National Pollutant Discharge Elimination System (NPDES): Use of Sufficiently Sensitive Test Methods for Permit Applications and Reporting, 49001-49013 [2014-19265]

Download as PDF Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations * * * * * [FR Doc. 2014–19557 Filed 8–18–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 122 and 136 [EPA–HQ–OW–2009–1019; FRL–9915– 18–OW] RIN 2040–AC84 National Pollutant Discharge Elimination System (NPDES): Use of Sufficiently Sensitive Test Methods for Permit Applications and Reporting Environmental Protection Agency. ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) is finalizing minor amendments to its Clean Water Act (CWA) regulations to codify that under the National Pollutant Discharge Elimination System (NPDES) program, permit applicants must use ‘‘sufficiently sensitive’’ analytical test methods when completing an NPDES permit application and the Director must prescribe that only ‘‘sufficiently sensitive’’ methods be used for analyses of pollutants or pollutant parameters under an NPDES permit. The final rule is based on requirements in the CWA and clarifies existing EPA regulations. It also codifies existing EPA guidance on the use of ‘‘sufficiently sensitive’’ analytical methods with respect to measurement of mercury and extends the approach outlined in that guidance to the NPDES program more generally. Specifically, EPA is modifying existing NPDES application, compliance monitoring, and analytical methods regulations. The amendments in this rulemaking affect only chemical-specific methods; they do not apply to the Whole Effluent Toxicity (WET) methods or their use. DATES: These final regulations are effective September 18, 2014. For judicial review purposes, this final rule is promulgated as of 1:00 p.m. Eastern Time, on September 2, 2014, as provided in 40 CFR 23.2. ADDRESSES: The record for this rulemaking is available for inspection and copying at the Water Docket, located at the EPA Docket Center (EPA/ DC), EPA West 1301 Constitution Ave. NW., Washington, DC 20004. The record is also available via EPA Dockets at http://www.regulations.gov under docket number EPA–HQ–OW–2009– 1019. The rule and key supporting wreier-aviles on DSK5TPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 documents are also available electronically on the Internet at http:// cfpub.epa.gov/npdes/ssmethods.cfm. Docket: All documents in the docket are listed in the www.regulations.gov index. Some information, however, is not publicly available, e.g., confidential business information (‘‘CBI’’) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is publicly available only in hard copy. Publicly available docket materials are available electronically in www.regulations.gov or in hard copy at the Water Docket, EPA Docket Center, EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the Water Docket is (202) 566–2426. For additional information, contact Kathryn Kelley, Water Permits Division, Office of Wastewater Management (4203M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564–7004, email address: kelley.kathryn@epa.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. General Information A. Potentially Affected Parties B. Legal Authority II. Background III. Summary of Public Comments and EPA’s Response IV. The Final Rule V. Impacts VI. Compliance Dates VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 49001 I. General Information A. Potentially Affected Parties In the NPDES program, point source dischargers obtain permits that are issued by EPA regions and authorized NPDES States, Territories, and Indian tribes (collectively referred to as ‘‘permitting authorities’’). These point source dischargers include publicly owned treatment works (POTWs) and various industrial and commercial facilities (collectively referred to as ‘‘NPDES applicants or permittees’’). Permitting authorities issue NPDES individual permits after analyzing the information contained in the application and making a determination that the application is ‘‘complete’’ under 40 CFR 122.21(e). In the case of a general permit, authorization to be covered by the permit is given if the information submitted demonstrates eligibility for coverage under 40 CFR 122.28. The NPDES permit prescribes the conditions under which the facility is allowed to discharge pollutants into waters of the United States and the conditions that will ensure the facility’s compliance with the CWA’s technologybased and water quality-based requirements. NPDES permits typically include restrictions on the mass and/or concentration of pollutants 1 that a permittee may discharge as well as requirements that the permittee conduct routine sampling and reporting of various parameters measured in the permitted discharge. In general, NPDES applicants and permittees are required to use EPA-approved methods 2 when measuring the pollutants in their discharges. The purpose of today’s final rule is to codify that where EPA-approved methods exist, NPDES applicants must use sufficiently sensitive EPA-approved analytical methods when quantifying the presence of pollutants in a 1 Where the term ‘‘pollutant’’ is used, it refers to both pollutants and pollutant parameters. 2 For purposes of this rule, the term ‘‘EPAapproved methods’’ refers to methods that have been approved under 40 CFR part 136 or are required under 40 CFR chapter I, subchapter N or O. This includes analytical methods for CWA pollutants developed by EPA, voluntary consensus standards bodies (VCSBs), and other government agencies (such as the U.S. Geological Survey), as well as Alternate Test Procedures (ATPs) developed by commercial method developers for nation-wide use. These methods have been reviewed by EPA and approved for use in compliance monitoring under the CWA. EPA publishes lists of the EPA, VCSB, and other agency methods as well as ATPs that it has found to be acceptable for such use at 40 CFR Part 136, and at 40 CFR Chapter I, subchapters N and O. As a point of clarification, this includes approved ATPs as described in 40 CFR 136.4 and 136.5. E:\FR\FM\19AUR1.SGM 19AUR1 49002 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations discharge, and the Director 3 must prescribe that only sufficiently sensitive EPA-approved methods be used for analyses of pollutants or pollutant parameters under the permit. The broad universe of entities 4 that would be affected by this final action includes NPDES permitting authorities and municipal and industrial applicants and permittees (Table I–1). This rule does not apply to indirect dischargers as defined in 40 CFR 122.2. The impact of this action, however, would only affect those entities that use or allow the use of any EPA-approved analytical methods (for one or more parameters) that are not ‘‘sufficiently sensitive’’ to detect pollutants being measured in the discharge. TABLE I–1—ENTITIES POTENTIALLY REGULATED BY THIS RULE Category Examples of potentially affected entities State, Territorial, and Indian Tribal Governments. Municipalities ................................... States, Territories, and Indian tribes authorized to administer the NPDES permitting program; States, Territories, and Indian tribes that provide certification under section 401 of the CWA. POTWs required to apply for or seek coverage under an NPDES individual or general permit and to perform routine monitoring as a condition of any issued NPDES permit. Facilities required to apply for or seek coverage under an NPDES individual or general permit and to perform routine monitoring as a condition of any issued NPDES permit. Industry ........................................... If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. wreier-aviles on DSK5TPTVN1PROD with RULES B. Legal Authority EPA is issuing today’s final rule pursuant to the authority of sections 301, 304(h), 308, 402(a), and 501(a) of the CWA [33 U.S.C. 1311, 1314(h), 1316, 1318, 1342(a), 1343, and 1361(a)]. Section 301(a) of the CWA prohibits the discharge of any pollutant except in compliance with an NPDES permit issued under section 402 of the act. Section 402(a) of the CWA authorizes the Administrator to issue permits that require a discharger to meet all the applicable requirements under sections 301, 302, 306, 307, 308, and 403. Section 301(b) of the CWA further requires that NPDES permits include effluent limitations that implement technology-based standards and, where necessary, water quality-based effluent limitations (WQBELs) that are as stringent as necessary to meet water quality standards. With respect to the protection of water quality, NPDES permits must include limitations to control all pollutants that the NPDES permitting authority determines are or might be discharged at a level that ‘‘will cause, have the reasonable potential to cause, or contribute to an excursion above any state water quality standard,’’ including both narrative and numeric criteria [40 CFR 122.44(d)(1)(i)]. If the Director determines that a discharge causes, has the reasonable potential to cause, or contributes to such an excursion, the permit must contain WQBELs for the pollutant [40 CFR 3 The term ‘‘Director’’ refers to the permitting authority. See definition at 40 CFR 122.2. 4 Although terms such as ‘‘authorities,’’ ‘‘applicants,’’ and ‘‘permittees’’ imply individuals, VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 122.44(d)(1)(iii)]. Section 402(a)(2) of the CWA requires EPA to prescribe permit conditions to ensure compliance with requirements, ‘‘. . . including conditions on data and information collection, reporting and such other requirements as [the Administrator] deems appropriate.’’ Thus, a prospective permittee might need to measure various pollutants in its effluent at two stages: First, at the permit application stage so that the Director can determine what pollutants are present in the applicant’s discharge and the amount of each pollutant present and, second, to quantify the levels of each pollutant limited in the permit to determine whether the discharge is in compliance with the applicable limits and conditions. Section 304(h) of the CWA requires the Administrator of EPA to ‘‘. . . promulgate guidelines establishing test procedures for the analysis of pollutants that shall include the factors which must be provided in any certification pursuant to [section 401of this Act] or permit application pursuant to [section 402 of this Act].’’ Section 501(a) of the act authorizes the Administrator to ‘‘. . . prescribe such regulations as are necessary to carry out this function under [the act].’’ EPA generally has codified its test procedure regulations (including analysis and sampling requirements) for CWA programs at 40 CFR part 136, although some requirements are codified in other parts (e.g., 40 CFR chapter I, subchapters N and O). The Director is required under 40 CFR 122.21(e) to determine when an NPDES permit application is complete. Moreover, the Director shall not begin processing an application for an individual permit until the applicant has fully complied with the application requirements for that permit [40 CFR 124.3(a)(2)]. Under 40 CFR 122.21(g)(13), applicants are required to provide to the Director, upon request, such other information as the Director may reasonably require to assess the discharge. Finally, 40 CFR 122.41(j)(1) requires NPDES permits to include a standard condition specifying that ‘‘samples and measurements taken for the purpose of monitoring shall be representative of the monitored activity.’’ Among other things, section 308 of the CWA authorizes EPA to require owners or operators of point sources to establish records, conduct monitoring activities, and make reports to enable the permitting authority to determine whether there is a violation of any prohibition or any requirement established under provisions including section 402 of the CWA. Under sections 308(c) and 402(b)(2)(A), a state’s authorized NPDES program must have authorities to inspect, monitor, enter, and require reports to at least the same extent as required in section 308. As summarized above, the legal requirements and authorities exist for EPA to require NPDES applicants and permittees to use sufficiently sensitive EPA-approved analytical methods when quantifying the presence of pollutants in a discharge and to require the Director to require and accept only such data. EPA uses these terms to refer to entities. For example, EPA uses the term ‘‘NPDES permitting authorities’’ to mean the EPA Regions, States, Territories, and Indian tribes granted authority to implement and manage the NPDES program. EPA uses the term ‘‘NPDES applicants’’ or ‘‘NPDES permittees’’ to mean facilities that have applied for, sought coverage under, or been issued an NPDES individual or general permit. PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 II. Background Multiple analytical test methods exist for many pollutants regulated under the CWA. Therefore, EPA has generally E:\FR\FM\19AUR1.SGM 19AUR1 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations wreier-aviles on DSK5TPTVN1PROD with RULES approved multiple methods for CWA pollutants under 40 CFR part 136 and 40 CFR chapter I, subchapters N and O. Some of the approved analytical test methods have greater sensitivities and lower minimum levels 5 6 or method detection limits (MDLs) 7 than other approved methods for the same pollutant. This situation often occurs because of advances made in instrumentation and in the analytical protocols themselves. Many metals and toxic compounds (for example, mercury) have an array of EPAapproved methods, including some methods that have greater sensitivities and lower minimum levels than the others. Although EPA has approved multiple analytical methods for individual pollutants, the Agency has historically expected that applicants would select from the array of available methods a specific analytical method that is sufficiently sensitive to quantify the presence of a pollutant in a given discharge. EPA has not expected that NPDES permit applicants would select a method with insufficient sensitivity, thereby masking the presence of a pollutant in their discharge, when an EPA-approved sufficiently sensitive method is available. Further, EPA anticipated that NPDES permitting authorities would specify an EPAapproved method in an NPDES permit where the Director determined that a particular analytical method was needed to provide meaningful results relative to the permit limit. EPA believes that the authority to prescribe a specific analytical method in an NPDES permit exists under the current 5 The term ‘‘minimum level’’ refers to either the sample concentration equivalent to the lowest calibration point in a method or a multiple of the method detection limit (MDL). Minimum levels may be obtained in several ways: They may be published in a method; they may be sample concentrations equivalent to the lowest acceptable calibration point used by a laboratory; or they may be calculated by multiplying the MDL in a method, or the MDL determined by a lab, by a factor. [See: (A) 40 CFR 136, appendix A, footnotes to table 2 of EPA Method 1624 and table 3 of EPA Method 1625 (49 FR 43234, October 26, 1984); (B) 40 CFR 136, section 17.12 of EPA Method 1631E (67 FR 65876–65888, October 29, 2002); (C) 61 FR 21, January 31, 1996; and (D) ‘‘Analytical Method Guidance for the Pharmaceutical Manufacturing Point Source Category,’’ EPA 821–B–99–003, August 1999]. 6 For the purposes of this rulemaking, EPA is considering the following terms related to analytical method sensitivity to be synonymous: ‘‘quantitation limit,’’ ‘‘reporting limit,’’ ‘‘level of quantitation,’’ and ‘‘minimum level.’’ 7 The MDL is determined using the procedure at 40 CFR Part 136, appendix B. It is defined as the minimum concentration of a substance that can be measured and reported with 99 percent confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a given matrix containing the analyte. VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 regulations. However, some state permitting authorities expressed concern that this authority was not explicit in current regulations, thus limiting states’ ability to prescribe an appropriate analytical method where needed to assess compliance with permit limits. This rule requires that, where EPA-approved methods exist, NPDES applicants must use sufficiently sensitive EPA-approved analytical methods when quantifying the presence of pollutants in a discharge and that the Director must prescribe that only sufficiently sensitive EPA-approved methods be used for analyses of pollutants or pollutant parameters under the permit. EPA and state permitting authorities use data from the permit application to determine whether pollutants are present in an applicant’s discharge and to quantify the levels of all detected pollutants. These pollutant data are then used to determine whether technologyor water quality-based effluent limits are needed in the facility’s NPDES permit. It is critical, therefore, that applicants provide data that have been measured at levels that will be meaningful to the decision-making process. Among other things, data must be provided that will enable the Director to make a sound ‘‘reasonable potential’’ determination and, if necessary, establish appropriate water quality-based permit limits. The same holds true for monitoring and reporting relative to permit limits established for regulated parameters. The intent is for applicants and permittees to use analytical methods that are capable of detecting and measuring the pollutants at, or below, the respective water quality criteria or permit limits.8 For example, in 2002 and 2007 EPA published two new analytical methods for mercury that were several orders of magnitude more sensitive than previously available methods. In addition, a number of states have set water quality criteria for mercury that are below the detection levels of the older methods for mercury that EPA approved prior to 2002. Unlike the previous methods, the new methods are capable of measuring whether effluent samples are above or below the current water quality criteria. In 2007 EPA addressed this issue with respect to mercury in a memorandum titled ‘‘Analytical Methods for Mercury in NPDES Permits,’’ from James A. Hanlon, Director of EPA’s Office of Wastewater 8 To address this situation some state permitting authorities have developed a list of monitored parameters and prescribed a required minimum level that must be achieved for each parameter as a part of their state regulations or policy. PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 49003 Management, to the Regional Water Division Directors. This memorandum is available at http://www.epa.gov/ npdes/pubs/mercurymemo_ analyticalmethods.pdf. The memorandum explains EPA’s expectation that ‘‘All facilities with the potential to discharge mercury will provide with their NPDES permit applications monitoring data for mercury using Method 1631E or another sufficiently sensitive EPA-approved method. Accordingly, EPA strongly recommends that the permitting authority determine that a permit application that lacks effluent data analyzed with a sufficiently sensitive EPA-approved method such as Method 1631E, is incomplete unless and until the facility supplements the original application with data analyzed with such a method.’’ Following issuance of the 2007 memorandum, EPA determined that the NPDES permit application regulations at 40 CFR 122.21 and the NPDES permit monitoring requirements at 40 CFR 122.44 should be revised to ensure that, where EPA-approved methods exist, applicants use sufficiently sensitive EPA-approved analytical methods when quantifying the presence of pollutants in a discharge and that Directors prescribe that only sufficiently sensitive EPAapproved methods be used to perform sampling and analysis for all pollutants, not just mercury. Therefore, in this rulemaking, EPA is revising the regulations to extend the requirement to use sufficiently sensitive EPA-approved analytical test methods, where they exist, to all pollutants and establish criteria for what qualifies as a ‘‘sufficiently sensitive’’ method. This final rule requires that NPDES applicants must use sufficiently sensitive EPA-approved analytical methods, where they exist, when submitting information required by a permit application quantifying the presence of pollutants in a discharge. If the applicant does not provide data using a sufficiently sensitive EPAapproved analytical method, the Director may determine that the application is ‘‘incomplete’’ per 40 CFR 122.21(e).The Director may require that the applicant provide new screening data obtained using a sufficiently sensitive EPA-approved analytical method before making a completeness determination and moving forward with permit development. The final rule also requires that, as a condition of permit development, to assure compliance with permit limitations the permit shall include requirements to monitor according to sufficiently sensitive EPAapproved methods, where they exist. E:\FR\FM\19AUR1.SGM 19AUR1 wreier-aviles on DSK5TPTVN1PROD with RULES 49004 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations Specifically, where an EPA-approved analytical method exists that would provide quantifiable results necessary to assess compliance with a permit limit and the permit allows monitoring to be conducted using different analytical methods that, although approved, would fail to produce data necessary to assess compliance, the permit would be inconsistent with the NPDES permitting requirements of 40 CFR 122.44(i). EPA is defining the term ‘‘sufficiently sensitive’’ in two sections of the NPDES regulations: At 40 CFR 122.21(e) (Completeness), as a new subsection (3), and at 40 CFR 122.44(i)(1)(iv) (Monitoring Requirements). EPA is also modifying 40 CFR 136.1 (Applicability) by adding a new paragraph (c), which is simply a cross-reference to the changes being promulgated in 40 CFR 122.21(e)(3) and 40 CFR 122.44(i)(1)(iv). The new and revised sections indicate that an EPA-approved method is sufficiently sensitive where: A. The method minimum level is at or below the level of the applicable water quality criterion or permit limitation for the measured pollutant or pollutant parameter; or B. In the case of permit applications, the method minimum level is above the applicable water quality criterion, but the amount of the pollutant or pollutant parameter in a facility’s discharge is high enough that the method detects and quantifies the level of the pollutant or pollutant parameter in the discharge; or C. The method has the lowest minimum level of the EPA-approved analytical methods. The requirement to use a ‘‘sufficiently sensitive’’ EPA-approved method does not apply where no EPA-approved method exists. When no analytical method is approved under 40 CFR part 136 or required under subchapter N or O, and a specific method is not otherwise required by the Director, an NPDES applicant may use any suitable method; however, the applicant shall provide a description of the method. The first two criteria, A and B, in the sufficiently sensitive definition address situations in which EPA has approved multiple methods for a pollutant and some of those approved methods have greater sensitivities and lower minimum levels than others. In this situation, the applicant or permitting authority may select a method based on the minimum level published in the EPA-approved method, where available, or using a derived minimum level. As noted in footnote 4, the minimum level may be explicitly listed in some EPA-approved methods. Where this is the case, the VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 applicant may reference the published minimum level when determining whether a method selected to provide data for their permit application is sufficiently sensitive. Where EPA has included a minimum level for a pollutant in a specific method, it reflects the minimum level obtained in a multilaboratory study of the new method in a wide variety of matrices, many of which EPA selects due to their complex nature. EPA acknowledges that complex matrices exist and provides flexibility and suggestions for ways to mitigate interferences in such instances, often within the published method for a specific pollutant. EPA’s experience is that many laboratories find solutions to address difficult matrices and are able to achieve the published minimum level within the required quality assurance specifications. However, applicants have always had the option of calculating a matrix-specific method detection limit (MDL). Extreme matrices may necessitate the use of an elevated sample specific minimum level, in which case the laboratory should be able to show that a reasonable effort (e.g., published cleanup procedures) was attempted to achieve as low a minimum level as possible for those samples. The use of sample or matrix specific minimum levels rather than the published levels has always been an available option, and consistent with that flexibility, use of a matrix-specific minimum level may sometimes be necessary when determining which methods are sufficiently sensitive. For EPA-approved methods that do not explicitly list minimum levels, the applicant can derive the minimum level from either the concentration of the lowest calibration standard in methods that dictate the concentrations of such standards, or as a multiple of the MDL or similar statistically derived detection limit concept. When the method dictates, or recommends, the concentration of the lowest calibration standard, that concentration can be converted to a minimum level by considering the weights and/or volumes of the sample and all of the intermediate preparation and analysis steps in the method. If a method provides a literature MDL for the matrix of interest, that MDL value can be used to estimate the minimum level as 10 times the standard deviation of the replicate measurements used to determine the MDL according to 40 CFR part 136, appendix B. However, MDLs are inherently method- and laboratoryspecific, so whenever a permittee is contracting a laboratory for NPDES work, it is prudent to obtain that PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 laboratory’s MDL and compare it to the published MDL to ensure that both their MDL and their minimum level are appropriate for the intended application. The third criterion, C, of the definition addresses situations in which none of the EPA-approved methods for a pollutant can achieve the minimum levels necessary to assess reasonable potential or to monitor compliance with a permit limit. In these situations, applicants or permittees must use the method with the lowest minimum level among the EPA-approved methods for the pollutant, and this method would meet the definition of sufficiently sensitive. As explained above, the requirement to use a ‘‘sufficiently sensitive’’ EPAapproved method does not apply where no EPA-approved methods exist. The final rule addresses these situations, for permit applicants, where no approved analytical method exists under 40 CFR part 136 or is required under subchapter N or O, and one is not otherwise required by the Director. In such situations, an applicant may use any suitable method but shall provide a description of the method. With respect to pollutant limits in permits, where an EPA-approved analytical method does not exist, monitoring shall be conducted in accordance with a test procedure specified in the permit. EPA recognizes that other factors beyond the minimum level or MDL can also be important in determining method performance, including a method’s resolution, accuracy, and precision. Where there are no EPAapproved methods, this rule does not affect how those other factors are considered in selecting a method. Rather, the rule notes that permit applicants may consider these other factors when selecting a suitable method where no EPA-approved method exists. For EPA-approved methods, however, these factors have already been considered during the method validation and approval process. As explained above, EPA evaluates method performance in a wide variety of wastewater matrices and approves those methods that have sensitivity, precision and accuracy that are appropriate for wastewater compliance monitoring. 40 CFR 136.6 also allows flexibility to tailor approved methods to more challenging wastewater matrices or overcome methodological problems. Based on data and information provided to EPA by analytical laboratories, EPA finds that experienced laboratories are often capable of achieving minimum levels below those published with a E:\FR\FM\19AUR1.SGM 19AUR1 wreier-aviles on DSK5TPTVN1PROD with RULES Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations method while maintaining the precision and accuracy specified in the method. EPA acknowledges that while rare, methodological problems may exist that could affect the determination of a ‘‘sufficiently sensitive’’ method. In such rare situations, the Director may consider additional technical factors when determining whether the method is still ‘‘sufficiently sensitive.’’ Specifically, where the permit applicant or permittees can demonstrate to the Director that despite a good faith effort to overcome these methodological problems due to challenging wastewater matrices, either (1) the method’s minimum level is higher than originally anticipated, or (2) the method results no longer meet the methods quality assurance/quality control (‘‘QA/QC’’) specification, the Director may take these factors into account when determining whether the permit applicant has met the requirements to use a ‘‘sufficiently sensitive’’ method or in prescribing a ‘‘sufficiently sensitive’’ method in the permit. In the first situation, the matrix or sample-specific minimum level should be used to evaluate which of the EPA-approved methods is ‘‘sufficiently sensitive.’’ In the second situation, if the method’s results are no longer consistent with the QA/QC specifications, then the method is not performing adequately and a ‘‘sufficiently sensitive’’ method should be selected from the remaining EPAapproved methods. In either case, the permit applicant or permittee is responsible for demonstrating that a published minimum level is unachievable or a reasonable effort was applied to bring the original sufficiently sensitive method within the QA/QC specifications in the given matrix before selecting another EPA-approved method (e.g., cleanup procedures, dilution when appropriate, etc.). Additionally, where a technologybased requirement is specified as ‘‘zero discharge’’ or ‘‘no detect,’’ the permitting authority may take into account the sensitivity of the method used to establish the requirement when determining if a method is ‘‘sufficiently sensitive.’’ EPA recognizes that if a more sensitive method is approved after such a requirement has been established, its use may be inconsistent with the technological basis of the original requirement. In situations where a technology-based requirement reflects a technology that eliminates the discharge of the subject pollutant altogether, the newer sensitive method is appropriate. However, where a technology-based limit reflects a technology that may not achieve the minimum level of the newer more sensitive method, the Director may VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 determine that the method on which the requirement was originally based is ‘‘sufficiently sensitive’’ to determine compliance, as understood at the time the requirement was established. For both EPA-approved methods and non-EPA-approved methods, EPA’s understanding of standard practice is that if an applicant/permittee or laboratory has questions regarding the suitability of a specific method in a given situation, or has technical questions on its use, it will consult with its permitting authority. EPA has the same expectations in connection with today’s rulemaking for questions specifically about which methods are sufficiently sensitive. The permitting authority continues to have the ultimate responsibility for determining whether an NPDES application is complete (40 CFR 122.21(e)) and establishing permit conditions, including monitoring and reporting requirements (40 CFR 122.44(i)). The amendments in this rulemaking affect only chemical-specific methods; they do not apply to the Whole Effluent Toxicity (WET) methods or their use. Note that existing EPA regulations (40 CFR 122.44(d)(1)(ii)) and policy require permit writers to take into account the sensitivity of the species to toxicity testing when evaluating whole effluent toxicity. EPA has interpreted this provision as directing the permitting authority to develop criteria and limits based upon the most sensitive test species to ensure that the most sensitive species and all less sensitive species will be protected. III. Summary of Public Comments and EPA’s Response On June 23, 2010, EPA proposed changes to the existing NPDES regulations (75 FR 35712) and requested comments from the public. EPA received 25 comment letters. The majority of the comments came from publicly owned treatment works and industry organizations, but EPA also received comments from laboratories, and state and federal agencies. The majority of comments covered the following categories: Implementation and technology; administration and timing; and burden. The complete list of comments and responses is available in the record of this rulemaking. A. Implementation 1. Effect of the Rule on Current Practices EPA received several comments that indicated the approach outlined in the proposed rule would force applicants and permittees to make decisions regarding the selection of an appropriate PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 49005 method without adequate information upon which to base a decision. Specifically, commenters indicated that issues related to the definition of the method minimum level would make this rule difficult to implement and that method sensitivity should not be the sole factor in deciding which method should be used in the permitting process. They indicated that there are other factors including accuracy, precision, selectivity, and whether the method has been validated that should be considered. In response, EPA notes that applicants for NPDES permits have always needed to make decisions regarding which EPAapproved methods are the most appropriate for use when performing the screening analyses required under the various permit application regulations at 40 CFR 122.21. Similarly, NPDES permitting authorities, even before today’s rulemaking, have had to consider which of the EPA-approved methods are the most appropriate for permittees to use to meet their monitoring and reporting requirements under an NPDES permit. Today’s rule does not change the basic NPDES permit application or permit issuance process. Under 40 CFR 122.21, permittees seeking permit renewal or new applicants must provide the Director with adequate information to determine whether an NPDES application is complete. Once the Director makes this determination, the Director determines the applicable permit requirements, including any sampling or monitoring that must be taken that is ‘‘representative of the monitored activity.’’ See 40 CFR 122.41(j)(1). The effect of today’s final rulemaking is to codify that where EPA-approved methods exist, only ‘‘sufficiently sensitive’’ EPA-approved methods may be used in connection with permit applications and to conduct monitoring and reporting under a permit. To determine whether an EPAapproved analytical method is ‘‘sufficiently sensitive’’ in any particular case, NPDES applicants/permittees and permit authorities should use the best information available on what the minimum level is for the method, and EPA believes that in general a method’s accurate minimum level will be readily ascertainable. Where the minimum level is explicitly listed in the EPA-approved method, applicants may reference the published minimum level when determining whether a method selected to provide data for their permit application is sufficiently sensitive. Alternatively, applicants have always had the option of providing matrixspecific method detection limits and E:\FR\FM\19AUR1.SGM 19AUR1 wreier-aviles on DSK5TPTVN1PROD with RULES 49006 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations minimum levels rather than the published minimum levels, and nothing in today’s rule changes that flexibility, including with respect to selecting a sufficiently sensitive EPA-approved method. For these cases the laboratory should be able to show that a reasonable effort (e.g., published cleanup procedures) was attempted to achieve as low a minimum level as possible for those samples. For EPA-approved methods that do not explicitly list minimum levels, the minimum level can be obtained or derived by the applicant or permitting authority. Indeed, many permitting authorities have developed guidance, policies or regulations that establish minimum levels for various methods, or specify specific methods to be used by applicants and permittees. Where applicable, these policies and regulations will continue to affect method selection, although at the same time, states must ensure that such policies and regulations conform with the criteria established in today’s rulemaking that, where they exist, only ‘‘sufficiently sensitive’’ EPA-approved methods are being used when completing an NPDES permit application and when performing sampling and analysis pursuant to monitoring requirements in an NPDES permit. If the applicant does not provide data using a sufficiently sensitive EPAapproved analytical method where one exists, the Director may determine that the application is ‘‘incomplete’’ per 40 CFR 122.21(e). The Director may require that the applicant provide new screening data obtained using a sufficiently sensitive EPA-approved analytical method before making a completeness determination and moving forward with permit development. Thus, to avoid having the permitting authority reject data provided in an application because the data were not collected by means of a ‘‘sufficiently sensitive’’ method, the NPDES applicant should work closely with the permitting authority prior to conducting the required analyses. In addition, the permitting authority must ensure the permit includes a requirement to use a sufficiently sensitive EPA-approved analytical test method, where one exists, where necessary to perform sampling and analysis, consistent with 40 CFR 122.41(j) and 122.44(i). 2. Development of New or Alternate Test Procedures EPA received several comments that indicated the proposed rule would require the development of new analytical methods where no EPA- VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 approved methods exist or where existing EPA-approved methods would not quantify the pollutant concentration at or below the level of the criterion or permit limit. Other commenters indicated that the rule would alter the existing requirements for developing Alternate Test Procedures under 40 CFR part 136. EPA has modified the proposal to address these comments, as explained below. EPA has modified the proposed language for this final rule so that it does not change existing regulatory requirements with respect to unapproved methods. Where no EPAapproved analytical methods exist, an applicant will need to select a method from another source of available analytical methods (e.g., Standard Methods for the Examination of Water and Wastewater) to measure that pollutant or pollutant parameter. Today’s final rule does not require the applicant to develop new methods. The situation in which there are no EPAapproved methods is uncommon because there are EPA-approved methods for most pollutants or pollutant parameters screened and regulated under the NPDES program. Under the existing regulations at 40 CFR 122.21(g)(7), the NPDES applicant has the flexibility to use any suitable analytical method when no EPAapproved analytical method exists for that pollutant or pollutant parameter. Additionally, under the existing regulations at 40 CFR 122.44(i)(1)(iv), the NPDES permitting authority specifies a method in the permit when there is no EPA-approved method. Where EPA-approved methods exist, but none of the available methods will quantify the pollutant concentration at or below the level of the criterion or permit limit, today’s rulemaking does not require the development of any new analytical methods. However, in this situation, the rule will now require the use of the most sensitive of the EPAapproved methods. Finally, today’s rulemaking does not alter any of the existing requirements related to the development or approval of alternative test procedures under 40 CFR 136.4 and 136.5. 3. Consideration of Matrix Effects in Selecting a Sufficiently Sensitive Method EPA received several comments that indicated the approach outlined in the proposed rule would force applicants and permittees to make decisions regarding the selection of an appropriate method without adequate information upon which to base a decision. Specifically, commenters indicated that PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 issues related to the definition of the method minimum level would make this rule difficult to implement and that method sensitivity should not be the sole factor in deciding which method should be used in the permit process. They believe there are other critical factors including accuracy, precision, selectivity, and whether the method has been validated. In response, as noted above, EPA has clarified that the requirement to use a ‘‘sufficiently sensitive’’ EPA-approved method does not apply where no EPAapproved method exists. EPA agrees that other factors beyond the minimum level can also be important in determining method performance, including a method’s selectivity, resolution, accuracy, and precision. EPA has added language in the rule text that clarifies where no EPA-approved methods exist, permit applicants may consider these other factors, in conjunction with sensitivity, when selecting an appropriate method. For EPA-approved methods, however, these factors have already been considered during the method validation and approval process. As explained above, EPA evaluates method performance in a wide variety of wastewater matrices and approves those methods that have selectivity, sensitivity, precision and accuracy that are appropriate for wastewater compliance monitoring. 40 CFR 136.6 also allows flexibility to tailor approved methods to more challenging wastewater matrices. EPA notes that applicants have always had the option of providing matrix or sample-specific minimum levels rather than the published levels and nothing in today’s rule changes that flexibility, including with respect to selecting a sufficiently sensitive EPA-approved method. For these cases the laboratory should be able to show that a reasonable effort (e.g., published cleanup procedures) was attempted to achieve as low a minimum level as possible for those samples. If the most sensitive method listed in 40 CFR Part 136 is not performing adequately in a given wastewater matrix (e.g., with regard to sensitivity, accuracy, and precision), several options are available and should be pursued. Dilution is often a good option if it does not drive the sample specific minimum level above the permit requirements. Cleanup procedures included in the method can also be utilized. If those cleanups do not prove adequate for a particular matrix, the analyst should consult ‘‘Solutions to Analytical Chemistry Problems with Clean Water Act Methods,’’ EPA 821–R– 07–002 (or more recent revisions) to E:\FR\FM\19AUR1.SGM 19AUR1 wreier-aviles on DSK5TPTVN1PROD with RULES Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations determine if another cleanup procedure may be appropriate. If a solution is still not apparent, the permittee should consult EPA or the permitting authority. Based on data and information provided to EPA by analytical laboratories, EPA finds that experienced laboratories are often capable of achieving minimum levels below those published with a method while maintaining the precision and accuracy specified in the method. However, EPA acknowledges that while rare, situations may exist where a method cannot perform adequately in a specific matrix. In such rare situations, the Director may consider additional technical factors when determining whether the method is still ‘‘sufficiently sensitive.’’ Specifically, where the permit applicant or permittees can demonstrate to the Director that despite a good faith effort to overcome these methodological problems due to challenging wastewater matrices, either (1) the method’s minimum level is higher than originally anticipated, or (2) the method results no longer meet the methods QA/QC specification, the Director may take these factors into account when determining whether the permit applicant has met the requirements to use a ‘‘sufficiently sensitive’’ method or in prescribing a ‘‘sufficiently sensitive’’ method in the permit. In the first situation, the matrix or sample-specific minimum level should be used to evaluate which EPA-approved method is ‘‘sufficiently sensitive.’’ In the second situation, if the method’s results are no longer consistent with the QA/QC specifications, then the method is not performing adequately and a ‘‘sufficiently sensitive’’ method should be selected from the remaining EPAapproved methods. In either case, the permit applicant or permittee is responsible for demonstrating that a published minimum level is unachievable or a reasonable effort was applied to bring the original sufficiently sensitive method within the QA/QC specifications in the given matrix before selecting another EPA-approved method (e.g., cleanup procedures, dilution when appropriate, etc.). To illustrate the type of situations where this provision would be appropriate, EPA provides two examples below. EPA received comments about the situation where there are multiple EPAapproved methods for an organic pollutant and the methods employ different technologies (i.e., gas chromatography (GC) and gas chromatography/mass spectrometry (GC/MS)). These commenters raised concern that, in some instances, while the GC method may provide a lower VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 detection limit, the GC/MS method provides a greater degree of confidence in the correct identification of the regulated parameter. As explained above, this is not an issue if the laboratory has demonstrated that it can achieve a minimum level for GC/MS that is lower than the NPDES permit limit for the regulated parameter, in which case GC/MS would be considered ‘‘sufficiently sensitive.’’ EPA agrees that GC/MS is more selective than GC, but several options are available to remove the interferences from difficult matrices before using a dual-column GC method (e.g., solid-phase extraction as a cleanup procedure, Florisil cleanup, alumina cleanup, sulfur removal with copper or TBA sulfite, gel permeation chromatography, etc.). Generally, a result from a dual-column GC method would only be questioned if the chromatograms from the two columns did not yield similar numerical results or if the chromatograms contained many extraneous peaks that suggest interferences are present. If the permit applicant or permittee is still concerned that the peaks may be caused by a different contaminant, and the GC method provides a false positive result, the permit applicant or permittee could use a GC/MS to confirm the presence of the contaminant. However, since the GC/MS is less sensitive, it may not be able to confirm low-level dual column GC results. The more sensitive GC/MS method options (e.g., larger sample volume, smaller final extract volume, selected ion monitoring techniques, or high resolution GC/MS) may be necessary to prove whether the dual column GC result is a false positive. The permittee should also consult with EPA and/or its permitting authority for potential solutions. In this case, if the permittee has exhausted all practical options (e.g., solid-phase extraction as a cleanup procedure, Florisil cleanup, alumina cleanup, sulfur removal with copper or TBA sulfite, gel permeation chromatography, etc.) and has documentation to demonstrate that the dual-column GC creates false positive results for that specific matrix, then the Director would appropriately approve the selection of a different EPAapproved method that would then be considered a sufficiently sensitive method (e.g., GC/MS). As another example, EPA also received comments specific to Method 1631 for mercury. These commenters noted that use of the ‘‘clean’’ sampling methods associated with this method to minimize potential contamination from the sampling technique itself is not possible in many industrial settings. PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 49007 They noted that EPA’s documentation of the sampling technique acknowledges it is not intended for treated and untreated discharges from industrial uses. EPA notes that since approval of this method and the associated clean sampling techniques, these techniques have been successfully used in some industrial settings. For example, sewage treatment plants accepting industrial wastewater have successfully eliminated permit exceedances for mercury as measured by Method 1631 by employing the clean sampling procedures. Where the permittee has documentation that clean sampling techniques cannot be adopted for the site-specific application, the Director would appropriately approve the selection of a different EPAapproved method that meets the definition of a sufficiently sensitive method (e.g., the one with the lowest minimum level of the remaining EPAapproved methods). If the ambient level of mercury contamination at the site is too high to use clean sampling methods, then using a less sensitive EPAapproved method can meet the definition of a sufficiently sensitive method. Another commenter raised concerns specific to Method 1631. They questioned the method’s suggestion to minimize laboratory contamination by soaking laboratory air filters in gold chloride solution so that mercury in incoming air will amalgamize with the filter’s gold. This commenter questioned whether or not it was EPA’s expectation that laboratories go to such lengths to employ such a sufficiently sensitive method where required under this rule. EPA notes the procedure described by the commenter is only a suggestion if laboratories are having problems with laboratory contamination. There are now many laboratories that perform Method 1631 without undue difficulty. In this case, where necessary to meet the definition of ‘‘sufficiently sensitive’’ in today’s final rule, EPA would expect that the permittee use Method 1631, since the permittee should send their sample to a laboratory that can demonstrate it has control over sources of mercury within its own environment. Finally, where a technology-based requirement is specified as ‘‘zero discharge’’ or ‘‘no detect,’’ the permitting authority may take into account the sensitivity of the method used to establish the requirement when determining if a method is ‘‘sufficiently sensitive.’’ EPA recognizes that if a more sensitive method is approved after such a requirement has been established, its use may be inconsistent with the technological basis of the original requirement. In situations where a E:\FR\FM\19AUR1.SGM 19AUR1 49008 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations wreier-aviles on DSK5TPTVN1PROD with RULES technology-based requirement reflects a technology that eliminates the discharge of the subject pollutant altogether, the newer sensitive method is appropriate. However, where a technology-based limit reflects a technology that may not achieve the minimum level of the newer more sensitive method, the Director may determine that the method on which the requirement was originally based is ‘‘sufficiently sensitive’’ to determine compliance, as understood at the time the requirement was established. 4. Report of the Federal Advisory Committee on Detection and Quantitation Approaches and Uses in Clean Water Act Programs EPA received a number of comments that identified concerns that the proposed rule uses terms, such as minimum level, that are not defined in new or existing regulations. Commenters also indicated that the proposed rule fails to address a variety of issues regarding detection and quantitation that were raised in the Report of the Federal Advisory Committee on Detection and Quantitation Approaches and Uses in Clean Water Act Programs. EPA agrees that there are a variety of related issues raised in the aforementioned report, yet notes that the members of the Federal Advisory Committee (FAC) were unable to reach consensus over several key issues in the report. While several of these issues, such as the definition of minimum level, are discussed in today’s rulemaking, applicants and permitting authorities must still, on a regular and ongoing basis, choose which of the available analytical methods are most appropriate for use when screening effluent for permit applications and as part of permit conditions. This has always been the case, regardless of today’s rulemaking. EPA believes that the requirements of the rule are adequately described and can be implemented without having to address the myriad of issues considered by the FAC. For today’s rulemaking, EPA is not redefining or establishing new method detection limits (MDLs) or minimum levels, developing new procedures for determining detection or quantitation, or maintaining a clearinghouse on detection and quantitation issues. EPA considers such issues to be outside the scope of today’s rulemaking. 5. Other Factors Affecting Selection of Analytical Methods EPA received several comments that expressed concern that the rule would require the use of only the most sensitive available method, and that VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 other factors such as geographical isolation or unique sample collection constraints might preclude the use of certain available methods. Some comments also expressed concerns regarding the availability of laboratories qualified to conduct some of the more sensitive analytical methods, particularly where the state requires applicants and permittees to use laboratories certified by the state to conduct analyses. EPA is not requiring the use of any specific analytical technology or practice over others; only that the selected EPA-approved method is sufficiently sensitive. EPA expects that, in general, factors such as geographical isolation, or unique sampling collection constraints would not preclude the selection of a sufficiently sensitive method. The definition does not require the use of the most sensitive EPAapproved method available, so long as a less sensitive approved method still meets the criteria for being ‘‘sufficiently sensitive.’’ In cases where factors beyond a facility’s control render the use of a particular method infeasible, such as extreme geographical isolation, the permitting authority could consider such factors in deciding which method best meets the definition of ‘‘sufficiently sensitive.’’ EPA expects such situations would be rare. Issues related to sampling procedures, such as holding times, are frequently prescribed by the test procedures in 40 CFR Part 136, and may be contingent on the unique physical, chemical, and biological characteristics of the discharge. Standard practice has been and continues to be that if an applicant/ permittee or laboratory has questions regarding the appropriateness of using a specific method in a given situation, or has technical questions on its use, it should consult with its permitting authority prior to conducting monitoring. B. Administration and Timing EPA received a few comments regarding the effect of the rule on recordkeeping and reporting requirements. The rule does not change existing recordkeeping and reporting requirements at 40 CFR 122.21(p), 122.41(j) and 122.48. The permitting authority, however, has discretionary authority to require its applicants or permittees to provide information under the latter two provisions. In addition, a few comments asked whether the rule alters the terms or conditions of existing permits. The rule itself does not modify the terms or conditions of existing NPDES permits. If, under the requirements of today’s rulemaking, a PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 change needs to occur in the analytical methods specified in an existing permit, that change would occur at the time of permit renewal, or it could occur through a permit modification under the procedures of 40 CFR Part 124, if the permitting authority determined that such a modification was appropriate. EPA received a few comments regarding whether existing data, if collected using insufficiently sensitive methods, will be acceptable for submission with an application for permit renewal. NPDES application monitoring data that is collected after the effective date of the rule, or, if applicable, after an authorized state has revised its regulations to adopt the provisions of the rule,9 must be based on the use of sufficiently sensitive test methods. However, the rule does not negate the existing requirement for applicants to submit data from previous years, even where these data may have been collected using methods that did not conform to the sufficiently sensitive criteria established in this rule. Based on all of the data submitted with the permit application, the permitting authority will determine whether it has information adequate to develop an NPDES permit. Where the permitting authority determines that data was collected using insufficiently sensitive methods, it may choose to disregard this information and accept only data collected employing sufficiently sensitive EPA-approved methods. In addition, even prior to the effective date of today’s rulemaking, the permitting authority has the authority under the existing NPDES regulations to request additional data from applicants where insufficient data is provided with the application before considering an application complete. EPA received a few comments pertaining to the rule’s impact on indirect dischargers. The rule affects only direct dischargers (those applying for an individual NPDES permit) and state/EPA NPDES permitting authorities. The rule does not apply to indirect dischargers. POTWs with approved pretreatment programs may at their discretion (as authorized by their local ordinances and regulations) require their indirect dischargers to achieve specific minimum levels when performing analyses or may require the use of specific methods to enable them to better characterize contributions into their system. Where a state or EPA is the 9 Authorized NPDES states have up to one year following rule issuance to revise their own regulations to conform to the requirements of this rule. Authorized NPDES states have up to two years to conform to the rule’s requirements if they must make statutory changes. E:\FR\FM\19AUR1.SGM 19AUR1 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations wreier-aviles on DSK5TPTVN1PROD with RULES pretreatment Control Authority, the specific requirements for analytical methods can be specified in the control mechanism issued to the indirect discharger. EPA received several comments that indicated that while the commenters supported the concept established in the proposed rule, they believed additional flexibility should be provided to account for instream dilution. Specifically, the commenters requested that the criteria defining sufficiently sensitive be revised such that the minimum level would be compared to either ‘‘the applicable water quality criterion, wasteload allocation, permit limit, or other critical regulatory value.’’ EPA believes that the final rule need only require comparison of a method’s minimum level with the applicable water quality criterion, as proposed, and that this language is sufficiently flexible to address the commenters’ concern. Under this language, the permitting authority has adequate discretion to determine whether the data provided with a permit application were collected with methods that are sufficiently sensitive to measure at the relevant regulatory value. For example, where a permitting authority has conducted a timely and relevant dilution analysis (including an evaluation of ambient pollutant concentrations) and documented this analysis in the permit record, the permitting authority could provide this information to the applicant prior to the applicant sampling for the permit application. The applicant would then only need to show that the method it has selected has a minimum level that is at least as sensitive as necessary to determine compliance with the water quality criterion, after accounting for allowable dilution. The water quality criterion as adjusted for allowable dilution would be the ‘‘applicable water quality criterion’’ in this case, and the method would be ‘‘sufficiently sensitive’’ if it measures at this level. EPA considers this approach consistent with the requirements established in today’s rule. For these reasons, EPA is not revising the regulatory text to incorporate the language suggested by the commenters. C. Burden EPA received a few comments indicating that site-specific situations might increase the implementation costs of the rule beyond those costs outlined in the proposed rule. Some of these commenters provided examples of when site-specific conditions might result in increased costs. EPA recognizes that the burden estimated is a national average and that the cost for an individual VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 facility could be higher or lower than that average. However, EPA does not believe that the information provided by the commenters is representative of the impact for a typical facility affected by this rule, nor does it alter the Agency’s original burden estimates. EPA also recognizes that in some cases, use of a more sensitive method could have the practical effect of requiring a facility to adopt additional pollution control measures, even if the permit limit remained unchanged. This is because a more sensitive method may detect the presence of a pollutant that was previously undetected. EPA emphasizes that this rule would not be responsible for any change in stringency of the permit requirements in such a case, but acknowledges that a facility may incur additional pollution control costs if a previously undetected pollutant is later detected by the use of a sufficiently sensitive method, and additional treatment is required to meet the existing permit limit. In general, when EPA develops a cost analysis for a new regulation, there is an assumption made of full compliance with existing requirements. EPA does not have data that would allow it to predict in advance where or how often this situation might occur, or what a facility would be required to do to address it. Therefore, EPA has not attempted to quantify any such costs, as they are outside the scope of this rulemaking. As noted above, where a technologybased requirement is specified as ‘‘zero discharge’’ or ‘‘no detect,’’ the permitting authority may take into account the sensitivity of the method used to establish the requirement when determining if a method is ‘‘sufficiently sensitive.’’ EPA recognizes that if a more sensitive method is approved after such a requirement has been established, its use may be inconsistent with the technological basis of the original requirement. In situations where a technology-based requirement reflects a technology that eliminates the discharge of the subject pollutant altogether, the Agency included costs that reflect that technology, the newer sensitive method is appropriate, and the permittee would not incur additional costs. However, where a technology-based limit reflects a technology that may not achieve the minimum level of the newer more sensitive method, the Director may determine that the method on which the requirement was originally based is ‘‘sufficiently sensitive’’ to determine compliance, as understood at the time the requirement was established, and there would thus be no additional control costs incurred by the facility. PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 49009 EPA received a few comments regarding compliance with requirements under the statutory and Executive Order reviews contained in the proposed rule. EPA believes that there was a misunderstanding on the part of the commenters regarding the intent of the rule that led the commenters to believe that the rule would result in a higher cost of implementation than that estimated by EPA. EPA believes that the Agency has met its responsibilities under the applicable statutory and Executive Orders. IV. The Final Rule The final rule adds a new 40 CFR 122.21(e)(3) and revises 122.44(i)(1)(iv) to require that where EPA-approved methods exist, NPDES applicants use sufficiently sensitive EPA-approved analytical methods when submitting information quantifying the presence of pollutants in a discharge and that the Director must prescribe that only sufficiently sensitive EPA-approved analytical test methods be used for analyses of pollutants or pollutant parameters under the permit. EPA is also providing a cross-reference to these changes in a new 40 CFR 136.1(c). For the purposes of this rulemaking, if monitoring requirements are included as a condition of a general permit, those requirements are subject to the provisions established in 122.44(i)(1)(iv). Only these specific parts of the regulations undergoing revision are subject to challenge under section 509(b) of the Clean Water Act. In addition, based on public comments, EPA made certain minor modifications to the final rule from the original proposal. Specifically, EPA amended 122.21(e)(3)(i)(B) and 122.44(i)(1)(iv)(A)(1) to add the word ‘‘or’’ when defining the term ‘‘sufficiently sensitive,’’ which was unintentionally omitted in the proposed rule. In addition, EPA added ‘‘pollutant or pollutant parameter’’ to 122.21(e)(3)(i)(C) and 122.44(i)(1)(iv)(A) to clarify the applicability of the criteria established under the sufficiently sensitive method definition. EPA also removed the second ‘‘in accordance with’’ in the introductory paragraphs for 122.21(e)(3) and 122.44(i)(1)(iv) to clarify that the method selected must be approved under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N or O. EPA removed language in 122.44(i)(1)(iv)(A)(2) of the proposed rule because it was not applicable to requirements established in this section and created confusion about the implementation of the rule. In this instance, even if the permittee believes E:\FR\FM\19AUR1.SGM 19AUR1 49010 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations they are discharging above the permit limit and could potentially use a less sensitive method, the permitting authority is responsible for prescribing an EPA-approved method, where available, that is sensitive enough to detect at or below the permit limit in order to properly assess compliance with the permit. EPA revised the proposed regulatory text at 122.21(e)(3)(ii) and 122.41(i)(1)(iv)(B) for instances where there are no EPA-approved methods. The proposed language included additional requirements for situations where there are no EPA-approved methods. Specifically, the proposed rule would have required that applicants and permitting authorities select a ‘‘sufficiently sensitive’’ non EPAapproved method and that applicants provide a description of the method, including the minimum level. The situation in which there are no EPAapproved methods is uncommon because there are EPA-approved methods for most pollutants or pollutant parameters screened and regulated under the NPDES program. In addition, the existing regulations already require that applicants select a suitable method and provide a description of the method. Based on public comments, EPA determined that this additional requirement was unnecessary and has revised the regulatory text to revert the existing language in 40 CFR 122.21 and 122.41. As a result, today’s rule does not specify that non-EPA-approved methods must be sufficiently sensitive. To clarify this point, EPA also added language to the introduction of 122.21(e)(3) to specify that the requirement to use a sufficiently sensitive method applies ‘‘except as specified in 122.21(e)(3)(ii).’’ EPA amended 122.21(e)(3)(ii) by adding regulatory text to clarify that in the case where there are no EPAapproved methods, applicants may consider other relevant factors when selecting an appropriate method. In addition, EPA revised the proposed regulatory text to change ‘‘or otherwise required by the Director’’ to ‘‘and not otherwise required by the Director’’ to clarify that this provision applies to a situation where no EPA-approved methods exist and the Director has not required the use of a specific non-EPAapproved method. In this situation, the permit applicant may select a suitable non-EPA-approved method and provide a description of the method. Finally, in both places where the new definition of ‘‘sufficiently sensitive’’ appears, EPA added a note to clarify that, consistent with 40 CFR part 136, permittees have the option of providing matrix or sample-specific minimum levels rather than the published levels. In addition, the note clarifies that where a permittee can demonstrate that, despite a good faith effort to use a method that would otherwise meet the definition of ‘‘sufficiently sensitive,’’ the analytical results are not consistent with the QA/QC specifications for that method, then the Director may determine that the method is not performing adequately and a different method should be selected from the remaining EPA-approved methods consistent with 40 CFR 122.21(e)(3)(i) and 40 CFR 122.44(i)(1)(iv)(A). Where no other EPA-approved methods exist, a method should be selected consistent with 40 CFR 122.21(e)(3)(ii) and 40 CFR 122.44(i)(1)(iv)(B). V. Impacts Entities that discharge to waters of the United States vary in terms of the quantity of their discharges, the potential constituents contained in their discharges, and their operation and maintenance practices. Consequently, the Director’s NPDES application requirements vary depending on applicant type. For example, Form 2A for municipalities requires minimal screening for POTWs with design flows under 100,000 gallons per day; however, for POTWs with design flows above 1 million gallons per day, multiple priority pollutant scans are required. Similarly, existing industrial and commercial facilities that complete Form 2C are required to test for toxic pollutants based on the nature of their manufacturing operation. To assist permitting authorities (EPA regions, States, and Tribes), EPA developed several NPDES permit application forms. Table IV–1 provides a list of these forms and the discharger type(s) for which they are intended. Permitting authorities may use EPA’s forms or comparable forms of their own. TABLE IV–1—EPA NPDES PERMIT APPLICATION FORMS BY APPLICANT TYPE Applicant type 1 ......... 2 ......... 3 ......... Form 1 ........................................ Form 2A ...................................... Form 2B ...................................... 4 5 6 7 8 9 wreier-aviles on DSK5TPTVN1PROD with RULES Form or request Form 2C ...................................... Form 2D ...................................... Form 2E ...................................... Form 2F ...................................... 40 CFR 122.21(r) and 122.22(d) Form 2S ...................................... New and existing applicants, except POTWs and treatment works treating domestic sewage. New and existing POTWs (i.e., municipal facilities). New and existing concentrated animal feeding operations (CAFOs) and aquatic animal production facilities. Existing industries discharging process wastewater. New industries discharging process wastewater. New and existing industries discharging non-process wastewater only. New and existing industries discharging stormwater. New and existing industries with cooling water intake structures. New and existing POTWs and other treatment works treating domestic sewage (covers sludge). ......... ......... ......... ......... ......... ......... As noted earlier, permitting authorities issue and develop effluent limitations for individual NPDES permits after analyzing the data contained in each permittee’s application. The NPDES permit prescribes the conditions under which the facility is allowed to discharge to ensure the facility’s compliance with the CWA’s technology-based and water quality-based requirements. NPDES permits typically include restrictions on VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 the quantity of pollutants that a permittee may discharge and require the permittee to conduct routine measurements of, and report on, a number of parameters using EPAapproved, pollutant-specific test procedures (or approved alternative test procedures). In 2012 EPA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) that, in part, updated the Agency’s burden estimates for PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 applicants to complete Forms 1, 2A, 2C– 2F, and 2S and for permitting authorities to review and process such forms.10 The renewal ICR did not include updated estimates for Form 2B or for forms associated with cooling water intake structures (Item 8 in Table IV–1). Updated estimates to complete 10 USEPA. ‘‘Information Collection Request (ICR) for National Pollutant Discharge Elimination System (NPDES) Program (Renewal),’’ OMB Control No. 2040–0004, EPA ICR No. 0229.20, March 2012. E:\FR\FM\19AUR1.SGM 19AUR1 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations those forms were contained in separate ICRs.11 The existing ICRs include annual burden estimates for completing NPDES permit applications and for conducting ongoing compliance monitoring for both new and existing NPDES permittees. EPA’s expectation is that permit applicants and permittees will use a range of methods based on a need to appropriately quantify pollutants in their discharge. To calculate cost and burden, the ICRs use an average cost for analytical methods, which is then translated into burden hours. To assess the impact of this final rule, EPA also assessed the cost information for 40 CFR Part 136 methods found in the National Environmental Methods Index (NEMI) at http://www.nemi.gov. The NEMI site describes the ‘‘relative cost’’ as the cost per procedure of a typical analytical measurement using the specified methods (i.e., the cost of analyzing a single sample). Additional considerations affect total project costs (e.g., labor and equipment/supplies for a typical sample preparation, quality assurance/quality control requirements to validate results reported, number of samples being analyzed). EPA’s review of the cost ranges provided in NEMI indicated that there was generally little difference in the cost ranges across the EPA-approved analytical methods for a particular pollutant. A table with the NEMI cost ranges is included in the record. While EPA acknowledges that there are cost differentials for some facilities based on case-specific situations, on the basis of the analytical cost ranges provided in NEMI, and the assumptions used in the current ICRs (i.e., that applicants and permittees will use a range of available approved methods), the final rule is expected to result in little or no new or increased analytical burden to applicants or permittees. The existing ICRs also account for the ongoing burden to permitting authorities to review applications and to issue NPDES permits annually. They wreier-aviles on DSK5TPTVN1PROD with RULES 11 USEPA. ‘‘Supporting Statement for the Information Collection Request for the NPDES Regulation and Effluent Limitation Guidelines and Standards for Concentrated Animal Feeding Operations,’’ OMB Control No. 2040–0250, EPA ICR No. 1989.09, January 2014. USEPA, ‘‘Information Collection Request (ICR) for Cooling Water Intake Structures at Phase III Facilities (Final Rule),’’ OMB Control No. 2040– 0268, EPA ICR No. 2169.05, January 2014. USEPA, ‘‘Information Collection Request (ICR) for Cooling Water Intake Structures Phase II Existing Facilities (Renewal),’’ OMB Control No. 2040–0257, EPA ICR No. 2060.06, January 2014. USEPA, ‘‘Information Collection Request (ICR) for Cooling Water Intake Structures New Facility Rule (Renewal),’’ OMB Control No. 2040–0241, EPA ICR No. 1973.05, December 2011. VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 also account for the ongoing burden associated with reviewing discharge monitoring and other reports for compliance assessment purposes. Finally, the existing ICRs account for program revisions where they are necessary because the controlling Federal statutes or regulations were modified. As noted above, EPA also recognizes that in some cases, use of a more sensitive method could have the practical effect of requiring a facility to adopt additional pollution control measures, even if the permit limit remained unchanged. EPA does not have data that would allow it to predict in advance where or how often this situation might occur, or what a facility would be required to do to address it. EPA has not attempted to quantify the costs of any such new control measures that might be adopted, as they are outside the scope of this rulemaking. VI. Compliance Dates Following issuance of this rule, authorized states have up to one year to revise, as necessary, their NPDES regulations to adopt the requirements of this rule, or two years if statutory changes are needed, as provided at 40 CFR 123.62. VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a ‘‘significant regulatory action.’’ Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011) and any changes made in response to OMB recommendations have been documented in the docket for this action. B. Paperwork Reduction Act This action does not impose any new information collection burden. The final rulemaking requires the use of sufficiently sensitive EPA-approved analytical test methods, where they exist, when applying for an NPDES permit and when performing sampling and analysis pursuant to monitoring requirements in an NPDES permit. However, it does not change the recordkeeping or reporting requirements associated with the use of analytical methods. The Office of Management and Budget (OMB) has previously approved the information collection requirements PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 49011 contained in the existing regulations (which cover all potential NPDES applicants) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control numbers, as summarized in section V (Impacts) of this preamble. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this final rule on small entities, ‘‘small entity’’ is defined as (1) a small business based on the Small Business Administration regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. EPA has determined that the incremental analytical costs that NPDES permit applicants and permittees may bear as a result of this rule are minimal and would not rise to the level of a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act This rule does not contain a Federal mandate that might result in expenditures of $100 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any one year. Thus, this final rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has further determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this final rule is not subject to the requirements of section 203 of UMRA. E:\FR\FM\19AUR1.SGM 19AUR1 49012 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations E. Executive Order 13132: Federalism This final rule does not have federalism implications. When promulgated, it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of governments, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This final rule does not change the relationship between the national government and the States or change their roles and responsibilities. Rather, this final rulemaking requires that sufficiently sensitive EPA-approved analytical test methods be used, where they exist, when applying for an NPDES permit and when performing sampling and analysis pursuant to monitoring requirements in an NPDES permit. EPA does not expect this final rule to have any impact on local governments. Furthermore, the revised regulations would not alter the basic state-federal scheme established in the CWA, under which EPA authorizes states to carry out the NPDES permitting program. EPA expects the revised regulations to have little effect on the relationship between, or the distribution of power and responsibilities among, the Federal and State governments. wreier-aviles on DSK5TPTVN1PROD with RULES F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This final rule does not have tribal implications, as specified in Executive Order 13175, ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. The final rule requires that sufficiently sensitive EPA-approved analytical test methods must be used, where they exist, when applying for an NPDES permit and when performing sampling and analysis pursuant to monitoring requirements in an NPDES permit. Nothing in this final rule would prevent an Indian tribe from exercising its own organic authority to deal with such matters. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks The final rule is not subject to Executive Order 13045, ‘‘Protection of VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), because it is not economically significant and the Agency does not believe that the environmental health and safety risks addressed by this action present a disproportionate risk to children. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This rulemaking is not subject to Executive Order 13211, ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 (Pub. L. 104–113, section 12(d), 15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standard bodies. The NTTAA directs EPA to provide explanations to Congress, through OMB, when the Agency decides not to use available and applicable voluntary consensus standards. This final rulemaking does not change agency policy or requirements with respect to the use of voluntary consensus standards for the analysis of pollutants by NPDES permit applicants or permittees. J. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations) Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. As explained above, the Agency does not have reason to believe that the rule addresses environmental health and safety risks that present a disproportionate risk to minority populations and low-income populations. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). This rule will be effective September 18, 2014. List of Subjects 40 CFR Part 122 Administrative practice and procedure, Confidential business information, Environmental protection, Hazardous substances, Reporting and recordkeeping requirements, Water pollution control. 40 CFR Part 136 Environmental protection, Incorporation by reference, Reporting and recordkeeping requirements, Water pollution control. Dated: August 6, 2014. Gina McCarthy, Administrator. For the reasons set out in the preamble, title 40, chapter I, of the Code of Federal Regulations is amended as follows: PART 122—EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM 1. The authority citation for part 122 continues to read as follows: ■ E:\FR\FM\19AUR1.SGM 19AUR1 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Rules and Regulations Authority: The Clean Water Act, 33 U.S.C. 1251 et seq. 2. Section 122.21, is amended by adding a new paragraph (e)(3), to read as follows: ■ § 122.21 Application for a permit (applicable to State programs, see § 123.25). * * * * * (e) * * * (3) Except as specified in 122.21(e)(3)(ii), a permit application shall not be considered complete unless all required quantitative data are collected in accordance with sufficiently sensitive analytical methods approved under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N or O. (i) For the purposes of this requirement, a method approved under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N or O is ‘‘sufficiently sensitive’’ when: (A) The method minimum level (ML) is at or below the level of the applicable water quality criterion for the measured pollutant or pollutant parameter; or (B) The method ML is above the applicable water quality criterion, but the amount of the pollutant or pollutant parameter in a facility’s discharge is high enough that the method detects and quantifies the level of the pollutant or pollutant parameter in the discharge; or (C) The method has the lowest ML of the analytical methods approved under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N or O for the measured pollutant or pollutant parameter. wreier-aviles on DSK5TPTVN1PROD with RULES Note to paragraph (e)(3)(i)(C): Consistent with 40 CFR part 136, applicants have the option of providing matrix or sample specific minimum levels rather than the published levels. Further, where an applicant can demonstrate that, despite a good faith effort to use a method that would otherwise meet the definition of ‘‘sufficiently sensitive’’, the analytical results are not consistent with the QA/QC specifications for that method, then the Director may determine that the method is not performing adequately and the applicant should select a different method from the remaining EPA-approved methods that is sufficiently sensitive consistent with 40 CFR 122.21(e)(3)(i). Where no other EPAapproved methods exist, the applicant should select a method consistent with 40 CFR 122.21(e)(3)(ii). (ii) When there is no analytical method that has been approved under 40 CFR part 136, required under 40 CFR chapter I, subchapter N or O, and is not otherwise required by the Director, the applicant may use any suitable method but shall provide a description of the method. When selecting a suitable method, other factors such as a VerDate Mar<15>2010 14:25 Aug 18, 2014 Jkt 232001 method’s precision, accuracy, or resolution, may be considered when assessing the performance of the method. * * * * * ■ 3. Section 122.44 is amended by revising paragraph (i) (1) (iv) to read as follows: § 122.44 Establishing limitations, standards, and other permit conditions (applicable to State NPDES programs, see § 123.25). * * * * * (i) * * * (1) * * * (iv) According to sufficiently sensitive test procedures (i.e., methods) approved under 40 CFR part 136 for the analysis of pollutants or pollutant parameters or required under 40 CFR chapter I, subchapter N or O. (A) For the purposes of this paragraph, a method is ‘‘sufficiently sensitive’’ when: (1) The method minimum level (ML) is at or below the level of the effluent limit established in the permit for the measured pollutant or pollutant parameter; or (2) The method has the lowest ML of the analytical methods approved under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N or O for the measured pollutant or pollutant parameter. Note to paragraph (i)(1)(iv)(A)(2): Consistent with 40 CFR part 136, applicants or permittees have the option of providing matrix or sample specific minimum levels rather than the published levels. Further, where an applicant or permittee can demonstrate that, despite a good faith effort to use a method that would otherwise meet the definition of ‘‘sufficiently sensitive’’, the analytical results are not consistent with the QA/QC specifications for that method, then the Director may determine that the method is not performing adequately and the Director should select a different method from the remaining EPA-approved methods that is sufficiently sensitive consistent with 40 CFR 122.44(i)(1)(iv)(A). Where no other EPAapproved methods exist, the Director should select a method consistent with 40 CFR 122.44(i)(1)(iv)(B). (B) In the case of pollutants or pollutant parameters for which there are no approved methods under 40 CFR part 136 or methods are not otherwise required under 40 CFR chapter I, subchapter N or O, monitoring shall be conducted according to a test procedure specified in the permit for such pollutants or pollutant parameters. * * * * * PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 49013 PART 136—GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS 4. The authority citation for part 136 continues to read as follows: ■ Authority: Secs. 301, 304(h), 307, and 501(a) Pub. L. 95–217, 91 Stat. 1566, et seq. (33 U.S.C. 1251 et seq.) (The Federal Water Pollution Control Act Amendments of 1972 as amended by the Clean Water Act of 1977.) 5. Section 136.1 is amended by adding a new paragraph (c) to read as follows: ■ § 136.1 Applicability. * * * * * (c) For the purposes of the NPDES program, when more than one test procedure is approved under this part for the analysis of a pollutant or pollutant parameter, the test procedure must be sufficiently sensitive as defined at 40 CFR 122.21(e)(3) and 122.44(i)(1)(iv). [FR Doc. 2014–19265 Filed 8–18–14; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF THE INTERIOR Office of the Secretary 43 CFR Part 2 [145D0102DM DLSN00000.000000 DS62400000 DX62401] RIN 1090–AA94 Privacy Act Regulations; Exemption for the Debarment and Suspension Program Office of the Secretary, Interior. Final rule. AGENCY: ACTION: The Department of the Interior is issuing a final rule to amend its regulations to exempt certain records of the Debarment and Suspension Program system of records from particular provisions of the Privacy Act because these records contain investigatory material. DATES: This final rule is effective September 18, 2014. FOR FURTHER INFORMATION CONTACT: Teri Barnett, Departmental Privacy Officer, U.S. Department of the Interior, 1849 C Street NW., Mail Stop 5547 MIB, Washington, DC 20240. Email at privacy@ios.doi.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Background The Department of the Interior (DOI) published a notice of proposed rulemaking in the Federal Register, 76 FR 52295, August 22, 2011, proposing to E:\FR\FM\19AUR1.SGM 19AUR1

Agencies

[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Rules and Regulations]
[Pages 49001-49013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19265]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 122 and 136

[EPA-HQ-OW-2009-1019; FRL-9915- 18-OW]
RIN 2040-AC84


National Pollutant Discharge Elimination System (NPDES): Use of 
Sufficiently Sensitive Test Methods for Permit Applications and 
Reporting

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is finalizing minor 
amendments to its Clean Water Act (CWA) regulations to codify that 
under the National Pollutant Discharge Elimination System (NPDES) 
program, permit applicants must use ``sufficiently sensitive'' 
analytical test methods when completing an NPDES permit application and 
the Director must prescribe that only ``sufficiently sensitive'' 
methods be used for analyses of pollutants or pollutant parameters 
under an NPDES permit.
    The final rule is based on requirements in the CWA and clarifies 
existing EPA regulations. It also codifies existing EPA guidance on the 
use of ``sufficiently sensitive'' analytical methods with respect to 
measurement of mercury and extends the approach outlined in that 
guidance to the NPDES program more generally. Specifically, EPA is 
modifying existing NPDES application, compliance monitoring, and 
analytical methods regulations. The amendments in this rulemaking 
affect only chemical-specific methods; they do not apply to the Whole 
Effluent Toxicity (WET) methods or their use.

DATES: These final regulations are effective September 18, 2014. For 
judicial review purposes, this final rule is promulgated as of 1:00 
p.m. Eastern Time, on September 2, 2014, as provided in 40 CFR 23.2.

ADDRESSES: The record for this rulemaking is available for inspection 
and copying at the Water Docket, located at the EPA Docket Center (EPA/
DC), EPA West 1301 Constitution Ave. NW., Washington, DC 20004. The 
record is also available via EPA Dockets at http://www.regulations.gov 
under docket number EPA-HQ-OW-2009-1019. The rule and key supporting 
documents are also available electronically on the Internet at http://cfpub.epa.gov/npdes/ssmethods.cfm.
    Docket: All documents in the docket are listed in the 
www.regulations.gov index. Some information, however, is not publicly 
available, e.g., confidential business information (``CBI'') or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is publicly available only in 
hard copy. Publicly available docket materials are available 
electronically in www.regulations.gov or in hard copy at the Water 
Docket, EPA Docket Center, EPA West, Room 3334, 1301 Constitution 
Avenue NW., Washington, DC. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the Water Docket is (202) 566-2426.

FOR FURTHER INFORMATION CONTACT: For additional information, contact 
Kathryn Kelley, Water Permits Division, Office of Wastewater Management 
(4203M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460; telephone number: (202) 564-7004, email address: 
kelley.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:
I. General Information
    A. Potentially Affected Parties
    B. Legal Authority
II. Background
III. Summary of Public Comments and EPA's Response
IV. The Final Rule
V. Impacts
VI. Compliance Dates
VII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

I. General Information

A. Potentially Affected Parties

    In the NPDES program, point source dischargers obtain permits that 
are issued by EPA regions and authorized NPDES States, Territories, and 
Indian tribes (collectively referred to as ``permitting authorities''). 
These point source dischargers include publicly owned treatment works 
(POTWs) and various industrial and commercial facilities (collectively 
referred to as ``NPDES applicants or permittees''). Permitting 
authorities issue NPDES individual permits after analyzing the 
information contained in the application and making a determination 
that the application is ``complete'' under 40 CFR 122.21(e). In the 
case of a general permit, authorization to be covered by the permit is 
given if the information submitted demonstrates eligibility for 
coverage under 40 CFR 122.28. The NPDES permit prescribes the 
conditions under which the facility is allowed to discharge pollutants 
into waters of the United States and the conditions that will ensure 
the facility's compliance with the CWA's technology-based and water 
quality-based requirements. NPDES permits typically include 
restrictions on the mass and/or concentration of pollutants \1\ that a 
permittee may discharge as well as requirements that the permittee 
conduct routine sampling and reporting of various parameters measured 
in the permitted discharge. In general, NPDES applicants and permittees 
are required to use EPA-approved methods \2\ when measuring the 
pollutants in their discharges.
---------------------------------------------------------------------------

    \1\ Where the term ``pollutant'' is used, it refers to both 
pollutants and pollutant parameters.
    \2\ For purposes of this rule, the term ``EPA-approved methods'' 
refers to methods that have been approved under 40 CFR part 136 or 
are required under 40 CFR chapter I, subchapter N or O. This 
includes analytical methods for CWA pollutants developed by EPA, 
voluntary consensus standards bodies (VCSBs), and other government 
agencies (such as the U.S. Geological Survey), as well as Alternate 
Test Procedures (ATPs) developed by commercial method developers for 
nation-wide use. These methods have been reviewed by EPA and 
approved for use in compliance monitoring under the CWA. EPA 
publishes lists of the EPA, VCSB, and other agency methods as well 
as ATPs that it has found to be acceptable for such use at 40 CFR 
Part 136, and at 40 CFR Chapter I, subchapters N and O. As a point 
of clarification, this includes approved ATPs as described in 40 CFR 
136.4 and 136.5.
---------------------------------------------------------------------------

    The purpose of today's final rule is to codify that where EPA-
approved methods exist, NPDES applicants must use sufficiently 
sensitive EPA-approved analytical methods when quantifying the presence 
of pollutants in a

[[Page 49002]]

discharge, and the Director \3\ must prescribe that only sufficiently 
sensitive EPA-approved methods be used for analyses of pollutants or 
pollutant parameters under the permit. The broad universe of entities 
\4\ that would be affected by this final action includes NPDES 
permitting authorities and municipal and industrial applicants and 
permittees (Table I-1). This rule does not apply to indirect 
dischargers as defined in 40 CFR 122.2. The impact of this action, 
however, would only affect those entities that use or allow the use of 
any EPA-approved analytical methods (for one or more parameters) that 
are not ``sufficiently sensitive'' to detect pollutants being measured 
in the discharge.
---------------------------------------------------------------------------

    \3\ The term ``Director'' refers to the permitting authority. 
See definition at 40 CFR 122.2.
    \4\ Although terms such as ``authorities,'' ``applicants,'' and 
``permittees'' imply individuals, EPA uses these terms to refer to 
entities. For example, EPA uses the term ``NPDES permitting 
authorities'' to mean the EPA Regions, States, Territories, and 
Indian tribes granted authority to implement and manage the NPDES 
program. EPA uses the term ``NPDES applicants'' or ``NPDES 
permittees'' to mean facilities that have applied for, sought 
coverage under, or been issued an NPDES individual or general 
permit.

         Table I-1--Entities Potentially Regulated by This Rule
------------------------------------------------------------------------
                                      Examples of potentially affected
             Category                             entities
------------------------------------------------------------------------
State, Territorial, and Indian      States, Territories, and Indian
 Tribal Governments.                 tribes authorized to administer the
                                     NPDES permitting program; States,
                                     Territories, and Indian tribes that
                                     provide certification under section
                                     401 of the CWA.
Municipalities....................  POTWs required to apply for or seek
                                     coverage under an NPDES individual
                                     or general permit and to perform
                                     routine monitoring as a condition
                                     of any issued NPDES permit.
Industry..........................  Facilities required to apply for or
                                     seek coverage under an NPDES
                                     individual or general permit and to
                                     perform routine monitoring as a
                                     condition of any issued NPDES
                                     permit.
------------------------------------------------------------------------

    If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. Legal Authority

    EPA is issuing today's final rule pursuant to the authority of 
sections 301, 304(h), 308, 402(a), and 501(a) of the CWA [33 U.S.C. 
1311, 1314(h), 1316, 1318, 1342(a), 1343, and 1361(a)]. Section 301(a) 
of the CWA prohibits the discharge of any pollutant except in 
compliance with an NPDES permit issued under section 402 of the act. 
Section 402(a) of the CWA authorizes the Administrator to issue permits 
that require a discharger to meet all the applicable requirements under 
sections 301, 302, 306, 307, 308, and 403. Section 301(b) of the CWA 
further requires that NPDES permits include effluent limitations that 
implement technology-based standards and, where necessary, water 
quality-based effluent limitations (WQBELs) that are as stringent as 
necessary to meet water quality standards. With respect to the 
protection of water quality, NPDES permits must include limitations to 
control all pollutants that the NPDES permitting authority determines 
are or might be discharged at a level that ``will cause, have the 
reasonable potential to cause, or contribute to an excursion above any 
state water quality standard,'' including both narrative and numeric 
criteria [40 CFR 122.44(d)(1)(i)]. If the Director determines that a 
discharge causes, has the reasonable potential to cause, or contributes 
to such an excursion, the permit must contain WQBELs for the pollutant 
[40 CFR 122.44(d)(1)(iii)]. Section 402(a)(2) of the CWA requires EPA 
to prescribe permit conditions to ensure compliance with requirements, 
``. . . including conditions on data and information collection, 
reporting and such other requirements as [the Administrator] deems 
appropriate.'' Thus, a prospective permittee might need to measure 
various pollutants in its effluent at two stages: First, at the permit 
application stage so that the Director can determine what pollutants 
are present in the applicant's discharge and the amount of each 
pollutant present and, second, to quantify the levels of each pollutant 
limited in the permit to determine whether the discharge is in 
compliance with the applicable limits and conditions.
    Section 304(h) of the CWA requires the Administrator of EPA to ``. 
. . promulgate guidelines establishing test procedures for the analysis 
of pollutants that shall include the factors which must be provided in 
any certification pursuant to [section 401of this Act] or permit 
application pursuant to [section 402 of this Act].'' Section 501(a) of 
the act authorizes the Administrator to ``. . . prescribe such 
regulations as are necessary to carry out this function under [the 
act].'' EPA generally has codified its test procedure regulations 
(including analysis and sampling requirements) for CWA programs at 40 
CFR part 136, although some requirements are codified in other parts 
(e.g., 40 CFR chapter I, subchapters N and O).
    The Director is required under 40 CFR 122.21(e) to determine when 
an NPDES permit application is complete. Moreover, the Director shall 
not begin processing an application for an individual permit until the 
applicant has fully complied with the application requirements for that 
permit [40 CFR 124.3(a)(2)]. Under 40 CFR 122.21(g)(13), applicants are 
required to provide to the Director, upon request, such other 
information as the Director may reasonably require to assess the 
discharge. Finally, 40 CFR 122.41(j)(1) requires NPDES permits to 
include a standard condition specifying that ``samples and measurements 
taken for the purpose of monitoring shall be representative of the 
monitored activity.''
    Among other things, section 308 of the CWA authorizes EPA to 
require owners or operators of point sources to establish records, 
conduct monitoring activities, and make reports to enable the 
permitting authority to determine whether there is a violation of any 
prohibition or any requirement established under provisions including 
section 402 of the CWA. Under sections 308(c) and 402(b)(2)(A), a 
state's authorized NPDES program must have authorities to inspect, 
monitor, enter, and require reports to at least the same extent as 
required in section 308.
    As summarized above, the legal requirements and authorities exist 
for EPA to require NPDES applicants and permittees to use sufficiently 
sensitive EPA-approved analytical methods when quantifying the presence 
of pollutants in a discharge and to require the Director to require and 
accept only such data.

II. Background

    Multiple analytical test methods exist for many pollutants 
regulated under the CWA. Therefore, EPA has generally

[[Page 49003]]

approved multiple methods for CWA pollutants under 40 CFR part 136 and 
40 CFR chapter I, subchapters N and O. Some of the approved analytical 
test methods have greater sensitivities and lower minimum levels 
5 6 or method detection limits (MDLs) \7\ than other 
approved methods for the same pollutant. This situation often occurs 
because of advances made in instrumentation and in the analytical 
protocols themselves. Many metals and toxic compounds (for example, 
mercury) have an array of EPA-approved methods, including some methods 
that have greater sensitivities and lower minimum levels than the 
others.
---------------------------------------------------------------------------

    \5\ The term ``minimum level'' refers to either the sample 
concentration equivalent to the lowest calibration point in a method 
or a multiple of the method detection limit (MDL). Minimum levels 
may be obtained in several ways: They may be published in a method; 
they may be sample concentrations equivalent to the lowest 
acceptable calibration point used by a laboratory; or they may be 
calculated by multiplying the MDL in a method, or the MDL determined 
by a lab, by a factor. [See: (A) 40 CFR 136, appendix A, footnotes 
to table 2 of EPA Method 1624 and table 3 of EPA Method 1625 (49 FR 
43234, October 26, 1984); (B) 40 CFR 136, section 17.12 of EPA 
Method 1631E (67 FR 65876-65888, October 29, 2002); (C) 61 FR 21, 
January 31, 1996; and (D) ``Analytical Method Guidance for the 
Pharmaceutical Manufacturing Point Source Category,'' EPA 821-B-99-
003, August 1999].
    \6\ For the purposes of this rulemaking, EPA is considering the 
following terms related to analytical method sensitivity to be 
synonymous: ``quantitation limit,'' ``reporting limit,'' ``level of 
quantitation,'' and ``minimum level.''
    \7\ The MDL is determined using the procedure at 40 CFR Part 
136, appendix B. It is defined as the minimum concentration of a 
substance that can be measured and reported with 99 percent 
confidence that the analyte concentration is greater than zero and 
is determined from analysis of a sample in a given matrix containing 
the analyte.
---------------------------------------------------------------------------

    Although EPA has approved multiple analytical methods for 
individual pollutants, the Agency has historically expected that 
applicants would select from the array of available methods a specific 
analytical method that is sufficiently sensitive to quantify the 
presence of a pollutant in a given discharge. EPA has not expected that 
NPDES permit applicants would select a method with insufficient 
sensitivity, thereby masking the presence of a pollutant in their 
discharge, when an EPA-approved sufficiently sensitive method is 
available. Further, EPA anticipated that NPDES permitting authorities 
would specify an EPA-approved method in an NPDES permit where the 
Director determined that a particular analytical method was needed to 
provide meaningful results relative to the permit limit. EPA believes 
that the authority to prescribe a specific analytical method in an 
NPDES permit exists under the current regulations. However, some state 
permitting authorities expressed concern that this authority was not 
explicit in current regulations, thus limiting states' ability to 
prescribe an appropriate analytical method where needed to assess 
compliance with permit limits. This rule requires that, where EPA-
approved methods exist, NPDES applicants must use sufficiently 
sensitive EPA-approved analytical methods when quantifying the presence 
of pollutants in a discharge and that the Director must prescribe that 
only sufficiently sensitive EPA-approved methods be used for analyses 
of pollutants or pollutant parameters under the permit.
    EPA and state permitting authorities use data from the permit 
application to determine whether pollutants are present in an 
applicant's discharge and to quantify the levels of all detected 
pollutants. These pollutant data are then used to determine whether 
technology- or water quality-based effluent limits are needed in the 
facility's NPDES permit. It is critical, therefore, that applicants 
provide data that have been measured at levels that will be meaningful 
to the decision-making process. Among other things, data must be 
provided that will enable the Director to make a sound ``reasonable 
potential'' determination and, if necessary, establish appropriate 
water quality-based permit limits. The same holds true for monitoring 
and reporting relative to permit limits established for regulated 
parameters. The intent is for applicants and permittees to use 
analytical methods that are capable of detecting and measuring the 
pollutants at, or below, the respective water quality criteria or 
permit limits.\8\
---------------------------------------------------------------------------

    \8\ To address this situation some state permitting authorities 
have developed a list of monitored parameters and prescribed a 
required minimum level that must be achieved for each parameter as a 
part of their state regulations or policy.
---------------------------------------------------------------------------

    For example, in 2002 and 2007 EPA published two new analytical 
methods for mercury that were several orders of magnitude more 
sensitive than previously available methods. In addition, a number of 
states have set water quality criteria for mercury that are below the 
detection levels of the older methods for mercury that EPA approved 
prior to 2002. Unlike the previous methods, the new methods are capable 
of measuring whether effluent samples are above or below the current 
water quality criteria. In 2007 EPA addressed this issue with respect 
to mercury in a memorandum titled ``Analytical Methods for Mercury in 
NPDES Permits,'' from James A. Hanlon, Director of EPA's Office of 
Wastewater Management, to the Regional Water Division Directors. This 
memorandum is available at http://www.epa.gov/npdes/pubs/mercurymemo_analyticalmethods.pdf. The memorandum explains EPA's expectation that 
``All facilities with the potential to discharge mercury will provide 
with their NPDES permit applications monitoring data for mercury using 
Method 1631E or another sufficiently sensitive EPA-approved method. 
Accordingly, EPA strongly recommends that the permitting authority 
determine that a permit application that lacks effluent data analyzed 
with a sufficiently sensitive EPA-approved method such as Method 1631E, 
is incomplete unless and until the facility supplements the original 
application with data analyzed with such a method.''
    Following issuance of the 2007 memorandum, EPA determined that the 
NPDES permit application regulations at 40 CFR 122.21 and the NPDES 
permit monitoring requirements at 40 CFR 122.44 should be revised to 
ensure that, where EPA-approved methods exist, applicants use 
sufficiently sensitive EPA-approved analytical methods when quantifying 
the presence of pollutants in a discharge and that Directors prescribe 
that only sufficiently sensitive EPA-approved methods be used to 
perform sampling and analysis for all pollutants, not just mercury. 
Therefore, in this rulemaking, EPA is revising the regulations to 
extend the requirement to use sufficiently sensitive EPA-approved 
analytical test methods, where they exist, to all pollutants and 
establish criteria for what qualifies as a ``sufficiently sensitive'' 
method.
    This final rule requires that NPDES applicants must use 
sufficiently sensitive EPA-approved analytical methods, where they 
exist, when submitting information required by a permit application 
quantifying the presence of pollutants in a discharge. If the applicant 
does not provide data using a sufficiently sensitive EPA-approved 
analytical method, the Director may determine that the application is 
``incomplete'' per 40 CFR 122.21(e).The Director may require that the 
applicant provide new screening data obtained using a sufficiently 
sensitive EPA-approved analytical method before making a completeness 
determination and moving forward with permit development. The final 
rule also requires that, as a condition of permit development, to 
assure compliance with permit limitations the permit shall include 
requirements to monitor according to sufficiently sensitive EPA-
approved methods, where they exist.

[[Page 49004]]

Specifically, where an EPA-approved analytical method exists that would 
provide quantifiable results necessary to assess compliance with a 
permit limit and the permit allows monitoring to be conducted using 
different analytical methods that, although approved, would fail to 
produce data necessary to assess compliance, the permit would be 
inconsistent with the NPDES permitting requirements of 40 CFR 
122.44(i).
    EPA is defining the term ``sufficiently sensitive'' in two sections 
of the NPDES regulations: At 40 CFR 122.21(e) (Completeness), as a new 
subsection (3), and at 40 CFR 122.44(i)(1)(iv) (Monitoring 
Requirements). EPA is also modifying 40 CFR 136.1 (Applicability) by 
adding a new paragraph (c), which is simply a cross-reference to the 
changes being promulgated in 40 CFR 122.21(e)(3) and 40 CFR 
122.44(i)(1)(iv). The new and revised sections indicate that an EPA-
approved method is sufficiently sensitive where:
    A. The method minimum level is at or below the level of the 
applicable water quality criterion or permit limitation for the 
measured pollutant or pollutant parameter; or
    B. In the case of permit applications, the method minimum level is 
above the applicable water quality criterion, but the amount of the 
pollutant or pollutant parameter in a facility's discharge is high 
enough that the method detects and quantifies the level of the 
pollutant or pollutant parameter in the discharge; or
    C. The method has the lowest minimum level of the EPA-approved 
analytical methods.

The requirement to use a ``sufficiently sensitive'' EPA-approved method 
does not apply where no EPA-approved method exists. When no analytical 
method is approved under 40 CFR part 136 or required under subchapter N 
or O, and a specific method is not otherwise required by the Director, 
an NPDES applicant may use any suitable method; however, the applicant 
shall provide a description of the method.
    The first two criteria, A and B, in the sufficiently sensitive 
definition address situations in which EPA has approved multiple 
methods for a pollutant and some of those approved methods have greater 
sensitivities and lower minimum levels than others. In this situation, 
the applicant or permitting authority may select a method based on the 
minimum level published in the EPA-approved method, where available, or 
using a derived minimum level. As noted in footnote 4, the minimum 
level may be explicitly listed in some EPA-approved methods. Where this 
is the case, the applicant may reference the published minimum level 
when determining whether a method selected to provide data for their 
permit application is sufficiently sensitive. Where EPA has included a 
minimum level for a pollutant in a specific method, it reflects the 
minimum level obtained in a multi-laboratory study of the new method in 
a wide variety of matrices, many of which EPA selects due to their 
complex nature. EPA acknowledges that complex matrices exist and 
provides flexibility and suggestions for ways to mitigate interferences 
in such instances, often within the published method for a specific 
pollutant. EPA's experience is that many laboratories find solutions to 
address difficult matrices and are able to achieve the published 
minimum level within the required quality assurance specifications. 
However, applicants have always had the option of calculating a matrix-
specific method detection limit (MDL). Extreme matrices may necessitate 
the use of an elevated sample specific minimum level, in which case the 
laboratory should be able to show that a reasonable effort (e.g., 
published cleanup procedures) was attempted to achieve as low a minimum 
level as possible for those samples. The use of sample or matrix 
specific minimum levels rather than the published levels has always 
been an available option, and consistent with that flexibility, use of 
a matrix-specific minimum level may sometimes be necessary when 
determining which methods are sufficiently sensitive.
    For EPA-approved methods that do not explicitly list minimum 
levels, the applicant can derive the minimum level from either the 
concentration of the lowest calibration standard in methods that 
dictate the concentrations of such standards, or as a multiple of the 
MDL or similar statistically derived detection limit concept. When the 
method dictates, or recommends, the concentration of the lowest 
calibration standard, that concentration can be converted to a minimum 
level by considering the weights and/or volumes of the sample and all 
of the intermediate preparation and analysis steps in the method. If a 
method provides a literature MDL for the matrix of interest, that MDL 
value can be used to estimate the minimum level as 10 times the 
standard deviation of the replicate measurements used to determine the 
MDL according to 40 CFR part 136, appendix B. However, MDLs are 
inherently method- and laboratory-specific, so whenever a permittee is 
contracting a laboratory for NPDES work, it is prudent to obtain that 
laboratory's MDL and compare it to the published MDL to ensure that 
both their MDL and their minimum level are appropriate for the intended 
application.
    The third criterion, C, of the definition addresses situations in 
which none of the EPA-approved methods for a pollutant can achieve the 
minimum levels necessary to assess reasonable potential or to monitor 
compliance with a permit limit. In these situations, applicants or 
permittees must use the method with the lowest minimum level among the 
EPA-approved methods for the pollutant, and this method would meet the 
definition of sufficiently sensitive.
    As explained above, the requirement to use a ``sufficiently 
sensitive'' EPA-approved method does not apply where no EPA-approved 
methods exist. The final rule addresses these situations, for permit 
applicants, where no approved analytical method exists under 40 CFR 
part 136 or is required under subchapter N or O, and one is not 
otherwise required by the Director. In such situations, an applicant 
may use any suitable method but shall provide a description of the 
method. With respect to pollutant limits in permits, where an EPA-
approved analytical method does not exist, monitoring shall be 
conducted in accordance with a test procedure specified in the permit.
    EPA recognizes that other factors beyond the minimum level or MDL 
can also be important in determining method performance, including a 
method's resolution, accuracy, and precision. Where there are no EPA-
approved methods, this rule does not affect how those other factors are 
considered in selecting a method. Rather, the rule notes that permit 
applicants may consider these other factors when selecting a suitable 
method where no EPA-approved method exists.
    For EPA-approved methods, however, these factors have already been 
considered during the method validation and approval process. As 
explained above, EPA evaluates method performance in a wide variety of 
wastewater matrices and approves those methods that have sensitivity, 
precision and accuracy that are appropriate for wastewater compliance 
monitoring. 40 CFR 136.6 also allows flexibility to tailor approved 
methods to more challenging wastewater matrices or overcome 
methodological problems. Based on data and information provided to EPA 
by analytical laboratories, EPA finds that experienced laboratories are 
often capable of achieving minimum levels below those published with a

[[Page 49005]]

method while maintaining the precision and accuracy specified in the 
method.
    EPA acknowledges that while rare, methodological problems may exist 
that could affect the determination of a ``sufficiently sensitive'' 
method. In such rare situations, the Director may consider additional 
technical factors when determining whether the method is still 
``sufficiently sensitive.'' Specifically, where the permit applicant or 
permittees can demonstrate to the Director that despite a good faith 
effort to overcome these methodological problems due to challenging 
wastewater matrices, either (1) the method's minimum level is higher 
than originally anticipated, or (2) the method results no longer meet 
the methods quality assurance/quality control (``QA/QC'') 
specification, the Director may take these factors into account when 
determining whether the permit applicant has met the requirements to 
use a ``sufficiently sensitive'' method or in prescribing a 
``sufficiently sensitive'' method in the permit. In the first 
situation, the matrix or sample-specific minimum level should be used 
to evaluate which of the EPA-approved methods is ``sufficiently 
sensitive.'' In the second situation, if the method's results are no 
longer consistent with the QA/QC specifications, then the method is not 
performing adequately and a ``sufficiently sensitive'' method should be 
selected from the remaining 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 sufficiently sensitive method within the 
QA/QC specifications in the given matrix before selecting another EPA-
approved method (e.g., cleanup procedures, dilution when appropriate, 
etc.).
    Additionally, where a technology-based requirement is specified as 
``zero discharge'' or ``no detect,'' the permitting authority may take 
into account the sensitivity of the method used to establish the 
requirement when determining if a method is ``sufficiently sensitive.'' 
EPA recognizes that if a more sensitive method is approved after such a 
requirement has been established, its use may be inconsistent with the 
technological basis of the original requirement. In situations where a 
technology-based requirement reflects a technology that eliminates the 
discharge of the subject pollutant altogether, the newer sensitive 
method is appropriate. However, where a technology-based limit reflects 
a technology that may not achieve the minimum level of the newer more 
sensitive method, the Director may determine that the method on which 
the requirement was originally based is ``sufficiently sensitive'' to 
determine compliance, as understood at the time the requirement was 
established.
    For both EPA-approved methods and non-EPA-approved methods, EPA's 
understanding of standard practice is that if an applicant/permittee or 
laboratory has questions regarding the suitability of a specific method 
in a given situation, or has technical questions on its use, it will 
consult with its permitting authority. EPA has the same expectations in 
connection with today's rulemaking for questions specifically about 
which methods are sufficiently sensitive. The permitting authority 
continues to have the ultimate responsibility for determining whether 
an NPDES application is complete (40 CFR 122.21(e)) and establishing 
permit conditions, including monitoring and reporting requirements (40 
CFR 122.44(i)).
    The amendments in this rulemaking affect only chemical-specific 
methods; they do not apply to the Whole Effluent Toxicity (WET) methods 
or their use. Note that existing EPA regulations (40 CFR 
122.44(d)(1)(ii)) and policy require permit writers to take into 
account the sensitivity of the species to toxicity testing when 
evaluating whole effluent toxicity. EPA has interpreted this provision 
as directing the permitting authority to develop criteria and limits 
based upon the most sensitive test species to ensure that the most 
sensitive species and all less sensitive species will be protected.

III. Summary of Public Comments and EPA's Response

    On June 23, 2010, EPA proposed changes to the existing NPDES 
regulations (75 FR 35712) and requested comments from the public. EPA 
received 25 comment letters. The majority of the comments came from 
publicly owned treatment works and industry organizations, but EPA also 
received comments from laboratories, and state and federal agencies. 
The majority of comments covered the following categories: 
Implementation and technology; administration and timing; and burden. 
The complete list of comments and responses is available in the record 
of this rulemaking.

A. Implementation

1. Effect of the Rule on Current Practices
    EPA received several comments that indicated the approach outlined 
in the proposed rule would force applicants and permittees to make 
decisions regarding the selection of an appropriate method without 
adequate information upon which to base a decision. Specifically, 
commenters indicated that issues related to the definition of the 
method minimum level would make this rule difficult to implement and 
that method sensitivity should not be the sole factor in deciding which 
method should be used in the permitting process. They indicated that 
there are other factors including accuracy, precision, selectivity, and 
whether the method has been validated that should be considered.
    In response, EPA notes that applicants for NPDES permits have 
always needed to make decisions regarding which 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 appropriate for permittees to use to meet their monitoring and 
reporting requirements under an NPDES permit. Today's rule does not 
change the basic NPDES permit application or permit issuance process. 
Under 40 CFR 122.21, permittees seeking permit renewal or new 
applicants must provide the Director with adequate information to 
determine whether an NPDES application is complete. Once the Director 
makes this determination, the Director determines the applicable permit 
requirements, including any sampling or monitoring that must be taken 
that is ``representative of the monitored activity.'' See 40 CFR 
122.41(j)(1). The effect of today's final rulemaking is to codify that 
where EPA-approved methods exist, only ``sufficiently sensitive'' EPA-
approved methods may be used in connection with permit applications and 
to conduct monitoring and reporting under a permit.
    To determine whether an EPA-approved analytical method is 
``sufficiently sensitive'' in any particular case, NPDES applicants/
permittees and permit authorities should use the best information 
available on what the minimum level is for the method, and EPA believes 
that in general a method's accurate minimum level will be readily 
ascertainable. Where the minimum level is explicitly listed in the EPA-
approved method, applicants may reference the published minimum level 
when determining whether a method selected to provide data for their 
permit application is sufficiently sensitive. Alternatively, applicants 
have always had the option of providing matrix-specific method 
detection limits and

[[Page 49006]]

minimum levels rather than the published minimum levels, and nothing in 
today's rule changes that flexibility, including with respect to 
selecting a sufficiently sensitive EPA-approved method. For these cases 
the laboratory should be able to show that a reasonable effort (e.g., 
published cleanup procedures) was attempted to achieve as low a minimum 
level as possible for those samples. For EPA-approved methods that do 
not explicitly list minimum levels, the minimum level can be obtained 
or derived by the applicant or permitting authority. Indeed, many 
permitting authorities have developed guidance, policies or regulations 
that establish minimum levels for various methods, or specify specific 
methods to be used by applicants and permittees. Where applicable, 
these policies and regulations will continue to affect method 
selection, although at the same time, states must ensure that such 
policies and regulations conform with the criteria established in 
today's rulemaking that, where they exist, only ``sufficiently 
sensitive'' EPA-approved methods are being used when completing an 
NPDES permit application and when performing sampling and analysis 
pursuant to monitoring requirements in an NPDES permit. If the 
applicant does not provide data using a sufficiently sensitive 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 sensitive'' method, the NPDES 
applicant should work closely with the permitting authority prior to 
conducting the required analyses. In addition, the permitting authority 
must ensure the permit includes a requirement to use a sufficiently 
sensitive EPA-approved analytical test method, where one exists, where 
necessary to perform sampling and analysis, consistent with 40 CFR 
122.41(j) and 122.44(i).
2. Development of New or Alternate Test Procedures
    EPA received several comments that indicated the proposed rule 
would require the development of new analytical methods where no EPA-
approved methods exist or where existing EPA-approved methods would not 
quantify the pollutant concentration at or below the level of the 
criterion or permit limit. Other commenters indicated that the rule 
would alter the existing requirements for developing Alternate Test 
Procedures under 40 CFR part 136. EPA has modified the proposal to 
address these comments, as explained below.
    EPA has modified the proposed language for this final rule so that 
it does not change existing regulatory requirements with respect to 
unapproved methods. Where no 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 Wastewater) to measure that pollutant or pollutant parameter. 
Today's final rule does not require the applicant to develop new 
methods. The situation in which there are no EPA-approved methods is 
uncommon because there are EPA-approved methods for most pollutants or 
pollutant parameters screened and regulated under the NPDES program. 
Under the existing regulations at 40 CFR 122.21(g)(7), the NPDES 
applicant has the flexibility to use any suitable analytical method 
when no 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 specifies a method 
in the permit when there is no EPA-approved method.
    Where EPA-approved methods exist, but none of the available methods 
will quantify the pollutant concentration at or below the level of the 
criterion or permit limit, today's rulemaking does not require the 
development of any new analytical methods. However, in this situation, 
the rule will now require the use of the most sensitive of the EPA-
approved methods.
    Finally, today's rulemaking does not alter any of the existing 
requirements related to the development or approval of alternative test 
procedures under 40 CFR 136.4 and 136.5.
3. Consideration of Matrix Effects in Selecting a Sufficiently 
Sensitive Method
    EPA received several comments that indicated the approach outlined 
in the proposed rule would force applicants and permittees to make 
decisions regarding the selection of an appropriate method without 
adequate information upon which to base a decision. Specifically, 
commenters indicated that issues related to the definition of the 
method minimum level would make this rule difficult to implement and 
that method sensitivity should not be the sole factor in deciding which 
method should be used in the permit process. They believe there are 
other critical factors including accuracy, precision, selectivity, and 
whether the method has been validated.
    In response, as noted above, EPA has clarified that the requirement 
to use a ``sufficiently sensitive'' EPA-approved method does not apply 
where no EPA-approved method exists. EPA agrees that other factors 
beyond the minimum level can also be important in determining method 
performance, including a method's selectivity, resolution, accuracy, 
and precision. EPA has added language in the rule text that clarifies 
where no EPA-approved methods exist, permit applicants may consider 
these other factors, in conjunction with sensitivity, when selecting an 
appropriate method.
    For EPA-approved methods, however, these factors have already been 
considered during the method validation and approval process. As 
explained above, EPA evaluates method performance in a wide variety of 
wastewater matrices and approves those methods that have selectivity, 
sensitivity, precision and accuracy that are appropriate for wastewater 
compliance monitoring. 40 CFR 136.6 also allows flexibility to tailor 
approved methods to more challenging wastewater matrices. EPA notes 
that applicants have always had the option of providing matrix or 
sample-specific minimum levels rather than the published levels and 
nothing in today's rule changes that flexibility, including with 
respect to selecting a sufficiently sensitive EPA-approved method. For 
these cases the laboratory should be able to show that a reasonable 
effort (e.g., published cleanup procedures) was attempted to achieve as 
low a minimum level as possible for those samples.
    If the most sensitive method listed in 40 CFR Part 136 is not 
performing adequately in a given wastewater matrix (e.g., with regard 
to sensitivity, accuracy, and precision), several options are available 
and should be pursued. Dilution is often a good option if it does not 
drive the sample specific minimum level above the permit requirements. 
Cleanup procedures included in the method can also be utilized. If 
those cleanups do not prove adequate for a particular matrix, the 
analyst should consult ``Solutions to Analytical Chemistry Problems 
with Clean Water Act Methods,'' EPA 821-R-07-002 (or more recent 
revisions) to

[[Page 49007]]

determine if another cleanup procedure may be appropriate. If a 
solution is still not apparent, the permittee should consult EPA or the 
permitting authority.
    Based on data and information provided to EPA by analytical 
laboratories, EPA finds that experienced laboratories are often capable 
of achieving minimum levels below those published with a method while 
maintaining the precision and accuracy specified in the method. 
However, EPA acknowledges that while rare, situations may exist where a 
method cannot perform adequately in a specific matrix. In such rare 
situations, the Director may consider additional technical factors when 
determining whether the method is still ``sufficiently sensitive.'' 
Specifically, where the permit applicant or permittees can demonstrate 
to the Director that despite a good faith effort to overcome these 
methodological problems due to challenging wastewater matrices, either 
(1) the method's minimum level is higher than originally anticipated, 
or (2) the method results no longer meet the methods QA/QC 
specification, the Director may take these factors into account when 
determining whether the permit applicant has met the requirements to 
use a ``sufficiently sensitive'' method or in prescribing a 
``sufficiently sensitive'' method in the permit. In the first 
situation, the matrix or sample-specific minimum level should be used 
to evaluate which EPA-approved method is ``sufficiently sensitive.'' In 
the second situation, if the method's results are no longer consistent 
with the QA/QC specifications, then the method is not performing 
adequately and a ``sufficiently sensitive'' method should be selected 
from the remaining 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 sufficiently sensitive method within the 
QA/QC specifications in the given matrix before selecting another EPA-
approved method (e.g., cleanup procedures, dilution when appropriate, 
etc.). To illustrate the type of situations where this provision would 
be appropriate, EPA provides two examples below.
    EPA received comments about the situation where there are multiple 
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 raised 
concern that, in some instances, while the GC method may provide a 
lower detection limit, the GC/MS method provides a greater degree of 
confidence in the correct identification of the regulated parameter. As 
explained above, this is not an issue if the laboratory has 
demonstrated that it can achieve a minimum level for GC/MS that is 
lower than the NPDES permit limit for the regulated parameter, in which 
case GC/MS would be considered ``sufficiently sensitive.'' EPA agrees 
that GC/MS is more selective than GC, but several options are available 
to remove the interferences from difficult matrices before using a 
dual-column GC method (e.g., solid-phase extraction as a cleanup 
procedure, Florisil cleanup, alumina cleanup, sulfur removal with 
copper or TBA sulfite, gel permeation chromatography, etc.). Generally, 
a result from a dual-column GC method would only be questioned if the 
chromatograms from the two columns did not yield similar numerical 
results or if the chromatograms contained many extraneous peaks that 
suggest interferences are present. If the permit applicant or permittee 
is still concerned that the peaks may be caused by a different 
contaminant, and the GC method provides a false positive result, the 
permit applicant or permittee could use a GC/MS to confirm the presence 
of the contaminant. However, since the GC/MS is less sensitive, it may 
not be able to confirm low-level dual column GC results. The more 
sensitive GC/MS method options (e.g., larger sample volume, smaller 
final extract volume, selected ion monitoring techniques, or high 
resolution GC/MS) may be necessary to prove whether the dual column GC 
result is a false positive. The permittee should also consult with EPA 
and/or its permitting authority for potential solutions. In this case, 
if the permittee has exhausted all practical options (e.g., solid-phase 
extraction as a cleanup procedure, Florisil cleanup, alumina cleanup, 
sulfur removal with copper or TBA sulfite, gel permeation 
chromatography, etc.) and has documentation to demonstrate that the 
dual-column GC creates false positive results for that specific matrix, 
then the Director would appropriately approve the selection of a 
different EPA-approved method that would then be considered a 
sufficiently sensitive method (e.g., GC/MS).
    As another example, EPA also received comments specific to Method 
1631 for mercury. These commenters noted that use of the ``clean'' 
sampling methods associated with this method to minimize potential 
contamination from the sampling technique itself is not possible in 
many industrial settings. They noted that EPA's documentation of the 
sampling technique acknowledges it is not intended for treated and 
untreated discharges from industrial uses. EPA notes that since 
approval of this method and the associated clean sampling techniques, 
these techniques have been successfully used in some industrial 
settings. For example, sewage treatment plants accepting industrial 
wastewater have successfully eliminated permit exceedances for mercury 
as measured by Method 1631 by employing the clean sampling procedures. 
Where the permittee has documentation that clean sampling techniques 
cannot be adopted for the site-specific application, the Director would 
appropriately approve the selection of a different EPA-approved method 
that meets the definition of a sufficiently sensitive method (e.g., the 
one with the lowest minimum level 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-approved method can meet the definition of a sufficiently sensitive 
method.
    Another commenter raised concerns specific to Method 1631. They 
questioned the method's suggestion to minimize laboratory contamination 
by soaking laboratory air filters in gold chloride solution so that 
mercury in incoming air will amalgamize with the filter's gold. This 
commenter questioned whether or not it was EPA's expectation that 
laboratories go to such lengths to employ such a sufficiently sensitive 
method where required under this rule. EPA notes the procedure 
described by the commenter is only a suggestion if laboratories are 
having problems with laboratory contamination. There are now many 
laboratories that perform Method 1631 without undue difficulty. In this 
case, where necessary to meet the definition of ``sufficiently 
sensitive'' in today's final rule, EPA would expect that the permittee 
use Method 1631, since the permittee should send their sample to a 
laboratory that can demonstrate it has control over sources of mercury 
within its own environment.
    Finally, where a technology-based requirement is specified as 
``zero discharge'' or ``no detect,'' the permitting authority may take 
into account the sensitivity of the method used to establish the 
requirement when determining if a method is ``sufficiently sensitive.'' 
EPA recognizes that if a more sensitive method is approved after such a 
requirement has been established, its use may be inconsistent with the 
technological basis of the original requirement. In situations where a

[[Page 49008]]

technology-based requirement reflects a technology that eliminates the 
discharge of the subject pollutant altogether, the newer sensitive 
method is appropriate. However, where a technology-based limit reflects 
a technology that may not achieve the minimum level of the newer more 
sensitive method, the Director may determine that the method on which 
the requirement was originally based is ``sufficiently sensitive'' to 
determine compliance, as understood at the time the requirement was 
established.
4. Report of the Federal Advisory Committee on Detection and 
Quantitation Approaches and Uses in Clean Water Act Programs
    EPA received a number of comments that identified concerns that the 
proposed rule uses terms, such as minimum level, that are not defined 
in new or existing regulations. Commenters also indicated that the 
proposed rule fails to address a variety of issues regarding detection 
and quantitation that were raised in the Report of the Federal Advisory 
Committee on Detection and Quantitation Approaches and Uses in Clean 
Water Act Programs. EPA agrees that there are a variety of related 
issues raised in the aforementioned report, yet notes that the members 
of the Federal Advisory Committee (FAC) were unable to reach consensus 
over several key issues in the report. While several of these issues, 
such as the definition of minimum level, are discussed in today's 
rulemaking, applicants and permitting authorities must still, on a 
regular and ongoing basis, choose which of the available analytical 
methods are most appropriate for use when screening effluent for permit 
applications and as part of permit conditions. This has always been the 
case, regardless of today's rulemaking.
    EPA believes that the requirements of the rule are adequately 
described and can be implemented without having to address the myriad 
of issues considered by the FAC. For today's rulemaking, EPA is not 
redefining or establishing new method detection limits (MDLs) or 
minimum levels, developing new procedures for determining detection or 
quantitation, or maintaining a clearinghouse on detection and 
quantitation issues. EPA considers such issues to be outside the scope 
of today's rulemaking.
5. Other Factors Affecting Selection of Analytical Methods
    EPA received several comments that expressed concern that the rule 
would require the use of only the most sensitive available method, and 
that other factors such as geographical isolation or unique sample 
collection constraints might preclude the use of certain available 
methods. Some comments also expressed concerns regarding the 
availability of laboratories qualified to conduct some of the more 
sensitive analytical methods, particularly where the state requires 
applicants and permittees to use laboratories certified by the state to 
conduct analyses.
    EPA is not requiring the use of any specific analytical technology 
or practice over others; only that the selected EPA-approved method is 
sufficiently sensitive. EPA expects that, in general, factors such as 
geographical isolation, or unique sampling collection constraints would 
not preclude the selection of a sufficiently sensitive method. The 
definition does not require the use of the most sensitive EPA-approved 
method available, so long as a less sensitive approved method still 
meets the criteria for being ``sufficiently sensitive.'' In cases where 
factors beyond a facility's control render the use of a particular 
method infeasible, such as extreme geographical isolation, the 
permitting authority could consider such factors in deciding which 
method best meets the definition of ``sufficiently sensitive.'' EPA 
expects such situations would be rare.
    Issues related to sampling procedures, such as holding times, are 
frequently prescribed by the test procedures in 40 CFR Part 136, and 
may be contingent on the unique physical, chemical, and biological 
characteristics of the discharge. Standard practice has been and 
continues to be that if an applicant/permittee or laboratory has 
questions regarding the appropriateness of using a specific method in a 
given situation, or has technical questions on its use, it should 
consult with its permitting authority prior to conducting monitoring.

B. Administration and Timing

    EPA received a few comments regarding the effect of the rule on 
recordkeeping and reporting requirements. The rule does not change 
existing recordkeeping and reporting requirements at 40 CFR 122.21(p), 
122.41(j) and 122.48. The permitting authority, however, has 
discretionary authority to require its applicants or permittees to 
provide information under the latter two provisions. In addition, a few 
comments asked whether the rule alters the terms or conditions of 
existing permits. The rule itself does not modify the terms or 
conditions of existing NPDES permits. If, under the requirements of 
today's rulemaking, a change needs to occur in the analytical methods 
specified in an existing permit, that change would occur at the time of 
permit renewal, or it could occur through a permit modification under 
the procedures of 40 CFR Part 124, if the permitting authority 
determined that such a modification was appropriate.
    EPA received a few comments regarding whether existing data, if 
collected using insufficiently sensitive methods, will be acceptable 
for submission with an application for permit renewal. NPDES 
application monitoring data that is collected after the effective date 
of the rule, or, if applicable, after an authorized state has revised 
its regulations to adopt the provisions of the rule,\9\ must be based 
on the use of sufficiently sensitive test methods. However, the rule 
does not negate the existing requirement for applicants to submit data 
from previous years, even where these data may have been collected 
using methods that did not conform to the sufficiently sensitive 
criteria established in this rule. Based on all of the data submitted 
with the permit application, the permitting authority will determine 
whether it has information adequate to develop an NPDES permit. Where 
the permitting authority determines that data was collected using 
insufficiently sensitive methods, it may choose to disregard this 
information and accept only data collected employing sufficiently 
sensitive EPA-approved methods. In addition, even prior to the 
effective date of today's rulemaking, the permitting authority has the 
authority under the existing NPDES regulations to request additional 
data from applicants where insufficient data is provided with the 
application before considering an application complete.
---------------------------------------------------------------------------

    \9\ Authorized NPDES states have up to one year following rule 
issuance to revise their own regulations to conform to the 
requirements of this rule. Authorized NPDES states have up to two 
years to conform to the rule's requirements if they must make 
statutory changes.
---------------------------------------------------------------------------

    EPA received a few comments pertaining to the rule's impact on 
indirect dischargers. The rule affects only direct dischargers (those 
applying for an individual NPDES permit) and state/EPA NPDES permitting 
authorities. The rule does not apply to indirect dischargers. POTWs 
with approved pretreatment programs may at their discretion (as 
authorized by their local ordinances and regulations) require their 
indirect dischargers to achieve specific minimum levels when performing 
analyses or may require the use of specific methods to enable them to 
better characterize contributions into their system. Where a state or 
EPA is the

[[Page 49009]]

pretreatment Control Authority, the specific requirements for 
analytical methods can be specified in the control mechanism issued to 
the indirect discharger.
    EPA received several comments that indicated that while the 
commenters supported the concept established in the proposed rule, they 
believed additional flexibility should be provided to account for 
instream dilution. Specifically, the commenters requested that the 
criteria defining sufficiently sensitive be revised such that the 
minimum level would be compared to either ``the applicable water 
quality criterion, wasteload allocation, permit limit, or other 
critical regulatory value.'' EPA believes that the final rule need only 
require comparison of a method's minimum level with the applicable 
water quality criterion, as proposed, and that this language is 
sufficiently flexible to address the commenters' concern. Under this 
language, the permitting authority has adequate discretion to determine 
whether the data provided with a permit application were collected with 
methods that are sufficiently sensitive to measure at the relevant 
regulatory value. For example, where a permitting authority has 
conducted a timely and relevant dilution analysis (including an 
evaluation of ambient pollutant concentrations) and documented this 
analysis in the permit record, the permitting authority could provide 
this information to the applicant prior to the applicant sampling for 
the permit application. The applicant would then only need to show that 
the method it has selected has a minimum level that is at least as 
sensitive as necessary to determine compliance with the water quality 
criterion, after accounting for allowable dilution. The water quality 
criterion as adjusted for allowable dilution would be the ``applicable 
water quality criterion'' in this case, and the method would be 
``sufficiently sensitive'' if it measures at this level. EPA considers 
this approach consistent with the requirements established in today's 
rule. For these reasons, EPA is not revising the regulatory text to 
incorporate the language suggested by the commenters.

C. Burden

    EPA received a few comments indicating that site-specific 
situations might increase the implementation costs of the rule beyond 
those costs outlined in the proposed rule. Some of these commenters 
provided examples of when site-specific conditions might result in 
increased costs. EPA recognizes that the burden estimated is a national 
average and that the cost for an individual facility could be higher or 
lower than that average. However, EPA does not believe that the 
information provided by the commenters is representative of the impact 
for a typical facility affected by this rule, nor does it alter the 
Agency's original burden estimates.
    EPA also recognizes that in some cases, use of a more sensitive 
method could have the practical effect of requiring a facility to adopt 
additional pollution control measures, even if the permit limit 
remained unchanged. This is because a more sensitive method may detect 
the presence of a pollutant that was previously undetected. EPA 
emphasizes that this rule would not be responsible for any change in 
stringency of the permit requirements in such a case, but acknowledges 
that a facility may incur additional pollution control costs if a 
previously undetected pollutant is later detected by the use of a 
sufficiently sensitive method, and additional treatment is required to 
meet the existing permit limit. In general, when EPA develops a cost 
analysis for a new regulation, there is an assumption made of full 
compliance with existing requirements. EPA does not have data that 
would allow it to predict in advance where or how often this situation 
might occur, or what a facility would be required to do to address it. 
Therefore, EPA has not attempted to quantify any such costs, as they 
are outside the scope of this rulemaking.
    As noted above, where a technology-based requirement is specified 
as ``zero discharge'' or ``no detect,'' the permitting authority may 
take into account the sensitivity of the method used to establish the 
requirement when determining if a method is ``sufficiently sensitive.'' 
EPA recognizes that if a more sensitive method is approved after such a 
requirement has been established, its use may be inconsistent with the 
technological basis of the original requirement. In situations where a 
technology-based requirement reflects a technology that eliminates the 
discharge of the subject pollutant altogether, the Agency included 
costs that reflect that technology, the newer sensitive method is 
appropriate, and the permittee would not incur additional costs. 
However, where a technology-based limit reflects a technology that may 
not achieve the minimum level of the newer more sensitive method, the 
Director may determine that the method on which the requirement was 
originally based is ``sufficiently sensitive'' to determine compliance, 
as understood at the time the requirement was established, and there 
would thus be no additional control costs incurred by the facility.
    EPA received a few comments regarding compliance with requirements 
under the statutory and Executive Order reviews contained in the 
proposed rule. EPA believes that there was a misunderstanding on the 
part of the commenters regarding the intent of the rule that led the 
commenters to believe that the rule would result in a higher cost of 
implementation than that estimated by EPA. EPA believes that the Agency 
has met its responsibilities under the applicable statutory and 
Executive Orders.

IV. The Final Rule

    The final rule adds a new 40 CFR 122.21(e)(3) and revises 
122.44(i)(1)(iv) to require that where EPA-approved methods exist, 
NPDES applicants use sufficiently sensitive EPA-approved analytical 
methods when submitting information quantifying the presence of 
pollutants in a discharge and that the Director must prescribe that 
only sufficiently sensitive EPA-approved analytical test methods be 
used for analyses of pollutants or pollutant parameters under the 
permit. EPA is also providing a cross-reference to these changes in a 
new 40 CFR 136.1(c). For the purposes of this rulemaking, if monitoring 
requirements are included as a condition of a general permit, those 
requirements are subject to the provisions established in 
122.44(i)(1)(iv). Only these specific parts of the regulations 
undergoing revision are subject to challenge under section 509(b) of 
the Clean Water Act.
    In addition, based on public comments, EPA made certain minor 
modifications to the final rule from the original proposal. 
Specifically, EPA amended 122.21(e)(3)(i)(B) and 122.44(i)(1)(iv)(A)(1) 
to add the word ``or'' when defining the term ``sufficiently 
sensitive,'' which was unintentionally omitted in the proposed rule. In 
addition, EPA added ``pollutant or pollutant parameter'' to 
122.21(e)(3)(i)(C) and 122.44(i)(1)(iv)(A) to clarify the applicability 
of the criteria established under the sufficiently sensitive method 
definition. EPA also removed the second ``in accordance with'' in the 
introductory paragraphs for 122.21(e)(3) and 122.44(i)(1)(iv) to 
clarify that the method selected must be approved under 40 CFR part 136 
or required under 40 CFR chapter I, subchapter N or O.
    EPA removed language in 122.44(i)(1)(iv)(A)(2) of the proposed rule 
because it was not applicable to requirements established in this 
section and created confusion about the implementation of the rule. In 
this instance, even if the permittee believes

[[Page 49010]]

they are discharging above the permit limit and could potentially use a 
less sensitive method, the permitting authority is responsible for 
prescribing an EPA-approved method, where available, that is sensitive 
enough to detect at or below the permit limit in order to properly 
assess compliance with the permit.
    EPA revised the proposed regulatory text at 122.21(e)(3)(ii) and 
122.41(i)(1)(iv)(B) for instances where there are no EPA-approved 
methods. The proposed language included additional requirements for 
situations where there are no EPA-approved methods. Specifically, the 
proposed rule would have required that applicants and permitting 
authorities select a ``sufficiently sensitive'' non EPA-approved method 
and that applicants provide a description of the method, including the 
minimum level. The situation in which there are no EPA-approved methods 
is uncommon because there are EPA-approved methods for most pollutants 
or pollutant parameters screened and regulated under the NPDES program. 
In addition, the existing regulations already require that applicants 
select a suitable method and provide a description of the method. Based 
on public comments, EPA determined that this additional requirement was 
unnecessary and has revised the regulatory text to revert the existing 
language in 40 CFR 122.21 and 122.41. As a result, today's rule does 
not specify that non-EPA-approved methods must be sufficiently 
sensitive. To clarify this point, EPA also added language to the 
introduction of 122.21(e)(3) to specify that the requirement to use a 
sufficiently sensitive method applies ``except as specified in 
122.21(e)(3)(ii).''
    EPA amended 122.21(e)(3)(ii) by adding regulatory text to clarify 
that in the case where there are no EPA-approved methods, applicants 
may consider other relevant factors when selecting an appropriate 
method. In addition, EPA revised the proposed regulatory text to change 
``or otherwise required by the Director'' to ``and not otherwise 
required by the Director'' to clarify that this provision applies to a 
situation where no EPA-approved methods exist and the Director has not 
required the use of a specific non-EPA-approved method. In this 
situation, the permit applicant may select a suitable non-EPA-approved 
method and provide a description of the method.
    Finally, in both places where the new definition of ``sufficiently 
sensitive'' appears, EPA added a note to clarify that, consistent with 
40 CFR part 136, permittees have the option of providing matrix or 
sample-specific minimum levels rather than the published levels. In 
addition, the note clarifies that where a permittee can demonstrate 
that, despite a good faith effort to use a method that would otherwise 
meet the definition of ``sufficiently sensitive,'' the analytical 
results are not consistent with the QA/QC specifications for that 
method, then the Director may determine that the method is not 
performing adequately and a different method should be selected from 
the remaining EPA-approved methods consistent with 40 CFR 
122.21(e)(3)(i) and 40 CFR 122.44(i)(1)(iv)(A). Where no other EPA-
approved methods exist, a method should be selected consistent with 40 
CFR 122.21(e)(3)(ii) and 40 CFR 122.44(i)(1)(iv)(B).

V. Impacts

    Entities that discharge to waters of the United States vary in 
terms of the quantity of their discharges, the potential constituents 
contained in their discharges, and their operation and maintenance 
practices. Consequently, the Director's NPDES application requirements 
vary depending on applicant type. For example, Form 2A for 
municipalities requires minimal screening for POTWs with design flows 
under 100,000 gallons per day; however, for POTWs with design flows 
above 1 million gallons per day, multiple priority pollutant scans are 
required. Similarly, existing industrial and commercial facilities that 
complete Form 2C are required to test for toxic pollutants based on the 
nature of their manufacturing operation. To assist permitting 
authorities (EPA regions, States, and Tribes), EPA developed several 
NPDES permit application forms. Table IV-1 provides a list of these 
forms and the discharger type(s) for which they are intended. 
Permitting authorities may use EPA's forms or comparable forms of their 
own.

    Table IV-1--EPA NPDES Permit Application Forms by Applicant Type
------------------------------------------------------------------------
                  Form or request               Applicant type
------------------------------------------------------------------------
1............  Form 1..............  New and existing applicants, except
                                      POTWs and treatment works treating
                                      domestic sewage.
2............  Form 2A.............  New and existing POTWs (i.e.,
                                      municipal facilities).
3............  Form 2B.............  New and existing concentrated
                                      animal feeding operations (CAFOs)
                                      and aquatic animal production
                                      facilities.
4............  Form 2C.............  Existing industries discharging
                                      process wastewater.
5............  Form 2D.............  New industries discharging process
                                      wastewater.
6............  Form 2E.............  New and existing industries
                                      discharging non-process wastewater
                                      only.
7............  Form 2F.............  New and existing industries
                                      discharging stormwater.
8............  40 CFR 122.21(r) and  New and existing industries with
                122.22(d).            cooling water intake structures.
9............  Form 2S.............  New and existing POTWs and other
                                      treatment works treating domestic
                                      sewage (covers sludge).
------------------------------------------------------------------------

    As noted earlier, permitting authorities issue and develop effluent 
limitations for individual NPDES permits after analyzing the data 
contained in each permittee's application. The NPDES permit prescribes 
the conditions under which the facility is allowed to discharge to 
ensure the facility's compliance with the CWA's technology-based and 
water quality-based requirements. NPDES permits typically include 
restrictions on the quantity of pollutants that a permittee may 
discharge and require the permittee to conduct routine measurements of, 
and report on, a number of parameters using EPA-approved, pollutant-
specific test procedures (or approved alternative test procedures).
    In 2012 EPA submitted an Information Collection Request (ICR) to 
the Office of Management and Budget (OMB) that, in part, updated the 
Agency's burden estimates for applicants to complete Forms 1, 2A, 2C-
2F, and 2S and for permitting authorities to review and process such 
forms.\10\ The renewal ICR did not include updated estimates for Form 
2B or for forms associated with cooling water intake structures (Item 8 
in Table IV-1). Updated estimates to complete

[[Page 49011]]

those forms were contained in separate ICRs.\11\ The existing ICRs 
include annual burden estimates for completing NPDES permit 
applications and for conducting ongoing compliance monitoring for both 
new and existing NPDES permittees. EPA's expectation is that permit 
applicants and permittees will use a range of methods based on a need 
to appropriately quantify pollutants in their discharge. To calculate 
cost and burden, the ICRs use an average cost for analytical methods, 
which is then translated into burden hours.
---------------------------------------------------------------------------

    \10\ USEPA. ``Information Collection Request (ICR) for National 
Pollutant Discharge Elimination System (NPDES) Program (Renewal),'' 
OMB Control No. 2040-0004, EPA ICR No. 0229.20, March 2012.
    \11\ USEPA. ``Supporting Statement for the Information 
Collection Request for the NPDES Regulation and Effluent Limitation 
Guidelines and Standards for Concentrated Animal Feeding 
Operations,'' OMB Control No. 2040-0250, EPA ICR No. 1989.09, 
January 2014.
    USEPA, ``Information Collection Request (ICR) for Cooling Water 
Intake Structures at Phase III Facilities (Final Rule),'' OMB 
Control No. 2040-0268, EPA ICR No. 2169.05, January 2014.
    USEPA, ``Information Collection Request (ICR) for Cooling Water 
Intake Structures Phase II Existing Facilities (Renewal),'' OMB 
Control No. 2040-0257, EPA ICR No. 2060.06, January 2014.
    USEPA, ``Information Collection Request (ICR) for Cooling Water 
Intake Structures New Facility Rule (Renewal),'' OMB Control No. 
2040-0241, EPA ICR No. 1973.05, December 2011.
---------------------------------------------------------------------------

    To assess the impact of this final rule, EPA also assessed the cost 
information for 40 CFR Part 136 methods found in the National 
Environmental Methods Index (NEMI) at http://www.nemi.gov. The NEMI 
site describes the ``relative cost'' as the cost per procedure of a 
typical analytical measurement using the specified methods (i.e., the 
cost of analyzing a single sample). Additional considerations affect 
total project costs (e.g., labor and equipment/supplies for a typical 
sample preparation, quality assurance/quality control requirements to 
validate results reported, number of samples being analyzed). EPA's 
review of the cost ranges provided in NEMI indicated that there was 
generally little difference in the cost ranges across the EPA-approved 
analytical methods for a particular pollutant. A table with the NEMI 
cost ranges is included in the record. While EPA acknowledges that 
there are cost differentials for some facilities based on case-specific 
situations, on the basis of the analytical cost ranges provided in 
NEMI, and the assumptions used in the current ICRs (i.e., that 
applicants and permittees will use a range of available approved 
methods), the final rule is expected to result in little or no new or 
increased analytical burden to applicants or permittees.
    The existing ICRs also account for the ongoing burden to permitting 
authorities to review applications and to issue NPDES permits annually. 
They also account for the ongoing burden associated with reviewing 
discharge monitoring and other reports for compliance assessment 
purposes. Finally, the existing ICRs account for program revisions 
where they are necessary because the controlling Federal statutes or 
regulations were modified.
    As noted above, EPA also recognizes that in some cases, use of a 
more sensitive method could have the practical effect of requiring a 
facility to adopt additional pollution control measures, even if the 
permit limit remained unchanged. EPA does not have data that would 
allow it to predict in advance where or how often this situation might 
occur, or what a facility would be required to do to address it. EPA 
has not attempted to quantify the costs of any such new control 
measures that might be adopted, as they are outside the scope of this 
rulemaking.

VI. Compliance Dates

    Following issuance of this rule, authorized states have up to one 
year to revise, as necessary, their NPDES regulations to adopt the 
requirements of this rule, or two years if statutory changes are 
needed, as provided at 40 CFR 123.62.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is a ``significant regulatory action.'' Accordingly, EPA 
submitted this action to the Office of Management and Budget (OMB) for 
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 
2011) and any changes made in response to OMB recommendations have been 
documented in the docket for this action.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden. 
The final rulemaking requires the use of sufficiently sensitive EPA-
approved analytical test methods, where they exist, when applying for 
an NPDES permit and when performing sampling and analysis pursuant to 
monitoring requirements in an NPDES permit. However, it does not change 
the recordkeeping or reporting requirements associated with the use of 
analytical methods. The Office of Management and Budget (OMB) has 
previously approved the information collection requirements contained 
in the existing regulations (which cover all potential NPDES 
applicants) under the provisions of the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq. and has assigned OMB control numbers, as summarized 
in section V (Impacts) of this preamble. The OMB control numbers for 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to 
prepare a regulatory flexibility analysis of any rule subject to notice 
and comment rulemaking requirements under the Administrative Procedure 
Act or any other statute unless the agency certifies that the rule will 
not have a significant economic impact on a substantial number of small 
entities. Small entities include small businesses, small organizations, 
and small governmental jurisdictions.
    For purposes of assessing the impacts of this final rule on small 
entities, ``small entity'' is defined as (1) a small business based on 
the Small Business Administration regulations at 13 CFR 121.201; (2) a 
small governmental jurisdiction that is a government of a city, county, 
town, school district, or special district with a population of less 
than 50,000; or (3) a small organization that is any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field.
    After considering the economic impacts of this final rule on small 
entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. EPA has 
determined that the incremental analytical costs that NPDES permit 
applicants and permittees may bear as a result of this rule are minimal 
and would not rise to the level of a significant economic impact on a 
substantial number of small entities.

D. Unfunded Mandates Reform Act

    This rule does not contain a Federal mandate that might result in 
expenditures of $100 million or more for state, local, and tribal 
governments, in the aggregate, or the private sector in any one year. 
Thus, this final rule is not subject to the requirements of sections 
202 and 205 of the UMRA. EPA has further determined that this rule 
contains no regulatory requirements that might significantly or 
uniquely affect small governments. Thus, this final rule is not subject 
to the requirements of section 203 of UMRA.

[[Page 49012]]

E. Executive Order 13132: Federalism

    This final rule does not have federalism implications. When 
promulgated, it will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of governments, as specified in Executive Order 13132 (64 FR 
43255, August 10, 1999). This final rule does not change the 
relationship between the national government and the States or change 
their roles and responsibilities. Rather, this final rulemaking 
requires that sufficiently sensitive EPA-approved analytical test 
methods be used, where they exist, when applying for an NPDES permit 
and when performing sampling and analysis pursuant to monitoring 
requirements in an NPDES permit. EPA does not expect this final rule to 
have any impact on local governments.
    Furthermore, the revised regulations would not alter the basic 
state-federal scheme established in the CWA, under which EPA authorizes 
states to carry out the NPDES permitting program. EPA expects the 
revised regulations to have little effect on the relationship between, 
or the distribution of power and responsibilities among, the Federal 
and State governments.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This final rule does not have tribal implications, as specified in 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments'' (65 FR 67249, November 9, 2000). It will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
The final rule requires that sufficiently sensitive EPA-approved 
analytical test methods must be used, where they exist, when applying 
for an NPDES permit and when performing sampling and analysis pursuant 
to monitoring requirements in an NPDES permit. Nothing in this final 
rule would prevent an Indian tribe from exercising its own organic 
authority to deal with such matters.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    The final rule is not subject to Executive Order 13045, 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because it is not economically 
significant and the Agency does not believe that the environmental 
health and safety risks addressed by this action present a 
disproportionate risk to children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This rulemaking is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) of 1995 (Pub. L. 104-113, section 12(d), 15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standard bodies. The NTTAA directs EPA 
to provide explanations to Congress, through OMB, when the Agency 
decides not to use available and applicable voluntary consensus 
standards. This final rulemaking does not change agency policy or 
requirements with respect to the use of voluntary consensus standards 
for the analysis of pollutants by NPDES permit applicants or 
permittees.

J. Executive Order 12898 (Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations)

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes 
federal executive policy on environmental justice. Its main provision 
directs federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse human health or environmental effects of their programs, 
policies, and activities on minority populations and low-income 
populations in the United States.
    EPA has determined that this final rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it does not 
affect the level of protection provided to human health or the 
environment. As explained above, the Agency does not have reason to 
believe that the rule addresses environmental health and safety risks 
that present a disproportionate risk to minority populations and low-
income populations.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective September 18, 2014.

List of Subjects

40 CFR Part 122

    Administrative practice and procedure, Confidential business 
information, Environmental protection, Hazardous substances, Reporting 
and recordkeeping requirements, Water pollution control.

40 CFR Part 136

    Environmental protection, Incorporation by reference, Reporting and 
recordkeeping requirements, Water pollution control.

    Dated: August 6, 2014.
Gina McCarthy,
Administrator.
    For the reasons set out in the preamble, title 40, chapter I, of 
the Code of Federal Regulations is amended as follows:

PART 122--EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT 
DISCHARGE ELIMINATION SYSTEM

0
1. The authority citation for part 122 continues to read as follows:


[[Page 49013]]


    Authority:  The Clean Water Act, 33 U.S.C. 1251 et seq.

0
2. Section 122.21, is amended by adding a new paragraph (e)(3), to read 
as follows:


Sec.  122.21  Application for a permit (applicable to State programs, 
see Sec.  123.25).

* * * * *
    (e) * * *
    (3) Except as specified in 122.21(e)(3)(ii), a permit application 
shall not be considered complete unless all required quantitative data 
are collected in accordance with sufficiently sensitive analytical 
methods approved under 40 CFR part 136 or required under 40 CFR chapter 
I, subchapter N or O.
    (i) For the purposes of this requirement, a method approved under 
40 CFR part 136 or required under 40 CFR chapter I, subchapter N or O 
is ``sufficiently sensitive'' when:
    (A) The method minimum level (ML) is at or below the level of the 
applicable water quality criterion for the measured pollutant or 
pollutant parameter; or
    (B) The method ML is above the applicable water quality criterion, 
but the amount of the pollutant or pollutant parameter in a facility's 
discharge is high enough that the method detects and quantifies the 
level of the pollutant or pollutant parameter in the discharge; or
    (C) The method has the lowest ML of the analytical methods approved 
under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N 
or O for the measured pollutant or pollutant parameter.

    Note to paragraph (e)(3)(i)(C): Consistent with 40 CFR part 136, 
applicants have the option of providing matrix or sample specific 
minimum levels rather than the published levels. Further, where an 
applicant can demonstrate that, despite a good faith effort to use a 
method that would otherwise meet the definition of ``sufficiently 
sensitive'', the analytical results are not consistent with the QA/
QC specifications for that method, then the Director may determine 
that the method is not performing adequately and the applicant 
should select a different method from the remaining EPA-approved 
methods that is sufficiently sensitive consistent with 40 CFR 
122.21(e)(3)(i). Where no other EPA-approved methods exist, the 
applicant should select a method consistent with 40 CFR 
122.21(e)(3)(ii).

    (ii) When there is no analytical method that has been approved 
under 40 CFR part 136, required under 40 CFR chapter I, subchapter N or 
O, and is not otherwise required by the Director, the applicant may use 
any suitable method but shall provide a description of the method. When 
selecting a suitable method, other factors such as a method's 
precision, accuracy, or resolution, may be considered when assessing 
the performance of the method.
* * * * *
0
3. Section 122.44 is amended by revising paragraph (i) (1) (iv) to read 
as follows:


Sec.  122.44  Establishing limitations, standards, and other permit 
conditions (applicable to State NPDES programs, see Sec.  123.25).

* * * * *
    (i) * * *
    (1) * * *
    (iv) According to sufficiently sensitive test procedures (i.e., 
methods) approved under 40 CFR part 136 for the analysis of pollutants 
or pollutant parameters or required under 40 CFR chapter I, subchapter 
N or O.
    (A) For the purposes of this paragraph, a method is ``sufficiently 
sensitive'' when:
    (1) The method minimum level (ML) is at or below the level of the 
effluent limit established in the permit for the measured pollutant or 
pollutant parameter; or
    (2) The method has the lowest ML of the analytical methods approved 
under 40 CFR part 136 or required under 40 CFR chapter I, subchapter N 
or O for the measured pollutant or pollutant parameter.

    Note to paragraph (i)(1)(iv)(A)(2):
     Consistent with 40 CFR part 136, applicants or permittees have 
the option of providing matrix or sample specific minimum levels 
rather than the published levels. Further, where an applicant or 
permittee can demonstrate that, despite a good faith effort to use a 
method that would otherwise meet the definition of ``sufficiently 
sensitive'', the analytical results are not consistent with the QA/
QC specifications for that method, then the Director may determine 
that the method is not performing adequately and the Director should 
select a different method from the remaining EPA-approved methods 
that is sufficiently sensitive consistent with 40 CFR 
122.44(i)(1)(iv)(A). Where no other EPA-approved methods exist, the 
Director should select a method consistent with 40 CFR 
122.44(i)(1)(iv)(B).

    (B) In the case of pollutants or pollutant parameters for which 
there are no approved methods under 40 CFR part 136 or methods are not 
otherwise required under 40 CFR chapter I, subchapter N or O, 
monitoring shall be conducted according to a test procedure specified 
in the permit for such pollutants or pollutant parameters.
* * * * *

PART 136--GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS 
OF POLLUTANTS

0
4. The authority citation for part 136 continues to read as follows:

     Authority:  Secs. 301, 304(h), 307, and 501(a) Pub. L. 95-217, 
91 Stat. 1566, et seq. (33 U.S.C. 1251 et seq.) (The Federal Water 
Pollution Control Act Amendments of 1972 as amended by the Clean 
Water Act of 1977.)


0
5. Section 136.1 is amended by adding a new paragraph (c) to read as 
follows:


Sec.  136.1  Applicability.

* * * * *
    (c) For the purposes of the NPDES program, when more than one test 
procedure is approved under this part for the analysis of a pollutant 
or pollutant parameter, the test procedure must be sufficiently 
sensitive as defined at 40 CFR 122.21(e)(3) and 122.44(i)(1)(iv).

[FR Doc. 2014-19265 Filed 8-18-14; 8:45 am]
BILLING CODE 6560-50-P