35712 Federal Register / Vol. 75, No. 120 / Wednesday, June 23, 2010 / Proposed Rules 

Executive Order 12866—Regulatory 

Planning and Review 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Executive Order classifies a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB) unless OMB waives such review, 

as any regulatory action that is likely to 

result in a rule that may: (1) Have an 

annual effect on the economy of $100 

million or more or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

The economic, interagency, 

budgetary, legal, and policy 

implications of this proposed rule have 

been examined, and it has been 

determined not to be a significant 

regulatory action under Executive Order 

12866 because it is unlikely to result in 

a rule that may raise novel legal or 

policy issues arising out of legal 

mandates, the President’s priorities, or 

principles set forth in the Executive 

Order. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

1 year. This proposed rule would have 

no such effect on State, local, and tribal 

governments, or on the private sector. 

Catalog of Federal Domestic Assistance 

Numbers and Titles 

The Catalog of Federal Domestic 

Assistance program numbers and titles 

for this proposal are 64.104, Pension for 

Non-Service-Connected Disability for 

Veterans, and 64.109, Veterans 

Compensation for Service-Connected 

Disability. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. John 

R. Gingrich, Chief of Staff, Department 

of Veterans Affairs approved this 

document on June 17, 2010 for 

publication. 

List of Subjects in 38 CFR Part 4 

Disability benefits, Pensions, 

Veterans. 

Dated: June 18, 2010. 

William F. Russo, 

Director of Regulations Management, Office 

of the General Counsel. 

For the reasons set out in the 

preamble, 38 CFR part 4, subpart B, is 

proposed to be amended as set forth 

below: 

PART 4—SCHEDULE FOR RATING 

DISABILITIES 

1. The authority citation for part 4 

continues to read as follows: 

Authority: 38 U.S.C. 1155, unless 

otherwise noted. 

Subpart B—Disability Ratings 

2. In § 4.124a, revise diagnostic code 

8017 to read as follows: 

§ 4.124a Schedule of ratings—neurological 

conditions and convulsive disorders. 

Rating 

* * * * * 

8017 Amyotrophic lateral sclerosis ............................................. 100 

Note: Consider the need for special 

monthly compensation. 

* * * * * 

[FR Doc. 2010–15169 Filed 6–22–10; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 122 and 136 

[EPA–HQ–OW–2009–1019; FRL–9166–7] 

RIN 2040–AC84 

National Pollutant Discharge 

Elimination System (NPDES): Use of 

Sufficiently Sensitive Test Methods for 

Permit Applications and Reporting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing minor 

amendments to its Clean Water Act 

(CWA) regulations to codify that under 

the National Pollutant Discharge 

Elimination System (NPDES) program, 

only ‘‘sufficiently sensitive’’ analytical 

test methods can be used when 

completing an NPDES permit 

application and when performing 

sampling and analysis pursuant to 

monitoring requirements in an NPDES 

permit. 

This proposal is based on 

requirements in the CWA and existing 

EPA regulations. It also would codify 

existing EPA guidance on the use of 

‘‘sufficiently sensitive’’ analytical 

methods with respect to measurement of 

mercury and extend the approach 

outlined in that guidance to the NPDES 

program more generally. Specifically, 

EPA is proposing to clarify the existing 

NPDES application, compliance 

monitoring, and analytical methods 

regulations. The amendments in this 

proposed rulemaking affect only 

chemical-specific methods; they do not 

apply to the Whole Effluent Toxicity 

(WET) methods or their use. 

DATES: Comments on this action must be 

received or postmarked on or before 

midnight August 9, 2010. 

ADDRESSES: You may submit comments, 

identified by EPA–HQ–OW–2009–1019, 

by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: ow-docket@epa.gov. Include 

EPA–HQ–OW–2009–1019 in the subject 

line of the message. 

• Mail: Send the original and three 

copies of your comments to: Water 

Docket, Environmental Protection 

Agency, Mail Code 2822T, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460, Attention: 

Docket ID No. EPA–HQ–OW–2009– 

1019. 

• Hand Delivery/Courier: Deliver 

your comments to EPA Docket Center, 


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

both pollutants and pollutant parameters. 2The term ‘‘Director’’ refers to the permitting 

authority. Per 40 CFR 122.2, ‘‘Director’’ means the 

Regional Administrator or the State Director, as the 

context requires, or an authorized representative. 

When there is no ‘‘approved State program’’’ and 

there is an EPA-administered program, ‘‘Director’’ 

means the Regional Administrator. When there is 

an approved State program, ‘‘Director’’ normally 

means the State Director. In some circumstances, 

however, EPA retains the authority to take certain 

actions even when there is an approved State 

program. (For example, when EPA has issued an 

NPDES permit prior to the approval of a State 

program, EPA may retain jurisdiction over that 

permit after program approval; see 40 CFR 123.1.) 

In such cases, the term ‘‘Director’’ means the 

Regional Administrator and not the State Director. 

3Although 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. 

EPA West, Room 3334, 1301 

Constitution Avenue, NW., Washington, 

DC, Attention Docket ID No. EPA–HQ– 

OW–2009–1019. Such deliveries are 

accepted only during the Docket’s 

normal hours of operation, which are 

8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. 

Special arrangements should be made 

for deliveries of boxed information. The 

telephone number for the Water Docket 

is 202–566–2426. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–OW–2009– 

1019. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identify 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA might not be 

able to consider your comment. Avoid 

the use of special characters and any 

form of encryption, and ensure that 

electronic files are free of any defects or 

viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Some 

information, however, is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is publicly 

available only in hard copy. Publicly 

available docket materials are available 

electronically in http:// 

www.regulations.gov or in hard copy at 

the Water Docket, EPA Docket Center, 

EPA West, Room 3334, 1301 

Constitution Avenue, NW., Washington, 

DC. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is 202–566–1744, 

and the telephone number for the Water 

Docket is 202–566–2426. 

FOR FURTHER INFORMATION CONTACT: For 

additional information, contact Kathryn 

Kelley, Water Permits Division, Office of 

Wastewater Management (4203M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460; telephone number: 202–564– 

7004, e-mail address: 

kelley.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Potentially Affected Parties 

B. Legal Authority 

II. Background 

III. Scope and Rationale of the Proposed Rule 

IV. Impacts 

V. Compliance Dates 

VI. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

I. General Information 

A. Potentially Affected Parties 

In the NPDES program, point source 

dischargers obtain permits that are 

issued by EPA regions and authorized 

NPDES States, Territories, and Indian 

Tribes (collectively referred to as 

‘‘permitting authorities’’). These point 

source dischargers include publicly 

owned treatment works (POTWs) and 

various industrial and commercial 

facilities (collectively referred to as 

‘‘NPDES applicants or permittees’’). 

Permitting authorities issue NPDES 

permits after analyzing the information 

contained in the application or in the 

case of a general permit, the information 

submitted to demonstrate eligibility for 

coverage. The NPDES permit prescribes 

the conditions under which the facility 

is allowed to discharge pollutants and 

that will ensure the facilities’ 

compliance with the CWA’s technologybased and water quality-based 

requirements. NPDES permits typically 

include restrictions on the mass and/or 

concentration of pollutants 1 that a 

permittee may discharge and require the 

permittee to conduct routine sampling 

and reporting of various parameters 

measured in the permitted discharge. In 

general, NPDES applicants and 

permittees are required to use EPAapproved, pollutant-specific test 

procedures (or approved alternative test 

procedures) when measuring the 

pollutants in their discharges. 

The purpose of today’s proposal is to 

clarify that NPDES applicants and 

permittees must use sufficiently 

sensitive analytical methods when 

quantifying the presence of pollutants in 

a discharge, and the Director 2 must 

require and accept only such data. The 

broad universe of entities‘‘ 3 that would 

be affected by this proposal includes 

NPDES permitting authorities and 

municipal and industrial applicants and 

permittees (Table I–1). The impact of 

this proposal, however, would only 

affect those entities that use or allow the 

use of any EPA-approved analytical 

methods (for one or more parameters) 

that are not ‘‘sufficiently sensitive’’ to 

detect pollutants being measured in the 

discharge. 


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4The term ‘‘minimum level’’ refers to either the 

lowest calibration point in a method or a multiple 

of the method detection limit (MDL), whichever is 

higher. Minimum levels may be obtained in several 

ways: They may be published in a method; they 

may be the lowest acceptable calibration point used 

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 would promulgate the rule being 

proposed today pursuant to the 

authority of sections 301, 304(h), 308, 

402(a), and 501(a) of the CWA [33 

U.S.C. 1311, 1314(h), 1316, 1318, 

1342(a), 1343, and 1361(a)]. Section 

501(a) of the CWA authorizes the 

Administrator of EPA to prescribe such 

regulations as are necessary to carry out 

the act. Section 301(a) of the CWA 

prohibits the discharge of any pollutant 

into navigable waters unless the 

discharge complies with an NPDES 

permit issued under section 402 of the 

act. Section 402(a) of the CWA 

authorizes the Administrator to issue 

permits that require a discharger to meet 

all the applicable requirements under 

sections 301, 302, 306, 307, 308, and 

403. Section 301(b) of the CWA further 

requires that NPDES permits include 

effluent limitations that implement 

technology-based standards of 

performance and, where necessary, 

water quality-based effluent limitations 

(WQBELs) that are as stringent as 

necessary to meet water quality 

standards. With respect to the 

protection of water quality, NPDES 

permits must include limitations to 

control all pollutants that the NPDES 

permitting authority determines are or 

might be discharged at a level that ‘‘will 

cause, have the ‘reasonable potential’ to 

cause, or contribute to an excursion 

above any State water quality standard,’’ 

including both narrative and numeric 

criteria [40 CFR 122.44(d)(1)(i)]. If the 

Director determines that a discharge 

causes, or has the reasonable potential 

to cause or contribute to, such an 

excursion, the permit must contain 

WQBELs for the pollutant [40 CFR 

122.44(d)(1)(iii)]. Section 402(a)(2) of 

the CWA requires EPA to prescribe 

permit conditions to ensure compliance 

with requirements, ‘‘* * * including 

conditions on data and information 

collection, reporting and such other 

requirements as [the Administrator] 

deems appropriate.’’ Thus, a prospective 

permittee might need to measure 

various pollutants in its effluent at two 

stages: First, at the permit application 

stage so that the Director can determine 

what pollutants are present in the 

applicant’s discharge and the amount of 

each pollutant present and, second, to 

quantify the levels of each pollutant 

limited in the permit to determine 

whether the discharge is in compliance 

with the applicable limits and 

conditions. 

Section 304(h) of the CWA requires 

the Administrator of EPA to ‘‘* * * 

promulgate guidelines establishing test 

procedures for the analysis of pollutants 

that shall include the factors which 

must be provided in any certification 

pursuant to [section 401of this Act] or 

permit application pursuant to [section 

402 of this Act].’’ Section 501(a) of the 

act authorizes the Administrator to 

‘‘* * * prescribe such regulations as are 

necessary to carry out this function 

under [the act].’’ EPA generally has 

codified its test procedure regulations 

(including analysis and sampling 

requirements) for CWA programs at 40 

CFR 136, although some requirements 

are codified in other parts (e.g., 40 CFR 

chapter I, subchapters N and O). 

The Director is authorized under 40 

CFR 122.21(e) to determine when an 

NPDES permit application is complete. 

Moreover, the Director shall not begin 

processing a permit until the applicant 

has fully complied with the application 

requirements for that permit [40 CFR 

124.3(a)(2)]. Under 40 CFR 

122.21(g)(13), applicants are required to 

provide to the Director, upon request, 

such other information as the Director 

may reasonably require to assess the 

discharge. Under 40 CFR 122.28(b)(2), 

dischargers (or treatment works treating 

domestic sewage) seeking coverage 

under a general permit must submit to 

the Director a written NOI to be covered 

by the general permit (with some 

exceptions set forth elsewhere in 40 

CFR 122.28(b)(2)). The contents of the 

NOI must be specified in the general 

permit, and they must require the 

submission of information necessary for 

adequate program implementation. 

Finally, 40 CFR 122.41(j)(1) requires 

NPDES permits to specify that sampling 

and measurements taken for the 

purposes of monitoring shall be 

‘‘representative of the monitored 

activity.’’ 

Among other things, section 308 of 

the CWA authorizes EPA to require 

owners or operators of point sources to 

establish records, conduct monitoring 

activities, and make reports to enable 

the permitting authority to determine 

whether there is a violation of any 

prohibition or any requirement 

established under provisions including 

section 402 of the CWA. Under sections 

308(c) and 402(b)(2)(A), a State’s 

authorized NPDES program must have 

authorities for inspection, monitoring, 

and issuing permits that are applicable 

to at least the same extent as those 

under section 308. 

As summarized above, the legal 

requirements and authorities exist for 

EPA to require NPDES applicants and 

permittees to use sufficiently sensitive 

analytical methods when quantifying 

the presence of pollutants in a discharge 

and to require the Director to require 

and accept only such data. 

II. Background 

Multiple analytical test methods exist 

for many pollutants regulated under the 

CWA. Therefore, EPA has generally 

approved multiple methods for CWA 

pollutants under 40 CFR 136 and 40 

CFR chapter I, subchapters N and O. 

Some of the approved analytical test 

methods have greater sensitivities and 

lower minimum levels 4 5 or method 


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by a laboratory; or they may be calculated by 

multiplying the MDL in a method, or the MDL 

determined by a lab, by a factor. [See: (A) 40 CFR 

136, appendix A, footnotes to table 2 of EPA 

Method 1624 and table 3 of EPA Method 1625 (49 

FR 43234, October 26, 1984); (B) 40 CFR 136, 

section 17.12 of EPA Method 1631E (67 FR 65876– 

65888, October 29, 2002); (C) 61 FR 21, January 31, 

1996; (D) ‘‘Analytical Method Guidance for the 

Pharmaceutical Manufacturing Point Source 

Category,’’ EPA 821–B–99–003, August 1999; and 

(E) ‘‘EPA Region 10 Guidance For WQBELs Below 

Analytical Detection/Quantitation Level,’’ EPA 

Region 10, March 22, 1996.] 

5For the purposes of this rulemaking, EPA is 

considering the following terms to be synonymous: 

‘‘quantitation limit,’’ ‘‘reporting limit,’’ and 

‘‘minimum level.’’ 

6The MDL is determined using the procedure at 

40 CFR 136, appendix B. It is defined as the 

minimum concentration of a substance that can be 

measured and reported with 99 percent confidence 

that the analyte concentration is greater than zero 

and is determined from analysis of a sample in a 

given matrix containing the analyte. 

7To 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. 

detection limits (MDLs) 6 than other 

approved methods for the same 

pollutant. This situation often occurs 

because of advances having been made 

in instrumentation and in the analytical 

protocols themselves. Many metals and 

toxic compounds (for example, 

mercury) have an array of EPAapproved methods, including some 

methods that have greater sensitivities 

and lower minimum levels than the 

others. 

EPA and State permitting authorities 

use data from the permit application to 

determine whether pollutants are 

present in an applicant’s discharge and 

to quantify the levels of all detected 

pollutants. These pollutant data are then 

used to determine whether technologyor water quality-based effluent limits are 

needed in the facility’s NPDES permit. 

It is critical, therefore, that applicants 

provide data that have been measured 

with precision and accuracy so that they 

will be meaningful to the decisionmaking process. Among other things, 

data must be provided at a level that 

will enable the Director to make a 

sound, reasonable potential 

determination and, if necessary, 

establish appropriate water qualitybased permit limits. The same holds 

true for monitoring and reporting 

relative to permit limits established for 

regulated parameters. The aim is for 

applicants and permittees to use 

analytical methods that are capable of 

detecting and measuring the pollutants 

at, or below, the respective water quality 

criteria or permit limits.7

For example, in 2002 and 2007 EPA 

published two new analytical methods 

for mercury that were several orders of 

magnitude more sensitive than 

previously available methods. In 

addition, a number of States have set 

water quality criteria for mercury that 

are below the detection levels of the 

older methods for mercury that EPA 

approved prior to 2002. Unlike the 

previous methods, the new methods are 

capable of measuring whether effluent 

samples are above or below the current 

water quality criteria. In 2007 EPA 

addressed this issue with respect to 

mercury in a memorandum titled 

‘‘Analytical Methods for Mercury in 

NPDES Permits,’’ from James A. Hanlon, 

Director of EPA’s Office of Wastewater 

Management, to the Regional Water 

Division Directors. This memorandum 

is available at http://www.epa.gov/ 

npdes/pubs/ 

mercurymemo_analyticalmethods.pdf. 

The memorandum explains EPA’s 

expectation that ‘‘All facilities with the 

potential to discharge mercury will 

provide with their NPDES permit 

applications monitoring data for 

mercury using Method 1631E or another 

sufficiently sensitive EPA-approved 

method. * * * Accordingly, EPA 

strongly recommends that the 

permitting authority determine that a 

permit application that lacks effluent 

data analyzed with a sufficiently 

sensitive EPA-approved method such as 

Method 1631E, is incomplete unless and 

until the facility supplements the 

original application with data analyzed 

with such a method.’’ 

Following issuance of the 2007 

memorandum, EPA determined that the 

NPDES permit application regulations at 

40 CFR 122.21 and the NPDES permit 

monitoring requirements at 40 CFR 

122.44 should be clarified to ensure that 

applicants and permittees use 

sufficiently sensitive analytical methods 

for all pollutants, not just mercury. EPA 

is proposing to incorporate language in 

the regulations that extends the 

requirement to use sufficiently sensitive 

test methods to all pollutants. EPA is 

also proposing to codify the definition 

of ‘‘sufficiently sensitive’’ to include an 

additional criterion that was not part of 

the 2007 memorandum, as described 

below. 

III. Scope and Rationale of the 

Proposed Rule 

This proposed rule clarifies that 

NPDES applicants and permittees must 

use sufficiently sensitive analytical test 

methods when submitting information 

characterizing the discharge in an 

NPDES permit application and when 

performing sampling and analysis 

pursuant to monitoring requirements in 

an NPDES permit. In addition, the 

proposed rule clarifies that the Director 

must require NPDES applicants and 

permittees to use sufficiently sensitive 

analytical test methods and accept only 

data analyzed by such methods. EPA 

proposes adding or modifying language 

to define ‘‘sufficiently sensitive’’ at 40 

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

EPA also proposes providing a crossreference to these changes at 40 CFR 

136.1(c). For the purposes of this 

rulemaking, if monitoring requirements 

are included as a condition of the 

general permit, these requirements 

would be subject to the provisions 

established in 122.44(i)(1)(iv). 

As discussed earlier, it is critical that 

the Director make permitting decisions 

based on accurate data and, thus, sound 

science. The use of imprecise analytical 

methods could lead the Director to make 

assumptions regarding the presence or 

absence of a pollutant in an applicant’s 

discharge. These assumptions, in turn, 

could result in the Director’s making an 

incorrect permitting decision (e.g., the 

decision not to include a limit in a 

permit when, in fact, a waste stream 

concentration of a pollutant will cause, 

have the reasonable potential to cause, 

or contribute to an excursion above an 

applicable water quality criterion). 

Moreover, if the Director were to 

include imprecise analytical methods in 

permits for compliance monitoring 

purposes, the use of such methods 

could result in undetected exceedances 

of permit limits. 

Although EPA has approved multiple 

analytical methods for individual 

pollutants under 40 CFR 136, the 

Agency has historically expected that 

applicants and permittees would select 

from the array of available methods a 

specific analytical method that is 

sufficiently sensitive to quantify the 

presence of a pollutant in a given 

discharge. EPA has not expected that 

NPDES permit applicants would select 

a method with insufficient sensitivity, 

thereby masking the presence of a 

pollutant in their discharge, when an 

EPA-approved sufficiently sensitive 

method is available. This proposed rule, 

therefore, would clarify that NPDES 

applicants and permittees must use 

sufficiently sensitive analytical methods 

when quantifying the presence of 

pollutants in a discharge and that the 

Director must require and accept only 

such data. 

EPA proposes defining the term 

‘‘sufficiently sensitive’’ in two sections 

of the Federal NPDES regulations––at 40 

CFR 122.21(e) (Permit Application 

Completeness) as a new subsection (3) 

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

(Monitoring Requirements). EPA also 

proposes modifying 40 CFR 136.1 

(Applicability) by adding a new 


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8This provision is adopted from existing 

language in 40 CFR 122.21(g)(7). 

9EPA’s Office of Water issued Final Guidance on 

Section 304(1), ‘‘Listing and Permitting of Pulp and 

Paper Mills’’ (referred to as the 304(l) Guidance, 

March 15, 1989, available at http://www.epa.gov/ 

npdes/pubs/owm0360.pdf). The guidance 

recommended that where WQBELs are less than the 

detection level for the specified analytical method, 

the calculated WQBEL should be included as a 

requirement of the permit. EPA again addressed the 

issue of detection levels in its May 21, 1990, 

‘‘Strategy for the Regulation of Discharges of PCDDs 

and PCDFs from Pulp and Paper Mills to Waters of 

the United States’’ (the Dioxin Strategy, available at 

http://www.epa.gov/npdes/pubs/owm0286.pdf). 

This strategy modified the 304(l) Guidance by 

recommending that permit writers specify the 

minimum level in permits that limit dioxin. In 

March 1991, EPA further expanded its guidance on 

detection levels in the ‘‘Technical Support 

Document for Water Quality-based Toxics Control’’ 

by applying the concepts contained in the Dioxin 

Strategy to analytical detection levels for all 

pollutants (EPA Office of Water, EPA/505/2–90– 

001, PB91–127415; available at http://www.epa.gov/ 

waterscience/methods/det/faca/mtg20051208/ 

excerpt-detectionlimits.html). 

10See Content Notes 4–6. 

11Many States have adopted mercury water 

quality criteria of 12 parts per trillion (ppt) for the 

protection of aquatic life and 50 ppt for the 

subsection (c), which is simply a crossreference to the changes proposed for 40 

CFR 122.21(e)(3) and 40 CFR 

122.44(i)(1)(iv). The regulatory changes 

proposed are open to comment. EPA, 

however, is not reopening or taking 

comment on any other existing 

requirement in the regulations. 

A. The new and revised sections indicate 

that a method is sufficiently sensitive where: 

i. The method minimum level is at or 

below the level of the applicable water 

quality criterion or permit limitation for the 

measured pollutant or pollutant parameter; 

or 

ii. The method minimum level is above the 

applicable water quality criterion or permit 

limitation, but the amount of the pollutant or 

pollutant parameter in a facility’s discharge 

is high enough that the method detects and 

quantifies the level of the pollutant or 

pollutant parameter in the discharge; or 

iii. The method has the lowest minimum 

level of the analytical methods approved 

under 40 CFR 136. 

B. When no analytical method is approved 

under 40 CFR 136, required under 

subchapter N or O, or otherwise required by 

the Director, an NPDES applicant may use 

any suitable sufficiently sensitive method; 

however, the applicant shall provide a 

description of the method, including 

documentation of the minimum level.8

The first two criteria in the 

sufficiently sensitive definition are 

aimed at addressing situations in which 

EPA has approved multiple methods 

under 40 CFR 136 for a pollutant and 

some of those approved methods have 

greater sensitivities and lower minimum 

levels than others. 

The third criterion of the definition is 

included to address situations in which 

none of the approved 40 CFR 136 

methods for a pollutant are sufficiently 

sensitive to achieve the minimum levels 

necessary to assess reasonable potential 

with a water quality criterion or to 

monitor compliance with a permit limit. 

In these situations, EPA proposes that 

applicants or permittees use the ‘‘most 

sensitive’’ of the approved methods for 

the pollutant. This practice has long 

been the Agency’s policy, and it is 

consistent with the CWA and with the 

EPA regulations at 40 CFR 122.44(d) 

requiring that limits be protective of 

water quality standards.9 EPA 

acknowledges that a laboratory might 

achieve MDLs and minimum levels 

lower than those published when the 

promulgated method was developed.10

Thus, the Director should not rely solely 

on MDLs or minimum levels in 

published methods because they give 

only an upper, not a lower, bound on 

the lab’s MDL and minimum level. 

Flexibility is provided at 40 CFR 136.6, 

which allows a laboratory to 

demonstrate performance better than the 

MDL or minimum level published in a 

method. 

The final provision is intended to 

address situations where no approved 

analytical method exists under part 136, 

is required under subchapter N or O, or 

is otherwise required by the Director. In 

such situations, an applicant may use 

any suitable sufficiently sensitive 

method but shall provide a description 

of the method that includes 

documentation of the minimum level. 

Where an EPA-approved analytical 

method is nonexistent under part 136 or 

is not required under subchapter N or O 

for a pollutant limited in an NPDES 

permit, the Director must specify a 

sufficiently sensitive analytical method 

as a condition of the NPDES permit, 

consistent with the criteria established 

in this proposed rulemaking at 40 CFR 

122.44(i)(1)(iv)(A)–(B). 

Under the CWA, authorized NPDES 

States, Territories, and Indian Tribes 

must have in place legal authorities that 

are at least as stringent as the 

requirements in certain parts of the EPA 

regulations. See 40 CFR 123.25. The 

requirements of sections 122.21(e) and 

122.44(i), which are the subject of this 

proposal, are among those that States 

must include within their own 

programs. Therefore, once the revised 

regulations that EPA is proposing today 

are finalized, States will need to amend 

their own legal authorities, where 

necessary, to ensure that only 

sufficiently sensitive methods are used 

to produce data for permit applications 

and for monitoring under a permit. See 

40 CFR 123.62(e). 

In some cases, States currently have 

State statutes or regulations that require 

NPDES applicants to use a specific 

analytical method or achieve a specific 

minimum level for a particular pollutant 

(or they have a State policy or guidance 

that recommends a specific method or 

minimum level). A problem would arise 

if the State currently requires a 

particular method or minimum level 

that is not ‘‘sufficiently sensitive’’ as 

defined in new EPA regulations. In 

these situations, EPA would expect 

States to revise their statutes or 

regulations so that if they require the 

use of a particular method or minimum 

level, it is one that is sufficiently 

sensitive. States would need to revise 

any policy guidances as well. (No 

problem would arise, however, if the 

method or minimum level currently 

required by the State does qualify as 

‘‘sufficiently sensitive.’’) EPA will 

provide regular updates on its Web site 

at http://www.epa.gov/waterscience/ 

methods to keep permitting authorities 

and permittees informed of method 

updates and revised water quality 

criteria to better enable the permitting 

authorities to determine that their 

requirements for applicants and 

permittees remain sufficiently sensitive. 

The following example is provided to 

help clarify the importance of using 

sufficiently sensitive test methods in the 

NPDES program: 

Example III–1—Mercury 

Measurements included with an 

NPDES permit application and with 

reports required to be submitted under 

the NPDES permit must generally be 

made using analytical methods 

approved by EPA under 40 CFR 136. 

(See 40 CFR 136.1, 136.4, 136.5, 

122.21(g)(7), and 122.41(j).) EPA has 

four approved methods for mercury 

under 40 CFR 136––EPA Methods 

245.1, 245.2, 1631E, and 245.7. The first 

two methods, approved by EPA in 1974, 

can achieve measurement of mercury 

down to 200 parts per trillion (ppt). EPA 

approved Method 1631 Revision E in 

2002. Method 1631E has a minimum 

level of 0.5 ppt, making it 400 times 

more sensitive than EPA Methods 245.1 

and 245.2. In fact, the sensitivity of 

Methods 245.1 and 245.2 when last 

updated in 1994 and 1979, respectively, 

was well above the water quality criteria 

now adopted in most States, as well as 

the criteria included by EPA in its final 

‘‘Water Quality Guidance for the Great 

Lakes System’’ for the protection of 

aquatic life and human health, which 

generally fall in the range of 1 to 50 

ppt.11 In contrast, Method 1631E, with 


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protection of human health; for discharges to the 

Great Lakes Basin, the applicable water quality 

criteria for mercury are 1.3 ppt for the protection 

of wildlife and 1.8 ppt for the protection of human 

health. In 2001, EPA issued new recommended 

water quality criteria guidance for the protection of 

human health. This new guidance recommends 

adoption of a methylmercury water quality criterion 

of 0.3 milligrams of methylmercury per kilogram 

(mg/kg) in fish tissue. EPA published final guidance 

in April 2010 to assist States in implementing the 

methylmercury criterion (‘‘Guidance for 

Implementing the January 2001 Methylmercury 

Water Quality Criterion,’’ EPA–823–F–10–001). It is 

available at http://www.epa.gov/waterscience/ 

criteria/methylmercury/mercury.2010.pdf). 

12Examples of such modification may include 

changes in the sample preparation digestion 

procedures such as the use of reagents similar in 

properties to ones used in the approved method, 

changes in the equipment operating parameters 

such as the use of an alternate more sensitive 

wavelength, adjusting the sample volume to 

optimize method performance, and changes in the 

calibration ranges (provided that the modified range 

covers any relevant regulatory limit). 

a minimum level of 0.5 ppt, supports 

the measurement of mercury at these 

low levels. 

On March 12, 2007, EPA published 

the Methods Update Rule, or MUR (72 

FR 11200), under which the Agency 

approved Method 245.7 for mercury and 

also modified versions of other EPAapproved methods for the parameter. 

This method change applies to the 

implementation of both water column 

criteria and fish tissue criteria in 

permits. Method 245.7 has a minimum 

level of 5.0 ppt, making it 40 times more 

sensitive than Methods 245.1 and 245.2. 

Methods 245.1 and 245.2 may be 

modified to achieve lower minimum 

levels.12 Modifications to an EPAapproved method for mercury that meet 

the method performance requirements 

of 40 CFR 136.6 are considered to be 

approved methods and require no 

further EPA approval. (See 72 FR 

11239–40, March 12, 2007.) For 

analytical method modifications that do 

not fall within the flexibility of 40 CFR 

136.6, the modified methods may be 

approved under the alternate test 

procedure program, as defined at 40 

CFR 136.4 and 136.5. 

As noted, most States have adopted 

water quality criteria for the protection 

of aquatic life and human health that 

fall in the range of 1 to 50 ppt. If an 

applicant or permittee used Methods 

245.1 and 245.2, ‘‘the absence of a 

quantitative result’’ would show only 

that mercury levels are below 200 ppt 

(based on a minimum level of 200 ppt) 

but would not establish that the 

discharge is at or below the applicable 

water quality criterion. In such a 

circumstance, a permit writer would 

possibly lack the information needed to 

make a reasonable potential 

determination. Use of an insufficiently 

sensitive method when performing 

routine monitoring under an NPDES 

permit could also yield data that would 

not be adequate for the Director to 

assess compliance. In contrast, if the 

applicant used Method 1631E (or 245.7), 

which can detect and quantify mercury 

concentrations at or below the low 

water quality criteria levels, the permit 

writer would have adequate information 

to make a reasonable potential 

determination. Therefore, EPA proposes 

to clarify in the regulations that the 

Director must consider an NPDES 

permit application incomplete until the 

applicant submits analytical data using 

a sufficiently sensitive method as that 

term is defined in this rulemaking, and 

when specifying in a permit which 

analytical methods the permittee may 

use, the Director may only specify 

sufficiently sensitive methods. 

IV. Impacts 

Entities that discharge to waters of the 

United States vary in terms of the 

quantity of their discharges, the 

potential constituents contained in their 

discharges, and their operation and 

maintenance practices. Consequently, 

the Director’s NPDES application 

requirements vary depending on 

applicant type. For example, Form 2A 

for municipalities requires minimal 

screening for POTWs with design flows 

under 100,000 gallons per day; however, 

for POTWs with design flows above 1 

million gallons per day (MGD), multiple 

priority pollutant scans are required. 

Similarly, existing industrial and 

commercial facilities that complete 

Form 2C are required to test for toxic 

pollutants based on the nature of their 

manufacturing operation. To assist 

permitting authorities (EPA regions, 

States, and Tribes), EPA developed 

several NPDES permit application 

forms. Table IV–1 provides a list of 

these forms and the discharger type(s) 

for which they are intended. Permitting 

authorities may use EPA’s forms or 

comparable forms of their own. 

TABLE IV–1—EPA NPDES PERMIT APPLICATION FORMS BY APPLICANT TYPE

Form or request Applicant type 

1 ...... Form 1 .................................................................................................................. New and existing applicants, except POTWs and treatment works treating domestic sewage. 

2 ...... Form 2A ............................................................................................................... New and existing POTWs (i.e., municipal facilities). 

3 ...... Form 2B ............................................................................................................... New and existing concentrated animal feeding operations (CAFOs) and aquatic animal production facilities. 

4 ...... Form 2C ............................................................................................................... Existing industries discharging process wastewater. 

5 ...... Form 2D ............................................................................................................... New industries discharging process wastewater. 

6 ...... Form 2E ............................................................................................................... New and existing industries discharging non-process 

wastewater only. 

7 ...... Form 2F ................................................................................................................ New and existing industries discharging stormwater. 

8 ...... 40 CFR 122.21(r) and 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 


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13USEPA. ‘‘Information Collection Request (ICR) 

for National Pollutant Discharge Elimination 

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

No. 2040–0004, EPA ICR No. 0229.19, December 

2008. 

14USEPA. ‘‘Supporting Statement for the 

Information Collection Request for the NPDES 

Regulation and Effluent Limitation Guidelines and 

Standards for Concentrated Animal Feeding 

Operations,’’ OMB Control No. 2040–0250, EPA ICR 

No. 1989.04, June 2006. 

USEPA, ‘‘Information Collection Request (ICR) for 

Cooling Water Intake Structures at Phase III 

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

0268, EPA ICR No. 2169.02, February 2009. 

USEPA, ‘‘Information Collection Request (ICR) for 

Cooling Water Intake Structures Phase II Existing 

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

EPA ICR No. 2060.03, May 2007. 

USEPA, ‘‘Information Collection Request (ICR) for 

Cooling Water Intake Structures New Facility Rule 

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

No. 1973.04, June 2008. 

procedures (or approved alternative test 

procedures). 

In 2008 EPA submitted an 

Information Collection Request (ICR) to 

the Office of Management and Budget 

(OMB) that, in part, updated the 

Agency’s burden estimates for 

applicants to complete Forms 1, 2A, 2C– 

2F, and 2S and for permitting 

authorities to review and process such 

forms.13 The renewal ICR did not 

include updated estimates for Form 2B 

or for forms associated with cooling 

water intake structures (Item 8 in Table 

IV–1). Updated estimates to complete 

those forms were contained in separate 

ICRs.14 The existing ICRs include 

annual burden estimates for completing 

NPDES permit applications and for 

conducting ongoing compliance 

monitoring for both new and existing 

NPDES permittees. EPA’s expectation is 

that permit applicants and permittees 

will use a range of methods based on a 

need to appropriately quantify 

pollutants in their discharge. To 

calculate cost and burden, the ICRs use 

an average cost for analytical methods, 

which is then translated into burden 

hours. 

To assess the impact of this proposed 

rule, EPA also assessed the cost 

information for 40 CFR 136 methods 

found in the National Environmental 

Methods Index (NEMI) at http:// 

www.nemi.gov. The NEMI site describes 

the ‘‘relative cost’’ as the cost per 

procedure of a typical analytical 

measurement using the specified 

methods (i.e., the cost of analyzing a 

single sample). Additional 

considerations affect total project costs 

(e.g., labor and equipment/supplies for 

a typical sample preparation, quality 

assurance/quality control requirements 

to validate results reported, number of 

samples being analyzed). EPA’s review 

of the cost ranges provided in NEMI 

indicated that there was generally little 

difference in the cost ranges across the 

EPA-approved analytical methods for a 

particular pollutant. A table with the 

NEMI cost ranges is included in the 

record. We request comment on this 

assessment of the cost range for the 

various EPA-approved methods. While 

we acknowledge that there are cost 

differentials for some facilities based on 

case-specific situations, on the basis of 

the analytical cost ranges provided in 

NEMI, and the assumptions used in the 

current ICRs (i.e., that applicants and 

permittees will use a range of available 

approved methods), the proposed rule is 

expected to result in little or no new or 

increased burden to applicants or 

permittees. We request comment on the 

burden estimate resulting from this 

proposal. 

The existing ICRs also account for the 

ongoing burden to permitting 

authorities to review applications and to 

issue NPDES permits annually. They 

also account for the ongoing burden 

associated with reviewing discharge 

monitoring and other reports for 

compliance assessment purposes. 

Finally, the existing ICRs account for 

program revisions where they are 

necessary because the controlling 

Federal statutes or regulations were 

modified. 

V. Compliance Dates 

Following issuance of this rule, 

authorized States have up to one year to 

revise, as necessary, their NPDES 

regulations to adopt the requirements of 

this rule, or two years if statutory 

changes are needed, as provided at 40 

CFR 123.62. 

VI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

This rule is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order 12866 (58 FR 51735, 

October 4, 1993) and is therefore not 

subject to review under the EO. 

B. Paperwork Reduction Act 

This action does not impose any new 

information collection burden. This 

proposed rulemaking merely clarifies 

testing procedures under the NPDES 

program based on existing legal 

requirements and authorities. The 

proposed rulemaking requires the use of 

sufficiently sensitive analytical test 

methods when applying for an NPDES 

permit and when performing sampling 

and analysis pursuant to monitoring 

requirements in an NPDES permit. 

However, the Office of Management and 

Budget (OMB) has previously approved 

the information collection requirements 

contained in the existing regulations 

(which cover all potential NPDES 

applicants) under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. and has assigned OMB 

control numbers, as summarized in 

section IV (Impacts) of this preamble. 

The OMB control numbers for EPA’s 

regulations in 40 CFR are listed in 40 

CFR part 9. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

generally requires an agency to prepare 

a regulatory flexibility analysis of any 

rule subject to notice and comment 

rulemaking requirements under the 

Administrative Procedure Act or any 

other statute unless the agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. Small entities 

include small businesses, small 

organizations, and small governmental 

jurisdictions. 

For purposes of assessing the impacts 

of this proposed rule on small entities, 

‘‘small entity’’ is defined as (1) a small 

business based on the Small Business 

Administration regulations at 13 CFR 

121.201; (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district, or 

special district with a population of less 

than 50,000; or (3) a small organization 

that is any not-for-profit enterprise 

which is independently owned and 

operated and is not dominant in its 

field. 

After considering the economic 

impacts of this proposed rule on small 

entities, I certify that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Because EPA is simply clarifying, based 

on existing legal requirements and 

authorities, that sufficiently sensitive 

analytical test methods must be used 

when applying for an NPDES permit 

and when performing sampling and 

analysis pursuant to monitoring 

requirements in an NPDES permit, this 

proposed action will not impose any 

new legally binding requirements or 

burden on EPA, States, or the regulated 

community, and specifically, any 

burden on any small entity. EPA 

continues to be interested in the 

potential impacts of the proposed rule 

on small entities and welcomes 

comments on issues related to such 

impacts. 

D. Unfunded Mandates Reform Act 

This proposed rule does not contain 

a Federal mandate that might result in 

expenditures of $100 million or more 

for State, local, and Tribal governments, 


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in the aggregate, or the private sector in 

any one year. EPA is proposing to 

clarify under existing legal requirements 

and authorities that sufficiently 

sensitive analytical test methods may be 

used when applying for an NPDES 

permit and when performing sampling 

and analysis pursuant to monitoring 

requirements in an NPDES permit. The 

rulemaking will not impose any new 

legally binding requirements on EPA, 

States, or the regulated community. 

Thus, this proposed rule is not subject 

to the requirements of sections 202 and 

205 of the UMRA. For the same reason, 

EPA has determined that this rule 

contains no regulatory requirements that 

might significantly or uniquely affect 

small governments. Thus, this proposed 

rule is not subject to the requirements 

of section 203 of UMRA. 

E. Executive Order 13132: Federalism 

This proposed rule does not have 

federalism implications. If promulgated, 

it will not have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132 (64 

FR 43255, August 10, 1999). This 

proposed rule does not change the 

relationship between the national 

government and the States or change 

their roles and responsibilities. Rather, 

this proposed rulemaking would 

confirm Agency policy, which is based 

on existing legal requirements and 

authorities, that sufficiently sensitive 

analytical test methods must be used 

when applying for an NPDES permit 

and when performing sampling and 

analysis pursuant to monitoring 

requirements in an NPDES permit. EPA 

does not expect this proposed rule to 

have any impact on local governments. 

Furthermore, the revised regulations 

would not alter the basic State-Federal 

scheme established in the CWA, under 

which EPA authorizes States to carry 

out the NPDES permitting program. EPA 

expects the revised regulations to have 

little effect on the relationship between, 

or the distribution of power and 

responsibilities among, the Federal and 

State governments. In the spirit of 

Executive Order 13132, and consistent 

with EPA policy to promote 

communications between EPA and State 

and local governments, EPA specifically 

solicits comment on this proposed 

action from State and local officials. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

Tribal implications, as specified in 

Executive Order 13175, ‘‘Consultation 

and Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000). It will not have substantial 

direct effects on Tribal governments, on 

the relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes, as 

specified in Executive Order 13175. The 

proposed rule, which is based on 

existing legal requirements and 

authorities, clarifies that sufficiently 

sensitive analytical test methods must 

be used when applying for an NPDES 

permit and when performing sampling 

and analysis pursuant to monitoring 

requirements in an NPDES permit. 

Nothing in this proposed rule would 

prevent an Indian Tribe from exercising 

its own organic authority to deal with 

such matters. EPA specifically solicits 

additional comment on this proposed 

action from Tribal officials. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

The proposed rule is not subject to 

Executive Order 13045, ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant and the 

Agency does not believe that the 

environmental health and safety risks 

addressed by this action present a 

disproportionate risk to children. This 

proposed rule only interprets existing 

legal requirements and authorities and 

clarifies Agency policy that sufficiently 

sensitive analytical test methods must 

be used when applying for an NPDES 

permit and when performing sampling 

and analysis pursuant to monitoring 

requirements in an NPDES permit. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rulemaking is not subject to 

Executive Order 13211, ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because it is not a significant 

regulatory action under Executive Order 

12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act (NTTAA) of 1995 (Pub. L. 104–113, 

section 12(d), 15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standard bodies. 

The NTTAA directs EPA to provide 

explanations to Congress, through OMB, 

when the Agency decides not to use 

available and applicable voluntary 

consensus standards. This proposed 

rulemaking does not involve technical 

standards. The proposed rulemaking 

does, however, clarify Agency policy 

based on existing regulations and 

authorities that sufficiently sensitive 

analytical test methods must be used 

when applying for an NPDES permit 

and when performing sampling and 

analysis pursuant to monitoring 

requirements in an NPDES permit. 

J. Executive Order 12898 (Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations) 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this 

proposed rule will not have 

disproportionately high and adverse 

human health or environmental effects 

on minority or low-income populations 

because it does not affect the level of 

protection provided to human health or 

the environment. As explained above, 

the Agency does not have reason to 

believe that the rule addresses 

environmental health and safety risks 

that present a disproportionate risk to 

minority populations and low-income 

populations. This proposed rule only 

interprets existing legal requirements 

and authorities and clarifies Agency 

policy as stated above. 


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List of Subjects 

40 CFR Part 122 

Administrative practice and 

procedure, Confidential business 

information, Environmental protection, 

Hazardous substances, Reporting and 

recordkeeping requirements, Water 

pollution control. 

40 CFR Part 136 

Environmental protection, 

Incorporation by reference, Reporting 

and recordkeeping requirements, Water 

pollution control. 

Dated: June 16, 2010. 

Lisa P. Jackson, 

Administrator. 

For the reasons set out in the 

preamble, title 40, chapter I, of the Code 

of Federal Regulations is proposed to be 

amended as follows: 

PART 122—EPA ADMINISTERED 

PERMIT PROGRAMS: THE NATIONAL 

POLLUTANT DISCHARGE 

ELIMINATION SYSTEM 

1. The authority citation for part 122 

continues to read as follows: 

Authority: The Clean Water Act, 33 U.S.C. 

1251 et seq. 

2. Section 122.21, is amended by 

adding a new paragraph (e)(3), to read 

as follows: 

§ 122.21 Application for a permit 

(applicable to State programs, see § 123.25). 

* * * * * 

(e) * * * 

(3) A permit application shall not be 

considered complete unless all required 

quantitative data are collected in 

accordance with sufficiently sensitive 

analytical methods approved under 40 

CFR part 136 or in accordance with 

another method required under 40 CFR 

chapter I, subchapter N or O. 

(i) For the purposes of this 

requirement, a method approved under 

40 CFR part 136 is ‘‘sufficiently 

sensitive’’ when: 

(A) The method minimum level (ML) 

is at or below the level of the applicable 

water quality criterion for the measured 

pollutant or pollutant parameter; 

(B) The method ML is above the 

applicable water quality criterion, but 

the amount of the pollutant or pollutant 

parameter in a facility’s discharge is 

high enough that the method detects 

and quantifies the level of the pollutant 

or pollutant parameter in the discharge; 

(C) The method has the lowest ML of 

the analytical methods approved under 

40 CFR part 136. 

(ii) When there is no analytical 

method that has been approved under 

40 CFR part 136, required under 40 CFR 

chapter I, subchapter N or O, or 

otherwise required by the Director, the 

applicant may use any suitable, 

sufficiently sensitive method but shall 

provide a description of the method that 

includes documentation of the ML. 

* * * * * 

3. Section 122.44 is amended by 

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

follows: 

§ 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 

in accordance with another method 

required under 40 CFR chapter I, 

subchapter N or O. 

(A) For the purposes of this 

paragraph, a method is ‘‘sufficiently 

sensitive’’ when: 

(1) The method minimum level (ML) 

is at or below the level of the effluent 

limit established in the permit; 

(2) The method ML is above the level 

of the effluent limit in the permit, but 

the amount of the pollutant or pollutant 

parameter in a facility’s discharge is 

high enough that the method detects 

and quantifies the amount of the 

pollutant or pollutant parameter in the 

discharge; 

(3) The method has the lowest ML of 

the analytical methods approved under 

40 CFR part 136. 

(B) In the case of pollutants or 

pollutant parameters for which there are 

no approved methods under 40 CFR 

part 136 or methods are not otherwise 

required under 40 CFR chapter I, 

subchapter N or O, monitoring shall be 

conducted according to a sufficiently 

sensitive test procedure specified in the 

permit for such pollutants or pollutant 

parameters. 

* * * * * 

PART 136—GUIDELINES 

ESTABLISHING TEST PROCEDURES 

FOR THE ANALYSIS OF POLLUTANTS 

4. The authority citation for part 136 

continues to read as follows: 

Authority: Secs. 301, 304(h), 307, and 

501(a) Pub. L. 95–217, 91 Stat. 1566, et seq. 

(33 U.S.C. 1251 et seq.) (The Federal Water 

Pollution Control Act Amendments of 1972 

as amended by the Clean Water Act of 1977.) 

5. Section 136.1 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 136.1 Applicability. 

* * * * * 

(c) For the purposes of the NPDES, 

when more than one test procedure is 

available under this part for the analysis 

of a pollutant or pollutant parameter, 

the test procedure selected shall be 

sufficiently sensitive as defined at 40 

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

[FR Doc. 2010–15254 Filed 6–22–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R01–RCRA–2010–0468; FRL–9166–6] 

Massachusetts: Final Authorization of 

State Hazardous Waste Management 

Program Revisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Commonwealth of 

Massachusetts has applied to EPA for 

final authorization of changes to its 

hazardous waste program under the 

Resource Conservation and Recovery 

Act (RCRA). EPA proposes to grant final 

authorization to Massachusetts. EPA has 

determined that these changes satisfy all 

requirements needed to qualify for final 

authorization, and is authorizing the 

State’s changes through an immediate 

final action. 

DATES: Comments must be received on 

or before July 23, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R01– 

RCRA–2010–0468, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: biscaia.robin@epa.gov. 

• Fax: (617) 918–0642, to the 

attention of Robin Biscaia. 

• Mail: Robin Biscaia, RCRA Waste 

Management Section, Office of Site 

Remediation and Restoration (OSRR 07– 

1), EPA New England—Region 1, 5 Post 

Office Square, Suite 100, Boston, MA 

02109–3912. 

• Hand Delivery or Courier: Deliver 

your comments to: Robin Biscaia, RCRA 

Waste Management Section, Office of 

Site Restoration and Remediation 

(OSRR 07–1), EPA New England— 

Region 1, 5 Post Office Square, Suite 

100, Boston, MA 02109–3912. Such 

deliveries are only accepted during the 

Office’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 


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