parameter’’ to 

122.21(e)(3)(i)(C) and 122.44(i)(1)(iv)(A) 

to clarify the applicability of the criteria 

established under the sufficiently 

sensitive method definition. EPA also 

removed the second ‘‘in accordance 

with’’ in the introductory paragraphs for 

122.21(e)(3) and 122.44(i)(1)(iv) to 

clarify that the method selected must be 

approved under 40 CFR part 136 or 

required under 40 CFR chapter I, 

subchapter N or O. 

EPA removed language in 

122.44(i)(1)(iv)(A)(2) of the proposed 

rule because it was not applicable to 

requirements established in this section 

and created confusion about the 

implementation of the rule. In this 

instance, even if the permittee believes 


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10USEPA. ‘‘Information Collection Request (ICR) 

for National Pollutant Discharge Elimination 

System (NPDES) Program (Renewal),’’ OMB Control 

No. 2040–0004, EPA ICR No. 0229.20, March 2012. 

they are discharging above the permit 

limit and could potentially use a less 

sensitive method, the permitting 

authority is responsible for prescribing 

an EPA-approved method, where 

available, that is sensitive enough to 

detect at or below the permit limit in 

order to properly assess compliance 

with the permit. 

EPA revised the proposed regulatory 

text at 122.21(e)(3)(ii) and 

122.41(i)(1)(iv)(B) for instances where 

there are no EPA-approved methods. 

The proposed language included 

additional requirements for situations 

where there are no EPA-approved 

methods. Specifically, the proposed rule 

would have required that applicants and 

permitting authorities select a 

‘‘sufficiently sensitive’’ non EPAapproved method and that applicants 

provide a description of the method, 

including the minimum level. The 

situation in which there are no EPAapproved methods is uncommon 

because there are EPA-approved 

methods for most pollutants or pollutant 

parameters screened and regulated 

under the NPDES program. In addition, 

the existing regulations already require 

that applicants select a suitable method 

and provide a description of the 

method. Based on public comments, 

EPA determined that this additional 

requirement was unnecessary and has 

revised the regulatory text to revert the 

existing language in 40 CFR 122.21 and 

122.41. As a result, today’s rule does not 

specify that non-EPA-approved methods 

must be sufficiently sensitive. To clarify 

this point, EPA also added language to 

the introduction of 122.21(e)(3) to 

specify that the requirement to use a 

sufficiently sensitive method applies 

‘‘except as specified in 122.21(e)(3)(ii).’’ 

EPA amended 122.21(e)(3)(ii) by 

adding regulatory text to clarify that in 

the case where there are no EPAapproved methods, applicants may 

consider other relevant factors when 

selecting an appropriate method. In 

addition, EPA revised the proposed 

regulatory text to change ‘‘or otherwise 

required by the Director’’ to ‘‘and not 

otherwise required by the Director’’ to 

clarify that this provision applies to a 

situation where no EPA-approved 

methods exist and the Director has not 

required the use of a specific non-EPAapproved method. In this situation, the 

permit applicant may select a suitable 

non-EPA-approved method and provide 

a description of the method. 

Finally, in both places where the new 

definition of ‘‘sufficiently sensitive’’ 

appears, EPA added a note to clarify 

that, consistent with 40 CFR part 136, 

permittees have the option of providing 

matrix or sample-specific minimum 

levels rather than the published levels. 

In addition, the note clarifies that where 

a permittee can demonstrate that, 

despite a good faith effort to use a 

method that would otherwise meet the 

definition of ‘‘sufficiently sensitive,’’ the 

analytical results are not consistent with 

the QA/QC specifications for that 

method, then the Director may 

determine that the method is not 

performing adequately and a different 

method should be selected from the 

remaining EPA-approved methods 

consistent with 40 CFR 122.21(e)(3)(i) 

and 40 CFR 122.44(i)(1)(iv)(A). Where 

no other EPA-approved methods exist, a 

method should be selected consistent 

with 40 CFR 122.21(e)(3)(ii) and 40 CFR 

122.44(i)(1)(iv)(B). 

V. 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, 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 122.22(d) New and existing industries with cooling water intake structures. 

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 EPAapproved, pollutant-specific test 

procedures (or approved alternative test 

procedures). 

In 2012 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.10 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 


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11USEPA. ‘‘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. 1989.09, January 2014. 

USEPA, ‘‘Information Collection Request (ICR) for 

Cooling Water Intake Structures at Phase III 

Facilities (Final Rule),’’ OMB Control No. 2040– 

0268, EPA ICR No. 2169.05, January 2014. 

USEPA, ‘‘Information Collection Request (ICR) for 

Cooling Water Intake Structures Phase II Existing 

Facilities (Renewal),’’ OMB Control No. 2040–0257, 

EPA ICR No. 2060.06, January 2014. 

USEPA, ‘‘Information Collection Request (ICR) for 

Cooling Water Intake Structures New Facility Rule 

(Renewal),’’ OMB Control No. 2040–0241, EPA ICR 

No. 1973.05, December 2011. 

those forms were contained in separate 

ICRs.11 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 final rule, 

EPA also assessed the cost information 

for 40 CFR Part 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. While EPA acknowledges 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 final rule is expected to 

result in little or no new or increased 

analytical burden to applicants or 

permittees. 

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. 

As noted above, EPA also recognizes 

that in some cases, use of a more 

sensitive method could have the 

practical effect of requiring a facility to 

adopt additional pollution control 

measures, even if the permit limit 

remained unchanged. EPA does not 

have data that would allow it to predict 

in advance where or how often this 

situation might occur, or what a facility 

would be required to do to address it. 

EPA has not attempted to quantify the 

costs of any such new control measures 

that might be adopted, as they are 

outside the scope of this rulemaking. 

VI. 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. 

VII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is a 

‘‘significant regulatory action.’’ 

Accordingly, EPA submitted this action 

to the Office of Management and Budget 

(OMB) for review under Executive 

Orders 12866 and 13563 (76 FR 3821, 

January 21, 2011) and any changes made 

in response to OMB recommendations 

have been documented in the docket for 

this action. 

B. Paperwork Reduction Act 

This action does not impose any new 

information collection burden. The final 

rulemaking requires the use of 

sufficiently sensitive EPA-approved 

analytical test methods, where they 

exist, when applying for an NPDES 

permit and when performing sampling 

and analysis pursuant to monitoring 

requirements in an NPDES permit. 

However, it does not change the 

recordkeeping or reporting requirements 

associated with the use of analytical 

methods. 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 V (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 final 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 final rule on small 

entities, I certify that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

EPA has determined that the 

incremental analytical costs that NPDES 

permit applicants and permittees may 

bear as a result of this rule are minimal 

and would not rise to the level of a 

significant economic impact on a 

substantial number of small entities. 

D. Unfunded Mandates Reform Act 

This rule does not contain a Federal 

mandate that might result in 

expenditures of $100 million or more 

for state, local, and tribal governments, 

in the aggregate, or the private sector in 

any one year. Thus, this final rule is not 

subject to the requirements of sections 

202 and 205 of the UMRA. EPA has 

further determined that this rule 

contains no regulatory requirements that 

might significantly or uniquely affect 

small governments. Thus, this final rule 

is not subject to the requirements of 

section 203 of UMRA. 


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E. Executive Order 13132: Federalism 

This final rule does not have 

federalism implications. When 

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 governments, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This final rule does 

not change the relationship between the 

national government and the States or 

change their roles and responsibilities. 

Rather, this final rulemaking requires 

that sufficiently sensitive EPA-approved 

analytical test methods be used, where 

they exist, 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 final 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. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This final 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 

final rule requires that sufficiently 

sensitive EPA-approved analytical test 

methods must be used, where they exist, 

when applying for an NPDES permit 

and when performing sampling and 

analysis pursuant to monitoring 

requirements in an NPDES permit. 

Nothing in this final rule would prevent 

an Indian tribe from exercising its own 

organic authority to deal with such 

matters. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

The final 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. 

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 likely to have 

a significant adverse effect on the 

supply, distribution, or use of energy. 

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 final 

rulemaking does not change agency 

policy or requirements with respect to 

the use of voluntary consensus 

standards for the analysis of pollutants 

by NPDES permit applicants or 

permittees. 

J. Executive Order 12898 (Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations) 

Executive Order 12898 (59 FR 7629, 

February 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 final 

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. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). This rule 

will be effective September 18, 2014. 

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: August 6, 2014. 

Gina McCarthy, 

Administrator. 

For the reasons set out in the 

preamble, title 40, chapter I, of the Code 

of Federal Regulations is 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: 


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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). 

* * * * * 

(e) * * * 

(3) Except as specified in 

122.21(e)(3)(ii), 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 

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 or required under 40 

CFR chapter I, subchapter N or O 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; or 

(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; 

or 

(C) The method has the lowest ML of 

the analytical methods approved under 

40 CFR part 136 or required under 40 

CFR chapter I, subchapter N or O for the 

measured pollutant or pollutant 

parameter. 

Note to paragraph (e)(3)(i)(C): Consistent 

with 40 CFR part 136, applicants have the 

option of providing matrix or sample specific 

minimum levels rather than the published 

levels. Further, where an applicant can 

demonstrate that, despite a good faith effort 

to use a method that would otherwise meet 

the definition of ‘‘sufficiently sensitive’’, the 

analytical results are not consistent with the 

QA/QC specifications for that method, then 

the Director may determine that the method 

is not performing adequately and the 

applicant should select a different method 

from the remaining EPA-approved methods 

that is sufficiently sensitive consistent with 

40 CFR 122.21(e)(3)(i). Where no other EPAapproved methods exist, the applicant 

should select a method consistent with 40 

CFR 122.21(e)(3)(ii). 

(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, and is not 

otherwise required by the Director, the 

applicant may use any suitable method 

but shall provide a description of the 

method. When selecting a suitable 

method, other factors such as a 

method’s precision, accuracy, or 

resolution, may be considered when 

assessing the performance of the 

method. 

* * * * * 

■ 3. Section 122.44 is amended by 

revising paragraph (i) (1) (iv) to read as 

follows: 

§ 122.44 Establishing limitations, 

standards, and other permit conditions 

(applicable to State NPDES programs, see 

§ 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 

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 for the 

measured pollutant or pollutant 

parameter; or 

(2) The method has the lowest ML of 

the analytical methods approved under 

40 CFR part 136 or required under 40 

CFR chapter I, subchapter N or O for the 

measured pollutant or pollutant 

parameter. 

Note to paragraph (i)(1)(iv)(A)(2): 

Consistent with 40 CFR part 136, applicants 

or permittees have the option of providing 

matrix or sample specific minimum levels 

rather than the published levels. Further, 

where an applicant or permittee can 

demonstrate that, despite a good faith effort 

to use a method that would otherwise meet 

the definition of ‘‘sufficiently sensitive’’, the 

analytical results are not consistent with the 

QA/QC specifications for that method, then 

the Director may determine that the method 

is not performing adequately and the Director 

should select a different method from the 

remaining EPA-approved methods that is 

sufficiently sensitive consistent with 40 CFR 

122.44(i)(1)(iv)(A). Where no other EPAapproved methods exist, the Director should 

select a method consistent with 40 CFR 

122.44(i)(1)(iv)(B). 

(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 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: 

§ 136.1 Applicability. 

* * * * * 

(c) For the purposes of the NPDES 

program, when more than one test 

procedure is approved under this part 

for the analysis of a pollutant or 

pollutant parameter, the test procedure 

must be sufficiently sensitive as defined 

at 40 CFR 122.21(e)(3) and 

122.44(i)(1)(iv). 

[FR Doc. 2014–19265 Filed 8–18–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Office of the Secretary 

43 CFR Part 2 

[145D0102DM DLSN00000.000000 

DS62400000 DX62401] 

RIN 1090–AA94 

Privacy Act Regulations; Exemption 

for the Debarment and Suspension 

Program 

AGENCY: Office of the Secretary, Interior. 

ACTION: Final rule. 

SUMMARY: The Department of the 

Interior is issuing a final rule to amend 

its regulations to exempt certain records 

of the Debarment and Suspension 

Program system of records from 

particular provisions of the Privacy Act 

because these records contain 

investigatory material. 

DATES: This final rule is effective 

September 18, 2014. 

FOR FURTHER INFORMATION CONTACT: Teri 

Barnett, Departmental Privacy Officer, 

U.S. Department of the Interior, 1849 C 

Street NW., Mail Stop 5547 MIB, 

Washington, DC 20240. Email at 

privacy@ios.doi.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Department of the Interior (DOI) 

published a notice of proposed 

rulemaking in the Federal Register, 76 

FR 52295, August 22, 2011, proposing to 


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