### 1



# National Pollutant Discharge Elimination System (NPDES): Use of Sufficiently
Sensitive Test Methods for Permit Applications and Reporting : EPA’s Response to Public Comments

U.S. Environmental Protection Agency

Water Permits Division Office of Wastewater Management

Office of Water 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

A ugust 6, 2014

### 2 FOREWORD

This document provides responses to all comments submitted on EPA ’s Proposed National Pollutant Discharge Elimination System (NPDES): Use of Sufficiently Sensitive Test Methods for Permit Applications and Reporting Rulemaking. EPA ’s Notice of Proposed Rulemaking was published i n the Federal Register on June 23 , 20 10 (75 FR 3 5712 )

. Submitted
comments are available electro nically through http://www.regulations.gov by searching Docket

ID No. EPA

- HQ

- OW

- 200 9

- 1019 and in hard copy at the EPA Docket Center Public Reading

Room

. The telephone number for the Water Docket is (202) 566

- 2426 and the telephone number for the Public Reading Room is (202) 566

- 1744. The Water Docket assigned a unique Document Control Number (DCN) to each comment submittal.

To organize the comments and to facilitate EPA ’s responses, c omments or portions of

commen ts are broken into comment excerpts

. The comment experts are organized in a table at the end of this document, and EPA ’s corresponding response code is provided immediately following the comment excerpt . EPA notes that many commenters raised similar or rel ated
issues

. In order to assist commenters, EPA ’s comment responses are organized into 18 different responses. Each comment excerpt is assigned a comment response code. EPA notes that the full record and response to comments for this action consists of all relevant information found throughout the response to comment document, preamble, and other supporting documentation

. EPA thus cautions commenters to read all of these materials to ensure that they are viewing the full Agency response to the issue raised.

The primary contact s regarding questions or comments on this document are :

Kathryn Kelley (202) 56 4

- 7004 (telephone)
David Hair (202) 56 4

- 2287 (telephone)

U.S. Environmental Protection Agency
O ffice of Water Office of Wastewater Management
Mail Code 4203M 1200 Pennsylvania Avenue, NW Washington , DC 20460

### 3



# Table of Contents

FOREWORD

................................ ................................ ................................ ................................ .. 2

Part I: List of Commenters

................................ ................................ ................................ .............. 4

Part II. Response Essays

................................ ................................ ................................ ................. 5

Part III. Comment Excerpts with Response Codes

................................ ................................ ....... 23

### Part I: List of Commenters

Docket Assignment
Number Commenter Name Total No.
Comments Comment ID

0005 Department of the Navy 2 A

- B

0006/0008 Pennsylvania Department of Environmental Protection (PADEP) 3 C

- E

0007 American Bottoms Regional Wastewater Treatment Facility 19 F

- X

0009 Anonymous Public Comment 1 Y

0010 King County Water and Land Resources Division 1 Z

0011 National Council for Air and Stream Improvement, Inc. 8 AA

- AH

0012 American Water 2 AI

- AJ

0013 Hampton Roads Sanitation District 17 AK

- BA

0014 Environmental Laboratory Advisory Board Federal Advisory

Commission 1 BB
0015 The Inter Industry Analytical Group 7 BC

- BI

0016 Metro Wastewater Reclamation District 6 BJ

- BO

0017 New Jersey Department of Environmental Protection 4 BP

- BS

0018 American Petroleum Institute 1 BT

0019 Ford Motor Company 5 BU

- BY

0020 Albuquerque Bernalillo County 7 BZ

- CF

0021 Oklahoma Department of Environmental Quality 12 CG

- CR

0022 West Virginia Municipal Water Quality Association 1 CS

0023 Alaska Oil and Gas Association 5 CT

- CX

0024 Virginia Association of Municipal Wastewater Agencies, Inc. 1 CY

0025 The Dow Chemical Company 6 CZ

- DE

0026 Wisconsin Department of Natural Resources 1 DF

0027 National Association of Clean Water Agencies 21 DG

- EA

0028 South Carolina Water Quality Association 1 EB
0029 Federal Water Quality Coalition 37 EC

- FM

0030 North Carolina Water Quality Association, Inc. 1 FN

0031 Maryland Association of Municipal Wastewater Agencies, Inc. 1 FO5 

### Part II. Response Essays

Response 1:

A few commenters indicated 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 incre ased

costs. EPA recognizes that the burden estimated is a national average and that the cost for an individual facility could be h igher or

lower than that average. However, EPA does not believe that the information provided by the commenters is representat ive of the

impact for a typical facility affected by this rule, nor does it alter the Agency’s original burden estimates. To assess the impact of this

final rule, EPA assessed the cost information for 40 CFR Part 136 methods found in the National Environme ntal Methods Index

(NEMI). 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 repor ted,

number of samples being analyzed). EPA’s review of the cost ranges provided in NEMI indicated that ther e 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 faci lities 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 exp ected to result in little or no new or

increased analytical burden to applicants or permittees.

EPA also recognizes that in some cases, use of a more sensitive method could have the practical effect of requiring a facilit y to

adopt additional pollution co ntrol 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 responsibl e for any6



### change in stringenc y 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 tr eatment is

req uired to meet the existing permit limit. In general, when EPA develops a cost analysis for a new regulation, there is an assu mption

made of full compliance with existing requirements. EPA does not have data that would allow it to predict in advance where o r 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

A few commenters claimed that EPA did not compl y with its requirements under the statutory and Executive Order reviews

contained in the proposed rule at 75 FR 35718. 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 following: (a) Executive Order 128 66:

Regulatory Planning and Review, (b) Paperwork Reduct ion 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 Government s,
(g) Executive Order 13045: Protection of Children Fro m Environmental Health and Safety Risks, (i) National Technology Transfer

and Advancement Act, and (j) Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and

Low Income Populations).

Response 2:

One commenter raised a concern about the potential costs to states to establish minimum levels. The rule does not require states to

develop or establish minimum levels as a result of the rule. EPA is aware that some states and regions, including EPA region 6, have

speci fied minimum levels in guidance or policy to assist their NPDES applicants and permittees. EPA, however, did not survey

regions or states to determine the exact numbers that have issued such guidance or policy. Because the rule does not require states to

d evelop minimum levels, EPA believes the issue raised by the commenter is outside the scope of this rulemaking.7



### Response 3:

Effect of the Rule on Current Practices

EPA received several comments that indicated the approach outlined in the proposed rule w ould 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 mini mum level (ML) 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 t he

permitting process. They indicated that there are other factors including accuracy, precisi on, selectivity, and whether the method has

been validated that should be considered.

I n response, EPA notes that applicants for NPDES permits have always needed to make decisions regarding which EPA

- approved

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 app ropriate for permittees to use to meet their monitoring and reporting requirements

under a NPDES permit. Today’s rule does not change the basic NPDES permit application or permit issuance process. Under 40 CF R

122.21, permittees seeking permit renewal or n ew 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 monit oring 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 p ermit.

To determine whether an EPA

- approved analytical method is “sufficiently sensitive” in any particular case, NPDES

applicants/permittees and permit authorities sh ould use the best information available on what the ML is for the method, and EPA

believes that in general a method’s accurate ML will be readily ascertainable. Where the ML is explicitly listed in the EPA

- approved8



### method, applicants may reference the publ ished ML 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 matrix specific met hod

detection limits and 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 MLs, the ML can be obtained or derived by the applicant or

permitting authority. Indeed, ma ny permitting authorities have developed guidance, policies or regulations that establish MLs for

various methods, or specify specific methods to be used by applicants and permittees. Where applicable, these policies and

regulations will continue to affec t 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 EPA

- approved

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 s ensitive”

method, the NPDES applicant should w ork 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 they exist, where necessary to perform sampling and analysis, consistent with 40 CFR 122.41(j) and 122.44(i).

Development of New or Alternate Test Procedures

EPA received several comments that indicated the proposed rule would require the development of new analytica l methods where

no EPA

- approved methods exist or where existing EPA

- approved methods would not quantify the pollutant concentration at or below9



### the level of the criterion or permit limit. Other commenters indicated that the rule would alter the existing re quirements 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 regulat ory requirements with respect

to unapproved methods. Where no EPA

- approved 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 Waste water) 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 EPA approved methods is uncommon because there are EPA

- approved methods for most pollutan ts or pollutant

parameters screened and regu lated 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 EPA

- approved 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 s pecifies

a method in the permit when there is no EPA

- approved method.

Where EPA

- approved methods exist, but non e 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. Ho wever, in

this situation, the rule will now re quire the use of the most sensitive of the EPA

- approved methods.

Finally, today’s rulemaking does not alter any of the existing requirements related to the development or approval of alterna tive

test procedures under 40 CFR 136.4 and 136.5.

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 appro priate method without adequate information upon which to base a decision.

Specifically, commenters indicated that issues related to the definition of the method minimum level (ML) would make this rul e
difficult to implement and that method sensitivity sho uld not be the sole factor in deciding which method should be used in the permit10



### 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

- EPA approved method exits. EPA agrees that other factors beyond the ML can also be important in determining

method performance, including a me thod’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 app ropriate 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 th ose
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 appl icants have

always had the option of providing matrix or sample specific minimum levels rather than the published levels and nothing in t oday’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 l ow a
minimum level as possible for those samples.

If the most sensitive method listed in 40 CFR Part 136 i s not performing adequately in a given wastewater matrix (e.g., sensitivity,

accuracy, and precision), several options are available and should be pursued. Dilution is often a good option if it does no t drive the

sample specific minimum level above the pe rmit 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 P roblems

with Clean Water Act Methods,” EPA 821

- R

- 07

- 002 (or more recent revisions) to determine if another cleanup procedure may be

appropriate. If a solution is still not apparent, the permittee should consult EPA or the permitting authority.11



### Based on data and information provided to EPA by anal ytical 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 specifie d in

the method. However, EPA acknowledges that while rare, situations may exist where a method cannot perform adequately in a

specific matrix. In response, EPA added a note in the regulation to clarify this issue. In such rare situations, the Director may

consider additional technical factors when determining w hether the method is still “sufficiently sensitive.” Specifically, where a the

permit applicant or permittees can demonstrate to the Director that despite a good faith effort to overcome these methodologi cal

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 th e 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 method s 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 EPA

- approved 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 suffici ently

sensitive method within the QA/QC spe cifications 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 EPA

- approved 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 r aised 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 i s not an

issue if the laboratory has demonstrated that it can achieve an ML for GC/MS that is lower than the NPDES permit limit for the12



### regulated parameter, in which case GC/MS would be considered “sufficiently sensitive”. EPA agrees that GC/MS is more selecti ve

than GC, b ut 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, g el

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 s uggest interferences are present. If the permit applicant or permittee is still concerned that the peaks may be caused by a

different contaminant, and is a false positive for the GC method, the permit applicant or permittee could use a GC/MS to conf irm 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. Then more sensitive GC/MS method options (e.g., larger sample volume, smaller final extract volume, selected ion

mon itoring 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 per mit tee 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 d ual

- column GC

creates false positive results for that specific matrix, then the Director would appropriately approve the selection of a di fferent EPA

approved method that would then be considered a sufficiently sensitive method (e.g., GC/MS).

As anothe r example, EPA also received comments specific to Method 1631 for mercury. These commenters noted the “clean”

sampling methods associated with this method to minimize potential contamination from the sampling technique itself are not p ossible

in many indu strial 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

techn iques, these techniques have been successfully used in some industrial settings. For example, sewage treatment plants accept ing

industrial wastewater have successfully eliminated permit exceedances for mercury as measured by Method 1631 by employing the

c lean sampling procedures. Where the permittee has documentation that clean sampling techniques cannot be adopted for the sit e

-13



### specific application, the Director would appropriately approve the selection of a different EPA

- approved method that meets the

de finition of a sufficiently sensitive method (e.g., the one with the lowest ML of the remaining EPA

- approved methods). If the

ambient level of mercury contamination at the site is too high to use clean sampling methods, then using a less sensitive EPA

appr oved 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 chlo ride 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 emp loy such

a sufficiently sensitive method where required unde r 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 Me thod

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 as the permittee should send their sample to a laboratory that can demonstrat e it has

control over sources of mercury wi thin its own environment.

Finally, where a technology based requirement is specified as “zero discharge” or “no detect” the permitting authority may ta ke

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 inco nsistent

with the technological basis of the original requirement. In situations where a tech nology 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 lev el 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.14



### Report of t he 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 (ML), tha t

are not defined in ne w 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 Quanti tation

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 is sues

in t he report. While several of these issues, such as the definition of ML, 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 appropr iate

for use when screening effluent for permit applications and as part of permit conditions. This has always been the case, rega rdless of

today’s rulemaking.

EPA believes that the requirements of the rule are adequately described and can be implemented w ithout having to address the

myriad of issues considered by the FAC. For today’s rulemaking, EPA is not redefining or establishing new method detection l imits

(MDLs) or MLs, developing new procedures for determining detection or quantitation, or maintaini ng a clearinghouse on detection

and quantitation issues. EPA considers such issues to be outside the scope of today’s rulemaking.

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 reg arding 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 ce rtified by

the state to conduct analyses.15



### 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 col lection

constraints wou ld not preclude the selection of a sufficiently sensitive method. The definition does not require the use of the most

sensitive EPA

- approved method available, so long as a less sensitive approved method still meets the criteria for being “sufficiently

sen sitive.” 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 definiti on o f

“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, chemica l, 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 speci fic method

in a given situation, or has technical questions on its use, it should consult with its permitting authority prior to conducting monitoring.

Response 4: Three commenters questioned whether EPA had omitted the word “or” when defining the term “sufficiently sensitive” in the

proposed rule at 40 CFR 122.21(e) (3) (i) (B) and 122.44(i) (1) (iv) (A) (2) (i.e., after the semicolon in the second to last item in the

series). EPA has corrected these inadvertent omissions in this rulemaking.

Response 5: EPA received a comment recommending that the Ag ency add the following language to the third criterion for sufficiently sensitive

at 40 CFR 122.21(e)(3)(i)(C) and 122.44(i)(1)(IV)(3) to read as follows: “The method has the lowest ML of the analytical meth ods

approved under 40 CFR part 136 for the measur ed pollutant or pollutant parameter . The commenter justifies this recommendation by

noting that EPA provides clarification that this is the case in the preamble to the proposed rule. EPA agrees that the sugges ted

language clarifies the Agencies intent. EPA has therefore revised the regulatory language in the final rule.16



### Response 6: EPA received one comment asking whether a laboratory would need to go through a demonstration pursuant to 40 CFR 136.6

before using a method for which the lab is able to achiev e a lower MDL and ML than specified in the approved method. EPA’s

response to this inquiry is that the rule does not change any alternative test procedures or requirements under 40 CFR part 1 36. If a

laboratory has already documented and received approval pursuant to 40 CFR 136.6 to modify a method and the lab achieves a lower

MDL and ML than is achieved by the promulgated method, then the MDL and ML from the modified method would be used to

determine whether the method is sufficiently sensitive as defined in the rule.

However, if the laboratory has not previously demonstrated the performance of a proposed method modification pursuant to 40

CFR 136.6, it would be responsible for doing so. The demonstration would be made to the applicable EPA Regional office per the

application requirements at 40 CFR 136.4.

Response 7: A few commenters asked to what extent the rule would affect recordkeeping and reporting requirements. The rule does not chang e
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.

Response 8: EPA received a comment relating to the permitting of nu trients when the nonpoint sources exceed point source contributions.

While EPA appreciates the concerns of the commenter, the issu es raised do not relate to the question of what the final provisions of

the sufficiently sensitive methods rule should be, and so are beyond the scope of this rulemaking.

Response 9: A few commenters raised issues pertaining to the rule’s impact on indirect dischargers. The rule affects only direct discharg ers
(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 and17



### regulations) require their indirect dischargers to achieve specific mi nimum 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 pretreatm ent

Control Authority, the specific requirements for analytical met hods can be specified in the control mechanism issued to the indirect

discharger.

Response 10: One commenter asked how an applicant would select a method where th ere is no water quality criterion established. If, in fact,

there is no applicable numeric wa ter quality criterion for the pollutant of concern, then any EPA

- approved analytical method would

meet the definition of "sufficiently sensitive.” While any of the EPA

- approved methods would satisfy the regulatory definition in this

situation, it may be p rudent for the applicant to contact the permitting authority to obtain guidance regarding the appropriateness of a

particular method.

Response 11: A few commenters asked whether the rule alters existing permit requirements. The rule itself does not modify the terms or

conditions of existing NPDES permits. If, under the requirements of this rulemaking, a change needs to occur in the analytica l

methods specified in an existing permit, that change would occur at the time of permit renewal, or could also occur thr ough a permit

modification (where provided for by 40 CFR 122.62 and the procedures of 40 CFR Part 124, or analogous provisions in the laws and

regulation of authorized states).

A few commenters asked whether existing data (collected using insuff iciently 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 r ule , or, if

applicable, after an authorized State has revised its reg ulations to adopt the provisions of the rule, 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 deter mine whether18



### it has information adequate to de velop 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 suffic iently

sensitive EPA

- approved metho ds. 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 be fore considering an application complete.

Response 12: A few commenters expressed confusion as to the effective date of the rule. EPA’s response is that the effective date of the f inal

rule as stated in the preamble, is 30 days after publication in the Fe deral Register However, 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 n eeded, as

provided at 40 CFR 123.62.

Response 13:

EPA received two comments indicating that the reference made on 75 FR 35716 of the proposed rule to EPA’s website as a means

of keeping permitting authorities and permittees informed of method updates and revised water quality criteria is irrelevant for states

that hav e adopted their own water quality criteria. The purpose of this discussion is to keep NPDES permittees and permitting

authorities informed when there are changes in EPA

- approved methods so that sufficiently sensitive methods are used in the NPDES

applicati on and permit monitoring/reporting processes at all times. EPA agrees that this will not provide updates to state programs

and recommends that applicants and permittees contact their states for the most up to date information on any state program u pdates.

Response 14: 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 commen ters requested that

the criteria defining sufficiently sensitive be revised such that the ML would be compared to either "the applicable water qu ality

criterion, wasteload allocation, permit limit, or other critical regulatory value."19



### The pollutant scree ning data submitted with an NPDES permit application are used for a variety of purposes by EPA and State

permitting authorities. One important use of the data is to determine whether any pollutant or pollutant parameter present i n the

discharge will cause , have a reasonable potential to cause, or contribute to an excursion above any state water quality standard [see 40

CFR §122.44(d) (1)]. This determination is often referred to as the permitting authority’s “reasonable potential” analysis..

In conducti ng a reasonable potential analysis, the permitting authority may consider the dilution of the discharge provided by the

receiving water [see 40 CFR §122.44(d)(1)(ii)]. However, many factors limit the availability of a dilution consideration, in cluding,

bu t not limited to the following: (a) presence of the pollutant or pollutant parameter upstream of the discharge (i.e., the amb ient

concentration of the pollutant), (b) presence of non

- motile organisms near the discharge point, (c) proximity of a drinking wa ter intake

or recreational area, (d) limitations within State water quality standards for certain classes of pollutants (e.g., bioaccumu lative

pollutants), and/or (e) low flow conditions at or near zero. Where these situations exist, little or no dilution may be available, and the

applicable water quality criteria must be met at the point of the undiluted discharge.

When performing pollutant analyses for a permit application, a new discharger or a discharger seeking renewal of its permit w ill

generally n ot have information available to know whether, or what quantity of, dilution may be available for consideration by the

permitting authority during the reasonable potential evaluation. Even if a dilution allowance was quantified and granted dur ing the

prev ious permit term, there is no assurance that the conditions noted above are the same as during the previous analysis conducte d by

the permitting authority. Because the pollutant

- specific dilution allowance is not generally known prior to sampling for the permit

application, it is generally necessary that the data provided be at or below the applicable water quality criteria (without a ccounting for

any dilution).

EPA believes that the final rule need only require comparison of a method’s ML with the applica ble water quality criterion, as

proposed, and that this language is sufficiently flexible to address the commenters’ concern. Under this language, the permi tting

authority has adequate discretion to determine whether the data provided with a permit applic ation were collected with methods that

are sufficiently sensitive to measure at the relevant regulatory value. For example, where a permitting authority has conduc ted a20



### timely and relevant dilution analysis (including an evaluation of ambient pollutant co ncentrations) and documented this analysis in the

permit record, the permitting authority could provide this information to the applicant prior to the applicant sampling for t he permit

application. The applicant would then only need to show that the metho d it has selected has an ML that is at least as sensitive as

necessary to determine compliance with the water quality criterion, after accounting for allowable dilution. The water qualit y criterion

as adjusted for allowable dilution would be the “applicabl e 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 reg ulatory text to incorporate the language suggested by the commenters.

Response 15: Two commenters asked EPA to explain what it means by “method is otherwise required by the Director” in 40 CFR §

122.21(e)(3)(ii) of the proposal. This language is intended t o address situations there are no EPA

- approved methods, and the State has

regulations that require NPDES applicants to use a specific analytical method or achieve a specific minimum level for a parti cular

pollutant (or they have a state policy or guidance that recommends a specific method or minimum level). In these cases, an applicant

should consult with the State to ensure they are meeting all existing State requirements. Where an NPDES applicant intends to

perform analyses for a pollutant or a pollutant parameter for which there is no analytical method approved under 40 CFR part 136, and

the State has not specified a particular method to be used, the existing regulations require that the applicant work with its laboratory to

identify the methods that are “suitable” for the purposes of the screening effort.

Response 16: Two commenters indicated that the rule requires the use of “suitable” unapproved methods in some circumstances. The

commenters asked EPA to define “suitable.” This term is in the existing re gulations, and is not redefined or otherwise affected by this

rulemaking. Therefore, this comment is beyond the scope of this rulemaking.21



### Response 17: One commenter asked EPA to add the words “or specified” after “required” at 40 CFR 122.21(e)(3)(ii) and 40 CFR

122.44(i)(1)(iv)(B) to clarify that test methods that are specified in applicable effluent limitation guidelines, new source performance

standards, or sludge standards are sufficient for compliance purposes. EPA believes that the existing langua ge already addresses

situations where a method is specified in an effluent guideline, new source performance standard or sludge standards by indic ating that

an applicant must use a method that has be approved under 40 CFR 136 or “in accordance with another method required under 40

CFR chapter I, subchapter N or O” and that the suggested revisions are not needed.

Response 18: One commenter expressed concern regarding the language at 40 CFR 122.21(e)(3)(ii), which states the following: “When there is

no ana lytical 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 des cription of

the method that includes documentation of the ML.” The commenter suggested that, where there is no EPA

- approved method the

Director should specify a suitable, sufficiently sensitive method to applicants. EPA concurs that there are certainly situat ions in whi ch

states may aid applicants by specifying a suitable method when there is no 40 CFR part 136 method available. However, this

regulation does not require the Director to provide a list of methods to an applicant. Where an NPDES applicant intends to pe rform

analyses for a pollutant or a pollutant parameter for which there is no analytical method approved under 40 CFR part 136, the existing

regulations require that the applicant work with its laboratory to identify the methods that are “suitable” for the purp oses of the

screening effort.

The commenter also raised a concern regarding the proposed regulatory text at 122.21(e) (3) (ii) and 122.41(i )(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 permitti ng authorities select a

“sufficiently sensitive” non EPA

- approved method and that applicants provide a description of the method, including the minimum22



### level. The situation in which there are no EPA

- approved methods is uncommon because there are EPA

- approv ed 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 these comm ents, EPA determined that

this additional requirement was unnecessary and has revised the regulatory text to reflect the existing language in 40 CFR 12 2.21 and

122.41. As such, today’s rule does not specify non

- EPA approved methods mus t be sufficiently sen sitive. 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 metho d applies

“except as specified in 122.21(e)(3)(ii).” Finally, EPA amended 122.21(e)(3)(ii) by ad ding regulatory text to clarify that in the case

where there are no EPA

- approved methods, applicants may consider other relevant factors to assess the performance of the method

(e.g., precision, accuracy, or resolution ) when selecting an appropriate method

.23 

### Part III. Comment Excerpts with Response Codes

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

0005 Department of the Navy

Clean Water Act Services Steering Committee (CWA

SSC) Donald R. Schregardus Deputy Assistant Secretary of the Navy (Environment) A Comment #1. EPA's definition and determination procedures for method "sensitivity" within the text of the proposed rule may need some revision in order to ensure a high data quali ty. The proposed rule does not require that permittees determine and report that determination of precision and bias of the "quantitation limit", "reporting limit", and "minimum level". In order for data to be considered reliable enough to utilize in

comp arative analysis and in decision making, "quantitation limits" or "minimum levels" should have an associated precision and bias. Additionally, setting a 'quantitation limit" or "minimum level" at the lowest calibration standard or multiple of the MDL may n ot be a scientifically valid means of determining test sensitivity. EPA's MDL procedure has been criticized as a poor estimator of the Detection Level (DL) for failing to account for analytical bias, for assuming uniform variance across all possible spike concentrations, failing to account for the fact that variance increases at higher concentrations. To judge that sufficiently sensitive test methods are being used, NPDES test methods should be robust enough to produce quantifiable data at values less than the required permit limits. Given that currently there are no universally accepted statistical procedures for estimating test sensitivity, EPA should provide guidance for determining the acceptability of the minimum levels in relation to the water quality criterion or permit limit in order to reduce confusion in implementation of this proposed rule.

Recommendations: Recommend that the concept and procedures in EPA's "Guidance on Systematic Planning Using the Data Quality Objectives Process" (EPA

- QA/G

- 4) b e followed to determine sufficient test methods. (p. 2 of comments) See Response
3

0005 Department of the Navy

Clean Water Act Services Steering Committee (CWA

SSC) Donald R. Schregardus Deputy Assistant Secretary of the Navy (Environment) B Comment #2. The use of the "most sensitive" approved method is not adequate for data quality and usability assessments unless the associated precision and bias data is included. In addition, a lower "minimum level" is not necessarily more precise than a higher "minim um level". Data precision and bias associated with the "minimum level" must be considered when assessing data quality and when using that data to make decisions. Specific requirements for method sensitivity should be determined on a case

by

- case basis in o rder to ensure that the test methods meet project requirements for reporting quantitative data with known precision and bias. Because of the complexities and room for error, EPA should provide guidance to assist permittees in choosing scientifically valid methods to determine test sensitivities. See Response
324

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

Recommendation: Recommend that EPA consider using scientifically valid detection and quantitation methods similar to those described in the "DoD Quality Systems Manual for Environmental Laboratories (V4.1). (p. 3 o f comments) 0006, 0008 Pennsylvania Department of

Environmental Protection (PADEP) Sean M. Furjanic, MS,
PE/Chief NPDES Information Analysis

Section C Comment #1 In general, PADEP agrees with the rationale for the rule changes but
believes EPA should concurrently establish technology

- based minimum levels and be cognizant of state programmatic issues with laboratory accreditation. (p. 1 of comments) See Response
3

0006, 0008 Pennsylvania Department of

Environmental Protection (PADEP)
Sean M . Furjanic, MS,
PE/Chief NPDES Information Analysis

Section D Comment #2. EPA should establish minimum levels. EPA acknowledges that some states have established required minimum levels for parameters. PADEP has not, but is wrestling with this issue now. We believe other states are in the same position. As noted in the docket, establishing required minimum levels i s important for both assessing NPDES permit applications and evaluating compliance, including the treatment of "non

detect" results. If the rule changes were to take effect tomorrow, permit writers in PA would not have the tools, i.e., method

- specific mi nimum levels, needed to implement the new requirements. By default, the practice in PA has often been to use Method Detection Limits (MDLs) as published in 40 CFR Part 136 as the minimum levels for permits. To change this approach we will need to have publ ished minimum levels. We find no reason
that EPA could not set method

- specific minimum levels on a national level. Determining such levels relies not on water quality criteria, which could vary across the states, but on analytical technology. We urge you to form a workgroup with state members to develop
these levels as an amendment to 40 CFR Part 136

. We would anticipate delays in implementation and inconsistencies between states that confound permit reviews by EPA staff if the development of minimum level s is left entirely up to states. (p. 1

- 2 of comments) See Response
3

0006, 0008 Pennsylvania Department of

Environmental Protection (PADEP) Sean M. Furjanic, MS,
PE/Chief NPDES Information Analysis

Section E Comment #3

- Clarification Requested in Situations Where No EPA

- Approved
Method Exists PADEP is concerned about how this rule would be applied in instances where no EPA

approved method exists for a parameter, with respect to the accreditation process for laboratories analyzing NPDES samples.

PA DEP's Laboratory Accreditation Program evaluates and accredits all laboratories analyzing samples for NPDES facilities in PA. We are concerned that PADEP laboratory accreditation officers could be forced to make determinations of a method's suitability for See Response
3 and Response 1825

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

meeting the "sufficiently sensitive" definition where no EPA

- approved method exists. If such determinations must be made by PADEP staff, then we are concerned that this would present an increased workload on already strained resources.

In addition, PADEP seeks clarification on how the use of sufficiently sensitive methods by a laboratory will impact the process of the laboratory's accreditation. (p. 2 of comments)

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager F Comment #1

- Desirability of quantitative data for the purposes of permitting and compliance reporting. We support the concept that data used for the purposes of permitting and compliance should be adequa te to provide quantitative results to provide meaningful permits and reliable compliance determinations. (p. 1 of comments) EPA acknowledges
the comment.

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson
Environmental Compliance Manager G Comment #2

- Use of minimum level (ML) as threshold for quantitative
determinations. We note that NELAC requires the use of limit of quantitation (LOQ), not ML, for laboratory certification requirement and these LOQs are often displaye d on the laboratory report. While the purposes of the LOQ and ML are similar, the method of determining the value of an LOQ is different. (http://www.nelac

institute.org/docs/2003nelacstandard.pdf, appendix C and D of section 5.) The use of two
methods for determining the quantitation threshold is likely to create confusion. We request that EPA clarify whether MLs must also be provided on the laboratory's report or whether LOQs can be used in lieu of MLs. (p. 1 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager H Comment #3

- Non

- applicability to whole effluent toxicity methods. We support the

non

- applicability to whole effluent toxicity testing. (p. 1 of comments) EPA acknowledges
the comment.

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager I Comment #4

- Applicability to indirect dischargers. It's not entirely clear whether the ML requirement is intended to apply to indirect discharges to POTWs. The description in
Table I

- 1 does not refer to indirect dischargers, but the preamble refers to subchapter N which includes pretreatment standards for direct and indirect discharge standards. The
rule or preamble should be clear as to whether the rule applies to the pretreatment program monitoring conducted for compliance with Part 403. Because of the challenges associated with industrial discharge matrices, we believe that the option to require the
achi evement of MLs below regulatory limits should be left to the discretion of the
POTW. (p. 1

- 2 of comments) See Response

926

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager J Comment #5

- Applicability for non

- WQBEL parameters. Monitoring is sometimes required in an NPDES permit for parameters for which numeric WQBELs are not specified in the permit. A condition may be included in the permit which states that the permittee may not cause a violation of instream standards. In the case of our facility's NPDES permit, there are dozens of compounds for which quarterly monitoring is required and which have state water quality standards but for which no numeric WQBELs are included in the permit. In such a case, does the ML requirement apply or does the ML requirement apply only to those parameters which have specific numerical effluent limits and for which monitoring results are required to be reported on the DMR? Our view is that the ML require ment should only apply to parameters with explicit numerical limits which are reported on the DMR. (p. 2 of comments) See Response
3 and Response 11

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager K Comment #6

- Applicability for NPDES permit application. We understand that EPA intends that the data required to be collected for the NPDES Permit application

-- typically three pollutant scans

-- should meet ML requirements. However, more data tha n the required three scans is often available from the four and one

- half year period of record used for permitting. If non

- detectable data or data below the ML is collected during the term of a permit, but the most sensitive method is not used, must that data be excluded
from consideration for NPDES re

- permitting if the water quality standard is below the ML of the method used? We believe that it is appropriate to allow the permit writer to use all the data collected during the term of the permit in addit ion to the data required to meet the minimum data requirements for the permit application and request that EPA clarify in the rule or preamble that this is allowed. (p. 2 of comments) See Response

11

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager L Comment #7

- Location of definitions. The definition of ML is provided in a footnote. Since the definition of ML is central to the application of the rule, the definition should be clearly establ ished within the body of the rule. (p. 2 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager M Comment #8

- Definition of ML. The first sentence of the definition in footnote 4 provides that the ML is the maximum of (1) the lowest calibration standard and the (2) MDL multiplied by a factor. The second sentence provides four options: (1) ML published in a method, (2) lowest calib ration point used in the laboratory, (3) published MDL multiplied by a factor, (4) laboratory MDL multiplied by a factor. In the second sentence, there is no indication of how the maximum is to be applied when the published ML is used. We interpret this language to mean that the ML can be either the ML published in the method or the maximum of the lowest calibration standard and the MDL (either laboratory specific or method) multiplied by a factor. We support the flexibility See Response
327

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

that EPA intends to provide i n determining the ML, but request that EPA clarify the language in the ML definition in the final rule. (p. 2

- 3 of comments)

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager N Comment #9

- MDL multiplied by a factor. The reference to the factor to be applied to the MDL to calculation the ML is obscure. It should not be necessary to refer to footnotes to Federal Register publications from more than ten years ago to determine how to perform this calculation. The documents do not appear to be in the rule docket. EPA should incorporate the information explicitly in Part 136. (p. 3 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager O Comment # 10

- Lowest acceptable calibration point. The definition in footnote 4 refers to the lowest "acceptable" calibration point. EPA should provide clarification as to the criteria it intends to be applied to a calibration point to make it "acceptable". (p. 3 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager P Comment #11

- Different determinations of ML. Due to the flexibility EPA provides in the determination of ML, more than one ML can be determined for a method. As a permittee, we are concerned about the potential for being "second

- guessed" by others after the fact. We request that EPA clarify in the preamble to the final rule that it is expected that the party doing the monitoring will make the determination. (p. 3 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager Q Comment #12

- Reporting levels/dilution adjusted MLs. Laboratories often use the term "reporting level" to refer to dilution

- adjusted MDLs or LOQs. In determining compliance with the requirements of this rule for NPDES purposes, is sample dilution to
be considere d? The definitions refer to the "method" minimum level. If the method ML is sufficiently low, but a particular sample is diluted after an analysis was attempted undiluted (perhaps for the removal of interferences) such that the dilution

- adjusted ML is
ab ove the regulatory limit, are the requirements of the rule met? (p. 3 of comments) See Response
328

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager R Comment #13

- Preferential use of GC vs GC/MS data. In many cases

-- PCBs, pesticides and other organics

-- the GC/MS MDLs are not sufficiently sensitive to detect the level of the water quality standard. In the case of most organics, there is an approved gas chromatography (GC) method which provides a lower detection limit than the approved GC/MS method. In the case of many organic parameters, the ML rule could trigger a requirement to change from GC/MS to GC methods. This would be undesirable. GC/MS provides a much greater degree of confidence in t he correct identification of the regulated parameter. Although use of dual columns in GC methods reduces uncertainty in the identification, GC/MS methods provide much greater confidence in the correct identification of organic parameters. The value of mo re sensitive quantitation is lost if one is not certain what is being quantified. The tables attached provide examples of some organic compounds which would fall into this category. In these cases, USEPA's criterion concentrations (http://www.epa.gov/wa terscience/criteria/wqctable/) were used as the regulatory level and the ML was determined as 3.14 times the published MDL. As can be seen, there are numerous cases in which a GC method might be considered the most sensitive method and its use required by the proposed rule. We believe that the sufficiently sensitive method rule should recognize the superiority of GC/MS methods to GC methods and provide an exception to the sufficiently sensitive methods rule for the
case of less sensitive GC/MS methods. ( p. 3

- 4 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager S Comment #14

- Multiparameter methods with similar detection limits. For multi

parameter approved methods which utilize similar technology with similar MDL/MLs (e.g. 624, 1624, 6210B 18th), is an analyte

- by

- analyte comparison necessary to determine the appropriate method? This would be a significant administrative difficulty and cost
increase if POTWs would h ave to divide one analysis into two or three because parameters have slightly different MLs. (p. 4 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager T Comment #15

- Multi

- parameter scans: GC vs GC/MS. Referring to Table 2, there are eight separate GC methods (604, 605, 606, 607, 609, 610, 611, 612) for the same parameters encompassed into one GC/MS method (625). As discussed above, the requirements of the draft rule appear to potentially require the use of multiple GC methods instead of or in addition to a single GC/MS method. This represents a significant administrative burden and cost increase. We believe the sufficiently sensitive methods rule should provide an e xception for GC/MS methods. (p. 4 of comments) See Response
329

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager U Comment #16

- Availability of method. Not all approved methods are available commercially. For example, we recently tried without success to identify a laboratory to perform method 603 for acrolein since method 603 is more sensitive than method. We recommend that the rule should provide an exception for sensitive methods which ar e not commercially available to prevent creating an obligation for regulated entities to fund laboratories to provide those analytical services. (p. 4 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager V Comment #17

- Centralized source of ML information. We recommend that USEPA provide a centralized source of ML information to allow for ready application of the rule. (p. 4 of comments) See Response
3

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance Manager W Comment #18

- Effective date. For NELAC and other laboratories, inclusion of ML information in data systems and reports will require significant time and resources to implement. We suggest an effective data at least 18 months after publication of the final
rule. (p. 4 of comments) See Response

12

0007 American Bottoms Regional

Wastewater Treatment Facility Kay E. Anderson Environmental Compliance

Ma nager X Comment #19

- Reporting of data below ML on DMR reports. Instructions for DMR reporting address the reporting of data below the MDL. The rule is silent on the communication of ML information on the DMR or NPDES application. We request that
EPA c larify in the preamble to the rule that there is no ML reporting obligation on the DMR or NPDES application. (p. 4 of comments) See Response
3 and Response 7

0009 Anonymous Public

Comment Y Comment #1 Is the EPA going to provide the minimum level (ML) that must be achieved for the pollutant or are States required to develop a list of ML [sic] that must be obtained by the pe rmittee. The methods available under 40 CFR Part 136 do not list a ML
for each me thod and pollutant in most cases. (p. 1 of comments) See Response
330

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

0010 King County Water and

Land Resources Division King County Environmental

Lab
Colin Elliot QA Officer Z Comment #1 We understand and agree with the rationale for using methods sensitive enough to meet permit requirements. We are however, concerned about how the proposed policy will be implemented. In particular, we have concerns with the use of the term Minimum Level (ML) and if the descriptions in footnote #4 and #6 in the Fe deral Register announcement will be applied to all chemical

- specific NPDES testing. We believe these definitions are inadequate or inappropriate for many of the methods approved for NPDES testing. Without detailed and appropriate definitions that are wid ely applicable to methods allowed for NPDES testing, it will be difficult for labs and permittees to comply with the proposed policy.

The deficiencies and limitations of the current approved methods for establishing the method detection limit (MDL) and th e lack of a program

- wide definition of a Quantitation Limit or Minimum Level have already been well documented by the EPA. There are a number of contradictory EPA definitions and conditions of compliance surrounding the ML. For instance, the background i nformation in the Federal Register announcement states that the ML is NOT a quantitation limit while the ACIL Environmental Services Section Technical Committee states that it is. ACIL is also recommending using a different statistical
calculation to deri ve MDLs and MLs than the current 40 CFR calculations.

In footnote #4, a calibration standard at or below the ML must be included in the calibration curve. This would not be appropriate for some EPA

- approved methods. An example is EPA
Method 200.07 where the ML would be unreasonable high since calibration must be done using a high level, single point standard. IF the single point standard were set at the true ML concentration, the instrument would not be properly calibrated (see section 11.4.4 of Metho d 200.7). The goal should be to prove that the method is valid at the ML. Depending upon the method and instrumentation being used, there are a variety of options that should be allowed. For instance a good approach to verifying quantitation limits are found in the SW

- 846 Method 6020A where a low level standards is used to verify the level and must pass between 70

- 130%.

It is our understanding that the most recent efforts to update procedures for determining the MDL and ML have not yet been completed. It also isn't clear if a program

- wide definition has yet been established for the ML. A more

- complete definition and approved procedures for determining and verifying the ML should be established before the term is implemented for regulatory compliance purposes. We suggest that the sufficient sensitivity policy be implemented provided that the EPA expedites promulgation of procedures to establish and verify MDLs and MLs for all chemical

- specific methods. Since all chemical disciplines can differ, havin g options for determining the MDL and ML is key to the success of a program

wide procedure. In some cases the MDL/ML determinations must be done by looking at a combination of 40 CFR Part 136 Appendix B as well as ACIL method. See Response
331

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

References:

- Revised Assessment of Detection and Quantitation Approaches, EPA

- 821

- B

- 04

- 005.
October 2004

- Report of the Federal Advisory Committee on Detection and Quantitation Approaches and Uses in Clean Water Act Programs, December 2007 (p. 1

- 2 of comments)32

Docket Assignment
Number Commenter Comment

ID Comment(s) Text as it appears in correspondence to EPA Response
Code

011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AA Comment #1. In general, although it seems intuitively obvious, it is appropriate to use an analytical method that is sufficiently sensitive provided it meets the other performance characteristics required of a regulatory compliance method. Thus, clarification of sufficient sensitivity is useful, if done correctly. The idea that a permittee or state agency
does not have to use a more sensiti ve method if the analyte is present within what is considered to be the range of acceptable performance of a method that might otherwise be considered less sensitive is also reasonable and appropriate. However, other method performance factors must also b e considered.

On page 35715 of the Federal Register notice, EPA states: "It is critical, therefore, that applicants provide data that have been measured with precision and accuracy so that they will be meaningful to the decision making process."

And:

"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 poll utant in an applicant's discharge." In the same paragraph the notice goes on to state: "Moreover, if the Director were to include imprecise analytical methods for compliance monitoring puposes, the use of such methods could result in undetected exceedance s of permit
limits."

We agree that these considerations are critical to sound regulatory decision making and are appropriate analytical methodology. However, the proposed regulation changes outlined in the Federal Register notice fail to adequately imple ment these criteria. (p. 1

- 2 of comments) See Response
3

011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AB Comment #2. The first problem with the proposed regulations is that they fail to establish a common scientifically sound basis for comparing performances of different methods. The proposal would require that the Minimum Level be used as the basis for comparison and evaluation of suitability for a given purpose. However, in footnotes 4, 5, and 6 EPA goes on to indicate that Minimum Level can be established in a multitude of different ways. This effectively renders the term Minimum Level meaningless. Comparing a method with a Minimum Level based on the lowest calibration point to a me thod with a Minimum Level based on a multiple of the method detection limit (MDL) is meaningless. Adoption or acceptance of multiple definitions of the Minimum Level is not a suitable See Response
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means for establishing which method is sufficiently sensitive because t here is not a common basis for comparison.

We recommend that as a starting point EPA establish a single, well defined, and technically sound definition and determination procedure for the Minimum Level. In 2005 EPA convened the Federal Advisory Committ ee for Detection and Quantitation's approaches and their use in the Clean Water Act Program (FACDQ) to provide consensus input on, among other issues, an appropriate definition and means of determining a quantification level. We recommend that EPA impleme nt the recommendations of that committee and use them as the basis for establishing a common, defensible means of comparing the sensitivities of different analytical protocols (see Report of the Federal Advisory Committee on Detection and Quantitation App roaches and Uses in Clean Water Act Programs (December 2007)). (p. 2 of comments)

011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AC Comment #3. The second major problem with the proposed regulations and the multiple definitions of the Minimum Levels is that most, if not all, of those definitions fail to address accuracy or precision, which EPA has stated is a critical component of regulatory decision making. Multiplying an MD L by a factor (e.g., 2.18, 5, or 10) does not assure achievement of any particular degree of accuracy or precision. Thus, comparing methods with Minimum Levels defined in different ways or in the ways EPA has identified does not allow meaningful considera tion of accuracy and precision in evaluating which methods are "sufficiently sensitive." Again, we recommend that the EPA adopt and implement the recommendations of the FACDQ prior to implementing the proposed regulations regarding determination of suffic ient sensitivity. (p. 2

- 3 of comments) See Response
3

011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AD Comment #4. It is generally recognized that analytical method performance begins to decline at the extreme lower range of applicability and eventually gets to a point where data may not be of suitable quality to support decision making. In the most general sense, it is this understanding that supports the utility of the term quantitation limit. Thus, evaluations of the suitability of a method is sufficiently sensitive must involve consideration of the lowest concentration at which the required accuracy and precision can be achieved. This is a clear example of the importance of EPA following its own guidelines and establishing Measurement Quality Objectives (MQOs; see EPA Guidance for the Data Quality Objectives Process (EPA QA/G

- 4) at pages D

- 2(EPA/600/R

- 96/055 Augus t 2000 ) that must be met for Clean Water Act regulatory compliance testing. Established MQOs and the method for determining quantitation levels recommended by the FACDQ would form a sound and meaningful basis for comparing methods that would
account for a ccuracy, precision, and sensitivity and thus sufficiency for permitting

purposes. (p 3 of comments) See Response
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011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AE Comment #5. Another major shortcoming of the proposed changes to the regulations is that they fail to consider the actual performance of methods on real world samples and that matrix effects may limit sensitivity in ways not accounted for when a Minimum
Level is estab lished. Almost all MDLs are determined on reagent water, and any of the proposed definitions for the Minimum Level that involve use of the MDL as a starting point are therefore also based on reagent water. Minimum Levels defined as the lowest
calibration point even go so far as to exclude performance of isolation, concentration, and /or cleanup steps in the procedures, and certainly do no consider matrix effects. For example, while on paper Method 608 may appear to be the most sensitive method for

many o f the analytes named in it, when applied to a real world matrix it is highly prone to false positives and/or high biases because it lacks selectivity. If EPA plans to proceed with regulations requiring use of "a [sufficiently] sensitive" method, it must i nclude provisions for addressing method performance in real world samples. To do otherwise risks developing critical regulatory decisions on potentially faulty or unreliable data. (p. 3 of comments) See Response
3

011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AF Comment #6

. The proposed "sufficiently sensitive" regulations also address situations
where EPA has no t promulgated method s for an analyte. Section 122.44(i) (1) (iv) as currently written requires that if there is no approved Part 136 method, monitoring must be conducted according to a test procedure "specified in the permit" [40 CFR 122.44(i) (1) (iv) (2009), 122.21(j) (4) (viii)]. The only stipulation EPA provides is documentati on of the Minimum Level [at 122.21(j) (4) (viii) (D)]. The requirement to use a suitably sensitive method as defined in the Notice is problematic for the reason stated above (i.e., it does not consider accuracy, precision, selectivity), does not define or characterize the appropriate degree of validation the method should be subjected to, and creates the burden of developing a "sufficiently sensitive" method on either the state or the permittee. It is quite possible that it may not be technically feasible to develop methods with "sufficient sensitivity" using current technology for analytes with extremely low water quality standards creating the problem where compliance with a legally enforceable provision is not possible. (p. 3

- 4 of comments) See Response
3

011 National Council for Air

and Stream Improvement,

INC. West Coast Regional Center Larry LaFleur
NCASI Fellow AG Comment #7. EPA's established Alternate Test Procedure (ATP) provides a framework
for method validation that would and should be applicable to situations where there are no sufficiently sensitive and approved methods. EPA should establish the MQOs required for the proposed testing, then use the levels of validation required of ATP petitioners to validate that those criteria are met (e.g., multi

- laboratory testing for a specific matrix for statewide application, and multi

- laboratory, multi

- matrix testing for nationwide application). (p. 4 of comments) See Response
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011 National Council for Air

and Stream Improvement,

INC.

West Coast Regional Center Larry LaFleur
NCASI Fellow AH Comment #8. EPA should not mandate use of a "sufficiently sensitive" method where a promulgated method does not exist, but should instead require use of the most sensitive method available that has underg one the required validation (and meets the required accuracy, precision, and selectivity and performs adequately on the subject matrix). Ideally, this
would be a method that is "sufficiently sensitive" but in situations where technology may
limit the abil ity to achieve the required sensitivity this would still allow permits to be
issued. (p. 4 of comments) See Response
18

0012 American Water

Matthew J. Corson, P.E. Manager Environmental Compliance and Stewardship AI Comment #1.
American Waterworks supports EPA's position "that NPDES applicants and permittees must use sufficiently sensitive analytical methods when quantifying the presence of pollutants in a discharge" (page 35713). This includes using a method with a low enough
minimum detection lim it to allow a permittee to meet a discharge limit or an applicant to meet data request from the regulator. (p. 1 of comments) EPA acknowledges
the comment.

0012 American Water

Matthew J. Corson, P.E. Manager Environmental Compliance and Stewardship AJ Comment #2. However, American Water is concerned with the increased focus on reducing nutrient levels from an individual point source when there are often other sources in the watershed contributing much higher levels. Reducing wastewater treatment plant discharge limits to the nanogram per liter level does very little to protect a watershed when non

- point source contributions result in receiving stream levels being measured in micrograms per liter or even milligrams per liter.

According to EPA's Han dbook for Developing Watershed Plans to Restore and Protect

Our Waters : "A watershed management plan defines and addresses existing or future water quality problems from both point sources and nonpoint sources of pollutants. Experience over the past dec ade has shown that effective watershed management includes active participation from stakeholders, analysis and quantification of the water quality goals, and implementation of specific actions needed to solve those problems." American Water supports thi s approach and suggests that in many cases resources would be better spent implementing a watershed management plan than installing additional treatment to reduce nutrient discharges to levels that can be one or more orders of magnitude below the levels in the receiving stream. (p. 1

- 2 of comments) See Response
8

0013 Hampton Roads Sanitation

District
Technical Services Division AK Comment #1. It seems inappropriate to use the ML as a regulatory decision point given
the current ML definition (3.18 x MDL) and MLs used in 40 CFR Part 136 methods are recognized to be flawed by all stakeholders including the states and EPA. Further, the Federal Advisory Committee (FAC) on Detection and Quantitation has made See Response
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James J. Pletl, Ph.D.
Chief recommendations to EPA o n how to address the ML definition but EPA has yet to address those recommendations in a rulemaking. EPA states that it is critical that it make permitting decisions based on sound science, but the use of the current ML definition has already failed that standard. (p. 1 of comments)

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AL Comment #2. The proposed rule also fails the standard of sound science because it offers three different but poss ible approaches for defining the ML: 1) 3.18 x MDL, 2) whatever is published for a method, and 3) the lowest acceptable calibration point. Method 1631E complicates the issue more by taking 3.18 x MDL and then “ rounding to the number nearest to (1, 2, or 5) x 10n, where n is an integer. ” The level of confusion regarding the ML can have different MLs than the respective methods. As stated above, this rule should not be made final until a new , single definition of ML is promulgated based on
the work of th e Detection and Quantitation FAC. (p. 1 of comments) See Response
3

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AM Comment #3. The driver for this proposed change is to provide data of sufficient precision and accuracy, but EPA has not defined the data quality objectives for precision and accuracy to be applied to NPDES

- related data. Therefore, no one can establish whether the ML meets this proposed need, even EPA. EPA goes on to say that is shou ld not use imprecise analytical methods in permits, but EPA has not defined what this means. EPA states it needs to make permitting decisions based on accurate data, but EPA has not defined the level of accuracy required for use of the data. (p. 1 of comm ents) See Response
3

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AN Comment #4. The FR notice itself is trying to defend the need for the use of sufficiently sensitive methods, and then goes on to expl ain this need in terms of accuracy and precision. Based on EPA's own guidance regarding data quality indicators (DQIs) EPA should recognize that sensitivity is different than accuracy and precision, and although we agree that accurate and precise data sh ould be used to meet NPDES requirements the desire to have more sensitivity will likely conflict with the need for accuracy and precision. Simply stated, values reported at lower concentrations do not inherently have greater accuracy or precision than hig her concentrations. Quite the contrary, one often compromises accuracy and precision as sensitivity increases. This is a serious flaw in EPA's approach to the problem at hand. However, it should be emphasized that a need for greater sensitivity should n ot abandon o r compromise needs for accuracy and precision. (p. 1

- 2 of comments) See Response
3

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AO Comment #5. EPA states that the ML should be less than the applicable water quality criteria. However, when following EPA ’ s guidance in the Technical Support Document for Water Quality

- based Toxics Control, the decision point for the reasonable potential process is the wasteload allocation (WLA) rather than the c riteria. The language needs to be adjusted accordingly. (p. 2 of comments) See Response

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0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AP Comment #6. The ML is used by labs as an internal gauge of perf ormance. However, independent reviews of performance (DMR QA studies, for example) generally do not monitor the actual performance of labs at concentrations approximating the ML. It is important that if the ML were to be used by EPA as suggested that sta keholders using laboratories to meet NPDES requirements have some assurance that test labs can actually meet the required quality objectives at or near the concentration of the ML. This will require a significant shift in how third parties (permittees, EP A, states) evaluate laboratories and this shift must occur before further weight is placed on the ML. (p. 2 of comments) See Response
3

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AQ Comment #7. The “ Scope and Rationale of the Proposed Rule ” states that where insufficient sensitivity among 40 CFR Part 136 methods is concluded the permitting agency would have the authority to require a non

- promulgated method in a NPDES permit based on the proposed langu age of the rule. This is problematic given the uncertainty associated with such methods and the fact that the public is not provided an opportunity to comment on the reliability and use of the methods other than through a permit negotiations or a challeng e. This issue becomes even more important with NPDES permit applications where the permittee has no opportunity for a formal comment process. This text is also problematic because it conflicts with the language of the actual proposed language where “ an N PDES applicant may use any suitable sufficiently sensitive method”. The latter language indicates that selection of the method is made by the permittee rather than the permitting authority. The decision should be made by the permittee, but any method req uired by a regulatory authority must first be interlaboratory validated and shown to meet the regulatory authorities ’ data quality objectives for the NPDES program. (p. 2 of comments) See Response
3

0013 Hampton Roads Sanitation

District
Technical Service s Division James J. Pletl, Ph.D. , Chief AR Comment #8. States only have a maximum of 2 years to implement this rule once finalized. It is not clear how this rule will impact NPDES permits which will not be renewed for up to 5 year after the rule has bee n adopted. Does the CWA modification trump the permit? (p. 2 of comments) See Response
11 and Response 12

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AS Comment #9. The FR notice states that published methods “ give only an upper, not a lower, bound on the lab ’ s MDL and minimum level ” . This is not universally true because the ML of the published method may not be based on a representative sample of lab performance. F or example, some MLs are based on the performance of research and federal labs but do not include the performance of industrial or municipal labs. This is one reason why it is important to test all methods intended for regulatory use in labs representing all stakeholders that will use or be held to use those methods. (p. 2

- 3 of comments) See Response
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0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AT Comment #10. EPA states that it will provide regular updates on water quality criteria to ensure that the states use sufficiently sensitive methods. This is irrelevant for states that have adopted their own water quality criteria. Once state criteria are EPA

- approv ed, only
the state criteria can be used. Later

- developed EPA criteria do not replace the properly adopted state criteria. Rather, the states are under an obligation to update their criteria periodically, but pending the states ’ updates the adopted state c riteria still control for NPDES purposes. The language should be removed because it infers to the contrary. (p. 3 of comments) See Response
13

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AU Comment #11. Upon promulgation of this rule, laboratories/permittees should be given sufficient time to change methodologies. The time period to do this should not start until the rule is incorporated by each regulatory authority and should be at least 18 months in length to allow for review and selection of labs or purchase of equipment and training. (p. 3 of comments) See Response

12

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AV Comment #12. EPA requires that da ta be collected within 4.5 years prior to the NPDES permit renewal application and cover different periods of the year to address discharge quality variability. If the rule is finalized in December of 2010 and a permit renewal is due in 2012 sampling/anal yses by the permittee have already begun and may not meet the requirement of the CWA modification. EPA and States should grandfather permit renewal data up to and including a date well after the rule is finalized to allow use of data already generated, to avoid loss of resources, and to avoid situations where permittees may be found in noncompliance because the data they provide does not complete the permit application. (p. 3 of comments) See Response

11

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AW Comment #13. The proposed rule specifically refers to “ the method ML ” . There are very few methods with a ML; therefore the proposed language does not address the vast majority of 40 CFR Part 136 methods. A footnote in the proposed rule states that the ML
can also be “ the lowest calibration point in a method ” . Methods in 40 CFR Part 136 do not define the lowest calibration point to be used; this is decided by the respective laboratory. It would seem to be more appropriate to refer to “ the lowest calibration point used by a laboratory ”

. (p. 3 of comments) See Response
3

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AX Comment #14. The proposed rule equates “ ML ”

, “ QL ” and “ RL ” , however these terms do not always apply to methods and the rule specifically applies to methods. For example, the QL and/or the RL for a lab may be one value equal to or less than the method ML, but they are not necessarily equivalent with the ML. Usin g the ML definition of 3.18 x MDL, it would be nearly impossible for a lab to use 3.18 x MDL as the lowest calibration standard. This is particularly true for methods that measure dozens of analytes. It is much more practical for labs to adopt MLs that a re similar in concentration across analytes and that are less than the respective WLAs than to calculate See Response
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a MDL for each analyte, multiply each of those MDLs by 3.18, and then create dozens of dilutions equaling that product for dozens of analytes. Therefo re, the QL/RL may be 5 ppb for numerous analytes in EPA method 625 but the MDL x 3.18 for each analyte does not equal 5 ppb. (p. 3 of comments)

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief A Y Comment #15. The FR notice suggests that it will apply to NPDES pollution prevention programs for dischargers to wastewater treatment facilities. Given the sample matrix issues of such samples permittees may not be able to meet these requirements beca use matrix effects often require dilution of samples which increases the ML. Some of these samples may even damage components of the more sensitive instruments due to their high concentrations. (p. 3

- 4 of comments) See Response

9

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief AZ Comment #16. EPA concludes in the proposal that it “ is expected to result in little or no new or increased burden to applicants or permittees ” . This conclusion is based on a c ost review of analytical methods conducted by EPA. This review included very few analytical procedures compared to those available in 40 CFR Part 136, equated single parameter methods with multi

- parameter methods, and artificially biased the conclusions by grouping all method costs over $400 together. These issues, along with others, significantly increase the probability that the conclusions reached by EPA are not defensible. Therefore, the question of costs to permittees due to this rule has not been adequately answered. (p. 4 of comments) See Response

1

0013 Hampton Roads Sanitation

District
Technical Services Division James J. Pletl, Ph.D.
Chief BA Comment #17. The proposed rule is problematic for many reasons and should not be

purs u ed without first completely addressing the ML issues raised by EPA ’s FACA on Detection and Quantitation. Given the EPA has not yet addressed these issues the process to complete this rulemaking should be suspended and the schedule for the rulemaking retracted. (p. 4 of comments) See Response
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0014 Environmental Laboratory

Advisory Board Federal Advisory Commission David N. Speis
Chair BB Comment #1. The Environmental Laboratory Advisory Board (ELAB), the Federal Advisory Committee to EPA on issues related to laboratory measurement and accreditation, would like to comment on EPA's proposed rule for the Use of Sufficiently
Sensitive Test Methods for Per mit Applications and Reporting, 75 Fed. Reg. 35, 712

- 20, June 23, 2010. The proposed rule would require that, for NPDES permit purposes, analytical methods from 40 CFR Part 136 be used that have method minimum levels (ML) low enough to measure the amount of pollutant in a facility's discharge, the effluent limit in the permit, or the water quality criterion, or lacking such a method, the Part 136 method with the lowest ML for the pollutant. Where there are no approved methods in Part 136 for a pollutant, the rule would suggest monitoring by unapproved methods, at
the discretion of the director.

Stakeholders have indicated to ELAB that while there are benefits to the concepts outlined in the rule, there is also the potential for unintended negative conseq uences. ELAB would like to meet with appropriate regulatory officials to further discuss the details prior to final promulgation of the rule. ELAB would like the opportunity to suggest improvements in the language to address stakeholder concerns so that the desired goals can be achieved without compromising the ultimate data quality objectives and resulting decisions. (p. 1 of comments) EPA acknowledges
the comment.41

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0015 The Inter Industry

Analytical Group BC Comment #1. Analytical methods need to be adequately characterized. Instead of the proposal, which is designed to force permit writers to assign sufficient methods even if none exist, EPA would be better served by adopting a uniform definition of detect ion limit and quantitation level and developing a consistent, non

- iterative, non

- arbitrary method for determining them

– a method that does not merely multiply the detection limit by some constant to estimate the quantitation limit. And the definitions sho uld start with measurement quality objectives (MQOs) that specify the level of performance that an analytical method should achieve. Uniform definitions and a consistent method for determining DLs and QLs would provide a “level playing field” and avoid hav ing different DLs and QLs for the same method from jurisdiction to jurisdiction or even from
lab to lab.

It is essential that the precision, bias, and quantitation limits of analytical methods be known if they are to be used to measure compliance with legal requirements (NPDES permit limits). In § 304(h) of the Clean Water Act, Congress directed EPA to “promulgate guidelines establishing test procedures for the analysis of pollutants.” 33 U.S.C. § 1314(h). Even without the statute, it is a bedrock prin ciple of Due Process that a person cannot be held liable for violating a law if he was not given notice of what behavior would violate it. In addition, an agency lacks the power to find a “violation” when the measured departure from a standard is within th e boundaries of probable measurement error. Amoco Oil Co. v. EPA, 501 F.2d 722, 743 (D.C. Cir 1974).

Industry experts in analytical methods have insisted for decades, both in dialogue with EPA [footnote omitted] and in the court cases summarized below, that EPA should determine and publish the characteristics of analytical methods that are to be used for compliance monitoring. Members of the IIAG have gone to court several times to defend this principle.

When EPA published the Part 136 regulations on October 26, 1984, 49 Fed. Reg. 43,234 (corrected at 50 Fed. Reg. 690

- 97 (Jan. 4, 1985)), one IIAG member sought review in the Fourth Circuit Court of Appeals. Virginia Electric & Power Co. v. EPA, Doc. No. 84

- 2227 (4th Cir., petition for review filed Nov. 9, 1984). UWAG asserted that the Part 136 rules did not adequately take into account the precision and bias of the analytical
methods. The case was settled in 1985.

EPA published its final direct current plasma (DCP) method and other methods in 1990.
55 Fed. Reg. 24,532 (June 15, 1990). On October 1, 1990, several companies filed See Response
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petitions for review in the Fourth Circuit Court of Appeals, primarily because EPA claimed it was not legally required to validate test methods based on interlaboratory data

or p ublish performance data for tests it was adding to Part 136. To address this issue, EPA published a technical correction to the DCP rule that incorporated the DCP protocol, including an appendix with method performance data. 56 Fed. Reg. 43,702 (September 4, 1991). Upon a motion by UWAG, the Fourth Circuit case was dismissed as unripe December 4, 1991. UWAG preserved its right to raise issues of analytical variability in future Part 136 rulemakings.

Members of the IIAG also challenged EPA’s Method 1631B for mercury. They petitioned the D.C. Circuit to review the rule, challenging the procedures EPA used to establish the MDL and ML. On October 19, 2000, EPA and the industry petitioners agreed to a settlement by which EPA would propose revised methods for d etermining detection and quantification limits. See 68 Fed. Reg. 11,773 (March 12, 2003).

EPA’s proposal, published March 12, 2003, was unsatisfactory. In 2003, 36 companies and organizations, representing a broad cross

- section of municipalities, industri es, and laboratories, wrote the Assistant Administrator for EPA’s Office of Water about the shortcomings in EPA’s MDL and ML procedures. Letter to G. Tracy Mehan, III, RIN

2040

- A053, August 15, 2003 (re 69 Fed. Reg. 11,770 (March 12, 2003)). The 36 signers of the letter agreed on six “Consensus Principles on Detection and Quantitation Levels.” Among the consensus principles was agreement that the Office of Water’s proposed MDL and ML procedures “do not provide a scientifically acceptable basis for

establis hing detection and quantitation levels, nor do they provide a sound basis for ascertaining compliance with NPDES permit limits set below levels of quantitation.”

The widespread dissatisfaction with EPA’s MDL and ML led EPA to convene a Federal Advisory Committee (the FACDQ), which provided its recommendations in December
2007. Report of the Federal Advisory Committee on Detection and Quantitation Approaches and Uses in Clean Water Act Programs 46 (December 2007) (hereinafter “FACDQ Report”). The FACDQ wa s composed of representative stakeholders from state regulatory agencies, municipalities, environmental laboratories, environmental groups, industry, and the EPA Office of Water. Four members from IIAG companies sat on the FACDQ. Among other things, the FA CDQ agreed unanimously that the current MDL procedure has deficiencies that “can and should be corrected.” FACDQ Report 62.43

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In short, industry has for over 26 years pressed the position, well supported by the science of analytical chemistry and by consi derations of due process and fundamental fairness, that analytical measurements used to determine compliance with legal requirements should be well characterized and their variability made known to the public and the regulated community. After 26 years, th ese issues remain unresolved, and we regret that with the proposed Sufficiently Sensitive rule, EPA has not only failed to make progress on these issues but has taken several steps backward. (p. 2

- 4 of comments).

0015 The Inter Industry

Analytical Group BD Comment #2. The proposed rule summarizes the flaws in the system but makes no
effort to correct them. This proposed rule is, frankly, a retreat from good science. In it EPA abandons the bedrock principle that regulatory decisions should be based on established measurement techniques whose characteristics (precision, bias, detection limit, and quantitation level) have been determined, and indeed determined by data from multiple laboratories to
reflect real

- world conditions.

Part of the p roposed rule, to be sure, seems reasonable on its face as far as it goes: NPDES permittees should use analytical methods that are capable of measuring down to the permit limits and water quality criteria that have to be achieved. About that there can
be no disagreement in principle, if there are such methods that produce reliable,
consistent results. See Response
3 and Response 1444

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But that is not the kind of guidance NPDES permittees and State permit agencies need. The problem that has vexed the regulated community, laboratories, and pe rmit writers for years is what to do when there is not a well

- characterized method that will reliably quantify analytes at appropriately low levels. EPA’s proposed rule fails to resolve this fundamental problem.

Footnotes 4, 5, and 7 in the Federal Regist er notice at 75 Fed. Reg. 35,714

- 15 provide a glimpse into the present regulatory system, with all its flaws:

(4) The term “minimum level” refers to either the lowest calibration point in a method or a multiple of the method detection limit (MDL), whichev er is higher. Minimum levels may be obtained in several ways: They may be published in a method; they may be the lowest acceptable calibration point used by a laboratory; or they may be calculated by multiplying the MDL in a method, or the MDL determined b y a lab, by a factor. [Citations omitted].

(5) For the purposes of this rulemaking, EPA is considering the following terms to be synonymous: “quantitation limit,” “reporting limit,” and “minimum level.”

7 To address this situation some State permitting a uthorities 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. 75 Fed. Reg. 35,714

- 15.

This reflects the shortcomings of the present system, but EPA’s proposal serves only to accept and perpetuate those shortcomings. Instead of defining the “minimum level” in footnote 4, EPA notes that the ML has several meanings, making it largely meaningless for practical purposes. A permit writer, a permittee, and an environmental group may each interpret the term “minimum level” differently as presented. Comparing different analytical methods by using a term with no established definition is senseless, because different methods may be characterized with respect to “quantitation” in completely different and noncomparable ways.

In particular, the ML depends on the sample matrix. As EPA notes in footnote 6, the MDL is determined from analysis of a sample in a given matrix. But the ML used by a regulato ry agency might be based on an entirely different matrix from the permittee’s45

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wastewater discharge. Disagreements between regulators and permittees are certain to
result. Suppose, for example, that a permittee, using its actual wastewater, finds that the M L in its matrix (not the published one) is below the water quality criterion or permit limit and thus “sufficiently sensitive”? The regulatory agency, using lower MLs from reagent water, might demand a different analytical method with an ML that could not consistently be attained in practice, causing the permittee to appear to be in noncompliance.

Part 2 of the proposed three

- part definition makes a method “sufficiently sensitive” if “[t]he method minimum level is above the applicable water quality criteri on 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.” However, this definition fa ils to specify what it means for a method to “detect” and “quantify.” By “detect” EPA may mean “register a signal higher than the MDL.” But the MDL is widely recognized as being highly variable and unanchored. Again, a definition for “quantify” is conspicu ously absent from EPA’s proposal.

To make matters worse, footnote 5 at 75 Fed. Reg. 35,715 col. 1 says that EPA considers “quantitation limit,” “reporting limit,” and “minimum level” to be synonymous. Thus EPA accepts not only multiple “MLs” as though the y were all the same but multiple “MLs,” “quantitation limits,” and “reporting limits” as though they were all the same. This sort of framework does nothing to ensure that the most sensitive method is used. The attached report by API, Analytical Detection a nd Quantification Limits: Survey of State and Federal Approaches (Pub. No. 4721) (June 2002), illustrates this very point. It demonstrates how many different procedures are being used to set benchmarks for quantification and how variable

– and arbitrary

– these various procedures are.

To further complicate matters, some published methods do not specify an ML at all. For such methods EPA’s proposal leaves permittees and regulators in the dark. If there is no published ML, what is the permittee to do? Use the method MDL multiplied by a constant? Use the lowest calibration standard listed in the published method? Use an individual laboratory’s MDL multiplied by a constant? Use the individual laboratory’s
lowest calibration standard?

On page 35,716 EPA backs away from the need to establish predictable detection and quantitation limits: EPA acknowledges that a laboratory might achieve MDLs and46

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minimum levels lower than those published when the promulgated method was developed. Thus, the Director should not rel y 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. (Footnote omitted.) This may imply that states can set a testing requirement based on the performance of a sing le laboratory. It would promote widely varying detection and quantitation limits from state to state and even from laboratory to laboratory. Much of the effort of members of the FACDQ was directed to avoiding such a result by seeking a uniform, national Q L national to discourage the practice of relying on the performance of a single laboratory. Out of twenty FACDQ members, only one (EPA’s Office of Water) opposed specific recommendations about how EPA should set target Measurement Quality Objectives for se tting National Quantitation Limits, and even EPA agreed that it should promulgate how a National Quantitation Limit is derived. FACDQ Report 37. Moreover, in defining “sufficiently sensitive” EPA creates more confusion than clarity. In EPA’s proposed form ulation, a “sufficiently sensitive” method is, among other things, a method whose ML is lower than the “applicable” water quality criterion. What this means in practice is ambiguous. A better definition would be a quantitation level below a water quality c riterion for the measured pollutant or pollutant parameter “that is contained in water quality standards that have been adopted for the water receiving the effluent .”

Another problem is that the proposal fails to distinguish between water quality standard s and permit limits that are derived from water quality standards. In determining “reasonable potential,” the permitting authority, referring to EPA’s proposed rule, will demand an analytical method with an ML below the in

- stream water quality criterion. B ut if the resulting permit limit is higher than the in

- stream criterion, the permitting agency should allow any method with a quantitation level below the permit limit, even if it is above the water quality criterion. EPA’s proposed rule makes it unlikely a regulatory agency will recognize this distinction. Another problem with the proposed rule is that it might be read to require a “sufficiently sensitive” method even when the method by its own terms should not be used. Method 1631 for mercury, for exampl e, is very sensitive. But because it is so sensitive, contamination is a problem, and “clean” sampling methods (as described in a different publication, EPA Method 1669) are called for. But Method 1669 itself (§ 1.4) says that “[t]his method is not intende d for determination of metals at concentrations normally found in treated and untreated discharges from industrial facilities.” It is virtually impossible, in an industrial setting, to avoid contamination by suiting up, as 1669 requires, in suits, gloves, and masks.47

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Moreover, Method 1631 suggests soaking laboratory air intake filters in gold chloride solution so that mercury in incoming air will amalgamize with the filter’s gold. Are labs required to go to such lengths to be “sufficiently sensitive”? If no t, how is a laboratory to know which precautions to take?

Still another problem with the proposed rule is how it is to be interpreted for technology

based limitations of “zero” or “no discharge” (where the Subchapter N or O regulations do not specify the method to be used for compliance monitoring). Since such limits can only be based on the administrative record at the time they were promulgated, they should not be interpreted as concentrations that can be detected by analytical methods
that were not in u se at the time. A “zero” or “no discharge” or “nondetect” limit should be understood to mean no lower than the detection limit of the analytical method that EPA used to determine that zero discharge was achievable and to establish the limit, not

some newer method capable of detecting even lower levels of the pollutant.

Some of the above problems could be ameliorated if EPA would expressly allow permittees to use a less sensitive method where it serves the regulator’s purpose. For example, suppose an NPDES permit requires sampling an internal wastestream where the pollutant concentration is higher than it is at the ultimate outfall to waters of the United States. In such a case the permittee should be allowed to use any approved method sensitive enough to me asure the levels at the internal point, even if the method’s minimum level is higher than the ultimate effluent limit at the outfall. In short, the proposed rule should say that the most sensitive method need not be required in circumstances in which the p ermitting agency determines that the most sensitive method is not necessary. (p. 5

- 10 of comments)

0015 The Inter Industry

Analytical Group BE Comment #3. The Federal Register notice establishes the need for measurement quality objectives but does nothing about it. The preamble to the proposed rule makes a good case for establishing measurement quality objectives (MQOs) [footnote omitted] for analytical methods. For example, on page 35,715 EPA says that precision and

acc uracy are important, indeed “critical”:

“It is critical, therefore, that applicants provide data that have been measured with precision and accuracy so that they will be meaningful to the decision making process.”

Similarly: “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 See Response
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could lead the Director to make assumptions regarding the presence or absence of a pollutant in an applicant’s dis charge.”

And in the same paragraph EPA explains why imprecise methods could be harmful: Moreover, if the Director were to include imprecise analytical methods in permits for compliance monitoring purposes, the use of such methods could result in undetecte d exceedances of permit limits.

These passages reinforce the fundamental point that the IIAG has been advocating for years: analytical methods used for regulatory purposes should meet measurement quality objectives. These MQOs should be set on the basis o f data from multiple laboratories so that the characteristics of a method, as used by different permittees, different regulatory agencies and different laboratories, are known.

EPA has already spent considerable effort toward setting data quality objective s. See, e.g., EPA QA

- 4, Guidance for the Data Quality Objectives Process (EPA/600/R

- 96/055 August 2000). Moreover, the Federal Advisory Committee would have recommended that EPA establish data quality objectives where detection and quantitation limits are used in decision making, except that the EPA Office of Water representative on the Committee disagreed. FACDQ Report 7. Even so, the FACDQ did recommend a ≤ 1% false positive rate objective for detection and an initial objective of ≤ 5% false negatives

for promulgated methods. FACDQ Report 9. Only the EPA Office of Water disagreed with the recommendation that target measurement quality objectives be established for quantitation limits in Part 136. Id. 10. Yet the proposed rule ignores the need for quality

o bjectives and indeed takes a step back from them.

Avoiding a commitment to set data quality objectives is not consistent with other EPA programs. Under EPA’s RCRA program, the Office of Solid Waste (OSW) uses precise statistics (80% coefficient of the co nfidence interval) to demonstrate whether a waste is hazardous. Also, the OSW has rejected the MDL.

The FACDQ, with only EPA disagreeing, determined that EPA should establish Data Quality Objectives (with indicators and Measurement Quality Objectives) fo r Clean Water Act programs where Detection/Quantitation Limits are used in decision making (FACDQ Report 7). There was unanimous agreement that, in order to maintain consistency, EPA programs that reference the MDL procedure should consider adopting
whatev er procedure replaces it (id. 59). Again, only the EPA representative disagreed that49

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EPA should evaluate and modify the uses of data in Clean Water Act programs (id. 60). (p. 10

- 12 of comments)

0015 The Inter Industry

Analytical Group BF Comment #4. Fourth, many 40 CFR Part 136 methods have no ML defined in the method at all. Therefore the ML would have to be defined using one of the arbitrary techniques EPA throws out in footnote 4 (that is, a multiple of the MDL or the lowest calibration point). What is not clear is whether the MDL in such cases would be based on the
method

- defined MDL (MDL method) and calibration range or the performance of an individual lab. If it is defined by the individual lab, will it be based on a lab wide MDL (MDL lab) or calibration range or on the basis of a single instrument within the laboratory? Will the MDL be determined using reagent water, or in the matrix being tested? Footnote 6 leaves these questions unanswered: The MDL is determined using the procedure at 40 CFR 136, appendix B. It is defined as the minimum concentration of a substance that can be measured and reported with 99 percent confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a given

mat rix containing the analyte. Finally, most of EPA’s calibration criteria are so wide as to be almost meaningless. In some cases they have been shown to lead to significant bias. (p. 12

- 13 of comments) See Response
3

0015 The Inter Industry

Analytical Group BG Comment #5. The rule for when there is no approved Part 136 method will weaken 40 CFR Part 136 and EPA’s ATP program.

A serious problem with the proposal is that it largely abandons the drive for reliable new methods. Instead it sacrifices qualit y and predictability in order to force permitting agencies to focus on methods that will purportedly measure as low as legal standards require

– regardless of the quality of the data.

Section 122.44(i)(iv) as presently written requires that, if there is n o approved Part 136 method, monitoring must be conducted according to a test procedure “specified in the permit.” 40 CFR §§ 122.44(i)(iv), 122.21(j)(4)(viii) (2009). The proposed change would require a “sufficiently sensitive” method specified in the perm it:

[When there is no Part 136 method] monitoring shall be conducted according to a sufficiently sensitive test method ....

Proposed 40 CFR § 122.44(i)(1)(B), 75 Fed. Reg. 35,720 col. 2. Thus, when EPA for any reason has failed to develop and approve a met hod suitable for Part 136, states and regions would be required to find a method that would register a signal at the level of the See Response
3 and Response 1850

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legal standards, with the only condition being that they describe the method and
“document” an “ML” of some kind.

This proposal would create a shortcut around the provisions (however inadequate) that EPA has created over the years to try to ensure the integrity of environmental data. It is
unwise for several reasons.

First, the requirement to use any method with a “documen ted” ML forces permitting agencies to use unapproved methods outside the framework of EPA’s Alternate Test Procedure (ATP) Program. See http://www.epa.gov/waterscience/methods/atpl. Sections 136.4 and .5 of 40 CFR establish the ATP program, and they contai n procedural safeguards. Unfortunately, the proposed “any sufficiently sensitive method” rule contains none. In effect, it may make 136.4 and .5 irrelevant. It would require permit writers to specify “alternative” methods without meeting any of the require ments of the ATP program. Henceforth, the only requirement for an alternative method would be that it was capable of measuring down to legal standards. If there is no method in Part 136, any sufficiently “sensitive” method would do, no matter how variable the results or how
robust the method. That is not to say the existing ATP program is perfect either. EPA should adopt measurement quality objectives for the ATP program. Then, for the different levels of demonstration (a method to be used only for a singl e discharger, a method to be approved statewide, or a method to be approved for the entire country), approval of non

- part 136 methods in quest of better sensitivity should follow the structure of the ATP program (distinguishing, for example, among methods to be made by a single lab, by several labs using a single matrix, or by several labs using multiple matrices). Second, although footnote 8 is correct that there is similar language in § 122.21(g)(7), the new proposed language expands this language into s omething new entirely. Subsection (g)(7) refers to “effluent characteristics” as characterized in the permit application for the purpose of determining “reasonable potential” to contribute to a water quality criterion exceedance. The new proposal, on the o ther hand, applies to all compliance monitoring. The data quality requirements for determining reasonable potential and for compliance monitoring may be, and in some cases should be, different, with compliance determinations demanding a higher level of qua lity.

More important, the current language of § 122.21(g)(7) requires a “suitable” method, which surely means suitable in terms of data quality, not just the ability to detect a signal at low levels. The new “sufficiently sensitive” language lacks any refe rence to “suitability” at all. The only requirement (other than measuring to a low

- enough level) is51

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to have a “documented” ML.

Third, the entire measure of quality under the proposal is the ML. Thus the proposed rule incorporates the shortcomings of the M L described above. An ML could be based on a single laboratory’s performance or calibration range and could be determined in different ways by different labs or by the same lab using different instruments.

Fourth, the requirement that the ML be “documente d” is exceptionally vague. Conceivably this may require nothing more than something in writing. The rule contains no requirements to ensure that the ML is replicable from laboratory to laboratory. A laboratory could run a calibration to a lower

- than

- usual range and provide no documentation of or information on method performance. EPA should insist on a higher standard of documentation of method performance for non

- Part 136 methods than “the applicant shall provide a description of the method, including docu mentation of the minimum level.” EPA has established tiers of method validation in its ATP program, and there is no reason why a similar set of requirements should not be a part of this proposed regulation. Fifth and finally, requiring the use of any “suff iciently sensitive” method when there is no Part 136 method removes the incentive to develop better analytical methods in the future. If the proposed rule is adopted, no regulatory agency need take responsibility for improving analytical methods. An agency may simply require each permittee to find a “sufficiently sensitive” method (even if none exists), require it in a permit, and be done. Part 136 of 40 CFR would become largely superfluous, with no provision for updating it or need to update it as far as t he regulatory agency is concerned. This is not what Congress intended when it directed EPA in § 304(h) to “promulgate test procedures for the analysis of pollutants.”

The FACDQ unanimously agreed that EPA should continue to act as the national lead for
Cle an Water Act programs in developing analytical methods and setting the performance standards for those methods (FACDQ Report 60). The proposed rule is contrary to that
recommendation. (p. 13

- 16 of comments)52

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0015 The Inter I ndustry

Analytical Group BH Comment #6. EPA’s analysis of “impacts” is inadequate. At pages 35,717

- 18 of the Federal Register notice, EPA analyzes the “impacts” of the proposed rule. The discussion contains no dollar numbers, but EPA’s conclusion is that “the proposed rule is expected to result in little or no new or increased burden to applicants or permittees.” This finding is not credible. Anyone who uses laboratory methods knows that a rule designed to force permittees to use newer and more sensitive analytical methods, including methods so new they have not been included in 40 CFR Part 136, will increase costs significantly. EPA’s contrary conclusion, based on cost ranges provided in NEMI and assumptions used in past ICRs, is arbitrary. (p. 16

- 17 of comments) See Response

1

0015 The Inter Industry

Analytical Group BI Comment #7. Conclusion. In concept, part of the proposed rule is sound. That is, clarifying that analytical methods should be able to measure down to the level of legal requirements woul d be useful if done correctly. Also, the idea that it is not necessary to use a more sensitive method if the analyte is present within the range of acceptable performance of a less sensitive method is reasonable and appropriate, and would save money withou t compromising data quality.

However, the license to use any “sufficiently sensitive” method so long as it is described and its ML documented is unacceptable, in that it will result in poor

- quality data and allow poor

- quality data to be used to impose pen alties and to brand permittees as
“violators.”

Instead of this flawed rule, EPA should establish measurement quality objectives, a single meaningful definition of detection and quantification, and appropriate procedures for determining detection limits an d quantitation levels of methods. A consistent framework along these lines would help permitting agencies make meaningful decisions about the
relative sensitivities of different methods. (p. 17 of comments) See Response
3

0016 Metro Wastewater

Reclamation District
Theresa Pfeifer Regulatory Compliance
Officer BJ Comment #1. The rule needs to define “minimum level” and what it is based on.(p. 1 of comments) See Response
3

0016 Metro Wastewater

Reclamation District
Theresa Pfeifer Regulatory Compliance
Officer BK Comment #2. There is no discussion of the need to validate methods and/or the accuracy requirements of the method. The rule should require methods to be scientifically acceptable and have to meet EPA’s Alternate Test Method criteria. (p. 1 of c omments) See Response
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0016 Metro Wastewater

Reclamation District
Theresa Pfeifer , Reg. Comp.

Ofcr. BL Comment #3. How do the concepts in EPA’s performance

- based guidance apply to this
situation? (p. 1 of comments) See Response
3

0016 Metro Wastewater

Reclamation District
Theresa Pfeifer Regulatory Compliance
Officer BM Comment #4. What if the Permittee is unable to locate a lab achieving a method minimum level low enough to determine compliance? Will EPA or States provide guidance in those situations or have a list of labs capable of achieving required minimum levels? Or what if costs to run the analyses are exorbitant compared to other methods? Any variances for such issues? (p. 1 of comments) See Response
3

0016 Metro Wastewater

Reclamation Distric t
Theresa Pfeifer Regulatory Compliance
Officer BN Comment #5. The proposed rules states, “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 suit able sufficiently sensitive method; however, the applicant shall provide a description of the method, including documentation of the minimum level.” The rule also goes on to state, “the Director must specify a sufficiently sensitive analytical method as a condition of the NPDES permit.” What if the NPDES permit does not specify a sufficiently sensitive method; are you required to comply with 40 CFR 136 until the permit requires sufficiently sensitive methods? What if there are no water quality standards for a pollutant; can you use any method? (p. 1 of comments) See Response
10 and Response 18

0016 Metro Wastewater

Reclamation District
Theresa Pfeifer Regulatory Compliance
Officer BO Comment #6. The State of Colorado (which is a delegated NPDES state) requires under the Pretreatment Section of its CDPS permits, “If based upon information available to the Permittee, there is reason to suspect the presence of any toxic or hazardous pollutant
liste d in Table V, or any other pollutant in a quantity or concentration known or suspected to adversely affect DWTW operation, receiving water quality, or solids disposal procedures, analysis for those pollutants shall be performed at least (required frequency ) on both the influent and the effluent.” And “Where analytical techniques are not specified or approved under 40 CFR Part 136, the Permittee shall use its best professional judgment and guidance from the State and the Approval Authority regarding analytic al procedures.” Will the Director address all of the pollutants identified in Table V and the required minimum detection limit or will this section now be site

- specific detailing what pollutants from Table V must be monitored by the Permittee and, for thos e with no method approved by 40 CFR 136, detail the method(s) that must be used? (p. 1

- 2 of comments) See Response

9

0017 New Jersey Department of

Environmental Protection
Bureau of Surface Water Permitting BP Comment #1. The term minimum level is defined under footnote 4 at the bottom of page 35714 of the Federal Register and continuing onto the top of page 35715 as “ either the lowest calibration point in a method or a multiple of the method detection limit (MDL),
whichev er is higher ” . However, we could not locate a definition of this term in the actual See Response
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Pilar Patterson
Chief rule language. Please provide a definition in the rule text or location where the definition may be found.(p. 1 of comments)

0017 New Jersey Department of

Environmental Protection
Bureau of Surface Water Permitting
Pilar Patterson
Chief BQ Comment #2. The amendments at 40 CFR 122.21(e)(3)(i) state that a method approved under 40 CFR part 136 is “ sufficiently sensitive ” when the “ method minimum level (ML)
i s at or below the level of the applicable water quality criterion for the measured pollutant or pollutant parameter ” or “ the method ML is above the applicable water quality criterion, but the amount of the pollutant or pollutant parameter in a facility ’ s d ischarge is high enough that the method detects and quantifies the level of the pollutant or pollutant parameter in the discharge. ” Each of these “ sufficiently sensitive ” method criteria cite the applicable water quality criterion as the reference level fo r the analytical method.

As cited at 40 CFR 122.44(d)(1)(ii) the applicable water quality criterion plays a critical role in determining the need for water quality based effluent limitations (WQBELs) for a pollutant. However, other factors play important roles as well; including, where appropriate, the dilution of the effluent in the receiving water. When dilution is available for a facility ’ s discharge, the maximum allowable effluent value is greater than the applicable water quality criterion. Please cla rify the intent of the rule when addressing the
site

- specific factors identified at 40 CFR 122.44(d)(1)(ii). (p. 1 of comments) See Response

14

0017 New Jersey Department of

Environmental Protection
Bureau of Surface Water Permitting
Pilar Patterson
Chief BR Comment #3. According to the proposed rule, it seems clear that only data that are at or above the minimum level (ie. Quantitation limit and not detection limit) are acceptable for NPDES purposes. Many laboratories typically report data that is b elow their quantitation limits but still detectable. This data is typically qualified or flagged with a “J” to designate an estimated concentration value. Please confirm that laboratory data results below the quantitation or minimum level and qualified as estimated are unacceptable for NPDES purposes. (p. 1

- 2 of comments) See Response
7 and Response 11

0017 New Jersey Department of

Environmental Protection
Bureau of Surface Water Permitting
Pilar Patterson
Chief BS Comment #4. In footnote 12 of the proposed rule, one example of an acceptable modification is provided. It states that “Examples of such modifications may include changes in the sample preparation digestion procedures such as the use of reagents similar in properties to ones used in the ap proved method”. It was our understanding that a change in reagents was not an allowable modification, as it would result in a change in chemistry. This because “similar in properties” is not well defined. 40 CFR Part 136.6 Section a.6.b.1 states “an analys t may modify an approved test procedure (analytical method) provided that the chemistry of the method or the determinative technique is not changed”. Section a.2 of that rule defines chemistry of the method as “the reagents and reactions used in a test pro cedure that allow determination of the analyte(s) of interest in an environmental sample”. Please comment further on the acceptability of allowing for See Response

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changes to reagents with similar properties and, specifically, how this rule will allow changes in reagen ts when previous versions did not. (p. 2 of comments)

0018 American Petroleum

Institute BT Submitted report titled: “ Analytical Detection and Quantification Limits: Survey of State and Federal Approaches ” EPA acknowledges
the comment.

0019 Ford Motor Company

Ford Environmental Quality

Office John H. Phillips BU Comment #1. EPA characterizes this proposal as a minor amendment of the CWA to codify that under the NPDES program only “ Sufficiently Sensitive ” analytical test methods may be used when completing NPDES permit applications and when performing sampling and analysis to monitor compliance with the permit. While this may be a

“ minor ” wording change it is far from a minor revision to the CWA, because o f its far reaching ramifications. This specific wording change has large implications related to compliance assessment and enforcement. The impact of pending EPA Office of Water actions, such as the promulgation of Method 1668 (PCB Congener Analysis by
HRG C/HRMS) and a new MDL procedure would be much greater should this proposal be accepted as written. The EPA needs to complete the long awaited revised MDL/ML rule making, which will consistently define detection (MDL) and quantification (ML),
based on sound scientific principles before it can proceed with this proposal.

The two commendable objectives of this proposal are; 1) the desire to be able to accurately measure the pollutant of concern in the matrix of concern at the permit (WQBEL) limit when ever po ssible and 2) the use of only “ quantitative ” data (results above the method Quantitation Limit) when assessing compliance. Unfortunately this proposal fails miserably to achieve either of these objectives. See Response
3

0019 Ford Motor Company

Ford Environmental Quality

Office John H. Phillips BV Comment #2. Under footnote #4 it explains that the Minimum Level (ML) can be derived a number of different ways. This is true because the USEPA has not been consistent or uniform in the way it defines and de rives the ML. It can be the lowest point on a calibration curve or it can be some multiple of the MDL with some being undefined (0.5x, 1x, 5x, 10x, 100x, ?x). The lowest acceptable calibration point does not ensure the ability to quantify or even detect an analyte in wastewater matrix at that concentration. Not only is the MDL an unanchored and highly variable parameter (very lab, instrument, technique and matrix dependent), but the multiplier used to derive the ML has not even
been defined. Per recommendat ions of the FACDQ and the EPA Office of Quality guidance (EPA QA/G

- 4) the quantitation (ML) must be defined based on method precision and bias (not arbitrarily) and the detection (MDL) must be based on both false positive and false negative error rates. Fo otnote #5 equates the ML as the “ quantitation See Response
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limit ” and footnote #6 defines the MDL as only addressing false positive error rates. The definition of the ML is nebulous and has not been clarified in any way in this proposal.

0019 Ford Motor Company

Ford Environmental Quality

Office John H. Phillips BW Comment #3. At the end of the second paragraph it states, "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". By definition an "undetected exceedance" is a false negative, which is not controlled for or evaluated for by either the MDL or the ML. The third paragraph states
that the Director must acce pt data that is generated only by sufficiently sensitive analytical methods. While this is good, the proposal fails to scientifically define what sufficiently sensitive means. The proposal uses a three part definition to describe when a
method is "sufficie ntly sensitive".

At the end of the second paragraph it states, "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". By definition an "undetected exceedance" is a false negative, which is not controlled for or evaluated for by either the MDL or the ML. The third paragraph states that the Director must accept data that is generated only by sufficiently sensitive analytical methods. While this is good, the proposal fails to scientifically define what sufficiently sensitive means. The proposal uses a three part definition to describe when a method is "sufficiently sensitive".

1. The method minimum level (ML) is "at or below the level of the applicable water quality criterion or permit limitation." 2. The ML is above the applicable criterion or permit limit, "but the amount of the pollutant or pollutant parameter in a facility's discharge is high enough that the meth od detects and quantifies the level of the pollutant or pollutant parameter in the discharge." 3. The method has the lowest ML of the methods approved by EPA under 40 CFR 136.

This definition has several problems. First most Part 136 methods do not have MLs and when they do there is little consistency from one method to the next as to how the ML was derived. Second the ML or "quantitation limit" is rarely if ever established based on the ability to quantify at a known level of precision and bias. Third an ML derived in

re a gent water is not representative of how well a method can quantify an analyte in a real world matrix. Next the proposal allows the any lab to define what "sufficiently sensitive" means. As long as the lab can detect (which is not defined) and quantify (which is not See Response
3 and Response 1257

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defined) the level of the pollutant parameter in the discharge. The agency makes no attempt to define what it means to detect or quantify, so it becomes a completely arbitrary
limit. How can we have a national standard or a nati onal environmental database with comparable data when their are no absolutes. Not only will MDLs and MLs vary from lab to lab, but so will data quality.

The proposed rule further loosens data quality standards when it goes on to propose;

"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."

The responsibility is now moved away from the USEPA having to generate and promulgate sufficiently sensitive test methods to enforce its regulations and placed squarely on the permitting agency or the permi ttee. No criteria are provided, such as currently used by the EPA through the Alternative Test Procedure (ATP) approval process. This also eliminates public review of test methods and allows for the use of test
methods which have not been validated or vett ed for use in the CWA program. The only criteria given that a method is sufficiently sensitive is the ML. Unfortunately method sensitivity is not the only characteristic that allows one to accurately measure the concentration of an analyte at the required level. Method selectivity may be just as important or even more important than sensitivity when it comes to measuring pollutant concentrations in wastewater, surface water or groundwater. These matrices can be complex and present positive and negative inte rferences, which confound precision, accuracy and sensitivity. A highly sensitive method may be unable to quantify or detect the pollutant of interest until orders of magnitude over the method ML, in which case a
more selective and less sensitive method ma y be a better choice, reducing the chance of false positives and false negatives and improving the precision and accuracy of the result.

The proposal goes on to say that individual States will need to amend their statutes or regulations if they do not req uire the use of sufficiently sensitive test methods. This will require significant time to accomplish as there will be many conflicts that arise between current state regulations and the new nebulous definition of "sufficiently sensitive" test
methods. Som e states such as Texas are already going down a different more scientifically defendable path regarding method sensitivity. If the states' programs are already more protective of the environment, because they use methods that are more58

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selective or use a mo re scientifically sound approach than "sufficiently sensitive" to set permit limits will those programs and rules be allowed to remain unchanged?

0019 Ford Motor Company

Ford Environmental Quality

Office
John H. Phillips BX Comment #4 This rule change will impact all NPDES permit holders directly (municipalities and industries with direct discharges of either wastewater or storm water) into a public waterway, but will impact many, many more parties who are indirec t discharges to municipal systems with discharge permits. All laboratories currently providing analytical test results in support of NPDES programs will also be impacted, due to the requirement to provide method performance data (MDLs, RLs, QLs or MLs
and calibration data). If there is no 40 CFR Part 136 method approved for a parameter of interest then the lab will need to develop or implement a new method, which is "sufficiently sensitive" to meet the permit conditions. These method development costs
will likely be borne by the permit holder.

The cost to switch to a "sufficiently sensitive" method will almost always be higher, due to the higher method analytical costs. In some cases this cost can be an order of magnitude or more. The method costs derived f rom the NEMI database presented in the docket are clearly an insufficient cost analysis and misleading. Consider the following;

- There are hundreds of methods approved for use in 40 CFR Part 136, only 33 are
evaluated for cost.

- Method costs are listed in broad price ranges only <$50, $51

- $200, $201

- $400 and >$400.

- No consideration is taken regarding the cost of a method that is able to analyze multiple parameters at a time verses single parameter methods (cost/parameter).

- No consideration is taken o n how many additional methods may need to be used to achieve sufficient sensitivity for all parameters of interest.

- No consideration is taken for highly sensitive and very costly methods which have been proposed, but not yet promulgated, such as method 1 668B.

- No consideration is taken for the need to develop additional methods for parameters, which do not currently have an applicable 40 CFR Part 136 method.

- Total compliance monitoring costs must include, sampling costs, test frequency, number of parame ters, number of methods, specific methods, sample matrix, method QC, required detection and quantitation limits. See Response
1 and Response 959

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0019 Ford Motor Company

Ford Environmental Quality

Office John H. Phillips BY Comment #5. Ford believes that this proposed rule is based on shifting and week foundations (the ML and MDL) at best and offers no improvement over the current regulatory status. This rule would clearly complicate the implementation of regulatory compliance programs. To the extent that EPA decides to proceed with a rule, that should not happen unless and until the Agency proceeds with, and completes, the rulemaking recommended by the FACDQ to clearly define key regulatory terms, including Quantitation Limit (ML) and Detection Limit (MDL) . To assist EPA to that end we recommend the following changes if the rule is to be promulgated:

- Set target national measurement quality objectives for setting Quantitation Limits to replace the ambiguous MLs.

- Specify that in determining which method should be used, the permitting agency must consider, in addition to sensitivity, the important issues of accuracy and precision.

- Provide that test methods should not be used unless they have been validated. In addition, methods should have to meet the cr iteria set forth in the EPA "Alternate Test Procedure" program before they can be used.

- Include a provision specifying that in cases where there are matrix interference concerns with a specific effluent, alternate methods that are less sensitive, but hav e less of an interference problem, may be used. (p. 1

- 3 of comments)

- Allow the permitting agency to determine, for site

- specific reasons, that use of the sensitive method is not necessary (for example, if testing with a less sensitive method at
an intern al monitoring point can allow the permittee to calculate whether it is complying at the final effluent point) See Response
3

0020 Albuquerque Bernalillo

County Water Utility Authority John M. Stomp III, P.E. Chief Operating Officer BZ Comment #1. Different laboratories report different minimum levels (MLs) for the same analytical method and some laboratories may have multiple MLs. EPA should clarify that if a laboratory is using the method listed in 40 CFR 136 with the lowest specified ML,
then the permittee may choose a laboratory based on the analytical “method” not the laboratory specific ML. Considerations for contracting lab work from competing laboratories is dependent on many factors including ML and cost. (p. 1 of comments) See Response
3

0 020 Albuquerque Bernalillo

County Water Utility Authority John M. Stomp III, P.E. Chief Operating Officer CA Comment #2.
EPA needs to define "suitable". (p. 1 of comments) See Response
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0020 Albuquerque Bernalillo

County Water Utility Authority
John M. Stomp III, P.E. Chief Operating Officer CB Comment #3. Regarding "EPA acknowledges that a laboratory might achieve MDLs and minimum levels lower than those published when the promulgated method was developed..." (p. 35716

- bottom of column one, top o f column two).

If a laboratory is able to achieve a lower MDL and ML than specified in a promulgated
method:

- Does the laboratory need to go through a demonstration pursuant to 40 CFR 136.6 before that method can be used for NPDES application or permi t compliance purposes?

- Does EPA need to approve the demonstration? (p. 1

- 2 of comments) See Response
3 and Response 6

0020 Albuquerque Bernalillo

County Water Utility Authority John M. Stomp III, P.E. Chief Operating Officer CC Comment #4. Some methods specified in 40 CFR 136 do not include MLs. Please explain how this rulewould apply to those methods. (p. 2 of comments) See Response
3

0020 Albuquerque Bernalillo

County Water Utility Authority John M. Stomp III, P.E. Chief Operating Officer CD Comment #5. Please further explain what is meant by "method is otherwise required by the Director". EPA needs to ensure that any "required" methods are scientifically acceptable. EPA should list the criteria that will be used to determine the approp riate
method. (p. 2 of comments) See Response
15

0020 Albuquerque Bernalillo

County Water Utility Authority John M. Stomp III, P.E. Chief Operating Officer CE Comment #6. It is difficult to forecast an impact on applicants because future changes to

Water Quality Standards and, therefore, requirements for using analytical methods with
lower MDLs are not understood at this time. (p. 2 of comments) See Response

1

0020 Albuquerque Bernalillo

County Water Utility Authority John M. Stomp III, P.E. , COO CF Comment #7. EPA should build in flexibility for the Director to determine, for site

specific reasons, that the use of an extremely sensitive method is not necessary (e.g., testing at an internal monitoring point with a less

- sensitive method to determine i f
treatment processes are performing correctly). (p. 2 of comments) See Response
3

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CG Comment #1. ODEQ has previously submitted comments on a proposal by EPA Region 6 to lower MQLs. These comments explained the practical and financial difficulties faced by the permittees and the Oklahoma accredited laboratories for the implementation of the proposed MQLs. Many of our previous comments also apply to EPA's prop osed
methods contained in this notice of modifications of 40 CFR Parts 122 and 136. These financial concerns have been magnified by the current recession this country is See Response

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experiencing. The financial burdens are even more of a concern and more still for sm all municipalities and businesses. (p. 1 of comments)

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CH Comment #2. EPA Region 6 has stated that these MLs are based on routinely achievable le vels, but does not indicate that these levels were achieved in a typical wastewater effluent matrix. EPA Region 6 goes on to say that a Federal Advisory Committee (FAC) has been formed to publish Minimum Levels (MLs) reflecting matrix effects. EPA should not publish this rule requiring the use of these methods without the appropriate MLs to address matrix effects. EPA should present this proposal to an organization such as the EPA FACA or the Environmental Lab Advisory Board for discussion before proposi ng to modify 40
CFR. (p. 1 of comments) See Response
3

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CI Comment #3. EPA has not determined what the best method is to determine MDLs and proposes to simply implement the most sensitive method. ODEQ believes this proposal is premature. (p. 1 of comments) See Response
3

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CJ Comment #4. EPA has stated that although some labs may have to purchase new equipment, the cost of monitoring to the regulated community should be reduced. Not only will labs have to purchase new equipment, they will have to dedicate space for clean sample preparat ion and retrofit clean room appurtenances into dedicated space for clean sample preparation and retrofit clean room appurtenances into dedicated space or build new clean rooms. EPA should consider the clean room requirements in its economic analysis. (p. 1 of comments) See Response

1

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CK Comment #5. Permittees will have to pay for clean sampling events which require more personnel and clean suits that need to be th rown away after each sample aliquot. For one six hour composite sample taken in Oklahoma, over $2,000 worth of disposables were used twice the staff were required for this sample. EPA should consider the increased cost of taking a sample to meet the qual ity requirements for the this level of analysis. ODEQ would like to review exactly how EPA determined the cost of implementing these MLs.(p. 2 of comments) See Response

1

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CL Comment #6. EPA has stated that compliance with water quality standards will improve. Using these MLs will not improve compliance with water quality standards. This proposal will cause more facilities to be out of compliance with permits. EPA
should consider the increase in non

- compliance to modify requirements on enforcement authorities or the associated costs and personnel effort by these enforcement authorities. (p. 2 of comments) See Response

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0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CM Comment #7. EPA Region 6 has stated that other states have already implemented MQLs using these MLs as a sufficiently sensitive method. The ODEQ would like to know which states have implemented these MLs so that their labs a nd regulated communities could be surveyed to determine issues, costs, and effects of this change. (p. 2 of comments) See Response

2

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CN Comment #8. The compliance date for adoption of this rule change to 40 CFR parts 122 and 136 is two years if statutory changes are required. Two years may not be enough time due to Oklahoma's rule making process. (p. 2 of comments) See Response

12

0021 Oklahoma Department of

Environmental Quality J immy D. Givens Deputy Executive Director CO Comment #9. EPA should restrict definition iii of sufficiently sensitive analytical test methods to only apply to the proposed pollutants in the Region 6 Minimum Quantific ation Level Guidance. This broad definition would require the most sensitive analysis of all 38 pollutants with criteria lower than current MQLs, with no increase in sensitivity obtained by analyzing for application purposes for almost one quarter of them (the nine pollutants that were apparently not routinely analyzed to the current MQL, much less the even lower ML). (p. 2 of comments) See Response

2

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CP Comment #10. Out of the 38 pollutants examined by EPA Region 6, nine pollutants were apparently not routinely analyzed to the current MQL. Those MQLs and associated
MLs should be raised. (p. 2 of comments) See Response

2

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CQ Comment #11. This notice states EPA welcomes comments on potential impacts of the proposed rule on small entities. For one six hour composite sample taken in Oklahoma, over $2,000 worth o f disposables were used and twice the staff were required for this sample. EPA should consider the increased cost of taking a sample to meet the quality requirements for this level of analysis. Small entities will have a higher percentage of their operat ing budget dedicated to meet the sampling requirements and analysis of this proposed rule change. Small entity analysis should include costs of clean sampling requirements and the added overhead to store all the newly required sampling equipment.
EPA sho uld consider the current recession that this country is in and its drastic affect on small business budgets. (p. 3 of comments) See Response

1

0021 Oklahoma Department of

Environmental Quality Jimmy D. Givens Deputy Executive Director CR Comment #12. If a more sensitive method is implemented and you have to dilute the sample, then you've raised the detection limit. This negates the increase in the "sufficiently sensitive method." (p. 3 of comments) See Response
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0022 West Virginia Municipal

Water Quality Association David C. Sago
President CS Comment #1. EPA's proposed amended regulation would require that, for NPDES permit applications and for permit compliance reporting, an approved Part 136 method be
used that is at or below the level of the applicable water quality criterion, or is at or below the level of the applicable water quality criterion, or if the concentration of the pollutant parameter is high enough, a method that properly quantifies the concentration. The MWQA generally supports EPA's proposal. However additional flexibility should be included in the regulation for those cases where there is a wasteload allocation ("WLA") or a permit limit above the water quality criterion.

We agree that an appropriate Part 136 analytical met hod should in all cases be used which allows a correct quantification of the pollutant parameter. In many cases the quantification level will be the water quality criterion. However, there are also many cases where dilution is available, and where there is a properly calculated WLA or similar value that is protective of the instream criterion, at a value than the criterion. In those instances the regulation should provide for the use of a method that provides a quantification level at or below the WLA or other appropriate value. In such cases there is no benefit to the use of a more sensitive method, and the more sensitive methods may have additional costs or other disadvantages.

We further note that, although the preamble to the proposal refers to the use of an analytical method with a QL at or below the water quality criterion or permit limit , the proposal itself does not appear designed to address permit limits at levels higher than the respective criteria.

Accordingly, we recommend that the regulation be changed before promulgation to address these important issues. We ask the EPA consider the following possible text to accomplish this.

40 C.F.R. 122.21 (e)(3). (i) For 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, wasteload allocation or other critical regulato ry value for the measured
parameter; (B) The method ML is above the applicable water quality criterion, wasteload allocation, permit limit or other critical regulatory value , but the amount of pollutant or pollutant See Response

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parameter in a facility's discharge i s high enough that the method detects quantifies the level of the pollutant or pollutant parameter in the discharge.... A comparable change should also be made to the proposed language at subsection
122.44. (p. 1

- 2 of comments)

0023 Alaska Oil and Gas

Association Marilyn Crockett
Executive Director CT Comment #1. The proposed rule would cause untenable and costly compliance problems
in isolated areas in Alaska. The number of available in

- state laboratories that can perform sufficien tly sensitive test methods is extremely limited. If this ruling is implemented as stated, shipments to laboratories outside of Alaska would be required. In addition, logistics from offshore platforms and remote sites typically require helicopter
transpor t to land to airplane to land transport. This would add to the challenge of meeting sample holding times and other preservation restrictions especially in light of delays caused by coordination between offshore facilities, air transport, laboratory schedu les, and Transportation Safety Administration restrictions. Furthermore, shipments of samples can be especially challenging and subject to delays in Alaska due to adverse weather conditions, volcanic eruptions, and earthquakes which can ground air
transpo rtation. (p. 1 of comments) See Response
3

0023 Alaska Oil and Gas

Association Marilyn Crockett
Executive Director CU Comment #2. The rule should include allowances for isolated areas for holding times, and sampling and monitoring delays due to problems transporting samples and limitation on laboratory capability. (p. 1 of comments) See Response
3

0023 Alaska Oil and Gas

Association Marilyn Crockett
Executive Director CV Comment #3. To be consistent with the "sufficiently sensitive" definition described in the preamble, the amended language in Part 122.21 (e)(3)(i) should clearly state that a method is "sufficiently sens itive" when either (A) or (B) or (C) applies. Amended language in Part 122.44 (i)(1)(iv)(A) should likewise state that a method is sufficiently sensitive when any of (1) or (2) or (3) apply. (p. 1 of comments) See Response

4

0023 Alaska Oil and Gas

Asso ciation Marilyn Crockett
Executive Director CW Comment #4. The analysis of sufficiently sensitive test methods must be practical for
site

- specific logistics. Conditions under 122.21 (e)(3) and 122.44 (i)(1)(iv) are needed

- 122.21 (e)(3)(iii) the method ML under (i) or (ii) above must account for holding times necessary for logistical constraints in Alaska.

- and similarly under 122.44 (i)(1)(iv)(C) the method ML under (A) or (B) above must account for holding times necessary for logistical constraints in Alaska. (p. 2 of comments) See Response
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0023 Alaska Oil and Gas

Association Marilyn Crockett
Executive Director CX Comment #5. The preamble provides additional explanation for the third criterion for sufficiently sensitive, however, the specific language in the proposed rule does not. Section III of the Scope and Rationale of the Proposed Rule EPA (page 35716) states that
for t he third criterion “... the applicants or permittees should use “ the most sensitive ” of the approved methods for the pollutant ” [emphasis added]. This qualification is missing in 122.21 (3)(i)(C) and 122.44 (1)(iv)(A)(3) and both should be revised to state:

- The method has the lowest ML of the analytical methods approved under 40 CFR 136 for the measured pollutant or pollutant parameter. (p. 2 of comments) See Response
5

0024 Virginia Association of

Municipal Wastewater Agencies, Inc. CY Comment #1. EPA ’ s proposed amended regulation would require that, for NPDES permit applications and for permit compliance reporting, an approved Part 136 method be used that is at or below the level of the applicable water quality criterion, or if the concentration of the p ollutant parameter is high enough, a method that properly quantifies the concentration. VAMWA generally supports EPA ’ s proposal; however, additional flexibility should be included in the regulation for those cases where there is a wasteload allocation ( “ W LA ” ) or a permit limit above the water quality criterion.

We agree that an appropriate Part 136 analytical method should be used which allows a correct quantification of the pollutant parameter. In many cases, the quantification level
will be the water quality criterion. However, there are also many cases where dilution is available, and where there is a properly calculated WLA or similar values that is protective of the instream criterion, at a value higher than the criterion. In those instances
the regulation should provide for the use of a method that provides a quantification level at or below the WLA or other appropriate values. In such cases there is no benefit to the use of a more sensitive method, and the more sensitive methods may have additi onal costs or other disadvantages.

We further note that, although the preamble to the proposal refers to the use of an analytical method with a QL at or below the water quality criterion or permit limit , the proposal itself does not appear designed to address permit limits at levels higher than the respective criteria.

Accordingly, we recommend that the regulation be changed before promulgation to address these important issues. We ask that EPA incorporate the following revisions to
address the fore going issues:

40 C.F.R. 122.21 (e)(3)

. See Response

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(i) For 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, wasteload allocation or other critical regulatory value for the measured
parameters; (B) The method ML is above the applicable water quality criterion, wa steload allocation, permit limit or other critical regulatory value , but the amount of 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

... A comparable change should also be made to the proposed language subsection 122.44. (p. 1

- 2 of comments)

0025 The Dow Chemical

Company Global Regulations Affairs Tracey Maloney, P.E. CZ Comment #1. EPA ’ s proposal is a “ significant regulatory action ” under Executive
Order 12866. Executive Order 12866, “ Regulatory Planning and Review, ” was intended to provide oversight and ensure careful consideration before promulgating any “ significant regulatory action. ” According to section 3(f) of that Executive Order, a regulatory action
is “ significant ” if (among other things):

- It may raise novel legal or policy issues, or

- It may have an annual effect on the economy of $100 million or more, or

- It may adver sely affect competition or jobs.

EPA ’ s proposal meets all three of the tests above. To explain this, we must provide some background information about the proposal.

- EPA ’ s rationale for the entire proposal is unsound . EPA ’ s explicit rationale for thi s action, is that the Agency is borrowing from its recent experience with analysis for mercury and applying the same approach to all pollutants. That approach is unsound. Pollutants are not all the same. An analytical approach that works for mercury (a m etal) may not work for volatile or semi

- volatile organic compounds. To cite the most obvious flaw, EPA actually has sensitive analytical methods for mercury. In contrast, EPA admits that there may not be any “ sufficiently sensitive ” test methods for some other compounds. Thus, it is literally impossible to “ extend ” the approach for mercury.

- EPA ’ s drive for greater sensitivity will increase the risk of “ false positives ” and thereby impair the validity of analytical data. EPA ’ s proposal is all about s ensitivity of analytical methods. Sensitivity is important, but it is not the only thing that is important. Greater sensitivity often comes at the cost of lest specificity. In other words, a method that can See Response
1 and Response 367

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detect a compound at a lower concentration ma y risk “ false positives ” by inaccurately identifying other substances as the target compound. This, of course, would defeat

EPA ’ s purposes. The Agency has specifically stated that “ it is critical that the Director make permitting decisions based on accur ate data and thus, sound science. ” If the use of a more sensitive method results in inaccurate identification of compounds, the Director ’ s decisions would be based on inaccurate data. Unfortunately, the Agency does not appear
to have considered this in t he proposal.

- The proposal would greatly increase the nation

- wide economic burden of chemical analyses required for NPDES permits and for permit applications . EPA does not appear to have recognized that the proposal would have any economic impact at al l. In reality, the proposal will impose substantial additional costs on permittees across the entire country. The potential magnitude of these additional costs makes the proposal a

“ significant regulatory action. ” For example:

- The proposal would have the effect of requiring permitted facilities to develop their own analytical methods, at their own expense. In cases where EPA does not have any approved methods for a particular compound, the proposal still requires monitoring to be conducted using “ a sufficiently sensitive test procedure specified in the permit. ” In some cases there may be an existing analytical method (although not EPA

- approved). That would be the best case. However, there will also be situations where no analytical
method

– at all

- exists that can detect and quantify a particular substance at the concentrations desired by the EPA. In that situation , EPA ’ s current proposal would appear to require the permitted facility to develop and validate an analytical method that
is “ suff iciently sensitive. ” The cost of developing even one method could be millions of dollars. Worse yet, any one facility may have to develop methods for multiple substances. And, if numerous facilities across the country

– perhaps in different EPA regions

– each discharge the same substance, they may each have to develop methods independently, thereby incurring massive costs in the most inefficient manner. This is because there is no obvious way for those permittees to know of each other. As a further

con cern, not only would money be wasted, but numerous divergent inconsistent methods would be developed for the same substance. This aspect alone could make the proposal a

“ significant regulatory action. ”

- Requiring more sensitive methods will increase the cost “ per analysis. ” In general, the

cost “ per analysis ” is higher for analytical methods that are more sensitive. The amount of incremental cost per analysis can vary from one method to another. However, more sensitive methods usually require more stringent laboratory procedures, and sometimes more costly la boratory equipment. Thus, the cost of analysis tends to increase. Nothing68

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in EPA ’ s proposal even mentions this. Considering that analyses under permits must be run repeatedly (for example, quarterly, monthly, weekly or even daily), and that the NPDES pr ogram applies to a very large number of facilities nationwide, this factor alone could make the proposal a “ significant regulatory action. ”

- EPA ’ s proposal will require more analyses to be run. For example, it is currently common to run a single sca n by a single method, and thereby receive analytical data for a large number of compounds. This keeps the cost down but may not achieve, for some compounds, the detection and quantifications level that EPA now desires. This means the permittee would now have to run the broad scan and a number of additional, single

compound analyses. This will obviously increase the cost of analysis under NPDES permits and to support permit applications, but EPA does not even mention this, anywhere in the proposal.

- EPA ’ s proposal will necessitate confirmatory analyses to address “ false positives. ” As mentioned above, greater analytical sensitivity often increases the risk of “ false positives. ” This means the methods may register a non

- target compound and mistakenly identify it as the target substance. Sometimes it is possible to dispel this “ mistaken identify ” by using a different analytical method. However, doing so requires additional expenditures. EPA ’ s proposal does not acknowledge this.

Based on the ration ale above, EPA ’ s proposal meets at least three test, any one of which would trigger applicability of Executive Order 12866. 1. The proposal raises novel legal or policy issues. For example:

- There is a question whether the Clean Water Act grants EPA the authority to require permittees to develop and validate analytical methods, at their own expense, whenever
EPA has failed to do so.

- There is an additional novel policy question whether EPA should be allowed to implement a proposal that would have t he effect of requiring multiple different permittees to independently develop duplicative and inconsistent, non

- EPA

- approved, “ in

- house ” analytical methods for the same pollutant.

– EPA has asserted that this proposal imposes
no new information collection burdens, and that OMB ’ s approval of the burdens of the existing regulations automatically covers the amended regulations. There is a legal question whether EPA may disregard the new burden of additional analyses, more costly analyses and especially the c ost of developing in

- house analytical methods, and thereby rely on OMB ’ s review of the burdens of the pre

- amendment regulations.

2. The proposal may have an annual effect on the economy of $100 million or more. The cost of developing in

- house analytica l methods, the cost of more expensive analyses, the69

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cost of more numerous analyses, and the cost of more confirmatory analyses to rule out

“ false positives ” will be extensive and nation wide. 3. The proposal may adversely affect competition and jobs in a meaningful way. The additional costs that this proposal will cause are truly substantial. In today ’ s economy, any substantial increase in costs has the potential to make American businesses less competitive in the global market, and thereby jeopardize jobs. For all these reasons,

EPA ’ s proposal is a “ significant regulatory action ” subject to Executive Order 12866. (p.

1

- 4 of comments)

0025 The Dow Chemical

Company Global Regulations Affairs Tracey Maloney, P.E. DA Comment #2. EPA ’ s proposal imposes new burdens that may not have been approved under the Paperwork Reduction Act. EPA asserts that this proposal “ does not impose any new information collection burden. ” However, as has been demonstrated above, the proposal will actually require enormous additional expenditures to develop analytical methods and conduct additional analyses. It is unclear on what basis EPA asserts that OMB has already approved those burde ns. Unless OMB agrees that those burdens were foreseen and approved previously, the proposal should be submitted to OMB for review under the Paperwork Reduction Act. (p. 4 of comments) See Response

1

0025 The Dow Chemical

Company Global Regulations Affairs Tracey Maloney, P.E. DB Comment #3. EPA ’ s proposal requires further review under the Regulatory Flexibility Act. EPA has asserted that the proposal “ will not have a significant economic impact on a substantial number of small entities. ” However , EPA has utterly failed to consider the economic impacts described above, and thus has not evaluated the extent to which those economic impacts would affect small entities. Small entities would likely experience particular difficulty if, for example, the y were required to develop sensitive analytical methods at their own expense. Due to the lack of consideration of these issues, EPA has not provided any valid basis to exclude this regulatory action from the Regulatory Flexibility Act. (p. 4 of comments) See Response

1

0025 The Dow Chemical

Company Global Regulations Affairs Tracey Maloney, P.E. DC Comment #4. EPA ’ s proposal requires further consideration of the Unfunded
Mandates Reform Act. According to EPA ’ s Federal Register notice, the Unfunded Mandates Reform Act applies to a federal mandate that might result in (among other possibilities) expenditures of $100 million or more by “ the private sector ” in any one year. As has been shown above, EPA ’ s proposal may result in expenditures by the private sector in excess of $100 million annually. EPA also asserts that the proposal

contains “ no regulatory requirements that might significantly or uniquely affect small
governments. ” However, small governments often operate wastewater treatment See Response

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facilities. Consequently, the increased costs that this proposal would create may heavily on small governments. For the reasons stated above, EPA ’ s rationale for excluding the
Unfunded Mandates Reform Act is incorrect. (p. 4

- 5 of comments)

0025 The Dow Chemical

Company Global Regulations Affairs Tracey Maloney, P.E. DD Comment #5. EPA ’ s exclusion of Executive Order 13175 may be incorrect. EPA has stated that the proposal is not subject to Executive Order 13175 (Consultation and Coordination with the Indian Tribal Governments) because 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. ” EPA ’ s assertion may be incorrect. If tribal governments implement permitting programs, this proposal may impose greater responsibilities on tribal governments to identify and recognize “ sufficiently sensitive ” analytical methods. The proposal may also impose new responsibilities on tribal governments to require and oversee the development of new analytical methods where

no ne exist. And if tribal governments operate wastewater treatment systems, the proposal may impose substantial new costs on those tribal governments. Consequently, it seems conceptually possible that the proposal may trigger Executive Order 13175. (p. 5 o f comments) See Response

1

0025 The Dow Chemical

Company Global Regulations Affairs Tracey Maloney, P.E. DE Comment #6. For all reasons stated above, our primary recommendation is that EPA should withdraw this proposed rule for further deliberation. It seems very evident that EPA has not recognized, much less evaluated, a number of the impacts of the regulation. Therefore, it seems only fair that EPA should reconsider the proposal in light of those impacts. The reconsideration should include such thing s as whether EPA really intends and desires to impose those burdens (and if not, how to rephrase the rule). If EPA does intend to impose those burdens, then presumably the reconsideration should include a justification for those burdens, then presumably t he reconsideration should include submittal of the proposal for review under appropriate executive orders and statutes as identified in the paragraphs above.

If EPA is unwilling to withdraw the proposal for reconsideration, then EPA must either
submit the proposal for review under the executive orders and statues identified above, or develop a valid rationale for excluding the proposal for such review.

In either case, the proposal should not move forward as presently constituted, without the
review that a re required by law. (p. 5 of comments) See Response

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0026 Wisconsin Department of

Natural Resources Tom Mugan DF Comment #1. I agree with the general objective of the general objective of the proposed changes: to formally clarify that method sensitivity should play a primary role in method selection for use in testing pollutant concentrations with very low water quality criteria in NPDES outfalls. However, I have a few concerns with actual language used.

The changes to 122.21 require that permittees use methods that are “ sufficiently
sensitive ” for application monitoring.

- In 122.21 (e)(3)(i), three options define what “ sufficiently sensitive ” means. It appears
that there should be an “ or ” following the second option [122.21(e)(3)(i)(B)]

.

- In 122.21 (e)(3)(ii), the permittee may use an un

- approved method for a substance that has no approved methods; but now 122.21 (e)(3)(i)(C) is no longer in play (an unapproved method cannot be the approved method with the lowest ML). If the pollutant in question has an extremely low water quality criterion, this provision could suggest a permittee must strive to meet an ML that is impossible with existing technology. This could be a problem if the Director fails to specify a method since the language limits the permittee choice of methods in that “... the applicant may use any suitable, sufficiently
sensitive method ...”

.

- In Wisconsin, we would normally suggest a suitable method in the application
instructions.

The changes to 122.44 require that permittees use methods that are “ sufficiently
sensitive ” for permit required monitoring.

- In 122.44(i)(1)(iv)(A), three options define what “ sufficiently sensitive ” means. IT appears that there should be an “ or following the second option [122.44(i)(1)(iv)(A)(2)].

- In 122.44(i)(1)(iv)(B), the permittee must use an un

- approved method for a substance that has no approved methods; but now 122.44(i)(1)(iv)(A)(3) is no longer in play. If the pollutant in question h as an extremely low water quality criterion, this provision could require the permittee to meet an ML that is impossible with existing technology. This could be a more significant problem since the language indicates that “... monitoring shall
be conducted a ccording to a sufficiently sensitive test procedure ...” (emphasis added).

- In Wisconsin, before settling a requirement in a permit, we would work with the laboratory community and the permittee to be sure there is a valid method that will provide the infor mation needed to assess the impact to water quality and compliance with limitations or other permit conditions. And we would normally specify that method in the permit. However, I have concerns that a future third party interpretation with legal preceden t might interfere with our desire to set realistic requirements in a permit. (p. 1 of comments) See Response
4 and Response 1872

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0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DG Comment #1. [National A ssociation of Clean Water Agencies (NACWA)] overarching
concern is that EPA ’ s proposed action seems premature given the Agency ’ s ongoing assessment of the [Federal Advisory Committee on Detection and Quantitation (FACDQ)] recommendations regarding the need for a new and consistent definition of minimum level. In addition, the proposed rule appears to require the use of methods that have not been approved by EPA through the 40 CFR Part 136 process and that may not have undergone validation of any other scie ntific review. Given the uncertainty associated with such methods and the fact that the public is not provided an opportunity to comment on the reliability and use of those methods, NACWA believes such an approach contravenes basic principles of valid sci ence. (p. 1 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DH Comment #2. Issues with the Use of the Minimum Level as Proposed. It seems inappropriate to use the minimum level (ML) as a regulatory decision point given the current ML definition (3.18 x method detection level (MDL)) and MLs used in 40 CFR Part 136 methods are recognized to be flawed by all stakeholders including the states and EPA. The FACDQ has made recomm endations to EPA on how to address the ML definitions but EPA has yet to address those recommendations in a rulemaking. EPA states that it is critical that it make permitting decisions based on sound science, but the
use of the current ML definition has f ailed that standard. (p. 2 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DI Comment #3. Issues with the Use of the Minimum Level as Proposed. The proposed
rule falls short of providing a sound, consistent approach because it offers three different options for defining the ML: a. 3.18 x MDL, b. Whatever is published for a method, or c. The lowest acceptable calibration point.

Mercury method 1631E confuses the issue more by taking 3.18 x MDL and then

“ rounding to the number nearest to (1, 2, or 5) x10n, where n is an integer. ” The level of confusion regarding the ML to be used in the proposed rule is further complicated by the fact that labs can have different MLs than the respective methods. As stated above, this rule should not be finalized until a new, single definition of ML is promulgated based on the work of the FACDQ. (p. 2 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DJ Comment #4. Issues with the Use of the Minimum Level as Proposed. EPA states that the ML should be less than the applicable water quality criteria. However, when following EPA ’ s guidance in the Technical Support Document for Water Quality

- based Toxics Control , the decision point for the reasonable potential process is the wasteload allocation (WLA) rather than the criteria. The language needs to be adjusted accordingly. (p. 2 of comments) See Response

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0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DK Comment #5. Issues with the Use of the Minimum Level as Proposed. The ML is used by labs as an internal gauge of performance. However, independent reviews of performance (discharge monitoring report (DMR) quality assurance (QA) studies, for example) gen erally do not monitor the actual performance of labs at concentrations approximating the ML. It is important that if the ML were to be used by the EPA as suggested, stakeholders using laboratories to meet NPDES requirements must have some
assurance that t hese labs can actually meet the required quality objectives at or near the concentration of the ML. This will require a significant shift in how third parties (permittees, EPA, states) evaluate laboratories and this shift must occur before further weight i s placed on the ML. (p. 2 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DL Comment #6. Issues with the Use of the Minimum Level as Proposed. The notice states that published methods “ give only an upper, not a lower, bound on the lab ’ s MDL
and minimum level. ” This is not universally true because the ML of the published methods may not be based on a representative sample of lab performance. F or example, some MLs are based on the performance of research and federal labs but do not include the performance of industrial or municipal labs. This is one reason why it is important to test methods intended for regulatory use in labs representing all stakeholders that will use
those methods. (p. 2 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DM Comment #7. Issues with the Use of the Minimum Level as Proposed. The proposed rule specifically refers to “ the method ML. ” There are very few methods with an ML. Therefore, the proposed language does not address the vast majority of 40 CFR Part 136 methods. A footnote in the proposed rule states that the ML can also be “ the lowest calibrations point in a method. ” Methods in 40 CFR Part 136 do not define the lower calibration point to be used. This is decided by the respective laboratory. It would be more appropriate to refers to “ the lowest calibration point used by a laboratory ” in this
instance. (p. 3 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DN Comment #8. Issues with the Use of the Minimum Level as Proposed. The proposed rule equates “ ML, ” “ quantitation level (QL) ” and reporting limit (RL), ” however these terms are not synonymous in all cases. For example, the QL and/or the RL for a lab may be one value equal to or less than the method ML, but they are not necessarily equivalent with the ML. Using the ML definitio n of 3.18 x MDL, it would be nearly impossible for a lab to use 3.18 x MDL as the lowest calibration standard. This is particularly true for methods that measure dozens of analytes. It is much more practical for labs to adopt MLs
that are similar in conc entration across analytes and that are less than the respective WLAs than to calculate a MDL for each analyte, multiply each of those MDLs by 3.18, and then create dozens of dilutions equaling that product for dozens of analytes. See Response
3 and Response 1474

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Therefore, the QL/RL may be 5 ppb for numerous analytes in EPA method 625 but the MDL x 3.18 for each analyte does not equal 5 ppb. (p. 3 of comments)

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DO Comment #9. Use of Most Appropriate Method, Not Most Sensitive

. The driver for this proposed change is to provide data of sufficient precision and accuracy, but EPA has not defined the data quality objectives for precision and accuracy to be a pplied to
NPDES

- related data. Therefore, no one including EPA can establish whether the ML meets this proposed need. EPA goes on to say that it should not use imprecise analytical methods in permits, but the EPA has not defined what this means. EPA stat es it needs to make permitting decisions based on accurate data, but EPA has not defined the level of accuracy required for use of the data. (p. 3 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DP Comment #10. Use of Most Appropriate Method, Not Most Sensitive. The notice defends the need for use of sufficiently sensitive methods, and explains this need in terms of accuracy and precision. Based on EPA ’ s own guidance reg arding quality indicators (DQIs) EPA should recognize that sensitivity is different than accuracy and precision. Although NACWA agrees that accurate and precise data should be used to meet NPDES requirements the desire to have more sensitivity will likely conflict with the need for accuracy and precision. Simply stated, values reported at lower concentrations do not inherently have greater accuracy or precision than higher concentrations. Quite the contrary, one often compromises accuracy and precision a s sensitivity increases. The need for greater sensitivity should not compromise the need for accuracy and precision. (p. 3 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DQ Comment #11. Use of Most Appropriate Method, Not Most Sensitive. In many cases such as PCBs, pesticides, and other organics, GC/MS MDLs are not sufficiently sensitive to detect the level of the water quality standard. In the case of most organics, there is an approved gas chromatography (GC) method which provides a lower detection limit than the approved GC/MS method. In the case of many organic parameters, the ML rule could trigger a requirement to change from GC/MS to GC methods. This would be undesir able. GC/MS provides a much greater degree of confidence in the correct identification of the regulated parameter. Although use of dual columns in GC methods reduces uncertainty in the identification, GC/MS methods provide much greater confidence in the correct identification of organic parameters. The value of more sensitive quantitation is lost if See Response
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one is not certain what is being quantified. There are numerous cases in which a GC method might be considered the most sensitive method. And its use requir ed by the proposed rule. NACWA believes that the sufficiently sensitive method rule should recognize the superiority of GC/MS methods to GC methods and provide an exception to the sufficiently sensitive methods rule for the case of less sensitive GC/MS me thods. (p. 3 of comments)

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DR Comment #12. Implementation of the Proposed Requirements. The “ Scope and Rationale of the Proposed Rule ” states that where insufficient sensitivity among 40 CFR Part 136 methods is concluded, the permitting agency would have the authority to require

a non

- promulgated method in an NPDES permit based on the proposed language of the rule. This preamble text is problematic because it conflicts with the language of the actual proposed regulation where “ an NPDES applicant may use any suitable sufficiently
sensitive method. ” The latter language indicates that selection of the method is made by the permittee rather than the permitting authority. NACWA believes that the decision should be made by the permittee. (p. 4 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback , Sr. Director DS Comment #13. Implementation of the Proposed Requirements. States only have a maximum of 2 years to implement this rule once finalized. It is not clear how this rule will impact NPDES permits which will not be renewed for up to 5 years after the rule has been adopted . EPA should clarify how this rule change impacts reporting under current NPDES permits. (p. 4 of comments) See Response
11 and Response 12

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DT Comment #1 4. Implementation of the Proposed Requirements. EPA states that it will provide regular updates on water quality criteria to ensure that the states use sufficiently sensitive methods. This is irrelevant for states that have adopted their own water quali ty criteria. Once state criteria are EPA

- approved, only the state criteria can be
used. Later

- developed EPA criteria do not replace the properly adopted state criteria. Rather, the states are under an obligation to update their criteria periodically, bu t pending
the states ’ updates the adopted state criteria still control for NPDES purposes. The language should be removed because it suggest the opposite. (p. 4 of comments) See Response
13

0027 National Association of

Clean Water Agencies Regulatory Aff

airs
Chris Hornback
Senior Director DU Comment #15. Implementation of the Proposed Requirements. Upon promulgation of this rule, laboratories/permittees should be given sufficient time to change methodologies. The time period to do this should not start until the rule is incorporated by each regulatory authority and should be at least 18 months in length to allow for review and selection of labs or purchase of equipment and training. (p. 4 of comments) See Response
11 and Response 12

0027 National Association of

Clean Water Agencies Regulatory Affairs DV Comment #16. Implementation of the Proposed Requirements. EPA requires that data be collected within 4.5 years prior to the NPDES permit renewal application and

cove r different periods of the year to address discharge quality variability. If the rule is finalized in December of 2010 and a permit renewal is due in 2012, sampling/analyses by See Response

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Chris Hornback
Senior Director the permittee have already begun and may not meet the requirement of the CWA

m odification. EPA and States should grandfather permit renewal data up to and including a date well after the rule is finalized to allow use of data already generated, to avoid loss of resources, and to avoid situations where permittees may be found in

non compliance because the data they provide does not complete the permit application.

Also, if non

- detectable or data below the ML is collected during the term of a permit, but the most sensitive method is not used, must that data be excluded from considerat ions for

NPDES re

- permitting if the water quality standard is below the ML of the method used? NACWA believes it is appropriate to allow the permit writer to use all the data collected during the term of the permit in addition to the data required to meet the minimum data requirements for the permit application, and requests that EPA clarify in the rule or preamble that this approach is allowed. (p. 4

- 5 of comments)

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DW Comment #17. Implementation of the Proposed Requirements. The notice is not clear whether the new requirements are intended to apply to indirect discharges to POTWs. The description in Table I

- 1, Entities Potentially Regulated by this Rule, does not refer to indirect dischargers, but the preamble refers to subchapter N which includes pretreatment standards for direct dischargers, but the preamble refers to subchapters N which includes pretreatment standards for direct and indirect discharge standards. The rule or preamble should be clear as to whether the rule applies to the pretreatment program monitoring conducted for compliance with Part 403. Because of the challenges associated with industrial discharge matrices , NACWA believes that the option to require the achievement of MLs below regulatory limits should be left to the discretion of the POTW. Industrial permittees may not be able to meet these requirements because matrix effects often require dilution of samp les which increases the ML. Some of these samples may even damage components of the more sensitive instruments due to their high
concentrations. (p. 5 of comments) See Response

9

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chri s Hornback
Senior Director DX Comment #18. Implementation of the Proposed Requirements. Monitoring is sometimes required in an NPDES permit for parameters for which numeric water quality based effluent limits (WQBELs) are not specified in the permit. A condition may be included in the permit which states that the permittee may not cause a violation of instream standards. For some utilities, there are dozens of compounds for which quarterly monitoring is required and which have state water quality stand ards but for which no numeric WQBELs are included in the permit. In such a case, do the new requirements apply or do they apply only to those parameters which have specific numerical effluent limits and for which monitoring results are required to be repo rted on See Response
3 and Response 1177

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the DMR? NACWA believes that the ML requirement should only apply to parameters with explicit numerical limits which are reported on the DMR. (p. 5 of comments)

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DY Comment #19. Implementation of the Proposed Requirements. Not all approved methods are available commercially. NACWA recommends that the rule provides an exception for sensitive methods which are not c ommercially available to prevent creating an obligation for regulated entities to fund laboratories to provide those analytical
services. (p. 5 of comments) See Response
3

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senior Director DZ Comment #20. Implementation of the Proposed Requirements. Instructions for DMR reporting address the reporting of data below the MDL. The rule is silent on the communication of ML information on the DMR or NPDES application. NACWA

re quests that EPA clarify in the preamble to the final rule that there is no ML reporting obligation on the DMR or NPDES application. (p. 5 of comments) See Response

6

0027 National Association of

Clean Water Agencies Regulatory Affairs
Chris Hornback
Senio r Director EA Comment #21. Implementation of the Proposed Requirements. For multi

- parameter approved methods which utilize similar technology with similar MDL/MLs (e.g. 624, 1624, 6210B 18 th ), is an analyte

- by

- analyte comparison necessary to determine the appropriate method? This would be a significant administrative difficulty and cost increase if POTWs would have to divide one analysis into two or three because parameters have slightly different MLs. (p. 5 of comments) See Response
3

0028 South Carolina Water

Quality Association
F. Paul Calamita
General Counsel EB Comment #1. EPA ’ s proposed amended regulation would require that, for NPDES permit applications and for permit compliance reporting, an approved Part 136 method be
used that is at or be low the level of the applicable water quality criterion, or if the concentration of the pollutant parameter is high enough, a method that properly quantifies the concentration. VAMWA generally supports EPA ’ s proposal; however, additional flexibility shoul d be included in the regulation for those cases where there is a wasteload allocation ( “ WLA ” ) or a permit limit above the water quality criterion.

We agree that an appropriate Part 136 analytical method should be used which allows a correct quantificati on of the pollutant parameter. In many cases, the quantification level will be the water quality criterion. However, there are also many cases where dilution is available, and where there is a properly calculated WLA or similar values that is protective of the instream criterion, at a value higher than the criterion. In those instances See Response

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the regulation should provide for the use of a method that provides a quantification level at or below the WLA or other appropriate values. In such cases there is no bene fit to the use of a more sensitive method, and the more sensitive methods may have additional costs or other disadvantages.

We further note that, although the preamble to the proposal refers to the use of an analytical method with a QL at or below the water quality criterion or permit limit , the proposal itself does not appear designed to address permit limits at levels higher than the respective criteria.

Accordingly, we recommend that the regulation be changed before promulgation to
address these i mportant issues. We ask that EPA incorporate the following revisions to address the foregoing issues:

40 C.F.R. 122.21 (e)(3)

. (i) For 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, wasteload allocation or other critical regulatory value for the measured
parameters; (B) The method ML is above the applicable water quality criterion, wa steload allocation, permit limit or other critical regulatory value , but the amount of 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

... A comparable change should also be made to the proposed language subsection 122.44. (p. 1

- 2 of comments)

0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator EC Comment #1. The stated goal of the proposed rul e is to ensure that NPDES permittees use analytical methods in permit applications and reports that are “ sufficiently sensitive. ” We believe that is a worthwhile goal. However, the specific provisions in the proposed
rule are not well

- tailored to achieve t hat goal. Those provisions raise substantial scientific concerns, and are too vague and undefined to implement effectively. As a result, the proposal would have substantial financial and operational impacts on FWQC members,
without a sufficient scientific basis or a significant practical benefit. (p. 2 of comments) See Response
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0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator ED Comment #2. The FWQC believes that this proposed rule is not necessary. To the extent
that EPA has a particular concern about States not using a new method, such as with mercury, EPA can address that problem directly. There is no need to make a substantial revision to the NPDES permitting regulations, particularly when that change would have
the collatera l impacts identified in these comments. To the extent that EPA decides to proceed with a rule, that should not happen unless and until the Agency proceeds with, and completes, the rulemaking recommended by the Federal Advisory Committee to define key regul atory terms as to quantitation and detection limits. (p. 2 of comments) See Response
3

0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator EE Comment #3. Scientific Concerns (Reliance on ML). The proposed rule establishes a preference for use of certain analytical methods, based solely on one factor: whether that method has the lowest "minimum level" (ML) of the available methods. We believe that method sensitivity should not be the sole, or even the primary, factor in deciding which
metho d should be used in the permit process. Other critical factors include accuracy, precision, selectivity, and whether the method has been validated. (As to accuracy, it is worth noting that in calculating ML, accuracy (i.e., percent recovery of analyte) is not considered; the MLs are calculated strictly based on standard deviation, or the ability of the lab to generate reproducible results. Thus, a lab can derive a very low ML (making method "sufficiently sensitive"), where the method is not acceptable from an accuracy perspective

- in other words, is not "sufficiently accurate.") Even if having the lowest ML should be a key factor, EPA has ignored critical problems in applying that test. In some cases, a method with the lowest ML can be verified in the lab, but not in the field (for example, TRC). Often, different labs have different MLs for the same pollutant, and in some cases, an individual lab will have multiple MLs for the same pollutant, derived from different instruments. These lab MLs are frequently lower than the ML specified by EPA in the approved method. In addition, it is often the case that due to matrix interferences, the ML actually experienced when a method is run on effluents is significantly different than the ML result from a lab study (Fo r example, it is common for a laboratory to experience "foaming" of a sample from the presence of detergents and surfactants during the purge and trap volatile organic compound analysis conducted by EPA Method 624. EPA Method 624 has MLs (as defined in the proposed rule, although no MLs are actually listed in the method) typically at 5 to 10 ug/L. To address samples that foam during analysis and therefore cause problems with the instrumentation, laboratories dilute the sample 5 to > 10 fold to minimize the sample matrix effects. As such, in the real sample matrix the sample

- specific ML may be 25 to 100 ug/L or more, which is far greater than the normal ML.). Also, some methods list no ML at all (for example, EPA Methods 624 and 625, which are commonly used) . For all of these reasons, specifying "the" ML for a given parameter is not a simple task. Further adding to See Response
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these complications is the fact that EPA itself does not have a single definition for the ML. Even in the EPA test method rules (40 CFR 136), the re are multiple ways of defining the term “ML,” one of which is based on applying a multiplying factor (such as 3 to 5 times) to the “method detection level” (MDL). Significant scientific flaws exist in the current EPA procedure to define MDL and, therefo re, the ML. To address this issue, EPA convened a Federal Advisory Committee, which provided the Agency with specific recommendations. (The report can be found at http://www.epa.gov/waterscience/methods/det/faca /final

- report

- 200712.pdf.) The Committee sp ecifically recommended (at page iii of the report) that EPA promulgate a rule defining how quantitation limits will be derived. However, EPA has not yet proceeded with the recommended rulemaking, to define and clarify these critical regulatory terms. EPA n eeds to complete that task before requiring regulated dischargers
to select test methods based

– to any extent

– on their MLs.

EPA has also recognized that there are flaws in current instrument calibration methods,
which influence how an ML is determine d, and that improvements in these methods are needed. (http://epa.gov/fem/calibration.htm) These improvements should be made before EPA requires permittees to make decisions on use of test methods based on their MLs.

While the concerns laid out here appl y to both applications and reports, they pose particular problems with regard to the application process. At the point when a discharger is applying for a permit, it may not know a great deal about pollutants for which it does not currently have limits or monitoring requirements. But this rule would require that discharger to make judgments about what levels of that pollutant are likely to be present in its discharge, in order to determine which method has to be used. (This situation raises
other concerns l ater: if the laboratory or instrument that is initially used to demonstrate compliance with the permit limits changes or becomes unavailable, the discharger may no longer be able to demonstrate compliance with the permit.) For this reason and all of the

o thers set forth above, EPA’s sole reliance on MLs to determine what methods must be used in the NPDES program is inappropriate and should be reconsidered. (p. 2

- 4 of comments)81

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0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator EF Comment #4. Scientific Concerns (Requiring Use of Unapproved Methods). In addition to improperly focusing on MLs as the sole test of whether a test method is the right one to use, the proposed rule has another serious scientific flaw: appe ars to require the use of methods that have not been approved by EPA through the 40 CFR 136 process, regardless of whether they have undergone validation or any other scientific review. That requirement contravenes basic principles of sound science. As th e proposed rule acknowledges, it is essential that data provided in support of permit applications or discharge monitoring reports be valid and reliable. EPA states that "[i]is critical...that applicants provide data that have been measured with precision and accuracy so that they will be meaningful to the decision making process...The same holds true for monitoring and reporting relative to permit limits established for regulated parameters...[I]t is critical that the Director make permitting decisions bas ed on accurate data and, thus, sound science." 75 Fed. Reg. at 35715. Given the acknowledged need for analytical methods that provide precise and accurate data, it would have been consistent with that need for EPA to limit the scope of the proposed rule t o methods that have been approved under 40 CFR Part 136 or are required under 40 CFR chapter I, subchapter N or O (collectively, "approved methods"). At a minimum, EPA could have explained in the proposed rule
how one could determine whether a method that is not an approved method is nevertheless valid and reliable. EPA did not do either. Instead, the proposed rule contemplates the use of unapproved methods, without any discussion of the need to establish that such methods are valid and reliable. EPA's only concern appears to be that an unapproved method have a low Minimum Level and be "suitable." 75 Fed. Reg. at 35716. But "suitable" is not defined. In particular, EPA does not specify whether unapproved methods have to meet the same level of validation set forth in the Agency’s "Alternate Test Procedure" (ATP) program before they can be used. The implication that the "Director" can require use of an unapproved method is particularly troubling, as it appears to permit EPA to require the use of analytical met hods that have not been validated in accordance with recognized scientific standards: EPA's Agency Policy
Directive No. FEM

- 2005

- 001, Ensuring the Validity of Agency Methods

-- Methods Validation and Peer Review Guidelines (2005) (hereinafter "Validation P olicy") and
FEM Document No. 2005

- 01, Validation and Peer Review of U.S. [EPA] Chemical Methods of Analysis (hereinafter "Validation Guidance"), neither of which are mentioned in the proposed rule. The Validation Policy states that "all methods of analysis should be validated prior to issuance as an agency method." Validation involves a demonstration that a method is "suitable for its intended purpose (i.e., yields acceptable accuracy for the analyte, matrix and concentration range of concern)." (Validation Policy, p.1). The Validation Guidance requires a showing that a method is "reproducible", meaning that the See Response
3 and Response 168 2

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method can be implemented consistently across labs. (Validation Guidance, p. 11). Absent validation, there is no way to know if an unapproved meth od will yield precise
and accurate results.

In addition to requiring use of unapproved methods, the proposed rule could be read to require States or affected parties to actually develop new methods if there are no existing methods that are "sufficiently sensitive." That would be both impracticable and well beyond EPA’s authority under the Clean Water Act. Moreover, as discussed in Appendix B, EPA has made no effort to assess the potentially substantial economic impact of imposing such a requirement. EPA s hould make it clear, in any regulatory language that is issued, that it is not attempting to require any party to develop new analytical methods. (p. 4

- 5 of comments)

0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator EG Comment #4. Vague and Undefined Provisions. Labs often have MLs that are lower than the ML published by EPA. It is not clear under what circumstances that lower ML can be used in determining if the method is "sufficiently sensitive." Additi onally, if the sample matrix or field conditions impact the sensitivity of the measurement, it is not clear which ML should be used in determining method sensitivity. (p. 5 of comments) See Response
3

0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator EH Comment #5. Vague and Undefined Provisions. Some unapproved methods involve use of high

- volume samplers. The cost of sampling is very high ($5,000 to $20,000 per sample for high

- volume samplers), and it is not feasible to apply those meth ods on a routine basis for NPDES reporting. EPA does not discuss whether those methods are required, simply because of their greater sensitivity. Most high

- volume sample collection methods have not been validated and therefore are not acceptable for use in compliance monitoring. (Yves Tondeur and Jerry Hart, Ultratrace extraction of persistent organic pollutants, Trends in Analytical Chemistry, Volume 28, Issue 10, November 2009, Pages
1137

- 1147). (p. 6 of comments) See Response

1

0029 Federal Water Quality

Coalition
Frediric P. Andes
Coordinator EI Comment #6. Vague and Undefined Provisions. Some methods require use of specialized sampling techniques, which may not be practicable to implement at specific outfalls. EPA does not address whether permit tees would still be required to attempt to apply those techniques, based solely on their having low MLs. (p. 6 of comments) See Response
3

0029 Federal Water Quality

Coalition
Frediric P. Andes

, Coordinator EJ Comment #7. Vague and Undefined Provisions. EPA refers to unapproved methods that are “otherwise required by the Director,” but does not explain what requirements it is intending to refer to. (p. 6 of comments) See Response
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0029 Federal Water Quality

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Frediric P. Andes
Coordinator EK Comment #8. Vague and Undefined Provisions. As noted above, the proposed rule requires the use of "suitable" unapproved methods in some circumstances, but EPA nowhere explains what "suitable" means. Also, EPA does not address how those methods
could be val idated sufficiently to be used in the permitting process. (p. 6 of comments) See Response
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Coordinator EL Comment #9. Vague and Undefined Provisions. The proposed rule sets forth three
tests for de termining when a method is "sufficiently sensitive." (40 CFR 122.21(e)(3)(i) and 40 CFR 122.44(i)(1)(iv)(A)). The preamble indicates that if a method meets any one of the three tests, it is "sufficiently sensitive." That makes sense. However, the regulator y language is not as clear. To be consistent with EPA’s intent, the Agency should put an "or" after each of the first two tests. Otherwise, the rule could be read to require the method with the lowest ML to be used, even if another method has an ML that is below the level of the water quality criterion. (p. 6 of comments) See Response

4

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Frediric P. Andes
Coordinator EM Comment #10. Vague and Undefined Provisions. EPA mentions certain methods that are "required" by EPA regulations. EPA should add the words "or specified" after "required" in those provisions (40 CFR 122.21(e)(3)(ii) and 40 CFR 122.44(i)(1)(iv)(B)), to clarify that test methods that are specified in applicable effluent limitations guidelines,

new source pe rformance standards, or sludge standards to be used for compliance purposes are sufficient under this rule. (p. 6 of cmts) See Response

17

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Frediric P. Andes
Coordinator EN Comment #11. Vague and Undefined Provisions. Many of the States with NPDES authority already have procedures that specify what methods are to be used, and how results are to be reported. Those procedures often differ from the requirements in the proposed rule. (For example, Texas has adopted specific provisions governing the
circumstances under which one can use a less

- sensitive method.) The proposed rule could be read to preempt those State procedures. EPA has not shown a need for such action, which would raise substantial legal concerns. EPA should make it clear that NPDES
States can address these method

- related issues in other ways, based on their judgments as to how best to ensure reliable and accurate reporting. (p. 7 of comments) See Response
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Frediric P. Andes
Coordinator EO Comment #12. Practical Impacts. There is a shortage of qualified labs that conduct the extremely sensitive methods that the proposed rule requires to be used. (This was evident, for example, in EPA’s Interlaboratory Validation Study for the "highly sensitive" Method 1668 for PCBs. When this study was conducted in 2003

- 2004, 8 out of 14 labs utilizing this procedure could not meet the quality requirements, even though the method had been in use for 5 years. Further, m uch of the science and emerging technologies supporting
these new methods is not well

- understood by state accreditation body auditors, so many of the labs using these methods are doing so without any standardized third

- party oversight and review. EPA must ensure that these sensitive methodologies are thoroughly validated, and can be applied consistently and reliably, before it references their use as a viable alternative to replace currently accepted and time

- proven methodologies.) Requiring all permittees to use these methods

-- even when that is not necessary

-- will overwhelm the capacity of those labs, leading to substantial delays in obtaining timely results and major problems for permittees in scheduling analyses of their samples. It will
also lead to significant increases in the cost of testing, due to increased method complexity, need to acquire new equipment, short supply and very large demand. (The proposed rule would cause particularly difficult and costly compliance problems in
isolated areas lik e Alaska and Hawaii. The number of available in

- state laboratories that can perform sufficiently sensitive test methods is even more limited than elsewhere. If this rule is implemented as proposed, shipments to laboratories in the contiguous US
would be re quired. This would add to the challenge of meeting sample holding times and other preservation restrictions, especially in light of delays caused by coordination between offshore facilities, air transport, laboratory schedules, and Transportation Safety
Ad ministration restrictions. Furthermore, shipments of samples can be delayed due to adverse weather conditions, volcanic eruptions, earthquakes and even tsunamis, grounding air transportation.) (p. 7 of comments) See Response
3

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Frediric P. Andes
Coordinator EP Comment #13. Practical Impacts (Problems with EPA's Cost Analysis). There are hundreds of methods approved for use in 40 CFR Part 136, but EPA evaluated costs for only 33. (p. 8 of comments) See Response

1

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Frediric P. Andes
Coordinator EQ Comment #14. Practical Impacts (Problems with EPA's Cost Analysis). Method costs are listed by EPA in broad price ranges only

- less than $50, $51

- $200, $201

- $400 and more than $400. (p. 8 o f comments) See Response

1

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- parameter me thods that See Response
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Frediric P. Andes
Coordinator EPA may require, versus costs for currently

- used methods that are able to analyze multiple parameters at a time. (p. 8 of comments)

0029 Federal Water Quality

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Frediric P. Andes

, Coordinator ES Comment #16. Practical Impacts (Problems with EPA's Cost Analysis). There is no analysis of how many additional methods may need to be used to achieve sufficient sensitivity for all parameters of interest. (p. 8 of comments) See Response

1

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Frediric P. Andes
Coordinator ET Comment #17. Practical Impacts (Problems with EPA's Cost Analysis). There is no discussion of the costs for highly sensitive and very costly methods that EPA has developed but not approved, such as method 1668B for PCBs. That method costs about $1,000 per sample to run, not including the costs of collecting the sample. In contrast, EPA’s approved methods for PCB analysis (EPA Methods 608 and 508) cost about $75

- $100 per sample to run. One FWQC member has calculated the costs of using Method 1668B for their operations to exceed $125,000 per year. (p. 8 of comments) See Response

1

0029 Federal Water Quality

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Frediric P. Andes
Coordinator EU Comment #18. Practical Impacts (Problems with EPA's Cost Analysis). There is no consideration of costs to develop additional methods for parameters that do not currently have an applicable 40 CFR Part 136 method. For example, recent method development

cost s ranging from $14,500 to $25,000 were obtained for the compound tolytriazole. These costs do not even include the costs of submitting the method to EPA and obtaining Agency approval. (p. 8 of comments) See Response
1 and Response 3

0029 Federal Water Qua lity

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Frediric P. Andes
Coordinator EV Comment #19. Practical Impacts (Problems with EPA's Cost Analysis). Total compliance monitoring costs must include consideration of all of the following factors: sampling costs, test frequency, number of par ameters, number of methods, specific methods, sample matrix, method QC, and required detection and quantitation limits. EPA’s analysis is too narrow, so it underestimates total monitoring costs. (p. 8 of comments) See Response

1

0029 Federal Water Quality

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Frediric P. Andes
Coordinator EW Comment #20. Lack of Statutory/Executive Order Reviews. EPA’s summary of this proposed rule begins by describing the regulatory changes as “minor amendments (75 Fed. Reg. 35712 column 3). In addition, EP A says the proposal does not constitute a "significant regulatory action" (See, e.g., 75 Fed. Reg. 35718 column 2) does not impose any new information collection burden (See, e.g., 75 Fed. Reg. 35718 column 2), will not have a significant economic impact o n a substantial number of small entities (See, e.g., 75 Fed. Reg. 35718 column 3), will not have substantial direct effects on Tribal governments (75 Fed. Reg. 35719 column 2), is exempt from Executive Order 13211 "because it is not a significant regulator y action under Executive Order 12866," (75 Fed. Reg. 35719 column 2) and "does not involve technical standards" (75 Fed. Reg. 35719 column 3). Individually and collectively, those assertions by EPA are unfounded. In reality, EPA’s proposed changes are ver y substantial, deserve considerable additional See Response

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thought by the Agency, and are subject to mandatory review under a variety of executive orders and regulatory review statutes. The reasons why review is required are discussed
in more detail in Attachment B. ( p. 9 of comments)

0029 Federal Water Quality

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Frediric P. Andes
Coordinator EX Comment #21. Recommendations. Specify that in determining which method should be used, the permitting agency must consider, in addition to sensitivity, the important issues of accuracy and precision. (p. 10 of comments) See Response
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Frediric P. Andes
Coordinator EY Comment #22. Recommendations. Provide that test methods should not be used unless they have been validated, in accordance with the principles set forth in EPA’s Validation Policy and Validation Guidance. Methods should have to meet the same level of validation set forth in the EPA “Alternate Test Procedure” program before they can be
used. (p. 10 of c omments) See Response
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Frediric P. Andes
Coordinator EZ Comment #23. Recommendations. Include a provision specifying that in cases where there are matrix interference concerns with a specific effluent, alternate metho ds that are less sensitive, but have less of an interference problem, may be used. (p. 10 of comments) See Response
3

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Frediric P. Andes
Coordinator FA Comment #24. Recommendations. Allow NPDES States to specify their own procedures concerning use of sensitive methods in the permitting process, including options for use of less sensitive methods under appropriate circumstances. (p. 10 of comments) See Response
3

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Frediric P. Andes
Co ordinator FB Comment #25. Recommendations. Allow flexibility in applying test method requirements to discharges in geographically isolated areas. (p. 10 of comments) See Response
3

0029 Federal Water Quality

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Frediric P. Andes
Coordinator FC Comment #26. Recommendations. Allow the permitting agency to determine, for site

specific reasons, that use of the sensitive method is not necessary (for example, if testing with a less sensitive method at an internal monitoring point can allow the permitt ee to calculate whether it is complying at the final effluent point). (p. 10 of comments) See Response
3

0029 Federal Water Quality

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Frediric P. Andes
Coordinator FD Comment #27. Recommendations. Allow the permittee to request use of a less sensitive method if use of the more sensitive method is impractical due to safety concerns (for example, if the test method requires the sampling personnel to locate very close to the discharge (as with mercury Method 1631), and the discharge is a large

- vo lume noncontact cooling water discharge into a lake). (p. 10 of comments) See Response
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Coordinator FE Comment #28. Attachment A

- Example of Lower Lab ML's. Due to EPA’s proposal to require the use of ‘‘sufficiently sensitive’’ analytical methods for mercury analysis, many in the regulated community will believe that they must abandon the traditional cold vapor atomic absorption spectroscopy (CVAAS) methods EPA 245.1 and 245.2 in favor See Response
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of the mor e expensive and problematic atomic fluorescence methods EPA 245.7 and 1631. Unfortunately, EPA method 245.1 states that the method is applicable from 0.2

- 10 ug/L, despite the fact that new CVAAS technology, teamed with contamination control,
can reduce th e analytical method detection level (MDL) from 0.2 ppb to 1 ppt for low

level mercury analysis.

The City of Boise’s Water Quality Laboratory has obtained a 1 ng/L MDL for low

- level mercury analysis by stringent contamination control: segregating labware a nd acid baths; using an automated closed system sample digester; enclosing the auto

- sampler; and adding stannous chloride via a closed sample loop. The signal to noise ratio was increased by reducing water vapor interference by use of a gas/liquid separato r and nafion dryer. Sensitivity was further enhanced through increasing the analyzed sample volume by varying the carrier gas flow and sample pump speed, using larger (22cm) sample and reference cells with twin solid state silicon detectors, and utilizing a thermally stabilized mercury lamp.

Stringent technique and use of technology may allow CVAAS methods to meet all required measurement quality objectives and continue to be "sufficiently sensitive" for many NPDES applications. This example demonstrates h ow important it is for the regulators to maintain options rather than further limit the acceptable methods based on published MDLs and MLs in dated documents. Analytical options advance much faster than the method updates are released, so care is needed in rule

- making to ensure that better science is an option to the regulated community. (p. 1 of comments)88

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0029 Federal Water Quality

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Frediric P. Andes
Coordinator FF Comment #29. Attachment B

- Lack of Statutory and Executive Order Reviews. EPA's analysis of the applicability of Executive Order 12866, the Paperwork Reduction Act, the Regulatory Flexibility Act, the Unfunded Mandates Reform Act, and Executive Order 13132 are superficial and conclusory at best. Executive Order 12866 is dismissed in one sentence: "This rule is not a 'significant regulatory action' . . . and therefore is not subject to review under the EO." 75 Fed. Reg. at 35718. The Paperwork Reduction Act and the Regulatory Flexibility Act take a little longer: four s entences. The Unfunded Mandates Reform Act merits five sentences, and the Regulatory Flexibility Act prompted a total of eight sentences. The principal basis for EPA's dismissal of each of these statutes
and Executive Orders is the assertion that EPA is n ot imposing any new burdens, but simply "clarifying, based on existing legal requirements and authorities, that sufficiently sensitive analytical test methods must be used" to develop data for NPDES permit applications and discharge monitoring reports. 75 Fed. Reg. at 35718

- 719 (emphasis added). That simply is not true. Over the years, EPA has approved multiple analytical text methods for many pollutants (75 Fed. Reg. at 35714), and permit writers and regulated entities have freely chosen from those methods (see Id. at 35713 (the proposed rule would affect "entities that use or allow the use of any EPA

- approved analytical methods")). Not until 2007 did EPA attempt to impose a requirement that regulated entities use a "sufficiently sensitive" method, and that effort was limited to mercury. See 75 Fed. Reg. at 35715. Even then, EPA only went so far as to "strongly recommend[]" that permitting authorities treat as incomplete permit applications that did not rely upon "sufficiently sensitive" methods. Thus, while EPA "has historically expected that applicants and permittees would select . . a . . . method . . . that is sufficiently sensitive" (Id.)(emphasis added), there is no evidence that EPA interpreted the existing rules as imposing a binding requirement to us e "sufficiently sensitive" methods. The preamble to the proposed rule is replete with statements that demonstrate EPA;s intend to impose a new, legally binding obligation and burdens upon permit applicants and writers and permittees. For example:

- "[EPA ] is proposing minor amendments to its [CWA] regulations to codify that only 'sufficiently sensitive analytical test methods can be used . . ." 75 Fed. Reg. at 35712 (emphasis added).

- This proposal . . . would codify existing EPA guidance on . . .

mercur y and extend the approach outlined in that guidance to the NPDES program more generally." Id. (emphasis added).

- "The purpose of today's proposal is to clarify that NPDES applicants must use sufficiently sensitive analytical methods . . . and the Director [footnote omitted] must require and accept only such data." Id. at 35713 (emphasis added).

- "[I]f the State currently requires a particular method or minimum level that is not "sufficiently sensitive" as defined in new EPA regulations . . . EPA would exp ect States to revise their statutes or regulations . . . States would need to revise any policy guidance See Response

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as well." Id. at 35716.

- "EPA is simply clarifying . . . that sufficiently sensitive analytical test methods must be used." Id. at 35718 (emphasis add ed).

These and similar statements, combined with the fact that EPA has proposed amendments to the existing rules, instead of simply issuing a guidance document, contradict Administrator Jackson's certification that "this proposed action will not impose any new legally binding requirements or burden on EPA, States, or the regulated community, and specifically, and burden on any small entity." Id. EPA therefore needs to reassess whether it has met its obligations under the Executive Orders, the Paperwork R eduction Act, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act. We believe that it has not done so, for the reasons explained below. (p. 1

- 2 of comments)90

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0029 Federal Water Quality

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Frediric P. Andes
Coordinator FG Comment #30. Attachment B

- Lack of Statutory and Executive Order Reviews. A. EPA’s proposal is a "significant regulatory action" under Executive Order

12866. Executive Order 12866, "Regulatory Planning and Review," was intended to provide oversight and ensure careful consideration before promulgating any "significant regulatory action." According to section 3(f) of that Executive Order, a regulatory action is "significant" if (among other things):

- It may raise novel legal or policy issue s, or

- It may have an annual effect on the economy of $100 million or more, or

- It may adversely affect competition or jobs.

- EPA’s proposal meets all three of the tests above. As an initial matter, we believe that the costs of compliance, and the resu lting effect on the economy, will be substantial. As noted in the main body of the FWQC comments, EPA has seriously underestimated the costs that will result from implementing the new requirements. Those costs fall into the following basic areas:

- The p roposal would have the effect of requiring permitted facilities to develop their own analytical methods, at their own expense. In cases where EPA does not have any approved method for a particular compound, the proposal still requires monitoring to be
cond ucted using "a sufficiently sensitive test procedure specified in the permit." (Proposed text of 40 CFR 122.44(i)(1)(iv)(B)). In some cases there may be an existing analytical method (although not EPA

- approved). That would be the best case. However,
there will also be situations where no analytical method

-- at all

-- exists that can detect and quantify a particular substance at the concentrations desired by EPA. In that situation, EPA’s current proposal would appear to require the permitted facility to de velop and validate an analytical method that is "sufficiently sensitive." The cost of developing even one method could be millions of dollars. Worse yet, any one facility may have to develop methods for multiple substances. And, if numerous facilities acro ss the country

-- perhaps in different EPA regions

-- each discharge the same substance, they may have to develop methods independently, thereby incurring massive costs in the most inefficient manner. This is because there is no obvious way for those permi ttees to know of each other. As a further concern, this means not only would money be wasted, but numerous divergent, inconsistent methods would be developed for the same substance. This aspect alone could make the proposal a "significant regulatory action ."

- Requiring more sensitive methods will increase the cost 'per analysis." In general, the cost "per analysis" is higher for analytical methods that are more sensitive. The amount of incremental cost per analysis can vary from one method to another. However, more sensitive methods usually require more stringent laboratory proced ures, and sometimes more costly laboratory equipment. Thus, the cost on analysis tends to increase. Nothing See Response

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in EPA’s proposal even mentions this. Considering that analyses under permits must be run repeatedly (for example, quarterly, monthly, weekly or eve n daily), and that the NPDES program applies to a very large number of facilities nationwide, this factor alone could make the proposal a "significant regulatory action."

- EPA’s proposal will require more analyses to be run. For example, it is currently common to run a single scan by a single method, and thereby receive analytical data for a large number of compounds. This keeps the cost down but may not achieve, for some compounds, the detection and quantifications levels that EPA now desires. This mean s the permittee would now have to run the broad scan and a number of additional, single

compound analyses. This will obviously increase the cost of analysis under NPDES permits and to support permit applications, but EPA does not even mention this, anywher e in the proposal.

- EPA’s proposal will necessitate confirmatory analyses to address "false positives." As mentioned above, greater analytical sensitivity often increases the risk of "false positives." This means the methods may register a non

- target

comp ound and mistakenly identify it as the target substance. Sometimes it is possible to dispel this "mistaken identity" by using a different analytical method. However, doing so requires additional expenditures. EPA’s proposal does not acknowledge this. Base d on the rationale above, EPA’s proposal meets at least three tests, any one of which would trigger applicability of Executive Order 12866.

1. The proposal raises novel legal or policy issues. For example:

- EPA here appears to claim legal authority, u nder the Clean Water Act, to require permittees to develop and validate analytical methods, at their own expense, whenever
EPA has failed to do so.

- EPA also appears to claim authority to require multiple different permittees to independently develop dupl icative and inconsistent, non

- EPA

approved, "in

- house" analytical methods for the same pollutant.

- EPA has asserted that this proposal imposes no new information collection burdens (75 Fed. Reg. 35718 column 2.), and that OMB’s approval of the burdens of the existing regulations automatically covers the amended regulations. We believe that EPA may not legally disregard the new burden of additional analyses, more costly analyses and especially the cost of developing in

- house analytical methods, and thereby shield the proposal from OMB review. 2. The proposal could easily have an annual effect on the economy of $100 million or more. The cost of developing in

- house analytical methods, the cost of more expensive analyses, the cost of more numerous analyses, and the cost of confirmatory analyses to rule out “false positives” will be extensive and nationwide.92

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3. The proposal could adversely affect competition and jobs in a meaningful way. The additional costs that this proposal will case are truly substantial . In today’s economy, any substantial increase in costs has the potential to make American businesses less competitive in the global market, and thereby to jeopardize jobs.

For all these reasons, EPA’s proposal is a "significant regulatory action" subje ct to Executive Order 12866. (p. 2

- 4 of comments)

0029 Federal Water Quality

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Frediric P. Andes
Coordinator FH Comment #31. Lack of Statutory and Executive Order Reviews. B. EPA’s proposal imposes new burdens that have not been approved under the Paperwork Reduction Act. EPA asserts that this proposal "does not impose any new information collection burden." (75 Fed. Reg. 35718 column 2) However, as has been demonstrated above, the proposal will actually require enormous addition al expenditures to develop analytical methods and conduct additional analyses. These burdens were not present in the existing regulations, and have not been approved by OMB. The proposal should be submitted to OMB for review under the Paperwork Reduction A ct. (p. 4 of comments) See Response

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Frediric P. Andes
Coordinator FI Comment #32. Lack of Statutory and Executive Order Reviews. C. EPA’s proposal requires further review under the Regulatory Flexibility Act.

EPA has asserted that the proposal "will not have a significant economic impact on a substantial number of small entities." (75 Fed. Reg. 35718 column 3) However, EPA has utterly failed to consider the economic impacts described above, and thus has not
evalua ted the extent to which those impacts would affect small entities. Small entities would likely experience particular difficulty if, for example, they were required to develop sensitive analytical methods at their own expense. Due to the lack of
considerati on of these issues, EPA has not provided any valid basis to exclude this regulatory action from the Regulatory Flexibility Act. (p. 4 of comments) See Response

1

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Frediric P. Andes
Coordinator F J Comment #33. Lack of Statutory and Executive Order Reviews. D. EPA’s proposal requires further consideration of the Unfunded Mandates Reform Act. According to EPA’s Federal Register notice, the Unfunded Mandates Reform Act applies to a federal mandate that might result in (am ong other possibilities) expenditures of $100 million or more by "the private sector" in any one year. As has been shown above, EPA’s proposal could easily result in expenditures by the private sector in excess of $100 million annually. EPA also asserts t hat that the proposal contains "no regulatory requirements that might significantly or uniquely affect small governments." (75 Fed. Reg. 35719 column 1) However, small governments often operate wastewater treatment facilities. Consequently, the increased costs that this proposal would create, will fall heavily on small governments. For the reasons stated above, EPA’s rationale for excluding the
Unfunded Mandates Reform Act is incorrect. (p. 4 of comments) See Response

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Frediric P. Andes
Coordinator F K Comment #34. Lack of Statutory and Executive Order Reviews. E. EPA’s needs to reassess whether Executive Order 13175 applies. EPA has stated that the proposal is not subject to Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because 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." (75 Fed. Reg. 35719 column 2). EPA’s offers no analysis to support this assertion. If tribal governments implement permitting programs, this proposal may impose greater responsibilities on tribal governments to i dentify and recognize "sufficiently sensitive" analytical methods. The proposal may also impose new responsibilities on tribal governments to require and oversee the development of new analytical methods where none exist. And if tribal governments operate wastewater treatment systems, the proposal may impose substantial new costs on those tribal governments. Consequently, EPA needs to reassess whether Executive Order 13175, based on those possible impacts. (p. 4 of comments) See Response

1

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Frediric P. Andes
Coordinator F L Comment #35. Lack of Statutory and Executive Order Reviews. F. EPA has incorrectly excluded this proposal from coverage under Executive Order 13211. EPA asserts that this proposal is not subject to E xecutive Order 13211 (Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use). The Agency says this Executive Order does not apply "because [the proposal] is nota significant regulatory action under Executive Order 128 66." (75 Fed. Reg. 35719 column 2). That rationale is incorrect. As has been demonstrated above, this proposal is a significant regulatory action under Executive Order 12866. Therefore, EPA has incorrectly excluded
Executive Order 13045. (p. 5 of comments ) See Response

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Frediric P. Andes
Coordinator F M Comment #36. Lack of Statutory and Executive Order Reviews. G. EPA should reconsider whether this proposal is subject to section 12(d) of the National Technology
Transfer and Advancement Act. EPA has stated that this proposal is not subject to section 12(d) of the National Technology Transfer and Advancement Act. The Agency’s stated rationale is that "This proposed rulemaking does not involve technical standards." EPA does not explain why that is the case. This rulemaking involves analytical methods, which conceptually would seem to fit a reasonable definition of "technical standards.' The rulemaking appears to have the effect of requiring development of new analyti cal methods where none exist. Therefore, EPA should reconsider whether the NTTAA is applicable. (p. 6 of comments) See Response

1

0030 North Carolina Water

Quality Association, Inc
F. Paul Calamita
General Counsel FN Comment #1. EPA's proposed amended regulation would require that, for NPDES permit applications and for permit compliance reporting, an approved Part 136 method be used that is at or below the level of the applicable water quality criterion, or if the concentration of the pollutant paramete r is high enough, a method that properly quantifies the concentration. VAMWA generally supports EPA's proposal; however, additional flexibility should be included in the regulation for those cases where there is a wasteload allocation ("WLA") or a permit limit above the water quality criterion.

We agree that an appropriate Part 136 analytical method should be used which allows a correct quantification of the pollutant parameter. In many cases, the quantification level will be the water quality criterio n. However, there are also many cases where dilution is available, and where there is a properly calculated WLA or similar values that is protective of the instream criterion, at a value higher than the criterion. In those instances the regulation should provide for the use of a method that provides a quantification level at or below the WLA or other appropriate values. In such cases there is no benefit to the use of a more sensitive method, and the more sensitive methods may have additional
costs or oth er disadvantages.

We further note that, although the preamble to the proposal refers to the use of an analytical method with a QL at or below the water quality criterion or permit limit , the proposal itself does not appear designed to address permit li mits at levels higher than the respective criteria.

Accordingly, we recommend that the regulation be changed before promulgation to address these important issues. We ask that EPA incorporate the following revisions to address the foregoing issues: See Response

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40 C.F.R. 122.21 (e)(3)

. (i) For 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, wasteload alloca tion or other critical regulatory value for the measured
parameters; (B) The method ML is above the applicable water quality criterion, wasteload allocation, permit limit or other critical regulatory value , but the amount of pollutant or pollutant
paramet er 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... A comparable change should also be made to the proposed language subsection 122.44. (p. 1

- 2 of comme nts)

0031 Maryland Association of

Municipal Wastewater Agencies, Inc FO Comment #1. EPA's proposed amended regulation would require that, for NPDES permit applications and for permit compliance reporting, an approved Part 136 method be used that is at or below the level of the applicable water quality criterion, or if the concentration of the pollutant parameter is high enough, a method that properly quantifies the concentration. VAMWA generally supports EPA's proposal; however, additio nal flexibility should be included in the regulation for those cases where there is a wasteload allocation ("WLA") or a permit limit above the water quality criterion.

We agree that an appropriate Part 136 analytical method should be used which allows a correct quantification of the pollutant parameter. In many cases, the quantification level will be the water quality criterion. However, there are also many cases where dilution is available, and where there is a properly calculated WLA or similar value s that is protective of the instream criterion, at a value higher than the criterion. In those instances the regulation should provide for the use of a method that provides a quantification level at or below the WLA or other appropriate values. In such c ases there is no benefit to the use of a more sensitive method, and the more sensitive methods may have additional costs or other disadvantages.

We further n ote that, although the preamble to the proposal refers to the use of an analytical method with a QL at or below the water quality criterion or permit limit , the proposal itself does not appear designed to address permit limits at levels higher than the respective criteria. See Response

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ID Comment(s) Text as it appears in correspondence to EPA Response
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Accordingly, we recommend that the regulation be changed before promulgatio n to address these important issues. We ask that EPA incorporate the following revisions to address the foregoing issues:

40 C.F.R. 122.21 (e)(3)

. (i) For purposes of this requirement, a method approved under 40 CFR Part 136 is "sufficiently sensitiv e" when: (A)The method minimum level (ML) is at or below the level of the applicable water quality criterion, wasteload allocation or other critical regulatory value for the measured
parameters; ( continued from above ) (B) The method ML is above the appli cable water quality criterion, wasteload allocation, permit limit or other critical regulatory value , but the amount of pollutant or pollutant parameter in a facility's discharge is high enough that the method detects and quantifies the level of the pollut ant or pollutant parameter in the discharge... A comparable change should also be made to the proposed language subsection 122.44. (p. 1

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