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EPA Final Rule: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review

2024-04-05T05:00:00Z

This action finalizes the residual risk and technology review (RTR) conducted for the Commercial Sterilization Facilities source category regulated under national emission standards for hazardous air pollutants (NESHAP) under the Clean Air Act. The EPA is finalizing decisions concerning the RTR, including definitions for affected sources, emission standards for previously unregulated sources, amendments pursuant to the risk review to address ethylene oxide (EtO) emissions from certain sterilization chamber vents (SCVs), aeration room vents (ARVs), chamber exhaust vents (CEVs), and room air emissions, and amendments pursuant to the technology review for certain SCVs and ARVs. In addition, we are taking final action to correct and clarify regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing exemptions for periods of SSM. We are also taking final action to require owners and operators to demonstrate compliance through the use of EtO continuous emissions monitoring systems (CEMS), with exceptions for very small users of EtO; add provisions for electronic reporting of performance test results and other reports; and include other technical revisions to improve consistency and clarity. We estimate that these final amendments will reduce EtO emissions from this source category by approximately 21 tons per year (tpy).

DATES: This final rule is effective on April 5, 2024, published in the Federal Register April 5, 2024, page 24090.

View final rule.

Appendix B to Part 60—Performance Specifications
Performance Specification 19AddedView text
Appendix F to Part 60—Quality Assurance Procedures
Procedure 7AddedView text
§63.14 Incorporations by reference.
(a), (f), (i) introductory textRevisedView text
(i)(88)-(120)RedesignatedView text
Subpart O—Ethylene Oxide Emissions Standards for Sterilization Facilities
Entire subpartRevisedView text

Previous Text

§63.14 Incorporations by reference.

(a) The materials listed in this section are incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, a document must be published in the Federal Register and the material must be available to the public. All approved materials are available for inspection at the Air and Radiation Docket and Information Center (Air Docket) in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW, Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the Air Docket is (202) 566-1742. These approved materials are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. In addition, these materials are available from the following sources:

* * * *

(f) American Society of Mechanical Engineers (ASME), Three Park Avenue, New York, NY 10016-5990, Telephone (800) 843-2763, http://www.asme.org; also available from HIS, Incorporated, 15 Inverness Way East, Englewood, CO 80112, Telephone (877) 413-5184, http://global.ihs.com.

(1) ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analyses [Part 10, Instruments and Apparatus], issued August 31, 1981, IBR approved for §§63.309(k), 63.457(k), 63.772(e) and (h), 63.865(b), 63.997(e), 63.1282(d) and (g), and 63.1625(b), table 5 to subpart EEEE, §§63.3166(a), 63.3360(e), 63.3545(a), 63.3555(a), 63.4166(a), 63.4362(a), 63.4766(a), 63.4965(a), and 63.5160(d), table 4 to subpart UUUU, table 3 to subpart YYYY, §§63.7822(b), 63.7824(e), 63.7825(b), 63.8000(d), 63.9307(c), 63.9323(a), 63.9621(b) and (c), 63.11148(e), 63.11155(e), 63.11162(f), 63.11163(g), 63.11410(j), 63.11551(a), 63.11646(a), and 63.11945, and table 4 to subpart AAAAA, table 5 to subpart DDDDD, table 4 to subpart JJJJJ, table 4 to subpart KKKKK, table 4 to subpart SSSSS, tables 4 and 5 of subpart UUUUU, table 1 to subpart ZZZZZ, and table 4 to subpart JJJJJJ.

(2) [Reserved]

* * * *

(i) ASTM International, 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428-2959, Telephone (610) 832-9585, http://www.astm.org; also available from ProQuest, 789 East Eisenhower Parkway, Ann Arbor, MI 48106-1346, Telephone (734) 761-4700, http://www.proquest.com.

Subpart O—Ethylene Oxide Emissions Standards for Sterilization Facilities

§63.360 Applicability.

(a) All sterilization sources using 1 ton (see definition) in sterilization or fumigation operations are subject to the emissions standards in §63.362, except as specified in paragraphs (b) through (e) of this section. Owners or operators of sources using 1 ton (see definition) subject to the provisions of this subpart must comply with the requirements of subpart A, of this part according to the applicability of subpart A of this part to such sources in Table 1 of this section.

Table 1 of Section 63.360 - General Provisions Applicability to Subpart O
ReferenceApplies to sources using 10 tons in subpart O aApplies to sources using 1 to 10 tons in subpart O aComment
a See definition.
63.1(a)(1) YesAdditional terms defined in §63.361; when overlap between subparts A and O occurs, subpart O takes precedence.
63.1(a)(2) Yes
63.1(a)(3) Yes
63.1(a)(4) Yes Subpart O clarifies the applicability of each paragraph in subpart A to sources subject to subpart O.
63.1(a)(5) NoReserved.
63.1(a)(6) Yes
63.1(a)(7) Yes
63.1.1(a)(8)Yes
63.1(a)(9)NoReserved.
63.1(a)(10) Yes
63.1(a)(11) Yes §63.366(a) of subpart O also allows report submissions via fax and on electronic media.
63.1(a)(12)-(14) Yes
63.1(b)(1)-(2) Yes
63.1(b)(3) No §63.367 clarifies the applicability of recordkeeping requirements for sources that determine they are not subject to the emissions standards.
63.1(c)(1) Yes Subpart O clarifies the applicability of each paragraph in subpart A to sources subject to subpart O in this table.
63.1(c)(2) Yes §63.360(f) exempts area sources subject to this subpart from the obligation to obtain Title V operating permits.
63.1(c)(3) NoReserved.
63.1(c)(4)Yes
63.1(c)(5) No §63.360 specifies applicability.
63.1(d) NoReserved.
63.1(e) Yes
63.2 YesAdditional terms defined in §63.361; when overlap between subparts A and O occurs, subpart O takes precedence.
63.3 YesOther units used in subpart O are defined in the text of subpart O.
63.4(a)(1)-(3) Yes
63.4(a)(4)NoReserved.
63.4(a)(5)Yes
63.4(b) Yes
63.4(c) Yes
63.5(a) No §63.366(b)(1) contains applicability requirements for constructed or reconstructed sources.
63.5(b)(1) YesNo
63.5(b)(2) NoReserved.
63.5(b)(3) NoSee §63.366(b)(2).
63.5(b)(4) YesNo
63.5(b)(5) YesNo
63.5(b)(6) YesNo
63.5(c) NoReserved.
63.5(d)(1)-(2) NoSee §63.366(b)(3).
63.5(d)(3)-(4) YesNo
63.5(e) YesNo
63.5(f)(1)-(2) NoSee §63.366(b)(4).
63.6(a)(1) Yes
63.6(a)(2) No §63.360 specifies applicability.
63.6(b)-(c) No §63.360(g) specifies compliance dates for sources.
63.6(d) NoReserved.
63.6(e) NoSubpart O does not contain any operation and maintenance plan requirements.
63.6(f)(1) No §63.362(b) specifies when the standards apply.
63.6(f)(2)(i) Yes
63.6(f)(2)(ii) No §63.363 specifies parameters for determining compliance.
63.6(f)(2)(iii)-(iv) Yes
63.6(f)(2)(v) No
63.6(f)(3) Yes
63.6(g) Yes
63.6(h) NoSubpart O does not contain any opacity or visible emission standards.
63.6(i)(1)-(14) Yes
63.6(i)(15) NoReserved
63.6(i)(16) Yes
63.6(j) Yes
63.7(a)(1) Yes
63.7(a)(2) Yes
63.7(a)(3) Yes
63.7(b) Yes
63.7(c) YesNo
63.7(d) YesNo
63.7(e) Yes §63.365 also contains test methods specific to sources subject to the emissions standards.
63.7(f) Yes
63.7(g)(1) Yes
63.7(g)(2) NoReserved
63.7(g)(3) Yes
63.7(h) Yes
63.8(a)(1) Yes
63.8(a)(2) Yes
63.8(a)(3) NoReserved
63.8(a)(4) Yes
63.8(b)(1) Yes
63.8(b)(2) Yes
63.8(b)(3) No
63.8(c)(1) (i)-(ii) NoA startup, shutdown, and malfunction plan is not required for these standards.
63.8(c)(1)(iii) Yes
63.8(c)(2)-(3) Yes
63.8(c)(4)-(5) NoFrequency of monitoring measurements is provided in §63.364; opacity monitors are not required for these standards.
63.8(c)(6) NoPerformance specifications for gas chromatographs and temperature monitors are contained in §63.365.
63.8(c)(7)(i)(A)-(B) NoPerformance specifications for gas chromatographs and temperature monitors are contained in §63.365.
63.8(c)(7)(i)(C) NoOpacity monitors are not required for these standards.
63.8(c)(7)(ii) NoPerformance specifications for gas chromatographs and temperature monitors are contained in §63.365.
63.8(c)(8) No
63.8(d) YesNo
63.8(e)(1) Yes
63.8(e)(2) Yes
63.8(e)(3) YesNo
63.8(e)(4) Yes
63.8(e)(5)(i) Yes
63.8(e)(5)(ii) NoOpacity monitors are not required for these standards.
63.8(f)(1)-(5) Yes
63.8(f)(6) No
63.8(g)(1) Yes
63.8(g)(2) No
63.8(g)(3)-(5) Yes
63.9(a) Yes
63.9(b)(1)-(i) Yes
63.9(b)(1)(ii)-(iii) No §63.366(c)(1)(i) contains language for sources that increase usage such that the source becomes subject to the emissions standards.
63.9(b)(2)-(3) Yes §63.366(c)(3) contains additional information to be included in the initial report for existing and new sources.
63.9(b)(4)-(5) No §63.366(c)(1)(ii) and (iii) contains requirements for new or reconstructed sources subject to the emissions standards.
63.9(c) Yes
63.9(d) No
63.9(e) Yes
63.9(f) NoOpacity monitors are not required for these standards.
63.9(g)(1) Yes
63.9(g)(2)-(3) NoOpacity monitors and relative accuracy testing are not required for these standards.
63.9(h)(1)-(3) Yes
63.9(h)(4) NoReserved.
63.9(h)(5) No §63.366(c)(2) instructs sources to submit actual data.
63.9(h)(6) Yes
63.9(i) Yes
63.9(j) Yes
63.10(a) Yes
63.10(b)(1) Yes
63.10(b)(2)(i) NoNot applicable due to batch nature of the industry.
63.10(b)(2)(ii) Yes
63.10(b)(2)(iii) No
63.10(b)(2)(iv)-(v) NoA startup, shutdown, and malfunction plan is not required for these standards.
63.10(b)(2)(vi)-(xii) Yes
63.10(b)(2)(xiii) No
63.10(b)(2)(xiv) Yes
63.10(b)(3) No §63.367 (b) and (c) contains applicability determination requirements.
63.10(c)(1) Yes
63.10(c)(2)-(4) NoReserved.
63.10(c)(5) Yes
63.10(c)(6) No
63.10(c)(7) NoNot applicable due to batch nature of the industry.
63.10(c)(8) Yes
63.10(c)(9) No
63.10(c)(10)-(13) Yes
63.10(c)(14) YesNo
63.10(c)(15) NoA startup, shutdown, and malfunction plan is not required for these standards.
63.10(d)(1) Yes
63.10(d)(2) Yes
63.10(d)(3) NoSubpart O does not contain opacity or visible emissions standards.
63.10(d)(4) Yes
63.10(d)(5) NoA startup, shutdown, and malfunction plan is not required for these standards.
63.10(e)(1) Yes
63.10(e)(2)(i) Yes
63.10(e)(2)(ii) NoOpacity monitors are not required for these standards.
63.10(e)(3)(i)-(iv) Yes
63.10(e)(3)(v) No §63.366(a)(3) specifies contents and submittal dates for excess emissions and monitoring system performance reports.
63.10(e)(3)(vi)-(viii) Yes
63.10(e)(4) NoOpacity monitors are not required for these standards.
63.10(f) Yes
63.11 Yes
63.12-63.15 Yes

(b) Sterilization sources using less than 1 ton (see definition) are not subject to the emissions standards in §63.362. The recordkeeping requirements of §63.367(c) apply.

(c) This subpart does not apply to beehive fumigators.

(d) This subpart does not apply to research or laboratory facilities as defined in section 112(c)(7) of title III of the Clean Air Act Amendment of 1990.

(e) This subpart does not apply to ethylene oxide sterilization operations at stationary sources such as hospitals, doctors offices, clinics, or other facilities whose primary purpose is to provide medical services to humans or animals.

(f) If you are an owner or operator of an area source subject to this subpart, you are exempt from the obligation to obtain a permit under 40 CFR part 70 or 71, provided you are not required to obtain a permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your status as an area source under this subpart. Notwithstanding the previous sentence, you must continue to comply with the provisions of this subpart applicable to area sources.

(g) The owner or operator shall comply with the provisions of this subpart as follows:

(1) All sterilization chamber vents subject to the emissions standards in §63.362 with an initial startup date before December 6, 1998, no later than December 6, 1998.

(2) All sterilization chamber vents subject to the emissions standards in §63.362 with an initial startup date on or after December 6, 1998, immediately upon initial startup of the source.

(3) All sterilization chamber vents at sources using less than 1 ton of ethylene oxide that increase their ethylene oxide usage after December 6, 1998 such that the sterilization chamber vent becomes subject to the emissions standards in §63.362(c), immediately upon becoming subject to the emission standards.

(4) All aeration room vents subject to the emissions standards in §63.362 with an initial startup date before December 6, 2000, no later than December 6, 2000.

(5) All aeration room vents subject to the emissions standards in §63.362 with an initial startup date on or after December 6, 2000, immediately upon initial startup of the source.

(6) All aeration room vents at sources using less than 10 tons that increase their ethylene oxide usage after December 6, 2000, such that the aeration room vents become subject to the emissions standards in §63.362, immediately upon becoming subject to the emission standards.

(7)-(10) [Reserved]

§63.361 Definitions.

Terms and nomenclature used in this subpart are defined in the Clean Air Act (the Act) as amended in 1990, §§63.2 and 63.3 of subpart A of this part, or in this section. For the purposes of subpart O, if the same term is defined in subpart A and in this section, it shall have the meaning given in this section.

Aeration room means any vessel or room that is used to facilitate off-gassing of ethylene oxide at a sterilization facility.

Aeration room vent means the point(s) through which the evacuation of ethylene oxide-laden air from an aeration room occurs.

Baseline temperature means a minimum temperature at the outlet from the catalyst bed of a catalytic oxidation control device or at the exhaust point from the combustion chamber of a thermal oxidation control device.

Chamber exhaust vent means the point(s) through which ethylene oxide-laden air is removed from the sterilization chamber during chamber unloading following the completion of sterilization and associated air washes.

Compliance date means the date by which a source subject to the emissions standards in §63.362 is required to be in compliance with the standard.

Deviation means any instance in which an affected source, subject to this subpart, or an owner or operator of such a source:

(1) Fails to meet any requirement or obligation established by this subpart including, but not limited to, any emission limitation (including any operating limit) or work practice standard;

(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit; or

(3) Fails to meet any emission limitation (including any operating limit) or work practice standard in this subpart during startup, shutdown, or malfunction, regardless of whether or not such failure is permitted by this subpart.

Effective date means the date of promulgation in the Federal Register notice.

Initial startup date means the date when a source subject to the emissions standards in §63.362 first begins operation of a sterilization process.

Manifolding emissions means combining ethylene oxide emissions from two or more different vent types for the purpose of controlling these emissions with a single control device.

Maximum ethylene glycol concentration means any concentration of ethylene glycol in the scrubber liquor of an acid-water scrubber control device established during a performance test when the scrubber achieves at least 99-percent control of ethylene oxide emissions.

Maximum liquor tank level means any level of scrubber liquor in the acid-water scrubber liquor recirculation tank established during a performance test when the scrubber achieves at least 99-percent control of ethylene oxide emissions.

Oxidation temperature means the temperature at the outlet point of a catalytic oxidation unit control device or at the exhaust point from the combustion chamber for a thermal oxidation unit control device.

Source(s) using less than 1 ton means source(s) using less than 907 kg (1 ton) of ethylene oxide within all consecutive 12-month periods after December 6, 1996.

Source(s) using 1 ton means source(s) using 907 kg (1 ton) or more of ethylene oxide within any consecutive 12-month period after December 6, 1996.

Source(s) using 1 to 10 tons means source(s) using 907 kg (1 ton) or more of ethylene oxide in any consecutive 12-month period but less than 9,070 kg (10 tons) of ethylene oxide in all consecutive 12-month periods after December 6, 1996.

Source(s) using less than 10 tons means source(s) using less than 9,070 kg (10 tons) of ethylene oxide in all consecutive 12-month periods after December 6, 1996.

Source(s) using 10 tons means source(s) using 9,070 kg (10 tons) or more of ethylene oxide in any consecutive 12-month period after December 6, 1996.

Sterilization chamber means any enclosed vessel or room that is filled with ethylene oxide gas, or an ethylene oxide/inert gas mixture, for the purpose of sterilizing and/or fumigating at a sterilization facility.

Sterilization chamber vent means the point (prior to the vacuum pump) through which the evacuation of ethylene oxide from the sterilization chamber occurs following sterilization or fumigation, including any subsequent air washes.

Sterilization facility means any stationary source where ethylene oxide is used in the sterilization or fumigation of materials.

Sterilization operation means any time when ethylene oxide is removed from the sterilization chamber through the sterilization chamber vent or the chamber exhaust vent or when ethylene oxide is removed from the aeration room through the aeration room vent.

Thermal oxidizer means all combustion devices except flares.

§63.362 Standards.

(a) Each owner or operator of a source subject to the provisions of this subpart shall comply with these requirements on and after the compliance date specified in §63.360(g). The standards of this section are summarized in Table 1 of this section.

Table 1 of Section 63.362 - Standards for Ethylene Oxide Commercial Sterilizers and Fumigators
Existing and new sourcesSource typeSterilization chamber ventAeration room ventChamber exhaust vent
Source size<907 kg (<1 ton)No control required; minimal recordkeeping requirements apply (see §63.367(c)).
≥907 kg and <9,070 kg (≥1 ton and <10 tons)99% emission reduction (see §63.362(c))No controlNo control.
≥9,070 kg (≥10 tons)99% emission reduction (see §63.362(c))1 ppm maximum outlet concentration or 99% emission reduction (see §63.362(d))No control.

(b) Applicability of emission limits. The emission limitations of paragraphs (c), (d), and (e) of this section apply during sterilization operation. The emission limitations do not apply during periods of malfunction.

(c) Sterilization chamber vent at sources using 1 ton. Each owner or operator of a sterilization source using 1 ton shall reduce ethylene oxide emissions to the atmosphere by at least 99 percent from each sterilization chamber vent.

(d) Aeration room vent at sources using 10 tons. Each owner or operator of a sterilization source using 10 tons shall reduce ethylene oxide emissions to the atmosphere from each aeration room vent to a maximum concentration of 1 ppmv or by at least 99 percent, whichever is less stringent, from each aeration room vent.

(e) [Reserved]

§63.363 Compliance and performance provisions.

(a)(1) The owner or operator of a source subject to emissions standards in §63.362 shall conduct an initial performance test using the procedures listed in §63.7 according to the applicability in Table 1 of §63.360, the procedures listed in this section, and the test methods listed in §63.365.

(2) The owner or operator of all sources subject to these emissions standards shall complete the performance test within 180 days after the compliance date for the specific source as determined in §63.360(g).

(b) The procedures in paragraphs (b)(1) through (3) of this section shall be used to determine initial compliance with the emission limits under §63.362(c), the sterilization chamber vent standard and to establish operating limits for the control devices:

(1) The owner or operator shall determine the efficiency of control devices used to comply with §63.362(c) using the test methods and procedures in §63.365(b).

(2) For facilities with acid-water scrubbers, the owner or operator shall establish as an operating limit either:

(i) The maximum ethylene glycol concentration using the procedures described in §63.365(e)(1); or

(ii) The maximum liquor tank level using the procedures described in §63.365(e)(2).

(3) For facilities with catalytic oxidizers or thermal oxidizers, the operating limit consists of the recommended minimum oxidation temperature provided by the oxidation unit manufacturer for an operating limit.

(4) Facilities with catalytic oxidizers shall comply with one of the following work practices:

(i) Once per year after the initial compliance test, conduct a performance test during routine operations, i.e., with product in the chamber using the procedures described in §63.365(b) or (d) as appropriate. If the percent efficiency is less than 99 percent, restore the catalyst as soon as practicable but no later than 180 days after conducting the performance test; or

(ii) Once per year after the initial compliance test, analyze ethylene oxide concentration data from §63.364(e) or a continuous emission monitoring system (CEMS) and restore the catalyst as soon as practicable but no later than 180 days after data analysis; or,

(iii) Every 5 years, beginning 5 years after the initial compliance test (or by December 6, 2002, whichever is later), replace the catalyst bed with new catalyst material.

(c) The procedures in paragraphs (c)(1) through (3) of this section shall be used to determine initial compliance with the emission limits under §63.362(d), the aeration room vent standard:

(1) The owner or operator shall comply with either paragraph (b)(2) or (3) of this section.

(2) Determine the concentration of ethylene oxide emitted from the aeration room into the atmosphere (after any control device used to comply with §63.362(d)) using the methods in §63.365(c)(1); or

(3) Determine the efficiency of the control device used to comply with §63.362(d) using the test methods and procedures in §63.365(d)(2).

(d) [Reserved]

(e) For facilities complying with the emissions limits under §63.362 with a control technology other than acid-water scrubbers or catalytic or thermal oxidizers, the owner or operator of the facility shall provide to the Administrator or delegated authority information describing the design and operation of the air pollution control system, including recommendations for the operating parameters to be monitored to demonstrate continuous compliance. Based on this information, the Administrator will determine the operating parameter(s) to be measured during the performance test. During the performance test required in paragraph (a) of this section, using the methods approved in §63.365(g), the owner or operator shall determine the site-specific operating limit(s)for the operating parameters approved by the Administrator.

(f) A facility must demonstrate continuous compliance with each operating limit and work practice standard required under this section, except during periods of startup, shutdown, and malfunction, according to the methods specified in §63.364.

§63.364 Monitoring requirements.

(a)(1) The owner or operator of a source subject to emissions standards in §63.362 shall comply with the monitoring requirements in §63.8 of subpart A of this part, according to the applicability in Table 1 of §63.360, and in this section.

(2) Each owner or operator of an ethylene oxide sterilization facility subject to these emissions standards shall monitor the parameters specified in this section. All monitoring equipment shall be installed such that representative measurements of emissions or process parameters from the source are obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the monitoring equipment shall include completion of the manufacturer's written specifications or recommendations for installation, operation, and calibration of the system.

(b) For sterilization facilities complying with §63.363(b) or (d) through the use of an acid-water scrubber, the owner or operator shall either:

(1) Sample the scrubber liquor and analyze and record once per week the ethylene glycol concentration of the scrubber liquor using the test methods and procedures in §63.365(e)(1). Monitoring is required during a week only if the scrubber unit has been operated; or

(2) Measure and record once per week the level of the scrubber liquor in the recirculation tank. The owner or operator shall install, maintain, and use a liquid level indicator to measure the scrubber liquor tank level (i.e., a marker on the tank wall, a dipstick, a magnetic indicator, etc.). Monitoring is required during a week only if the scrubber unit has been operated.

(c) For sterilization facilities complying with §63.363(b) or (c) through the use of catalytic oxidation or thermal oxidation, the owner or operator shall either comply with §63.364(e) or continuously monitor and record the oxidation temperature at the outlet to the catalyst bed or at the exhaust point from the thermal combustion chamber using the temperature monitor described in paragraph (c)(4) of this section. Monitoring is required only when the oxidation unit is operated. From 15-minute or shorter period temperature values, a data acquisition system for the temperature monitor shall compute and record a daily average oxidation temperature. Strip chart data shall be converted to record a daily average oxidation temperature each day any instantaneous temperature recording falls below the minimum temperature.

(1)-(3) [Reserved]

(4) The owner or operator shall install, calibrate, operate, and maintain a temperature monitor accurate to within ±5.6°C (±10°F) to measure the oxidation temperature. The owner or operator shall verify the accuracy of the temperature monitor twice each calendar year with a reference temperature monitor (traceable to National Institute of Standards and Technology (NIST) standards or an independent temperature measurement device dedicated for this purpose). During accuracy checking, the probe of the reference device shall be at the same location as that of the temperature monitor being tested. As an alternative, the accuracy temperature monitor may be verified in a calibrated oven (traceable to NIST standards).

(d) For sterilization facilities complying with §63.363(b) or (c) through the use of a control device other than acid-water scrubbers or catalytic or thermal oxidizers, the owner or operator shall monitor the parameters as approved by the Administrator using the methods and procedures in §63.365(g).

(e) Measure and record once per hour the ethylene oxide concentration at the outlet to the atmosphere after any control device according to the procedures specified in §63.365(c)(1). The owner or operator shall compute and record a 24-hour average daily. The owner or operator will install, calibrate, operate, and maintain a monitor consistent with the requirements of performance specification (PS) 8 or 9 in 40 CFR part 60, appendix B, to measure ethylene oxide. The daily calibration requirements of section 7.2 of PS-9 or Section 13.1 of PS-8 are required only on days when ethylene oxide emissions are vented to the control device.

(f) [Reserved]

§63.365 Test methods and procedures.

(a) Performance testing. The owner or operator of a source subject to the emissions standards in §63.362 shall comply with the performance testing requirements in §63.7 of subpart A of this part, according to the applicability in Table 1 of §63.360, and in this section.

(b) Efficiency at the sterilization chamber vent. California Air Resources Board (CARB) Method 431 or the following procedures shall be used to determine the efficiency of all types of control devices used to comply with §63.362(c), sterilization chamber vent standard.

(1) First evacuation of the sterilization chamber. These procedures shall be performed on an empty sterilization chamber, charged with a typical amount of ethylene oxide, for the duration of the first evacuation under normal operating conditions (i.e., sterilization pressure and temperature).

(i) The amount of ethylene oxide loaded into the sterilizer (Wc) shall be determined by either:

(A) Weighing the ethylene oxide gas cylinder(s) used to charge the sterilizer before and after charging. Record these weights to the nearest 45 g (0.1 lb). Multiply the total mass of gas charged by the weight percent ethylene oxide present in the gas.

(B) Installing calibrated rotameters at the sterilizer inlet and measuring flow rate and duration of sterilizer charge. Use the following equation to convert flow rate to weight of ethylene oxide:



where:

Wc = weight of ethylene oxide charged, g (lb)

Fv = volumetric flow rate, liters per minute (L/min) corrected to 20°C and 101.325 kilopascals (kPa) (scf per minute (scfm) corrected to 68°F and 1 atmosphere of pressure (atm)); the flowrate must be constant during time (t)

t = time, min

%EOV = volume fraction ethylene oxide

SV = standard volume, 24.05 liters per mole (L/mole) = 22.414 L/mole ideal gas law constant corrected to 20°C and 101.325 kPa (385.32 scf per mole (scf/mole) = 359 scf/mole ideal gas law constant corrected to 68°F and 1 atm).

MW = molecular weight of ethylene oxide, 44.05 grams per gram-mole (g/g-mole) (44.05 pounds per pound-mole (lb/lb-mole)), or

(C) Calculating the mass based on the conditions of the chamber immediately after it has been charged using the following equation:



where:

P = chamber pressure, kPa (psia)

V = chamber volume, liters (L) (ft 3)

R = gas constant, 8.313 L·kPa/g-mole·(10.73 psia·ft 3/mole°R)

T = temperature, K (°R)

Note:

If the ethylene oxide concentration is in weight percent, use the following equation to calculate mole fraction:



where:

WEO = weight percent of ethylene oxide

Wx = weight percent of compound in the balance of the mixture

MWx = molecular weight of compound in the balance gas mixture

(ii) The residual mass of ethylene oxide in the sterilizer shall be determined by recording the chamber temperature, pressure, and volume after the completion of the first evacuation and using the following equation:



where:

Wr = weight of ethylene oxide remaining in chamber (after the first evacuation), in g (lb)

(iii) Calculate the total mass of ethylene oxide at the inlet to the control device (Wi) by subtracting the residual mass (Wr) calculated in paragraph (b)(1)(ii) of this section from the charged weight (Wc) calculated in paragraph (b)(1)(i) of this section.

(iv) The mass of ethylene oxide emitted from the control device outlet (Wo) shall be calculated by continuously monitoring the flow rate and concentration using the following procedure.

(A) Measure the flow rate through the control device exhaust continuously during the first evacuation using the procedure found in 40 CFR part 60, appendix A, Test Methods 2, 2A, 2C, or 2D, as appropriate. (Method 2D (using orifice plates or Rootstype meters) is recommended for measuring flow rates from sterilizer control devices.) Record the flow rate at 1-minute intervals throughout the test cycle, taking the first reading within 15 seconds after time zero. Time zero is defined as the moment when the pressure in the sterilizer is released. Correct the flow to standard conditions (20°C and 101.325 kPa (68°F and 1 atm)) and determine the flow rate for the run as outlined in the test methods listed in paragraph (b) of this section.

(B) Test Method 18 or 25A, 40 CFR part 60, appendix A (hereafter referred to as Method 18 or 25A, respectively), shall be used to measure the concentration of ethylene oxide.

(1) Prepare a graph of volumetric flow rate versus time corresponding to the period of the run cycle. Integrate the area under the curve to determine the volume.

(2) Calculate the mass of ethylene oxide by using the following equation:



Where:

Wo = Mass of ethylene oxide, g (lb)

C = concentration of ethylene oxide in ppmv

V = volume of gas exiting the control device corrected to standard conditions, L (ft 3)

1/10 6 = correction factor LEO/10 6 LTOTAL GAS (ft 3EO/10 6 ft 3TOTAL GAS)

(3) Calculate the efficiency by the equation in paragraph (b)(1)(v) of this section.

(C) [Reserved]

(v) Determine control device efficiency (% Eff) using the following equation:



where:

% Eff = percent efficiency

Wi = mass flow rate into the control device

Wo = mass flow rate out of the control device

(vi) Repeat the procedures in paragraphs (b)(1) (i) through (v) of this section three times. The arithmetic average percent efficiency of the three runs shall determine the overall efficiency of the control device.

(2) [Reserved]

(c) Concentration determination. The following procedures shall be used to determine the ethylene oxide concentration.

(1) Parameter monitoring. For determining the ethylene oxide concentration required in §63.364(e), follow the procedures in PS 8 or PS 9 in 40 CFR part 60, appendix B. Sources complying with PS 8 are exempt from the relative accuracy procedures in sections 2.4 and 3 of PS-8.

(2) Initial compliance. For determining the ethylene oxide concentration required in §63.363(c)(2), the procedures outlined in Method 18 or Method 25 A (40 CFR part 60, appendix A) shall be used. A Method 18 or Method 25A test consists of three 1-hour runs. If using Method 25A to determine concentration, calibrate and report Method 25A instrument results using ethylene oxide as the calibration gas. The arithmetic average of the ethylene oxide concentration of the three test runs shall determine the overall outlet ethylene oxide concentration from the control device.

(d) Efficiency determination at the aeration room vent (not manifolded). The following procedures shall be used to determine the efficiency of a control device used to comply with §63.362(d), the aeration room vent standard.

(1) Determine the concentration of ethylene oxide at the inlet and outlet of the control device using the procedures in Method 18 or 25A in 40 CFR part 60, appendix A. A test is comprised of three 1-hour runs.

(2) Determine control device efficiency (% Eff) using the following equation:



Where:

% Eff = percent efficiency

Wi = mass flow rate into the control device

WO = mass flow rate out of the control device

(3) Repeat the procedures in paragraphs (d)(1) and (2) of this section three times. The arithmetic average percent efficiency of the three runs shall determine the overall efficiency of the control device.

(e) Determination of baseline parameters for acid-water scrubbers. The procedures in this paragraph shall be used to determine the monitored parameters established in §63.363(b), (d), or (e) for acid-water scrubbers and to monitor the parameters as established in §63.364(b).

(1) Ethylene glycol concentration. For determining the ethylene glycol concentration, the facility owner or operator shall establish the maximum ethylene glycol concentration as the ethylene glycol concentration averaged over three test runs; the sampling and analysis procedures in ASTM D 3695-88, Standard Test Method for Volatile Alcohols in Water By Direct Aqueous-Injection Gas Chromatography, (incorporated by reference - see §63.14) shall be used to determine the ethylene glycol concentration.

(2) Scrubber liquor tank level. For determining the scrubber liquor tank level, the sterilization facility owner or operator shall establish the maximum liquor tank level based on a single measurement of the liquor tank level during one test run.

(f) [Reserved]

(g) An owner or operator of a sterilization facility seeking to demonstrate compliance with the standards found at §63.362(c), (d), or (e) with a control device other than an acid-water scrubber or catalytic or thermal oxidation unit shall provide to the Administrator the information requested under §63.363(f). The owner or operator shall submit: a description of the device; test results collected in accordance with §63.363(f) verifying the performance of the device for controlling ethylene oxide emissions to the atmosphere to the levels required by the applicable standards; the appropriate operating parameters that will be monitored; and the frequency of measuring and recording to establish continuous compliance with the standards. The monitoring plan submitted identifying the compliance monitoring is subject to the Administrator's approval. The owner or operator of the sterilization facility shall install, calibrate, operate, and maintain the monitor(s) approved by the Administrator based on the information submitted by the owner or operator. The owner or operator shall include in the information submitted to the Administrator proposed performance specifications and quality assurance procedures for their monitors. The Administrator may request further information and shall approve appropriate test methods and procedures.

(h) An owner or operator of a sterilization facility seeking to demonstrate compliance with the requirements of §63.363 or §">63.364, with a monitoring device or procedure other than a gas chromatograph or a flame ionization analyzer, shall provide to the Administrator information describing the operation of the monitoring device or procedure and the parameter(s) that would demonstrate continuous compliance with each operating limit. The Administrator may request further information and will specify appropriate test methods and procedures.

§63.366 Reporting requirements.

(a) The owner or operator of a source subject to the emissions standards in §63.362 shall fulfill all reporting requirements in §§63.10(a), (d), (e), and (f) of subpart A, according to the applicability in Table 1 of §63.360. These reports will be made to the Administrator at the appropriate address identified in §63.13 of subpart A of this part.

(1) Reports required by subpart A and this section may be sent by U.S. mail, fax, or by another courier.

(i) Submittals sent by U.S. mail shall be postmarked on or before the specified date.

(ii) Submittals sent by other methods shall be received by the Administrator on or before the specified date.

(2) If acceptable to both the Administrator and the owner or operator of a source, reports may be submitted on electronic media.

(3) Content and submittal dates for deviations and monitoring system performance reports. All deviations and monitoring system performance reports and all summary reports, if required per §63.10(e)(3)(vii) and (viii), shall be delivered or postmarked within 30 days following the end of each calendar half or quarter as appropriate (see §63.10(e)(3)(i) through (iv) for applicability). Written reports of deviations from an operating limit shall include all information required in §63.10(c)(5) through (13), as applicable in Table 1 of §63.360, and information from any calibration tests in which the monitoring equipment is not in compliance with PS 9 or the method used for temperature calibration. The written report shall also include the name, title, and signature of the responsible official who is certifying the accuracy of the report. When no deviations have occurred or monitoring equipment has not been inoperative, repaired, or adjusted, such information shall be stated in the report.

(b) Construction and reconstruction. The owner or operator of each source using 10 tons shall fulfill all requirements for construction or reconstruction of a source in §63.5 of subpart A of this part, according to the applicability in Table 1 of §63.360, and in this paragraph.

(1) Applicability.(i) This paragraph and §63.5 of subpart A of this part implement the preconstruction review requirements of section 112(i)(1) for sources subject to these emissions standards. In addition, this paragraph and §63.5 of subpart A of this part include other requirements for constructed and reconstructed sources that are or become subject to these emissions standards.

(ii) After the effective date, the requirements in this section and in §63.5 of subpart A of this part apply to owners or operators who construct a new source or reconstruct a source subject to these emissions standards after December 6, 1994. New or reconstructed sources subject to these emissions standards with an initial startup date before the effective date are not subject to the preconstruction review requirements specified in paragraphs (b) (2) and (3) of this section and §63.5(d) (3) and (4) and (e) of subpart A of this part.

(2) After the effective date, whether or not an approved permit program is effective in the State in which a source is (or would be) located, no person may construct a new source or reconstruct a source subject to these emissions standards, or reconstruct a source such that the source becomes a source subject to these emissions standards, without obtaining advance written approval from the Administrator in accordance with the procedures specified in paragraph (b)(3) of this section and §63.5(d) (3) and (4) and (e) of subpart A of this part.

(3) Application for approval of construction or reconstruction. The provisions of paragraph (b)(3) of this section and §63.5(d) (3) and (4) of subpart A of this part implement section 112(i)(1) of the Act.

(i) General application requirements.(A) An owner or operator who is subject to the requirements of paragraph (b)(2) of this section shall submit to the Administrator an application for approval of the construction of a new source subject to these emissions standards, the reconstruction of a source subject to these emissions standards, or the reconstruction of a source such that the source becomes a source subject to these emissions standards. The application shall be submitted as soon as practicable before the construction or reconstruction is planned to commence (but not sooner than the effective date) if the construction or reconstruction commences after the effective date. The application shall be submitted as soon as practicable before the initial startup date but no later than 60 days after the effective date if the construction or reconstruction had commenced and the initial startup date had not occurred before the effective date. The application for approval of construction or reconstruction may be used to fulfill the initial notification requirements of paragraph (c)(1)(iii) of this section. The owner or operator may submit the application for approval well in advance of the date construction or reconstruction is planned to commence in order to ensure a timely review by the Administrator and that the planned commencement date will not be delayed.

(B) A separate application shall be submitted for each construction or reconstruction. Each application for approval of construction or reconstruction shall include at a minimum:

(1) The applicant's name and address.

(2) A notification of intention to construct a new source subject to these emissions standards or make any physical or operational change to a source subject to these emissions standards that may meet or has been determined to meet the criteria for a reconstruction, as defined in §63.2 of subpart A of this part.

(3) The address (i.e., physical location) or proposed address of the source.

(4) An identification of the relevant standard that is the basis of the application.

(5) The expected commencement date of the construction or reconstruction.

(6) The expected completion date of the construction or reconstruction.

(7) The anticipated date of (initial) startup of the source.

(8) The type and quantity of hazardous air pollutants emitted by the source, reported in units and averaging times and in accordance with the test methods specified in the standard, or if actual emissions data are not yet available, an estimate of the type and quantity of hazardous air pollutants expected to be emitted by the source reported in units and averaging times specified. The owner or operator may submit percent reduction information, if the standard is established in terms of percent reduction. However, operating parameters, such as flow rate, shall be included in the submission to the extent that they demonstrate performance and compliance.

(9) Other information as specified in paragraph (b)(3)(ii) of this section and §63.5(d)(3) of subpart A of this part.

(C) An owner or operator who submits estimates or preliminary information in place of the actual emissions data and analysis required in paragraphs (b)(3)(i)(B)(8) and (ii) of this section shall submit the actual, measured emissions data and other correct information as soon as available but no later than with the notification of compliance status required in paragraph (c)(2) of this section.

(ii) Application for approval of construction. Each application for approval of construction shall include, in addition to the information required in paragraph (b)(3)(i)(B) of this section, technical information describing the proposed nature, size, design, operating design capacity, and method of operation of the source subject to these emissions standards, including an identification of each point of emission for each hazardous air pollutant that is emitted (or could be emitted) and a description of the planned air pollution control system (equipment or method) for each emission point. The description of the equipment to be used for the control of emissions shall include each control device for each hazardous air pollutant and the estimated control efficiency (percent) for each control device. The description of the method to be used for the control of emissions shall include an estimated control efficiency (percent) for that method. Such technical information shall include calculations of emission estimates in sufficient detail to permit assessment of the validity of the calculations. An owner or operator who submits approximations of control efficiencies under paragraph (b)(3) of this section shall submit the actual control efficiencies as specified in paragraph (b)(3)(i)(C) of this section.

(4) Approval of construction or reconstruction based on prior State preconstruction review. (i) The Administrator may approve an application for construction or reconstruction specified in paragraphs (b)(2) and (3) of this section and §63.5(d)(3) and (4) of subpart A of this part if the owner or operator of a new or reconstructed source who is subject to such requirement demonstrates to the Administrator's satisfaction that the following conditions have been (or will be) met:

(A) The owner or operator of the new or reconstructed source subject to these emissions standards has undergone a preconstruction review and approval process in the State in which the source is (or would be) located before the effective date and has received a federally enforceable construction permit that contains a finding that the source will meet these emissions standards as proposed, if the source is properly built and operated;

(B) In making its finding, the State has considered factors substantially equivalent to those specified in §63.5(e)(1) of subpart A of this part.

(ii) The owner or operator shall submit to the Administrator the request for approval of construction or reconstruction no later than the application deadline specified in paragraph (b)(3)(i) of this section. The owner or operator shall include in the request information sufficient for the Administrator's determination. The Administrator will evaluate the owner or operator's request in accordance with the procedures specified in §63.5 of subpart A of this part. The Administrator may request additional relevant information after the submittal of a request for approval of construction or reconstruction.

(c) Notification requirements. The owner or operator of each source subject to the emissions standards in §63.362 shall fulfill all notification requirements in §63.9 of subpart A of this part, according to the applicability in Table 1 of §63.360, and in this paragraph.

(1) Initial notifications. (i)(A) If a source that otherwise would be subject to these emissions standards subsequently increases its use of ethylene oxide within any consecutive 12-month period after December 6, 1996, such that the source becomes subject to these emissions standards or other requirements, such source shall be subject to the notification requirements of §63.9 of subpart A of this part.

(B) Sources subject to these emissions standards may use the application for approval of construction or reconstruction under paragraph (b)(3)(ii) of this section and §63.5(d) (3) of subpart A of this part, respectively, if relevant to fulfill the initial notification requirements.

(ii) The owner or operator of a new or reconstructed source subject to these emissions standards that has an initial startup date after the effective date and for which an application for approval of construction or reconstruction is required under paragraph (b)(3) of this section and §63.5(d) (3) and (4) of subpart A of this part shall provide the following information in writing to the Administrator:

(A) A notification of intention to construct a new source subject to these emissions standards, reconstruct a source subject to these emissions standards, or reconstruct a source such that the source becomes a source subject to these emissions standards with the application for approval of construction or reconstruction as specified in paragraph (b)(3)(i)(A) of this section;

(B) A notification of the date when construction or reconstruction was commenced, submitted simultaneously with the application for approval of construction or reconstruction, if construction or reconstruction was commenced before the effective date of these standards;

(C) A notification of the date when construction or reconstruction was commenced, delivered or postmarked not later than 30 days after such date, if construction or reconstruction was commenced after the effective date of these standards;

(D) A notification of the anticipated date of startup of the source, delivered or postmarked not more than 60 days nor less than 30 days before such date; and

(E) A notification of the actual date of initial startup of the source, delivered or postmarked within 15 calendar days after that date.

(iii) After the effective date, whether or not an approved permit program is effective in the State in which a source subject to these emissions standards is (or would be) located, an owner or operator who intends to construct a new source subject to these emissions standards or reconstruct a source subject to these emissions standards, or reconstruct a source such that it becomes a source subject to these emissions standards, shall notify the Administrator in writing of the intended construction or reconstruction. The notification shall be submitted as soon as practicable before the construction or reconstruction is planned to commence (but no sooner than the effective date of these standards) if the construction or reconstruction commences after the effective date of the standard. The notification shall be submitted as soon as practicable before the initial startup date but no later than 60 days after the effective date of this standard if the construction or reconstruction had commenced and the initial startup date has not occurred before the standard's effective date. The notification shall include all the information required for an application for approval of construction or reconstruction as specified in paragraph (b)(3) of this section and §63.5(d)(3) and (4) of subpart A of this part. For sources subject to these emissions standards, the application for approval of construction or reconstruction may be used to fulfill the initial notification requirements of §63.9 of subpart A of this part.

(2) If an owner or operator of a source subject to these emissions standards submits estimates or preliminary information in the application for approval of construction or reconstruction required in paragraph (b)(3)(ii) of this section and §63.5(d)(3) of subpart A of this part, respectively, in place of the actual emissions data or control efficiencies required in paragraphs (b)(3)(i)(B)(8) and (ii) of this section, the owner or operator shall submit the actual emissions data and other correct information as soon as available but no later than with the initial notification of compliance status.

(3) The owner or operator of any existing sterilization facility subject to this subpart shall also include the amount of ethylene oxide used during the previous consecutive 12-month period in the initial notification report required by §63.9(b)(2) and (3) of subpart A of this part. For new sterilization facilities subject to this subpart, the amount of ethylene oxide used shall be an estimate of expected use during the first consecutive 12-month period of operation.

§63.367 Recordkeeping requirements.

(a) The owner or operator of a source subject to §63.362 shall comply with the recordkeeping requirements in §63.10(b) and (c), according to the applicability in Table 1 of §63.360, and in this section. All records required to be maintained by this subpart or a subpart referenced by this subpart shall be maintained in such a manner that they can be readily accessed and are suitable for inspection. The most recent 2 years of records shall be retained onsite or shall be accessible to an inspector while onsite. The records of the preceding 3 years, where required, may be retained offsite. Records may be maintained in hard copy or computer-readable form including, but not limited to, on paper, microfilm, computer, computer disk, magnetic tape, or microfiche.

(b) The owners or operators of a source using 1 to 10 tons not subject to §63.362 shall maintain records of ethylene oxide use on a 12-month rolling average basis (until the source changes its operations to become a source subject to §63.362).

(c) The owners or operators of a source using less than 1 ton shall maintain records of ethylene oxide use on a 12-month rolling average basis (until the source changes its operations to become a source subject to §63.362).

(d) The owners or operators complying with §63.363(b) (4) shall maintain records of the compliance test, data analysis, and if catalyst is replaced, proof of replacement.

§63.368 Implementation and enforcement.

(a) This subpart can be implemented and enforced by the U.S. EPA, or a delegated authority such as the applicable State, local, or Tribal agency. If the U.S. EPA Administrator has delegated authority to a State, local, or Tribal agency, then that agency, in addition to the U.S. EPA, has the authority to implement and enforce this subpart. Contact the applicable U.S. EPA Regional Office to find out if implementation and enforcement of this subpart is delegated to a State, local, or Tribal agency.

(b) In delegating implementation and enforcement authority of this subpart to a State, local, or Tribal agency under subpart E of this part, the authorities contained in paragraph (c) of this section are retained by the Administrator of U.S. EPA and cannot be transferred to the State, local, or Tribal agency.

(c) The authorities that cannot be delegated to State, local, or Tribal agencies are as specified in paragraphs (c)(1) through (4) of this section.

(1) Approval of alternatives to the requirements in §§63.360 and 63.362.

(2) Approval of major alternatives to test methods under §63.7(e)(2)(ii) and (f), as defined in §63.90, and as required in this subpart.

(3) Approval of major alternatives to monitoring under §63.8(f), as defined in §63.90, and as required in this subpart.

(4) Approval of major alternatives to recordkeeping and reporting under §63.10(f), as defined in §63.90, and as required in this subpart.

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Most Recent Highlights In Environmental

2024-06-11T05:00:00Z

EPA Proposed Rule: Significant New Use Rules on Certain Chemical Substances (23-3.5e)

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to a TSCA Order. A SNUR requires persons who intend to manufacture (defined by statute to include import) or process a particular chemical substance for an activity that is identified as a significant new use in the SNUR to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use identified in the notification to EPA. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.

DATES: Comments must be received on or before July 11, 2024, published in the Federal Register June 11, 2024, page 49700.

View proposed rule.

2024-06-11T05:00:00Z

EPA Proposed Rule: Significant New Use Rules on Certain Chemical Substances (22-4.5e)

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to a TSCA Order. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.

DATES: Comments must be received on or before July 11, 2024, published in the Federal Register June 11, 2024, page 49121.

View proposed rule.

Methylene chloride ban: Is your facility affected?
2024-06-06T05:00:00Z

Methylene chloride ban: Is your facility affected?

Methylene chloride, a volatile liquid chemical, poses severe health risks to individuals exposed to the substance. Despite the hazards, its use continues across consumer, commercial, and industrial applications. For example, it's used in automotive products, adhesives, and solvents to form other chemicals.

To address the health hazards posed, the Environmental Protection Agency (EPA) finalized a risk management rule under the Toxic Substances Control Act (TSCA) that prohibits nearly all uses of methylene chloride.

Use this guide to help you determine whether the methylene chloride ban impacts your operations.

Risks of methylene chloride

EPA made a final determination in November 2022 that methylene chloride as a whole chemical substance presents an unreasonable risk of injury to health under its conditions of use. The chemical is known to cause neurotoxicity from short-term exposure and cancer and liver harm due to long-term exposure. There are even documented cases of sudden death caused by short-term contact with the chemical substance.

When EPA determines a chemical poses an unreasonable risk, TSCA requires the agency to develop regulations to reduce or eliminate the risk. That’s where this final rule comes in (40 CFR Part 751 Subpart B), banning all consumer uses and most commercial and industrial uses of methylene chloride.

Requirements of methylene chloride ban

Manufacturers (including importers), processors, and distributors must phase out methylene chloride (including methylene chloride-containing products) for all consumer uses within one year and most commercial and industrial uses within two years.

Here’s an overview of the phaseout schedule:

Methylene chloride phaseouts
Prohibited:For:After:
Distribution to retailersAny useFebruary 3, 2025
Distribution by retailersAny useMay 5, 2025
Manufacturing (including importing)Any use (apart from certain exempt commercial and industrial uses)May 5, 2025
ProcessingAny use (apart from certain exempt commercial and industrial uses)August 1, 2025
Distribution in commerceAny use (apart from certain exempt commercial and industrial uses)January 28, 2026
Use for commercial or industrial purposesAny use (apart from certain exempt commercial and industrial uses)April 28, 2026
Downstream notifications

The regulations also require manufacturers, processors, and distributors that ship methylene chloride to notify the receiving companies of the prohibitions through Safety Data Sheets (SDSs) and to maintain records that document:

  • Information about the companies that receive the shipments,
  • A copy of the required notification (listed at 751.111(d)) added to SDSs, and
  • The amount of methylene chloride shipped.

Remaining uses

The final rule allows very few time-limited exemptions for commercial and industrial uses of methylene chloride to:

  • Produce other chemicals,
  • Manufacture plastic and rubber (including polycarbonates),
  • Produce battery separators for electric vehicles,
  • Aid processing in a closed system,
  • Use as a laboratory chemical, and
  • Employ in solvent welding.

Facilities involved in the remaining uses of methylene chloride must comply with EPA’s new Workplace Chemical Protection Program. It requires facilities to:

  • Meet exposure limits,
  • Establish and maintain regulated areas,
  • Conduct exposure monitoring,
  • Implement controls to reduce exposure (including exposure plans),
  • Provide respiratory and dermal personal protective equipment to affected employees,
  • Train potentially exposed workers, and
  • Maintain records of:
    • Exposure control and monitoring data;
    • Objective data generated during the past five years (if used to forgo the initial exposure monitoring);
    • Notifying potentially exposed individuals of the exposure control plans;
    • Exemption-related documentation; and
    • Information related to refinishing wooden furniture, decorative pieces, and architectural fixtures, if applicable.

Facilities must keep these records for at least five years from the date they’re generated.

Does the rule apply to any amount of methylene chloride?

The final rule sets a de minimis exemption threshold of 0.1 percent by weight to account for impurities and the unintended presence of methylene chloride. In other words, products that contain less than 0.1 percent of methylene chloride aren’t subject to the final rule.

However, note that this provision doesn’t apply to 751.105, which bans the sale and distribution of methylene chloride-containing consumer paint and coating removal products.

Tips for phasing out methylene chloride

If your facility is involved in manufacturing, processing, or distributing methylene chloride (including methylene chloride-containing products), consider these tips to help you comply with the new regulations:

  • List your facility’s uses of methylene chloride to determine which processes will be impacted. Begin researching alternative products to replace methylene chloride in these processes.
  • Identify which phaseout timelines apply.
  • Audit your processes and procedures to identify ways to improve employee safety.
  • Establish a plan to implement any applicable phaseouts of methylene chloride and actions to better protect potentially exposed employees.

Key to remember: EPA will phase in its ban on methylene chloride for all consumer uses and most commercial and industrial uses over the next two years.

EPA launches Chemical Data Reporting resource portal
2024-05-28T05:00:00Z

EPA launches Chemical Data Reporting resource portal

Just in time for the 2024 Chemical Data Reporting (CDR) submission period (beginning June 1), the Environmental Protection Agency (EPA) launched CDR GuideME. This online portal centralizes all CDR resources into one location.

The portal contains all CDR guidance documents and other training materials, including reporting instructions, fact sheets, and EPA responses to industry questions. It also enables users to search all CDR questions and answers for specific topics.

In addition to the new resource portal, EPA updated the Central Data Exchange system (through which the reports are submitted). The agency:

  • Incorporated 2024 CDR reporting codes and the years covered by the report,
  • Added an updated spreadsheet for bulk uploads of chemical information, and
  • Improved the functionality to copy substantiations of Confidential Business Information claims and to access and save copies of submitted records.

2024 report

The 2024 CDR submission period runs from June 1 to September 30, 2024, and covers activities during the calendar years 2020-2023.

Manufacturers (including importers) that meet certain production volume thresholds of chemicals on the Toxic Substances Control Act Chemical Substance Inventory must submit a report every four years. The report includes data on the manufacturing, processing, and use of the chemicals during the preceding four calendar years.

Key to remember: EPA’s new CDR GuideME portal centralizes all Chemical Data Reporting guidance documents and resources into one place to make the reporting process easier.

2024-05-24T05:00:00Z

EPA Final Rule: Consumer Confidence Reports Water Infrastructure

The U.S. Environmental Protection Agency (EPA) is revising the Consumer Confidence Report (CCR) Rule in accordance with America's Water Infrastructure Act (AWIA) of 2018 (United States, 2018) and is requiring States, territories, and Tribes with primary enforcement responsibility to report compliance monitoring data (CMD) to the EPA. The revisions will improve the readability, clarity, and understandability of CCRs as well as the accuracy of the information presented, improve risk communication in CCRs, incorporate electronic delivery options, provide supplemental information regarding lead levels and control efforts, and require systems who serve 10,000 or more persons to provide CCRs to customers biannually (twice per year). The final rule requirements for States to submit to the EPA CMD for all National Primary Drinking Water Regulations (NPDWRs) will improve the EPA's ability to fulfill oversight responsibilities under the Safe Drinking Water Act (SDWA).

DATES: This final rule is effective on June 24, 2024, published in the Federal Register May 24, 2024, page 45980.

View final rule.

§141.151 Purpose and applicability of this subpart.
(a), (c), and (f)RevisedView text
§141.152 Effective dates.
(a) through (c), (d)(1), and (d)(2) RevisedView text
(d)(3) Added View text
§141.153 Content of the reports.
(a) and (b)(2) RevisedView text
(c)(1)(iii) and (c)(5) Added View text
(d) RevisedView text
(e)(1) introductory text and (e)(3) introductory textRevisedView text
(f) introductory text, (f)(3), and (h) RevisedView text
§141.154 Required additional health information.
(a), (b), (c)(1) and (2), and (d)(2)RevisedView text
(e) and (f)RemovedView text
§141.155 Report delivery, reporting, and recordkeeping.
Section heading, (a) through (c), (e), (f), (g) introductory text, (g)(1)(i), and (g)(2)RevisedView text
(i) and (j)AddedView text
§141.156 Summary of report contents.
Entire sectionAddedView text
Appendix A to Subpart O to Part 141—Regulated Contaminants
entries for “Total Coliform Bacteria †” and “Total Coliform Bacteria ‡”RemovedView text
entry for “Total Coliform Bacteria”AddedView text
entry for “Fecal coliform and E. coli †”RemovedView text
entries for “ E. coli ‡”and “Arsenic (ppb)”RevisedView text
footnotes †, ‡, and 1RemovedView text
§142.14 Records kept by States.
(h) AddedView text
§142.15 Reports by States.
(b) introductory text and (b)(2)RevisedView text
(b)(3)AddedView text
§142.16 Special primacy requirements.
(f)(1) and (3)RevisedView text
(f)(5)AddedView text

Previous Text

§141.151 Purpose and applicability of this subpart.

(a) This subpart establishes the minimum requirements for the content of annual reports that community water systems must deliver to their customers. These reports must contain information on the quality of the water delivered by the systems and characterize the risks (if any) from exposure to contaminants detected in the drinking water in an accurate and understandable manner.

* * * * *

(c) For the purpose of this subpart, customers are defined as billing units or service connections to which water is delivered by a community water system.

* * * * *

(f) For purpose of §141.154 and 141.155 of this subpart, the term "primacy agency" refers to the State or tribal government entity that has jurisdiction over, and primary enforcement responsibility for, public water systems, even if that government does not have interim or final primary enforcement responsibility for this rule. Where the State or tribe does not have primary enforcement responsibility for public water systems, the term "primacy agency" refers to the appropriate EPA regional office.

§141.152 Effective dates.

(a) The regulations in this subpart shall take effect on September 18, 1998.

(b) Each existing community water system must deliver its first report by October 19, 1999, its second report by July 1, 2000, and subsequent reports by July 1 annually thereafter. The first report must contain data collected during, or prior to, calendar year 1998 as prescribed in §141.153(d)(3). Each report thereafter must contain data collected during, or prior to, the previous calendar year.

(c) A new community water system must deliver its first report by July 1 of the year after its first full calendar year in operation and annually thereafter.

(d) * * *

(1) No later than April 19, 1999, by April 1, 2000, and by April 1 annually thereafter or

(2) On a date mutually agreed upon by the seller and the purchaser, and specifically included in a contract between the parties.

* * * * *

§141.153 Content of the reports.

(a) Each community water system must provide to its customers an annual report that contains the information specified in this section and §141.154.

(b) * * *

(2) If a source water assessment has been completed, the report must notify consumers of the availability of this information and the means to obtain it. In addition, systems are encouraged to highlight in the report significant sources of contamination in the source water area if they have readily available information. Where a system has received a source water assessment from the primacy agency, the report must include a brief summary of the system's susceptibility to potential sources of contamination, using language provided by the primacy agency or written by the operator.

* * * * *

(d) Information on Detected Contaminants.

(1) This sub-section specifies the requirements for information to be included in each report for contaminants subject to mandatory monitoring (except Cryptosporidium). It applies to:

(i) Maximum Contaminant Level Goal or MCLG: The level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety.

(ii) Maximum Contaminant Level or MCL: The highest level of a contaminant that is allowed in drinking water. MCLs are set as close to the MCLGs as feasible using the best available treatment technology.

(2) The data relating to these contaminants must be displayed in one table or in several adjacent tables. Any additional monitoring results which a community water system chooses to include in its report must be displayed separately.

(3) The data must be derived from data collected to comply with EPA and State monitoring and analytical requirements during calendar year 1998 for the first report and subsequent calendar years thereafter except that:

(i) Where a system is allowed to monitor for regulated contaminants less often than once a year, the table(s) must include the date and results of the most recent sampling and the report must include a brief statement indicating that the data presented in the report are from the most recent testing done in accordance with the regulations. No data older than 5 years need be included.

(ii) Results of monitoring in compliance with §141.142 and 141.143 need only be included for 5 years from the date of last sample or until any of the detected contaminants becomes regulated and subject to routine monitoring requirements, whichever comes first.

(4) For detected regulated contaminants (listed in appendix A to this subpart), the table(s) must contain:

(i) The MCL for that contaminant expressed as a number equal to or greater than 1.0 (as provided in appendix A to this subpart);

(ii) The MCLG for that contaminant expressed in the same units as the MCL;

(iii) If there is no MCL for a detected contaminant, the table must indicate that there is a treatment technique, or specify the action level, applicable to that contaminant, and the report must include the definitions for treatment technique and/or action level, as appropriate, specified in paragraph (c)(3) of this section;

(iv) For contaminants subject to an MCL, except turbidity, total coliform, fecal coliform and E. coli, the highest contaminant level used to determine compliance with an NPDWR and the range of detected levels, as follows:

(A) When compliance with the MCL is determined annually or less frequently: The highest detected level at any sampling point and the range of detected levels expressed in the same units as the MCL.

(B) When compliance with the MCL is determined by calculating a running annual average of all samples taken at a monitoring location: the highest average of any of the monitoring locations and the range of all monitoring locations expressed in the same units as the MCL. For the MCLs for TTHM and HAA5 in §141.64(b)(2), systems must include the highest locational running annual average for TTHM and HAA5 and the range of individual sample results for all monitoring locations expressed in the same units as the MCL. If more than one location exceeds the TTHM or HAA5 MCL, the system must include the locational running annual averages for all locations that exceed the MCL.

(C) When compliance with the MCL is determined on a system-wide basis by calculating a running annual average of all samples at all monitoring locations: the average and range of detection expressed in the same units as the MCL. The system is required to include individual sample results for the IDSE conducted under subpart U of this part when determining the range of TTHM and HAA5 results to be reported in the annual consumer confidence report for the calendar year that the IDSE samples were taken.

Note to paragraph (d)(4)(iv): When rounding of results to determine compliance with the MCL is allowed by the regulations, rounding should be done prior to multiplying the results by the factor listed in appendix A of this subpart;

(v) For turbidity.

(A) When it is reported pursuant to §141.13: The highest average monthly value.

(B) When it is reported pursuant to the requirements of §141.71: the highest monthly value. The report should include an explanation of the reasons for measuring turbidity.

(C) When it is reported pursuant to §141.73 or §141.173 or §141.551: the highest single measurement and the lowest monthly percentage of samples meeting the turbidity limits specified in §141.73 or §141.173, or §141.551 for the filtration technology being used.

(vi) For lead and copper: the 90th percentile concentration of the most recent round(s) of sampling, the number of sampling sites exceeding the action level, and the range of tap sampling results;

(vii) For total coliform analytical results until March 31, 2016:

(A) The highest monthly number of positive samples for systems collecting fewer than 40 samples per month; or

(B) The highest monthly percentage of positive samples for systems collecting at least 40 samples per month;

(viii) For fecal coliform and E. coli until March 31, 2016: The total number of positive samples;

(ix) The likely source(s) of detected contaminants to the best of the operator's knowledge. Specific information regarding contaminants may be available in sanitary surveys and source water assessments, and should be used when available to the operator. If the operator lacks specific information on the likely source, the report must include one or more of the typical sources for that contaminant listed in appendix A to this subpart that is most applicable to the system;

(x) For E. coli analytical results under subpart Y: The total number of positive samples;

(xi) The report shall include a statement that a service line inventory (including inventories consisting only of a statement that there are no lead service lines) has been prepared and include instructions to access the service line inventory; and

(xii) The report shall notify consumers that complete lead tap sampling data are available for review and shall include information on how to access the data.

(5) If a community water system distributes water to its customers from multiple hydraulically independent distribution systems that are fed by different raw water sources, the table should contain a separate column for each service area and the report should identify each separate distribution system. Alternatively, systems could produce separate reports tailored to include data for each service area.

(6) The table(s) must clearly identify any data indicating violations of MCLs, MRDLs, or treatment techniques, and the report must contain a clear and readily understandable explanation of the violation including: the length of the violation, the potential adverse health effects, and actions taken by the system to address the violation. To describe the potential health effects, the system must use the relevant language of appendix A to this subpart.

(7) For detected unregulated contaminants for which monitoring is required (except Cryptosporidium), the table(s) must contain the average and range at which the contaminant was detected. The report may include a brief explanation of the reasons for monitoring for unregulated contaminants.

(e) * * *

(1) If the system has performed any monitoring for Cryptosporidium, including monitoring performed to satisfy the requirements of §141.143, which indicates that Cryptosporidium may be present in the source water or the finished water, the report must include:

* * * * *

(3) If the system has performed additional monitoring which indicates the presence of other contaminants in the finished water, EPA strongly encourages systems to report any results which may indicate a health concern. To determine if results may indicate a health concern, EPA recommends that systems find out if EPA has proposed an NPDWR or issued a health advisory for that contaminant by calling the Safe Drinking Water Hotline (800-426-4791). EPA considers detects above a proposed MCL or health advisory level to indicate possible health concerns. For such contaminants, EPA recommends that the report include:

* * * * *

(f) Compliance with NPDWR. In addition to the requirements of §141.153(d)(6), the report must note any violation that occurred during the year covered by the report of a requirement listed below, and include a clear and readily understandable explanation of the violation, any potential adverse health effects, and the steps the system has taken to correct the violation.

* * * * *

(3) Lead and copper control requirements prescribed by subpart I of this part. For systems that fail to take one or more actions prescribed by §141.80(d), 141.81, 141.82, 141.83 or 141.84, the report must include the applicable language of appendix A to this subpart for lead, copper, or both.

* * * * *

(h) Additional information:

(1) The report must contain a brief explanation regarding contaminants which may reasonably be expected to be found in drinking water including bottled water. This explanation may include the language of paragraphs (h)(1)(i) through (iii) or systems may use their own comparable language. The report also must include the language of paragraph (h)(1)(iv) of this section.

(i) The sources of drinking water (both tap water and bottled water) include rivers, lakes, streams, ponds, reservoirs, springs, and wells. As water travels over the surface of the land or through the ground, it dissolves naturally-occurring minerals and, in some cases, radioactive material, and can pick up substances resulting from the presence of animals or from human activity.

(ii) Contaminants that may be present in source water include:

(A) Microbial contaminants, such as viruses and bacteria, which may come from sewage treatment plants, septic systems, agricultural livestock operations, and wildlife.

(B) Inorganic contaminants, such as salts and metals, which can be naturally-occurring or result from urban stormwater runoff, industrial or domestic wastewater discharges, oil and gas production, mining, or farming.

(C) Pesticides and herbicides, which may come from a variety of sources such as agriculture, urban stormwater runoff, and residential uses.

(D) Organic chemical contaminants, including synthetic and volatile organic chemicals, which are by-products of industrial processes and petroleum production, and can also come from gas stations, urban stormwater runoff, and septic systems.

(E) Radioactive contaminants, which can be naturally-occurring or be the result of oil and gas production and mining activities.

(iii) In order to ensure that tap water is safe to drink, EPA prescribes regulations which limit the amount of certain contaminants in water provided by public water systems. FDA regulations establish limits for contaminants in bottled water which must provide the same protection for public health.

(iv) Drinking water, including bottled water, may reasonably be expected to contain at least small amounts of some contaminants. The presence of contaminants does not necessarily indicate that water poses a health risk. More information about contaminants and potential health effects can be obtained by calling the Environmental Protection Agency's Safe Drinking Water Hotline (800-426-4791).

(2) The report must include the telephone number of the owner, operator, or designee of the community water system as a source of additional information concerning the report.

(3) In communities with a large proportion of non-English speaking residents, as determined by the Primacy Agency, the report must contain information in the appropriate language(s) regarding the importance of the report or contain a telephone number or address where such residents may contact the system to obtain a translated copy of the report or assistance in the appropriate language.

(4) The report must include information (e.g., time and place of regularly scheduled board meetings) about opportunities for public participation in decisions that may affect the quality of the water.

(5) The systems may include such additional information as they deem necessary for public education consistent with, and not detracting from, the purpose of the report.

(6) Systems required to comply with subpart S.

(i) Any ground water system that receives notice from the State of a significant deficiency or notice from a laboratory of a fecal indicator-positive ground water source sample that is not invalidated by the State under §141.402(d) must inform its customers of any significant deficiency that is uncorrected at the time of the next report or of any fecal indicator-positive ground water source sample in the next report. The system must continue to inform the public annually until the State determines that particular significant deficiency is corrected or the fecal contamination in the ground water source is addressed under §141.403(a). Each report must include the following elements.

(A) The nature of the particular significant deficiency or the source of the fecal contamination (if the source is known) and the date the significant deficiency was identified by the State or the dates of the fecal indicator-positive ground water source samples;

(B) If the fecal contamination in the ground water source has been addressed under §141.403(a) and the date of such action;

(C) For each significant deficiency or fecal contamination in the ground water source that has not been addressed under §141.403(a), the State-approved plan and schedule for correction, including interim measures, progress to date, and any interim measures completed; and

(D) If the system receives notice of a fecal indicator-positive ground water source sample that is not invalidated by the State under §141.402(d), the potential health effects using the health effects language of Appendix A of subpart O.

(ii) If directed by the State, a system with significant deficiencies that have been corrected before the next report is issued must inform its customers of the significant deficiency, how the deficiency was corrected, and the date of correction under paragraph (h)(6)(i) of this section.

(7) Systems required to comply with subpart Y. (i) Any system required to comply with the Level 1 assessment requirement or a Level 2 assessment requirement that is not due to an E. coli MCL violation must include in the report the text found in paragraph (h)(7)(i)(A) and paragraphs (h)(7)(i)(B) and (C) of this section as appropriate, filling in the blanks accordingly and the text found in paragraphs (h)(7)(i)(D)(1) and (2) of this section if appropriate.

(A) Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially harmful, waterborne pathogens may be present or that a potential pathway exists through which contamination may enter the drinking water distribution system. We found coliforms indicating the need to look for potential problems in water treatment or distribution. When this occurs, we are required to conduct assessment(s) to identify problems and to correct any problems that were found during these assessments.

(B) During the past year we were required to conduct [INSERT NUMBER OF LEVEL 1ASSESSMENTS] Level 1 assessment(s). [INSERT NUMBER OF LEVEL 1 ASSESSMENTS] Level 1 assessment(s) were completed. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.

(C) During the past year [INSERT NUMBER OF LEVEL 2 ASSESSMENTS] Level 2 assessments were required to be completed for our water system. [INSERT NUMBER OF LEVEL 2 ASSESSMENTS] Level 2 assessments were completed. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.

(D) Any system that has failed to complete all the required assessments or correct all identified sanitary defects, is in violation of the treatment technique requirement and must also include one or both of the following statements, as appropriate:

(1) During the past year we failed to conduct all of the required assessment(s).

(2) During the past year we failed to correct all identified defects that were found during the assessment.

(ii) Any system required to conduct a Level 2 assessment due to anE. coliMCL violation must include in the report the text found in paragraphs (h)(7)(ii)(A) and (B) of this section, filling in the blanks accordingly and the text found in paragraphs (h)(7)(ii)(C)(1) and (2) of this section, if appropriate.

(A) E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Human pathogens in these wastes can cause short-term effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for infants, young children, the elderly, and people with severely compromised immune systems. We found E. coli bacteria, indicating the need to look for potential problems in water treatment or distribution. When this occurs, we are required to conduct assessment(s) to identify problems and to correct any problems that were found during these assessments.

(B) We were required to complete a Level 2 assessment because we found E. coli in our water system. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.

(C) Any system that has failed to complete the required assessment or correct all identified sanitary defects, is in violation of the treatment technique requirement and must also include one or both of the following statements, as appropriate:

(1) We failed to conduct the required assessment.

(2) We failed to correct all sanitary defects that were identified during the assessment that we conducted.

(iii) If a system detects E. coli and has violated the E. coli MCL, in addition to completing the table as required in paragraph (d)(4) of this section, the system must include one or more of the following statements to describe any noncompliance, as applicable:

(A) We had an E. coli-positive repeat sample following a total coliform-positive routine sample.

(B) We had a total coliform-positive repeat sample following an E. coli-positive routine sample.

(C) We failed to take all required repeat samples following an E. coli-positive routine sample.

(D) We failed to test for E. coli when any repeat sample tests positive for total coliform.

(iv) If a system detects E. coli and has not violated the E. coli MCL, in addition to completing the table as required in paragraph (d)(4) of this section, the system may include a statement that explains that although they have detected E. coli, they are not in violation of the E. coli MCL.

§141.154 Required additional health information.

(a) All reports must prominently display the following language: Some people may be more vulnerable to contaminants in drinking water than the general population. Immuno-compromised persons such as persons with cancer undergoing chemotherapy, persons who have undergone organ transplants, people with HIV/AIDS or other immune system disorders, some elderly, and infants can be particularly at risk from infections. These people should seek advice about drinking water from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk of infection by Cryptosporidium and other microbial contaminants are available from the Safe Drinking Water Hotline (800-426-4791).

(b) Ending in the report due by July 1, 2001, a system which detects arsenic at levels above 0.025 mg/L, but below the 0.05 mg/L, and beginning in the report due by July 1, 2002, a system that detects arsenic above 0.005 mg/L and up to and including 0.010 mg/L:

(1) Must include in its report a short informational statement about arsenic, using language such as: While your drinking water meets EPA's standard for arsenic, it does contain low levels of arsenic. EPA's standard balances the current understanding of arsenic's possible health effects against the costs of removing arsenic from drinking water. EPA continues to research the health effects of low levels of arsenic, which is a mineral known to cause cancer in humans at high concentrations and is linked to other health effects such as skin damage and circulatory problems.

(2) May write its own educational statement, but only in consultation with the Primacy Agency.

(c) * * *

(1) Must include a short informational statement about the impacts of nitrate on children using language such as: Nitrate in drinking water at levels above 10 ppm is a health risk for infants of less than six months of age. High nitrate levels in drinking water can cause blue baby syndrome. Nitrate levels may rise quickly for short periods of time because of rainfall or agricultural activity. If you are caring for an infant you should ask advice from your health care provider.

(2) May write its own educational statement, but only in consultation with the Primacy Agency.

(d) * * *

(2) A system may write its own educational statement, but only in consultation with the State.

* * * *

§141.155 Report delivery and recordkeeping.

(a) Except as provided in paragraph (g) of this section, each community water system must mail or otherwise directly deliver one copy of the report to each customer.

(b) The system must make a good faith effort to reach consumers who do not get water bills, using means recommended by the primacy agency. EPA expects that an adequate good faith effort will be tailored to the consumers who are served by the system but are not bill-paying customers, such as renters or workers. A good faith effort to reach consumers would include a mix of methods appropriate to the particular system such as: Posting the reports on the Internet; mailing to postal patrons in metropolitan areas; advertising the availability of the report in the news media; publication in a local newspaper; posting in public places such as cafeterias or lunch rooms of public buildings; delivery of multiple copies for distribution by single-biller customers such as apartment buildings or large private employers; delivery to community organizations.

(c) No later than the date the system is required to distribute the report to its customers, each community water system must mail a copy of the report to the primacy agency, followed within 3 months by a certification that the report has been distributed to customers, and that the information is correct and consistent with the compliance monitoring data previously submitted to the primacy agency.

* * * * *

(e) Each community water system must make its reports available to the public upon request.

(f) Each community water system serving 100,000 or more persons must post its current year's report to a publicly-accessible site on the Internet.

(g) The Governor of a State or his designee, or the Tribal Leader where the tribe has met the eligibility requirements contained in §142.72 for the purposes of waiving the mailing requirement, can waive the requirement of paragraph (a) of this section for community water systems serving fewer than 10,000 persons. In consultation with the tribal government, the Regional Administrator may waive the requirement of §141.155(a) in areas in Indian country where no tribe has been deemed eligible.

(1) * * *

(i) Publish the reports in one or more local newspapers serving the area in which the system is located;

* * * * *

(2) Systems serving 500 or fewer persons may forego the requirements of paragraphs (g)(1)(i) and (ii) of this section if they provide notice at least once per year to their customers by mail, door- to-door delivery or by posting in an appropriate location that the report is available upon request.

* * * * *

Appendix A to Subpart O to Part 141—Regulated Contaminants

Contaminant (units) Traditional MCL in mg/LTo convert for CCR, multiply byMCL in CCR unitsMCLGMajor sources in drinking waterHealth effects language
* * * * ** * * * ** * * * ** * * * ** * * * ** * * * ** * * * *
E. coliRoutine and repeat samples are total coliform- positive and either is E. coli-positive or system fails to take repeat samples following E. coli-positive routine sample or system fails to analyze total coliformpositive repeat sample for E. coli.Routine and repeat samples are total coliform- positive and either is E. coli-positive or system fails to take repeat samples following E. coli-positive routine sample or system fails to analyze total coliformpositive repeat sample for E. coli.0Human and animal fecal waste.E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Human pathogens in these wastes can cause short-term effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for infants, young children, the elderly, and people with severely- compromised immune systems.
* * * * ** * * * ** * * * ** * * * ** * * * ** * * * ** * * * *
Arsenic (ppb)10.0101000110.10Erosion of natural deposits; Runoff from orchards; Runoff from glass and electronics production wastesSome people who drink water containing arsenic in excess of the MCL over many years could experience skin damage or problems with their circulatory system, and may have an increased risk of getting cancer.

§142.15 Reports by States.

* * * * *

(b) Each State which has primary enforcement responsibility shall submit annual reports to the Administrator on a schedule and in a format prescribed by the Administrator, consisting of the following information:

* * * * *

(2) A summary of the status of each variance and exemption currently in effect.

* * * * *

§142.16 Special primacy requirements.

* * * * *

(f) * * *

(1) Each State that has primary enforcement responsibility must adopt the requirements of 40 CFR part 141, subpart O no later than August 21, 2000. States must submit revised programs to EPA for approval using the procedures in §142.12(b) through (d).

* * * * *

(3) Each State that has primary enforcement responsibility must maintain a copy of the reports for a period of one year and the certifications obtained pursuant to 40 CFR 141.155(c) for a period of 5 years.

* * * * *

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2024-05-24T05:00:00Z

EPA Final Rule: New Hampshire Asbestos Management and Control

The Environmental Protection Agency (EPA) is granting the New Hampshire Department of Environmental Services (NH DES) the authority to implement and enforce the state's amended Asbestos Disposal Site Rule in place of the National Emission Standard for Asbestos provisions for inactive waste disposal sites. NH DES's amended rule applies to all inactive waste disposal sites that ceased operation on or before July 9, 1981. This approval makes the NH DES amended Asbestos Disposal Site Rule federally enforceable. This action is being taken under the Clean Air Act (CAA).

DATES: This rule is effective on June 24, 2024, published in the Federal Register May 24, 2024, page 45770.

§61.04 Address.
(c)(1)(i)Revised View text
§61.18 Incorporations by reference.
(e)(1)Revised View text
§63.14 Incorporations by reference.
(n)(6)(i)Revised View text
§63.99 Delegated Federal authorities.
(a)(30)(iii)Revised View text

Previous Text

§61.04 Address.

* * * * *

(c) * * * (1) * * *

(i) Inactive waste disposal sites not operated after July 9, 1981 within the state of New Hampshire must comply with the New Hampshire Regulations at Env-Sw 2100: Management and Control of Asbestos Disposal Sites Not Operated after July 9, 1981, effective February 16, 2010 (incorporated by reference, see §61.18).

* * * * *

§61.18 Incorporations by reference.

* * * * *

(e) * * * *

(1)(i) New Hampshire Regulations at Env-Sw 2100, Management and Control of Asbestos Disposal Sites Not Operated after July 9, 1981, effective February 16, 2010 (including a letter from Thomas S. Burack, Commissioner, Department of Environmental Services, State of New Hampshire, to Carol J. Holahan, Director, Office of Legislative Services, dated February 12, 2010, certifying that the enclosed rule, Env-Sw 2100, is the official version of this rule). Incorporation By Reference approved for §61.04(c).

* * * * *

§63.14 Incorporations by reference.

* * * * *

(n) * * *

(6)(i) New Hampshire Regulations at Env-Sw 2100, Management and Control of Asbestos Disposal Sites Not Operated after July 9, 1981, effective February 16, 2010 (including a letter from Thomas S. Burack, Commissioner, Department of Environmental Services, State of New Hampshire, to Carol J. Holahan, Director, Office of Legislative Services, dated February 12, 2010, certifying that the enclosed rule, Env-Sw 2100, is the official version of this rule), IBR approved for §63.99(a).

* * * * *

§63.99 Delegated Federal authorities.

* * * * *

(a) * * *

(30) * * *

(iii) Affected inactive waste disposal sites not operated after July 9, 1981 within New Hampshire must comply with New Hampshire Regulations Chapter Env-Sw 2100: Management and Control of Asbestos Disposal Sites Not Operated after July 9, 1981, effective February 16, 2010 (incorporated by reference, see §63.14) as described in paragraph (a)(30)(iii)(A) of this section:

(A) The material incorporated by reference from Chapter Env-Sw 2100, Management and Control of Asbestos Disposal Sites Not Operated after July 9, 1981, pertains to inactive waste disposal sites not operated after July 9, 1981 in the State of New Hampshire's jurisdiction, and has been approved under the procedures in §63.93 to be implemented and enforced in place of the Federal NESHAPs for Inactive Waste Disposal Sites (40 CFR 61.151).

(B) [Reserved]

* * * * *

SPCC rule: Is your aboveground storage tank covered?
2024-05-23T05:00:00Z

SPCC rule: Is your aboveground storage tank covered?

It may not be worth crying over spilled milk, but spilled oil is a different story, especially if it reaches national waters. The Spill Prevention, Control, and Countermeasure (SPCC) rule requires certain facilities with aboveground storage tanks that contain oil to prepare and implement spill prevention and control measures.

A facility with an aboveground storage tank (AST) that contains any oil in any form (such as petroleum, fuel oil, sludge, vegetable oils, and synthetic oils) may be subject to the SPCC regulations. Covered facilities must take certain preventive actions and develop and apply an SPCC Plan.

Is your AST covered by the SPCC rule? Let’s find out.

First, keep this in mind.

The regulations may apply to your ASTs, even if you don’t see the specific term. The SPCC regulations at 40 CFR Part 112 don’t always use “ASTs.” Under the rule, ASTs include:

  • Bulk storage containers,
  • Bunkered tanks, and
  • Partially buried tanks.

To ensure you don’t miss relevant regulations, evaluate the rule’s definitions for each type of AST to determine whether they apply.

What facilities does the SPCC rule cover?

The SPCC rule covers facilities that:

  • Are non-transportation-related (i.e., facilities that store, process, refine, use, or consume oil);
  • Are engaged in drilling, producing, gathering, storing, processing, refining, transferring, distributing, using, or consuming oil;
  • Could be reasonably expected to discharge oil in quantities that may be harmful into navigable waters or adjoining shorelines; and
  • Have a total aggregate capacity of either aboveground oil storage greater than 1,320 gallons or completely buried storage tanks greater than 42,000 gallons in containers of 55 gallons or more.

If your facility meets the criteria and has a combined capacity of 1,320 gallons or more of oil in ASTs with capacities of 55 gallons or more, the SPCC rule applies.

Tips for determining applicability

  • “Navigable waters” refer to waters of the United States as defined at 120.2.
  • Oil discharges that may be considered harmful are defined at 110.3.
  • Each facility must determine the potential for a discharge since the SPCC rule doesn’t define “reasonably be expected."
  • Per 40 CFR 112.1(d)(1)(i), the determination for whether your facility could reasonably be expected to discharge potentially harmful amounts of oil into navigable waters must be based solely on geographical and location aspects of the facility. You may not account for man-made features (like equipment or structures) that could prevent or contain a discharge.
  • When calculating the total number of gallons of oil in your ASTs, don’t count aboveground containers with less than 55 gallons of storage capacity.

Is your facility considered a qualified facility?

Some facilities are eligible for streamlined requirements under the SPCC rule. These “qualified facilities” can prepare and self-certify their SPCC Plans instead of having them reviewed and certified by a professional engineer.

To qualify, your facility must:

  • Have a total aboveground oil storage capacity of 10,000 gallons or less; and
  • Over the previous three years, have no:
    • One discharge of oil greater than 1,000 gallons into navigable waters or adjoining shorelines, or
    • Two discharges of 42 gallons or more of oil into navigable waters or adjoining shorelines within any 12-month period.

Eligible facilities must determine the type of qualified facility that applies.

  • If your facility has no aboveground oil containers greater than 5,000 gallons, it’s a Tier I Qualified Facility. You may complete and self-certify the SPCC Plan template (Appendix G to Part 112).
  • If your facility has at least one aboveground oil container greater than 5,000 gallons, it’s a Tier II Qualified Facility. You may complete and self-certify the SPCC Plan per the requirements at 112.7 and either Subpart B or Subpart C of Part 112.

Key to remember: If your facility has an aboveground storage tank that holds any kind of oil, it may be subject to the Spill Prevention, Control, and Countermeasure rule.

2024-05-17T05:00:00Z

EPA Final Rule: Additions to Toxics Release Inventory

The Environmental Protection Agency (EPA) is updating the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). Specifically, this action updates the regulations to identify seven per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (FY2020 NDAA) enacted on December 20, 2019. As this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary.

DATES: This final rule is effective June 17, 2024, published in the Federal Register May 17, 2024, page 43331.

View final rule.

§372.65 Chemicals and chemical categories to which this part applies.
(d) Table 4: Entries for “Ammonium perfluorohexanoate”; “Betaines, dimethyl(γ-ω-perfluoro-γ-hydro-C8-18-alkyl)”; “Lithium bis[(trifluoromethyl)sulfonyl] azanide”; “Perfluorohexanoic acid”; “Perfluoropropanoic acid”; “Sodium perfluorohexanoate”; and “1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide”; and note to the end of the table Added View text
(e) Table 5: Entries for “307-24-4”; “422-64-0”; “2923-26-4”; “21615-47-4”; “82113-65-3”; “90076-65-6”; and “2816091-53-7”; and Revised View text

Previous Text

§372.65 Chemicals and chemical categories to which this part applies.

* * * *

(d)

* * * *

Table 4 to Paragraph (d)

* * * *

CAS No.

(e)

* * * *

Table 4 to Paragraph (d)

* * * *

CAS No.

2024-05-16T05:00:00Z

EPA Final Rule: Missouri: Final Approval of State Underground Storage Tank Program Revisions

Pursuant to the Resource Conservation and Recovery Act (RCRA or Act), the Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the State of Missouri's Underground Storage Tank (UST) program submitted by the Missouri Department of Natural Resources (MDNR). This action also codifies EPA's approval of Missouri's State program and incorporates by reference those provisions of the State regulations that we have determined meet the requirements for approval. The provisions will be subject to EPA's inspection and enforcement authorities under RCRA and other applicable statutory and regulatory provisions.

DATES: This rule is effective July 16, 2024, unless EPA receives adverse comment by June 17, 2024, published in the Federal Register May 17, 2024, page 43322.

View final rule.

§282.75 Missouri State-Administered Program.
Entire sectionAddedView text
Appendix A to Part 282—State Requirements Incorporated by Reference in Part 282 of the Code of Federal Regulations
Entry for “Missouri”AddedView text
2024-05-16T05:00:00Z

EPA Final Rule: New Source Performance Standards for the Synthetic Organic Chemical Manufacturing Industry and National Emission Standards for Hazardous Air Pollutants

This action finalizes amendments to the New Source Performance Standards (NSPS) that apply to the Synthetic Organic Chemical Manufacturing Industry (SOCMI) and amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) that apply to the SOCMI (more commonly referred to as the Hazardous Organic NESHAP or HON) and Group I and II Polymers and Resins (P&R I and P&R II, respectively) Industries. The EPA is finalizing decisions resulting from the Agency’s technology review of the HON and the P&R I and P&R II NESHAP, and its review of the NSPS that apply to the SOCMI. The EPA is also finalizing amendments to the NSPS for equipment leaks of volatile organic compounds (VOC) in SOCMI based on its reconsideration of certain issues raised in an administrative petition for reconsideration. Furthermore, the EPA is finalizing emission standards for ethylene oxide (EtO) emissions and chloroprene emissions after considering the results of a risk assessment for the HON and for Neoprene Production processes subject to the P&R I NESHAP, and is finalizing a fenceline monitoring work practice standard for certain hazardous air pollutants (HAP). Lastly, the EPA is finalizing the removal of exemptions from standards for periods of startup, shutdown, and malfunction (SSM), adding work practice standards for such periods where appropriate, finalizing standards for previously unregulated HAP, and adding provisions for electronic reporting of performance test reports and periodic reports.

DATES: This final rule is effective on July 15, 2024, published in the Federal Register May 16, 2024, page 42932.

View final rule.

See More

Most Recent Highlights In Safety & Health

Protecting yourself all season — All masks are not created equal!
2024-05-16T05:00:00Z

Protecting yourself all season — All masks are not created equal!

As the common cold, flu, and even lingering cases of COVID rear their heads throughout the year, many may reach for a mask as a precaution. But are your masks going to offer the protection you need? Employers must understand the differences between the various masks workers depend on for their safety.

Although most mask mandates have been lifted, the Centers for Disease Control (CDC) still recommends wearing quality masks over the nose and mouth in high traffic or congested areas, such as airplanes, at concerts, or in large groups. With many mask options floating around, it’s important to understand the differences between N95, KN95, cloth, and surgical masks.

Which mask is best?

According to the National Institute of Health (NIH), masks are intended to block respiratory droplets and aerosols that may contain viral particles. Overall, masks can be effective and are recommended during flu and cold season, but which mask is best is going to depend upon the circumstances.

Masks differ in the maximum internal leak proportion limit (the highest level of leak protection offered), so here’s the low-down:

  • N95— deemed more effective than surgical masks, N95 masks are the most common type of particulate filtering facepiece respirator. The “95” represents the 95% of airborne particles that are filtered out, which means that don’t entirely block the transmission of some viruses. These masks require fit testing to ensure proper protection.
  • KN95 — “KN” is a designation given by China as an indicator of effectiveness; though the designation is not as stringent as with N95 masks and therefore don’t qualify as N95s. These can be quickly identified by the ear loops versus the dual straps required on N95s.
  • Surgical — meant to protect from droplets and sprays, surgical masks filter large particles from the air when the wearer inhales. However, these disposable masks tend to be loose-fitting which could reduce their efficiency to lower than that of N95 masks.
  • Cloth— usually homemade, these masks offer limited protection from infection, especially persistent ones like COVID-19. Cloth masks are machine-washable and reusable, but they do fit more loosely especially near the nose, cheeks, and jawline, which reduces their effectiveness. Homemade masks create inconsistent and unknown protection levels, so are not recommended for sufficient defense against viruses or other infectious particles.
  • Other protections — scarfs, gators, and other protections have been used as an attempt to protect from contagious infections. Intended to trap respiratory droplets, these “masks” must be used in layers to have the same effectiveness as a mask, so are not the best option.

Overcoming the negatives of wearing a mask

The theory is that wearing some mask is better than wearing no mask at all. However, the use of some masks, such as N-95s can result in some not-so-pleasant physical responses such as anxiety, headaches, nausea, and vomiting. Additionally, wearing the wrong mask or incorrectly wearing a mask can create a false sense of security, placing the wearer at even greater risk. So, how can workers overcome the negatives of wearing a mask?

When wearing masks, workers can ease the “burden” by:

  • Selecting the most protective, yet comfortable mask for the expected exposure type.
  • Ensuring the mask is fit properly (around the face with no gaps around the edges) to help with air flow.
  • Using masks with bendable nose strips for efficacy and comfort.
  • Securing both straps around the ears to ensure optimal protection and prevent constant slippage.
  • Acclimating to mask use by wearing one for short periods initially and building up to longer durations.
  • Remaining aware of temperature extremes and humidity when required to wear masks.
  • Keeping your respiratory system fit and healthy so masks don’t seem like a barrier to normal breathing.

Keys to Remember: While surgical and cloth masks offer some protection from viruses, N95s and KN95s masks offer better protection in most cases. Employers must ensure workers are choosing masks that fit and filter properly to ensure safe use and appropriate level of protection.

2024-05-15T05:00:00Z

EPA Final Rule: South Dakota: Final Approval of State Underground Storage Tank Program Revisions

The State of South Dakota Department of Agriculture and Natural Resources (DANR) has applied to the EPA for final approval of the changes to its Underground Storage Tank (UST) program under the Resource Conservation and Recovery Act (RCRA). The EPA has reviewed South Dakota's application and determined that South Dakota's UST program revisions satisfy all requirements needed for program approval. This action also codifies the EPA's approval of South Dakota's State program and incorporates by reference those provisions of the State's regulations that we have determined meet the requirements for approval.

DATES: This rule is effective on July 15, 2024 unless EPA receives adverse written comment by June 14, 2024, published in the Federal Register May 15, 2024, page 42390.

View final rule.

§282.91 South Dakota State-Administered Program.
Entire sectionRevisedView text
Appendix A to Part 282—State Requirements Incorporated by Reference in Part 282 of the Code of Federal Regulations
Entry for “South Dakota”RevisedView text

Previous Text

§282.91 South Dakota State-Administered Program.

(a) The State of South Dakota is approved to administer and enforce an underground storage tank program in lieu of the federal program under Subtitle I of the Resource Conservation and Recovery Act of 1976 (RCRA), as amended, 42 U.S.C. 6991 et seq. The State's program, as administered by the South Dakota Department of Environment and Natural Resources, was approved by EPA pursuant to 42 U.S.C. 6991c and part 281 of this chapter. EPA approved the South Dakota program on March 16, 1995 and it was effective on May 15, 1995.

(b) South Dakota has primary responsibility for enforcing its underground storage tank program. However, EPA retains the authority to exercise its inspection and enforcement authorities under sections 9005 and 9006 of subtitle I of RCRA, 42 U.S.C. 6991d and 6991e, as well as under other statutory and regulatory provisions.

(c) To retain program approval, South Dakota must revise its approved program to adopt new changes to the federal subtitle I program which make it more stringent, in accordance with section 9004 of RCRA, 42 U.S.C. 6991c, and 40 CFR part 281, subpart E. If South Dakota obtains approval for the revised requirements pursuant to section 9004 of RCRA, 42 U.S.C. 6991c, the newly approved statutory and regulatory provisions will be added to this subpart and notice of any change will be published in the Federal Register.

(d) South Dakota has final approval for the following elements submitted to EPA in South Dakota's program application for final approval and approved by EPA on [insert date of publication]. Copies may be obtained from the Underground Storage Tank Program, South Dakota Department of Environment and Natural Resources, 523 East Capitol, Pierre, South Dakota 57501.

(1) State statutes and regulations. (i) The provisions cited in this paragraph are incorporated by reference as part of the underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991 et seq.

(A) South Dakota Statutory Requirements Applicable to the Underground Storage Tank Program, 1995.

(B) South Dakota Regulatory Requirements Applicable to the Underground Storage Tank Program, 1995.

(ii) The following statutes are part of the approved state program, although not incorporated by reference herein for enforcement purposes.

(A) The statutory provisions include: South Dakota Codified Law, Water Pollution Control, Chapter 34A-2, Sections 46 and 48, Sections 72 through 75, Chapters 34A-10 and 34A-12.

(iii) The following statutory provisions are broader in scope than the federal program, are not part of the approved program, and are not incorporated by reference herein for enforcement purposes.

(A) South Dakota statutes Annotated, Chapter 34A-2, Section 100, insofar as it applies to above ground stationary storage tanks, Section 102, insofar as it applies to installation of above ground stationary storage tanks, Section 101, insofar as it applies to corrective action for above ground stationary storage tanks.

(2) Statement of legal authority. (i) "Attorney General's Statement for Final Approval", signed by the Attorney General of South Dakota on June 17, 1992, though not incorporated by reference, is referenced as part of the approved underground storage tank program under Subtitle I of RCRA, 42 U.S.C. 6991 et seq.

(ii) Letter from the Attorney General of South Dakota to EPA, June 17, 1992, though not incorporated by reference, is referenced as part of the approved underground storage tank program under Subtitle I of RCRA, 42 U.S.C. 6991 et seq.

(3) Demonstration of procedures for adequate enforcement. The "Demonstration of Procedures for Adequate Enforcement" submitted as part of the complete application in October 1993, though not incorporated by reference, is referenced as part of the approved underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991 et seq.

(4) Program Description. The program description and any other material submitted as part of the original application in June 1992, though not incorporated by reference, are referenced as part of the approved underground storage tank program under Subtitle I of RCRA, 42 U.S.C. 6991 et seq.

(5) Memorandum of Agreement. The Memorandum of Agreement between EPA Region VIII and the South Dakota Department of Environment and Natural Resources, signed by the EPA Regional Administrator on February 23, 1995, though not incorporated by reference, is referenced as part of the approved underground storage tank program under Subtitle I of RCRA, 42 U.S.C. 6991 et seq.

Appendix A to Part 282—State Requirements Incorporated by Reference in Part 282 of the Code of Federal Regulations

* * * *

South Dakota

(a) The statutory provisions include South Dakota Statutes Annotated, Chapter 34A-2, Sections 98 and 99. Underground Storage Tanks:

Section 98 Underground storage tanks-Definitions. Section 99 Underground storage tanks-Adoption of Rules-Violation.

(b) The regulatory provisions include State of South Dakota Administrative Rules, Chapter 74:03:28, Underground Storage Tanks, Department of Environment and Natural Resources, June 24, 1992:

Section 74:03:28:01 Definitions.

Section 74:03:28:02 Performance standards for new UST systems-General requirements.

Section 74:03:28:03 Upgrading of existing UST systems-General requirements and deadlines.

Section 74:03:28:04 Notification requirements for UST systems.

Section 74:03:28:05 Spill and overfill control.

Section 74:03:28:06 Operation and maintenance of cathodic protection.

Section 74:03:28:07 Compatibility.

Section 74:03:28:08 Repairs allowed-general requirements.

Section 74:03:28:09 Maintenance and availability of records.

Section 74:03:28:10 Release detection for all UST systems-general requirements and deadlines.

Section 74:03:28:11 Release detection requirements for petroleum UST systems.

Section 74:03:28:12 Release detection requirements for pressure piping.

Section 74:03:28:13 Recordkeeping.

Section 74:03:28:14 Release notification plan.

Section 74:03:28:15 Reported of suspected releases.

Section 74:03:28:16 Release investigation and confirmation.

Section 74:03:28:17 Off-site impacts and source investigation.

Section 74:03:28:18 General requirements for corrective action for releases from UST systems.

Section 74:03:28:19 Initial abatement requirements and procedures for releases from UST systems.

Section 74:03:28:20 Free product removal.

Section 74:03:28:21 Additional site investigation for releases from UST systems.

Section 74:03:28:22 Soil and groundwater cleanup for releases from UST systems.

Section 74:03:28:23 Reporting of releases from UST systems.

Section 74:03:28:28 Reporting of hazardous substance releases from UST systems.

Section 74:03:28:29 Temporary removal from use.

Section 74:03:28:30 Temporary closure.

Section 74:03:28:31 Permanent closure.

Section 74:03:28:32 Postclosure requirements.

Section 74:03:29:01 Applicability.

Section 74:03:29:23 Definitions.

Section 74:03:29:24 Financial responsibility rules.

2021-12-27T06:00:00Z

86 FR 73131 Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 141

[EPA-HQ-OW-2020-0530; FRL-6791-03-OW]

RIN 2040-AF89

Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule and notice of public meetings.

SUMMARY: The U.S. Environmental Protection Agency (EPA) is finalizing a Safe Drinking Water Act (SDWA) rule that requires certain public water systems (PWSs) to collect national occurrence data for 29 per- and polyfluoroalkyl substances (PFAS) and lithium. Subject to the availability of appropriations, EPA will include all systems serving 3,300 or more people and a representative sample of 800 systems serving 25 to 3,299 people. If EPA does not receive the appropriations needed for monitoring all of these systems in a given year, EPA will reduce the number of systems serving 25 to 10,000 people that will be asked to perform monitoring. This final rule is a key action to ensure science-based decision-making and prioritize protection of disadvantaged communities in accordance with EPA's PFAS Strategic Roadmap. EPA is also announcing plans for public webinars to discuss implementation of the fifth Unregulated Contaminant Monitoring Rule (UCMR 5).

DATES: This final rule is effective on January 26, 2022. The incorporation by reference of certain publications listed in this final rule is approved by the Director of the Federal Register as of January 26, 2022.

ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OW-2020-0530. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brenda D. Bowden, Standards and Risk Management Division (SRMD), Office of Ground Water and Drinking Water (OGWDW) (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, Ohio 45268; telephone number: (513) 569-7961; email address: bowden.brenda@epa.gov; or Melissa Simic, SRMD, OGWDW (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, Ohio 45268; telephone number: (513) 569-7864; email address: simic.melissa@epa.gov. For general information, visit the Ground Water and Drinking Water web page at: https://www.epa.gov/ground-water-and-drinking-water.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Summary Information

A. Purpose of the Regulatory Action

1. What action is EPA taking?

2. Does this action apply to me?

3. What is EPA's authority for taking this action?

4. What is the applicability date?

B. Summary of the Regulatory Action

C. Economic Analysis

1. What is the estimated cost of this action?

2. What are the benefits of this action?

II. Public Participation

A. What meetings have been held in preparation for UCMR 5?

B. How do I participate in the upcoming meetings?

1. Meeting Participation

2. Meeting Materials

III. General Information

A. How are CCL, UCMR, Regulatory Determination process, and NCOD interrelated?

B. What are the Consumer Confidence Reporting and Public Notice Reporting requirements for public water systems that are subject to UCMR?

C. What is the UCMR 5 timeline?

D. What is the role of “States” in UCMR?

E. How did EPA consider Children's Environmental Health?

F. How did EPA address Environmental Justice?

G. How did EPA coordinate with Indian Tribal Governments?

H. How are laboratories approved for UCMR 5 analyses?

1. Request To Participate

2. Registration

3. Application Package

4. EPA's Review of Application Package

5. Proficiency Testing

6. Written EPA Approval

I. What documents are being incorporated by reference?

1. Methods From the U.S. Environmental Protection Agency

2. Alternative Methods From American Public Health Association—Standard Methods (SM)

3. Methods From ASTM International

IV. Description of Final Rule and Summary of Responses to Public Comments

A. What contaminants must be monitored under UCMR 5?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

a. Aggregate PFAS Measure

b. Legionella Pneumophila

c. Haloacetonitriles

d. 1,2,3-Trichloropropane

B. What is the UCMR 5 sampling design?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

C. What is the sampling frequency and timing?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

D. Where are the sampling locations and what is representative monitoring?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

E. How long do laboratories and PWSs have to report data?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

F. What are the reporting requirements for UCMR 5?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

a. Data Elements

b. Reporting State Data

G. What are the UCMR 5 Minimum Reporting Levels (MRLs) and how were they determined?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

H. What are the requirements for laboratory analysis of field reagent blank samples?

1. This Final Rule

2. Summary of Major Comments and EPA Responses

I. How will EPA support risk communication for UCMR 5 results?

V. Statutory and Executive Order Reviews

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

B. Paperwork Reduction Act (PRA)

C. Regulatory Flexibility Act (RFA)

D. Unfunded Mandates Reform Act (UMRA)

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 Risks 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 (NTTAA)

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

K. Congressional Review Act (CRA)

VI. References

Abbreviations and Acronyms

μg/L Microgram per Liter

11Cl-PF3OUdS 11-chloroeicosafluoro-3-oxaundecane-1-sulfonic Acid

4:2 FTS 1H, 1H, 2H, 2H-perfluorohexane Sulfonic Acid

6:2 FTS 1H, 1H, 2H, 2H-perfluorooctane Sulfonic Acid

8:2 FTS 1H, 1H, 2H, 2H-perfluorodecane Sulfonic Acid

9Cl-PF3ONS 9-chlorohexadecafluoro-3-oxanone-1-sulfonic Acid

ADONA 4,8-dioxa-3H-perfluorononanoic Acid

AES Atomic Emission Spectrometry

ASDWA Association of State Drinking Water Administrators

ASTM ASTM International

AWIA America's Water Infrastructure Act of 2018

CASRN Chemical Abstracts Service Registry Number

CBI Confidential Business Information

CCL Contaminant Candidate List

CCR Consumer Confidence Report

CFR Code of Federal Regulations

CRA Congressional Review Act

CWS Community Water System

DBP Disinfection Byproduct

DWSRF Drinking Water State Revolving Fund

EPA United States Environmental Protection Agency

EPTDS Entry Point to the Distribution System

FR Federal Register

FRB Field Reagent Blank

GW Ground Water

GWRMP Ground Water Representative Monitoring Plan

HFPO-DA Hexafluoropropylene Oxide Dimer Acid (GenX)

HRL Health Reference Level

ICP Inductively Coupled Plasma

ICR Information Collection Request

IDC Initial Demonstration of Capability

LCMRL Lowest Concentration Minimum Reporting Level

LC/MS/MS Liquid Chromatography/Tandem Mass Spectrometry

MDBP Microbial and Disinfection Byproduct

MRL Minimum Reporting Level

NAICS North American Industry Classification System

NCOD National Contaminant Occurrence Database

NDAA National Defense Authorization Act for Fiscal Year 2020

NEtFOSAA N-ethyl Perfluorooctanesulfonamidoacetic Acid

NFDHA Nonafluoro‐3,6‐dioxaheptanoic Acid

ng/L Nanogram per Liter

NMeFOSAA N-methyl Perfluorooctanesulfonamidoacetic Acid

NPDWR National Primary Drinking Water Regulation

NTNCWS Non-transient Non-community Water System

NTTAA National Technology Transfer and Advancement Act

NTWC National Tribal Water Council

OGWDW Office of Ground Water and Drinking Water

OMB Office of Management and Budget

PFAS Per- and Polyfluoroalkyl Substances

PFBA Perfluorobutanoic Acid

PFBS Perfluorobutanesulfonic Acid

PFDA Perfluorodecanoic Acid

PFDoA Perfluorododecanoic Acid

PFEESA Perfluoro (2‐ethoxyethane) Sulfonic Acid

PFHpA Perfluoroheptanoic Acid

PFHpS Perfluoroheptanesulfonic Acid

PFHxA Perfluorohexanoic Acid

PFHxS Perfluorohexanesulfonic Acid

PFMBA Perfluoro‐4‐methoxybutanoic Acid

PFMPA Perfluoro‐3‐methoxypropanoic Acid

PFNA Perfluorononanoic Acid

PFOA Perfluorooctanoic Acid

PFOS Perfluorooctanesulfonic Acid

PFPeA Perfluoropentanoic Acid

PFPeS Perfluoropentanesulfonic Acid

PFTA Perfluorotetradecanoic Acid

PFTrDA Perfluorotridecanoic Acid

PFUnA Perfluoroundecanoic Acid

PN Public Notice

PRA Paperwork Reduction Act

PT Proficiency Testing

PWS Public Water System

QC Quality Control

RFA Regulatory Flexibility Act

SBA Small Business Administration

SBREFA Small Business Regulatory Enforcement Fairness Act

SDWA Safe Drinking Water Act

SDWARS Safe Drinking Water Accession and Review System

SDWIS/Fed Safe Drinking Water Information System Federal Reporting Services

SM Standard Methods for the Examination of Water and Wastewater

SOP Standard Operating Procedure

SPE Solid Phase Extraction

SRMD Standards and Risk Management Division

SW Surface Water

SWTR Surface Water Treatment Rule

TNCWS Transient Non-community Water System

TOF Total Organic Fluorine

TOP Total Oxidizable Precursors

UCMR Unregulated Contaminant Monitoring Rule

UMRA Unfunded Mandates Reform Act of 1995

U.S. United States

USEPA United States Environmental Protection Agency

I. Summary Information

A. Purpose of the Regulatory Action

1. What action is EPA taking?

This final rule requires certain public water systems (PWSs), described in section I.A.2 of this preamble, to collect national occurrence data for 29 PFAS and lithium. PFAS and lithium are not currently subject to national primary drinking water regulations, and EPA is requiring collection of data under UCMR 5 to inform EPA regulatory determinations and risk-management decisions. Consistent with EPA's PFAS Strategic Roadmap, UCMR 5 will provide new data critically needed to improve EPA's understanding of the frequency that 29 PFAS (and lithium) are found in the nation's drinking water systems and at what levels. This data will ensure science-based decision-making and help prioritize protection of disadvantaged communities.

2. Does this action apply to me?

This final rule applies to PWSs described in this section. PWSs are systems that provide water for human consumption through pipes, or constructed conveyances, to at least 15 service connections or that regularly serve an average of at least 25 individuals daily at least 60 days out of the year. A community water system (CWS) is a PWS that has at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents. A non-transient non-community water system (NTNCWS) is a PWS that is not a CWS and that regularly serves at least 25 of the same people over 6 months per year. Under this final rule, all large CWSs and NTNCWSs serving more than 10,000 people are required to monitor. In addition, small CWSs and NTNCWSs serving between 3,300 and 10,000 people are required to monitor (subject to available EPA appropriations and EPA notification of such requirement) as are the PWSs included in a nationally representative sample of CWSs and NTNCWSs serving between 25 and 3,299 people (see “Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update” for a description of the statistical approach for EPA's selection of the nationally representative sample (USEPA, 2021a), available in the UCMR 5 public docket). EPA expects to clarify the monitoring responsibilities for affected small systems by approximately July 1 of each year preceding sample collection, based on the availability of appropriations each year.

As in previous UCMRs, transient non-community water systems (TNCWSs) ( i.e., non-community water systems that do not regularly serve at least 25 of the same people over 6 months per year) are not required to monitor under UCMR 5. EPA leads UCMR 5 monitoring as a direct-implementation program. States, Territories, and Tribes with primary enforcement responsibility (primacy) to administer the regulatory program for PWSs under SDWA (hereinafter collectively referred to in this document as “states”), can participate in the implementation of UCMR 5 through voluntary Partnership Agreements (see discussion of Partnership Agreements in Section III.D of this preamble). Under Partnership Agreements, states can choose to be involved in various aspects of UCMR 5 monitoring for PWSs they oversee; however, the PWS remains responsible for compliance with the final rule. Potentially regulated categories and entities are identified in the following table.

CategoryExamples of potentially regulated entitiesNAICS *
* NAICS = North American Industry Classification System.
State, local, & Tribal governmentsState, local, and Tribal governments that analyze water samples on behalf of PWSs required to conduct such analysis; State, local, and Tribal governments that directly operate CWSs and NTNCWSs required to monitor924110
IndustryPrivate operators of CWSs and NTNCWSs required to monitor221310
MunicipalitiesMunicipal operators of CWSs and NTNCWSs required to monitor924110

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the definition of PWS found in Title 40 in the Code of Federal Regulations (CFR) at 40 CFR 141.2 and 141.3, and the applicability criteria found in 40 CFR 141.40(a)(1) and (2). If you have questions regarding the applicability of this action to a particular entity, please consult the contacts listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

3. What is EPA's authority for taking this action?

As part of EPA's responsibilities under SDWA, the agency implements section 1445(a)(2), Monitoring Program for Unregulated Contaminants. This section, as amended in 1996, requires that once every five years, beginning in August 1999, EPA issue a list of not more than 30 unregulated contaminants to be monitored by PWSs. SDWA requires that EPA enter the monitoring data into the agency's publicly available National Contaminant Occurrence Database (NCOD) at https://www.epa.gov/sdwa/national-contaminant-occurrence-database-ncod.

EPA must vary the frequency and schedule for monitoring based on the number of people served, the source of supply, and the contaminants likely to be found. EPA is using SDWA Section 1445(a)(2) authority as the basis for monitoring the unregulated contaminants under this final rule.

Section 2021 of America's Water Infrastructure Act of 2018 (AWIA) (Pub. L. 115-270) amended SDWA and specifies that, subject to the availability of EPA appropriations for such purpose and sufficient laboratory capacity, EPA's UCMR program must require all PWSs serving between 3,300 and 10,000 people to monitor for the contaminants in a particular UCMR cycle, and ensure that only a nationally representative sample of systems serving between 25 and 3,299 people are required to monitor for those contaminants. EPA has developed this final rule anticipating that necessary appropriations will become available; however, to date, Congress has not appropriated additional funding ( i.e., funding in addition to the $2.0 million that EPA has historically set aside each year from the Drinking Water State Revolving Fund, using SDWA authority, to support UCMR monitoring at small systems) to cover monitoring expenses for all PWSs serving between 3,300 and 10,000 people. Provisions in the final rule enable the agency to adjust the number of these systems that must monitor based upon available appropriations.

AWIA did not amend the original SDWA requirements for large PWSs. Therefore, PWSs serving a population larger than 10,000 people continue to be responsible for participating in UCMR.

Section 7311 of the National Defense Authorization Act for Fiscal Year 2020 (NDAA) (Pub. L. 116-92) amended SDWA and specifies that EPA shall include all PFAS in UCMR 5 for which a drinking water method has been validated by the Administrator and that are not subject to a national primary drinking water regulation.

4. What is the applicability date?

The applicability date represents an internal milestone used by EPA to determine if a PWS is included in the UCMR program and whether it will be treated as small ( i.e., serving 25 to 10,000 people) or large ( i.e., serving more than 10,000 people). It does not represent a date by which respondents need to take any action. The determination of whether a PWS is required to monitor under UCMR 5 is based on the type of system ( e.g., CWS, NTNCWS, etc.) and its retail population served, as indicated by the Safe Drinking Water Information System Federal Reporting Services (SDWIS/Fed) inventory on February 1, 2021. SDWIS/Fed can be accessed at https://www.epa.gov/ground-water-and-drinking-water/safe-drinking-water-information-system-sdwis-federal-reporting. Examining water system type and population served as of February 1, 2021 allowed EPA to develop a draft list of PWSs tentatively subject to UCMR 5 and share that list with the states during 2021 for their review. This advance planning and review then allowed EPA to load state-reviewed PWS information into EPA's reporting system so that those PWSs can be promptly notified upon publication of this final rule. If a PWS receives such notification and believes it has been erroneously included in UCMR 5 based on an incorrect retail population, the system should contact their state authority to verify its population served as of the applicability date. If an error impacting rule applicability is identified, the state or the PWS may contact EPA to address the error. The 5-year UCMR 5 cycle spans January 2022 through December 2026, with preparations in 2022, sample collection between January 1, 2023, and December 31, 2025, and completion of data reporting in 2026. By approximately July 1 of the year prior to each year's sample collection ( i.e., by July 1, 2022 for 2023 sampling; by July 1, 2023 for 2024 sampling; and by July 1, 2024 for 2025 sampling) EPA expects to determine whether it has received necessary appropriations to support its plan to monitor at all systems serving between 3,300 and 10,000 people and at a representative group of 800 smaller systems. As EPA finalizes its small-system plan for each sample collection year, the agency will notify the small PWSs accordingly.

B. Summary of the Regulatory Action

EPA is requiring certain PWSs to collect occurrence data for 29 PFAS and lithium. This document addresses key aspects of UCMR 5, including the following: Analytical methods to measure the contaminants; laboratory approval; monitoring timeframe; sampling locations; data elements ( i.e., information required to be collected along with the occurrence data); data reporting timeframes; monitoring cost; public participation; conforming and editorial changes, such as those necessary to remove requirements solely related to UCMR 4; and EPA responses to public comments on the proposed rule. This document also discusses the implication for UCMR 5 of the AWIA Section 2021(a) requirement that EPA collect monitoring data from all systems serving more than 3,300 people “subject to the availability of appropriations.”

Regardless of whether EPA is able to carry out the small-system monitoring as planned, or instead reduces the scope of that monitoring, the small-system data collection, coupled with data collection from all systems serving more than 10,000 people under this action, will provide scientifically valid data on the national occurrence of 29 PFAS and lithium in drinking water. The UCMR data are the primary source of national occurrence data that EPA uses to inform regulatory and other risk management decisions for drinking water contaminant candidates.

EPA is required under SDWA Section 1445(a)(2)(C)(ii) to pay the “reasonable cost of such testing and laboratory analysis” for all applicable PWSs serving 25 to 10,000 people. Consistent with AWIA, EPA will require monitoring at as many systems serving 3,300 to 10,000 people as appropriations support (see Section IV.B of this preamble for more information on the agency's sampling design).

The agency received several public comments expressing concern that significant laboratory capacity will be needed to support the full scope envisioned for UCMR 5 PFAS monitoring. EPA anticipates that sufficient laboratory capacity will exist to support the expanded UCMR 5 scope. EPA's experience over the first four cycles of UCMR implementation has been that laboratory capacity quickly grows to meet UCMR demand. EPA also notes that the number of laboratories successfully participating in the early stages of the UCMR 5 laboratory approval program is a good indicator that there will be a robust national network of laboratories experienced in PFAS drinking water analysis.

By early 2022, EPA will notify all small CWSs and NTNCWSs serving between 3,300 and 10,000 people of their anticipated requirement to monitor, which EPA expects to confirm and schedule by July 1 preceding each collection year based on the availability of appropriations. The nationally representative sample of smaller PWSs described in Section I.A of this preamble will be similarly notified and advised of their schedules.

This final rule addresses the requirements of the NDAA by including all 29 PFAS that are within the scope of EPA Methods 533 and 537.1. Both of these methods have been validated by EPA for drinking water analysis.

C. Economic Analysis

1. What is the estimated cost of this action?

EPA estimates the total average national cost of this action would be $21 million per year over the 5-year effective period of the final rule (2022-2026) assuming EPA collects information from all systems serving between 3,300 and 10,000 people. All of these costs are associated with paperwork burden under the Paperwork Reduction Act (PRA). EPA discusses the expected costs as well as documents the assumptions and data sources used in the preparation of this estimate in the “Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021b). Costs are incurred by large PWSs (for sampling and analysis); small PWSs (for sampling); state regulatory agencies ( i.e., those who volunteer to assist EPA with oversight and implementation support); and EPA (for regulatory support and oversight activities, and analytical and shipping costs for samples from small PWSs). These costs are also summarized in Exhibit 1 of this preamble. EPA's estimates are based on executing the full monitoring plan for small systems ( i.e., including all systems serving 3,300 to 10,000 people and a representative group of 800 smaller systems). As such, those estimates represent an upper bound. If EPA does not receive the necessary appropriations in one or more of the collections years—and thus collects data from fewer small systems—the actual costs would be lower than those estimated here.

EPA received several comments on the cost of monitoring. EPA has accounted for the cost/burden associated with all of the PWS activities as part of the comprehensive cost/burden estimates. In order to provide the most accurate and updated cost estimate, EPA re-examined labor burden estimates for states, EPA, and PWS activities and updated costs of laboratory services for sample analysis, based on consultations with national drinking water laboratories, when developing this final rule.

The costs for a particular UCMR cycle are heavily influenced by the selection of contaminants and associated analytical methods. EPA identified three EPA-developed analytical methods (and, in the case of lithium, multiple optional alternative methods) to analyze samples for UCMR 5 contaminants. EPA's estimate of the UCMR 5 analytical cost is $740 per sample set ( i.e., $740 to analyze a set of samples from one sample point and one sample event for the 30 UCMR 5 contaminants).

Exhibit 1 of this preamble details the EPA-estimated annual average national costs (accounting for labor and non-labor expenses). Laboratory analysis and sample shipping account for approximately 65 percent of the estimated total national cost for the implementation of UCMR 5. EPA estimated laboratory costs based on consultations with multiple commercial drinking water testing laboratories. EPA's cost estimates for the laboratory methods include shipping and analysis.

EPA expects that states will incur modest labor costs associated with voluntary assistance with the implementation of UCMR 5. EPA estimated state costs using the relevant assumptions from the State Resource Model developed by the Association of State Drinking Water Administrators (ASDWA) (ASDWA, 2013) to help states forecast resource needs. Model estimates were adjusted to account for actual levels of state participation under UCMR 4. State assistance with EPA's implementation of UCMR 5 is voluntary; thus, the level of effort is expected to vary among states and will depend on their individual agreements with EPA.

EPA assumes that one-third of the systems will collect samples during each of the three sample-collection years from January 2023 through December 2025.

Exhibit 1—Estimated Average Annual Costs of UCMR 5 1
EntityAverage annual cost (million) (2022-2026) 2
1 Based on the scope of small-system monitoring described in AWIA.
2 Totals may not equal the sum of components due to rounding.
3 Labor costs pertain to PWSs, states, and EPA. Costs include activities such as reading the final rule, notifying systems selected to participate, sample collection, data review, reporting, and record keeping.
4 Non-labor costs will be incurred primarily by EPA and by large and very large PWSs. They include the cost of shipping samples to laboratories for testing and the cost of the laboratory analyses.
5 For a typical UCMR program that involves the expanded scope prescribed by AWIA, EPA estimates an average annual cost to the agency of $17M/year (over a 5-year cycle) ($2M/year for the representative sample of 800 PWSs serving between 25 and 3,299 people and $15M/year for all PWSs serving between 3,300 and 10,000 people). The projected cost to EPA for UCMR 5 implementation is lower than for a typical UCMR program because of lower sample analysis expenses. Those lower expenses are a result of analytical method efficiencies ( i.e., being able to monitor for 30 chemicals with only three analytical methods).
Small PWSs (25-10,000), including labor 3 only (non-labor costs 4 paid for by EPA)$0.3
Large PWSs (10,001-100,000), including labor and non-labor costs7.0
Very Large PWSs (100,001 and greater), including labor and non-labor costs2.2
States, including labor costs related to implementation coordination0.8
EPA, including labor for implementation and non-labor for small system testing5 10.5
Average Annual National Total20.8

Additional details regarding EPA's cost assumptions and estimates can be found in the Information Collection Request (ICR) (USEPA, 2021b), ICR Number 2040-0304, which presents estimated cost and labor hours for the 5-year UCMR 5 period of 2022-2026. Copies of the ICR may be obtained from the EPA public docket for this final rule under Docket ID No. EPA-HQ-OW-2020-0530.

2. What are the benefits of this action?

The public benefits from the information about whether or not unregulated contaminants are present in their drinking water. If contaminants are not found, consumer confidence in their drinking water should improve. If contaminants are found, related health effects may be avoided when subsequent actions, such as regulations, are implemented, reducing or eliminating those contaminants.

II. Public Participation

A. What meetings have been held in preparation for UCMR 5?

EPA held three public meetings on UCMR 5 over the period of 2018 through 2021. EPA held a meeting focused on drinking water methods for unregulated contaminants on June 6, 2018, in Cincinnati, Ohio. Representatives from state agencies, laboratories, PWSs, environmental organizations, and drinking water associations joined the meeting via webinar and in person. Meeting topics included an overview of regulatory process elements (including the Contaminant Candidate List (CCL), UCMR, and Regulatory Determination), and drinking water methods under development (see USEPA, 2018 for presentation materials). EPA held a second meeting on July 16, 2019, in Cincinnati, Ohio. Representatives from State agencies, Tribes, laboratories, PWSs, environmental organizations, and drinking water associations participated in the meeting via webinar and in person. Meeting topics included the impacts of AWIA, analytical methods and contaminants being considered by EPA, potential sampling design, and other possible aspects of the UCMR 5 approach (see USEPA, 2019a for meeting materials). EPA held two identical virtual meetings on April 6 and 7, 2021, during the public comment period for the proposed rule (see USEPA, 2021c for presentation materials). Topics included the proposed UCMR 5 monitoring requirements, analyte selection and rationale, analytical methods, the laboratory approval process, and ground water representative monitoring plans (GWRMPs). Representatives of state agencies, laboratories, PWSs, environmental organizations, and drinking water associations participated in the meeting via webinar. In Section II.B of this preamble, the agency is announcing additional meetings to be held in 2022, which will assist with implementation.

B. How do I participate in the upcoming meetings?

EPA will hold multiple virtual meetings during 2022 to discuss UCMR 5 implementation planning, data reporting using Safe Drinking Water Accession and Review System (SDWARS), and best practices for sample collection. Dates and times of the upcoming meetings will be posted on EPA's website at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials. EPA anticipates hosting the meetings focused on implementation planning in spring 2022, and the SDWARS and sample-collection meetings in fall 2022. Stakeholders who have participated in past UCMR meetings and/or those who register to use SDWARS will receive notification of these events. Other interested stakeholders are also welcome to participate.

1. Meeting Participation

Those who wish to participate in the public meetings, via webinar, can find information on how to register at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials. The number of webinar connections available for the meetings are limited and will be available on a first-come, first-served basis. If stakeholder interest results in exceeding the maximum number of available connections for participants in upcoming webinar offerings, EPA may schedule additional webinars, with dates and times posted on EPA's Unregulated Contaminant Monitoring Program Meetings and Materials web page at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.

2. Meeting Materials

EPA expects to send meeting materials by email to all registered participants prior to the meeting. The materials will be posted on EPA's website at https://www.epa.gov/dwucmr/unregulated-contaminant- monitoring-rule-ucmr-meetings-and-materials for people who do not participate in the webinar.

III. General Information

A. How are CCL, UCMR, Regulatory Determination process, and NCOD interrelated?

Under the 1996 amendments to SDWA, Congress established a multi-step, risk-based approach for determining which contaminants would become subject to drinking water standards. Under the first step, EPA is required to publish a CCL every five years that identifies contaminants that are not subject to any proposed or promulgated drinking water regulations, are known or anticipated to occur in PWSs, and may require future regulation under SDWA. EPA published the draft CCL 5 in the Federal Register on July 19, 2021 (86 FR 37948, July 19, 2021 (USEPA, 2021d)). Under the second step, EPA must require, every five years, monitoring of unregulated contaminants as described in this action. The third step requires EPA to determine, every five years, whether or not to regulate at least five contaminants from the CCL. Under Section 1412(b)(1)(A) of SDWA, EPA regulates a contaminant in drinking water if the Administrator determines that:

(1) The contaminant may have an adverse effect on the health of persons;

(2) The contaminant is known to occur or there is substantial likelihood that the contaminant will occur in PWSs with a frequency and at levels of public health concern; and

(3) In the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by PWSs.

For the contaminants that meet all three criteria, SDWA requires EPA to publish national primary drinking water regulations (NPDWRs). Information on the CCL and the regulatory determination process can be found at: https://www.epa.gov/ccl.

The data collected through the UCMR program are made available to the public through the National Contaminant Occurrence Database (NCOD) for drinking water. EPA developed the NCOD to satisfy requirements in SDWA Section 1445(g), to assemble and maintain a drinking water contaminant occurrence database for both regulated and unregulated contaminants in drinking water systems. NCOD houses data on unregulated contaminant occurrence; data from EPA's “Six-Year Review” of national drinking water regulations; and ambient and/or source water data. Section 1445(g)(3) of SDWA requires that EPA maintain UCMR data in the NCOD and use the data when evaluating the frequency and level of occurrence of contaminants in drinking water at a level of public health concern. UCMR results can be viewed by the public via NCOD ( https://www.epa.gov/sdwa/national-contaminant-occurrence-database-ncod ) or via the UCMR web page at: https://www.epa.gov/dwucmr.

B. What are the Consumer Confidence Reporting and Public Notice Reporting requirements for public water systems that are subject to UCMR?

In addition to reporting UCMR monitoring data to EPA, PWSs are responsible for presenting and addressing UCMR results in their annual Consumer Confidence Reports (CCRs) (40 CFR 141.153) and must address Public Notice (PN) requirements associated with UCMR (40 CFR 141.207). More details about the CCR and PN requirements can be viewed by the public at: https://www.epa.gov/ccr and https://www.epa.gov/dwreginfo/public-notification-rule, respectively.

C. What is the UCMR 5 timeline?

This final rule identifies a UCMR 5 sampling period of 2023 to 2025. Prior to 2023 EPA will coordinate laboratory approval, tentatively select representative small systems (USEPA, 2021a), organize Partnership Agreements, develop State Monitoring Plans (see Section III.D of this preamble), establish monitoring schedules and inventory, and conduct outreach and training. Exhibit 2 of this preamble illustrates the major activities that EPA expects will take place in preparation for and during the implementation of UCMR 5.

BILLING CODE 6560-50-P



BILLING CODE 6560-50-C

D. What is the role of “States” in UCMR?

UCMR is a direct implementation rule ( i.e., EPA has primary responsibility for its implementation) and state participation is voluntary. Under the previous UCMR cycles, specific activities that individual states agreed to carry out or assist with were identified and established exclusively through Partnership Agreements. Through Partnership Agreements, states can help EPA implement UCMR and help ensure that the UCMR data are of the highest quality possible to best support the agency decision making. Under UCMR 5, EPA will continue to use the Partnership Agreement process to determine and document the following: The process for review and revision of the State Monitoring Plans; replacing and updating PWS information, including inventory ( i.e., PWS identification codes (PWSID), facility identification code along with associated facility types and water source type, etc.); review of proposed GWRMPs; notification and instructions for systems; and compliance assistance. EPA recognizes that states often have the best information about their PWSs and encourages them to partner in the UCMR 5 program.

E. How did EPA consider Children's Environmental Health?

By monitoring for unregulated contaminants that may pose health risks via drinking water, UCMR furthers the protection of public health for all citizens, including children. Children consume more water per unit of body weight compared to adults. Moreover, formula-fed infants drink a large amount of water compared to their body weight; thus, children's exposure to contaminants in drinking water may present a disproportionate health risk (USEPA, 2011). The objective of UCMR 5 is to collect nationally representative drinking water occurrence data on unregulated contaminants for future regulatory consideration. Information on the prioritization process, as well as contaminant-specific information ( e.g., source, use, production, release, persistence, mobility, health effects, and occurrence), that EPA used to select the analyte list, is contained in “Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021e), available in the UCMR 5 public docket.

Since this is a final rule to monitor for contaminants and not to reduce their presence in drinking water to an acceptable level, the rule does not concern environmental health or safety risks presenting a disproportionate risk to children that would be addressed by this action (See Section V.G Executive Order 13045 of this preamble). Therefore, Executive Order 13045 does not apply to UCMR. However, EPA's Policy on Evaluating Health Risks to Children, which ensures that the health of infants and children is explicitly considered in the agency's decision making, is applicable, see: https://www.epa.gov/children/epas-policy-evaluating-risk-children.

EPA considered children's health risks during the development of UCMR 5. This included considering public comments about candidate contaminant priorities. Many commenters supported the agency's inclusion of PFAS and lithium in UCMR 5. Some commenters requested that EPA consider children and infant health risks in its risk communication for UCMR 5.

Using quantitation data from multiple laboratories, EPA establishes statistically-based UCMR reporting levels the agency considers feasible for the national network of approved drinking water laboratories. EPA generally sets the reporting levels as low as is technologically practical for measurement by that national network of laboratories, even if that level is well below concentrations that are currently associated with known or suspected health effects. In doing so, EPA positions itself to better address contaminant risk information in the future, including that associated with unique risks to children.

F. How did EPA address Environmental Justice (EJ)?

EPA has concluded that this action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard (see Section V.J Executive Order 12898 of this preamble). EPA Administrator Regan issued a directive to all EPA staff to incorporate environmental justice (EJ) into the agency's work, including regulatory activities, such as integrating EJ considerations into the regulatory development processes and considering regulatory options to maximize benefits to communities that “continue to suffer from disproportionately high pollution levels and the resulting adverse health and environmental impacts.” In keeping with this directive, and consistent with AWIA, EPA will, subject to the availability of sufficient appropriations, expand UCMR 5 to include all PWSs serving between 3,300 and 10,000 people as described in Sections I.A.4 and IV.B of this preamble. If there are sufficient appropriations, the expansion in the number of participating PWSs will provide a more comprehensive assessment of contaminant occurrence data from small and rural communities, including disadvantaged communities.

By developing a national characterization of unregulated contaminants that may pose health risks via drinking water from PWSs, UCMR furthers the protection of public health for all citizens. If EPA receives the needed appropriations, the expansion in monitoring scope reflected in UCMR 5 ( i.e., including all PWSs serving 3,300 to 10,000 people) will better support state and regional analyses and determination of potential EJ-related issues that need to be addressed. EPA structured the UCMR 5 rulemaking process to allow for meaningful involvement and transparency. EPA organized public meetings and webinars to share information regarding the development and implementation of UCMR 5; consulted with Tribal governments; and convened a workgroup that included representatives from several states. EPA will support stakeholder interest in UCMR 5 results by making them publicly available, as described in Section III.A of this preamble, and by developing additional risk-communication materials to help individuals and communities understand the significance of contaminant occurrence.

EPA received multiple comments on environmental justice considerations. Commenters expressed support for the continued collection of U.S. Postal Service Zip Codes for each PWS's service area and requested that EPA provide multilingual UCMR materials. EPA will continue to collect Zip Codes for UCMR 5, as collected under UCMR 3 and UCMR 4, to support potential assessments of whether or not certain communities are disproportionately impacted by particular drinking water contaminants. EPA also intends to develop the sampling instructions, fact sheets, and data summaries in both English and Spanish.

G. How did EPA coordinate with Indian Tribal Governments?

EPA has concluded that this action has Tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized Tribal governments, nor preempt Tribal law. (See section V.F Executive Order 13175 of this preamble).

EPA consulted with Tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this action to ensure meaningful and timely input into its development. EPA initiated the Tribal consultation and coordination process before proposing the rule by mailing a “Notification of Consultation and Coordination” letter on June 26, 2019, to the Tribal leadership of the then 573 federally recognized Tribes. The letter invited Tribal leaders and representatives of Tribal governments to participate in an August 6, 2019, UCMR 5 Tribal consultation and coordination informational meeting. Presentation topics included an overview of the UCMR program, potential approaches to monitoring and implementation for UCMR 5, and the UCMR 5 contaminants and analytical methods under consideration. After the presentation, EPA provided an opportunity for input and questions on the action. Eight representatives from five Tribes attended the August meeting. Tribal representatives asked clarifying questions regarding program costs to PWSs and changes in PWS participation per AWIA. EPA addressed the questions during the meeting. Following the meeting, EPA received and addressed one additional clarifying question from a Tribal representative during the Tribal consultation process. No other Tribal representatives submitted written comments during the UCMR 5 consultation comment period that ended September 1, 2019.

Prior to the August 2019 meeting, EPA provided additional opportunities for Tribal officials to provide meaningful and timely input into the development of the proposed rule. On July 10, 2019, EPA participated in a monthly conference call with the National Tribal Water Council (NTWC). EPA shared a brief summary of UCMR statutory requirements with the Council and highlighted the upcoming official Tribal meeting. EPA also invited Tribal leaders and representatives to participate in a public meeting, held on July 16, 2019, to discuss the development of the proposed rule. Representatives from six Tribes participated in the public meeting. Following the publication of the proposal, EPA advised the Indian Health Services of the 60-day public comment period to assist with facilitating additional Tribal comments on the proposed rule. EPA received no public comments from Tribal officials.

A complete summary of the consultation, titled, “Summary of the Tribal Coordination and Consultation Process for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” is provided in the UCMR 5 public docket listed in the ADDRESSES section of this preamble.

H. How are laboratories approved for UCMR 5 analyses?

Consistent with prior UCMRs, this action maintains the requirement that PWSs use laboratories approved by EPA to analyze UCMR 5 samples. Interested laboratories are encouraged to apply for EPA approval as early as possible. The UCMR 5 laboratory approval process, which began with the publication of the UCMR 5 proposal, is designed to assess whether laboratories possess the required equipment and can meet laboratory-performance and data-reporting criteria described in this action.

EPA expects demand for laboratory support to increase significantly based on the greater number of PWSs expected to participate in UCMR 5. EPA anticipates that the number of participating small water systems will increase from the typical 800 to approximately 6,000 (see Exhibit 5 in Section IV.B of this preamble). In preparation for this increase, EPA will solicit proposals and award contracts to laboratories to support small system monitoring prior to the end of the proficiency testing (PT) program. As in previous UCMR programs, EPA expects that laboratories awarded contracts by EPA will be required to first be approved to perform all methods. The requirements for the laboratory approval process are described in steps 1 through 6 of the following paragraphs.

EPA will require laboratories seeking approval to: (1) Provide EPA with data documenting an initial demonstration of capability (IDC) as outlined in each method; (2) verify successful performance at or below the minimum reporting levels (MRLs) as specified in this action; (3) provide information about laboratory standard operating procedures (SOPs); and (4) participate in two EPA PT studies for the analytes of interest. Audits of laboratories may be conducted by EPA prior to and/or following approval, and maintaining approval is contingent on timely and accurate reporting. The “UCMR 5 Laboratory Approval Manual” (USEPA, 2021f), available in the UCMR 5 public docket, provides more specific guidance on EPA laboratory approval program and the specific method acceptance criteria. EPA has included sample-collection procedures that are specific to the methods in the “UCMR 5 Laboratory Manual,” and will address these procedures in our outreach to the PWSs that will be collecting samples.

The UCMR 5 laboratory approval program will provide an assessment of the ability of laboratories to perform analyses using the methods listed in 40 CFR 141.40(a)(3), Table 1 of this preamble. Laboratory participation in the program is voluntary. However, as in the previous UCMRs, EPA will require PWSs to exclusively use laboratories that have been approved under the program. EPA will post a list of approved UCMR 5 laboratories to https://www.epa.gov/dwucmr and will bring this to the attention of the PWSs in our outreach.

1. Request To Participate

Laboratories interested in the UCMR 5 laboratory approval program first email EPA at: UCMR_Lab_Approval@epa.gov to request registration materials. EPA began accepting requests beginning with the publication of the proposal in the Federal Register .

2. Registration

Laboratory applicants provide registration information that includes laboratory name, mailing address, shipping address, contact name, phone number, email address, and a list of the UCMR 5 methods for which the laboratory is seeking approval. This registration step provides EPA with the necessary contact information and ensures that each laboratory receives a customized application package.

3. Application Package

Laboratory applicants will complete and return a customized application package that includes the following: IDC data, including precision, accuracy, and results of MRL studies; information regarding analytical equipment and other materials; proof of current drinking water laboratory certification (for select compliance monitoring methods); method-specific SOPs; and example chromatograms for each method under review.

As a condition of receiving and maintaining approval, the laboratory must promptly post UCMR 5 monitoring results and quality control data that meet method criteria (on behalf of its PWS clients) to EPA's UCMR electronic data reporting system, SDWARS.

Based on the January 1, 2023 start for UCMR 5 sample collection, the deadline for a laboratory to submit the necessary registration and application information is August 1, 2022.

4. EPA's Review of Application Package

EPA will review the application packages and, if necessary, request follow-up information. Laboratories that successfully complete the application process become eligible to participate in the UCMR 5 PT program.

5. Proficiency Testing

A PT sample is a synthetic sample containing a concentration of an analyte or mixture of analytes that is known to EPA, but unknown to the laboratory. To be approved, a laboratory must meet specific acceptance criteria for the analysis of a UCMR 5 PT sample(s) for each analyte in each method, for which the laboratory is seeking approval. EPA offered three PT studies between publication of the proposed rule and final rule, and anticipates offering at least two additional studies. Interested laboratories must participate in and report data for at least two PT studies. This allows EPA to collect a robust dataset for PT results, and provides laboratories with extra analytical experience using UCMR 5 methods. Laboratories must pass a PT for every analyte in the method to be approved for that method and may participate in multiple PT studies in order to produce passing results for each analyte. EPA has taken this approach in UCMR 5, recognizing that EPA Method 533 contains 25 analytes. EPA does not expect to conduct additional PT studies after the start of PWS monitoring; however, EPA expects to conduct laboratory audits (remote and/or on-site) throughout the implementation of UCMR 5 on an as needed and/or random basis. Initial laboratory approval is contingent on successful completion of PT studies, which includes properly uploading the PT results to SDWARS. Continued laboratory approval is contingent on successful completion of the audit process and satisfactorily meeting all the other stated conditions.

6. Written EPA Approval

For laboratories that have already successfully completed steps 1 through 5, EPA sent the laboratory a notification letter listing the methods for which approval was “pending” ( i.e., pending promulgation of this final rule). Because no changes have been made to the final rule that impact the laboratory approval program, laboratories that received pending-approval letters will be notified of full approval without further action on their part. Approval actions for additional laboratories that successfully complete steps 1 through 5 will also be documented by EPA in writing.

I. What documents are being incorporated by reference?

The following methods are being incorporated by reference into this section for UCMR 5 monitoring. All method material is available for inspection electronically at https://www.regulations.gov (Docket ID No. EPA-HQ-OW-2020-0530), or from the sources listed for each method. The methods that may be used to support monitoring under this final rule are as follows:

1. Methods From the U.S. Environmental Protection Agency

The following methods are available at EPA's Docket No. EPA-HQ-OW-2020-0530.

(i) EPA Method 200.7 “Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Revision 4.4, 1994. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma. This is an EPA method for the analysis of metals and trace elements in water by ICP-AES and may be used to measure lithium during UCMR 5. See also the discussion of non-EPA alternative methods for lithium in this section.

(ii) EPA Method 533 “Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” November 2019, EPA 815-B-19-020. Available at https://www.epa.gov/dwanalyticalmethods/analytical-methods-developed-epa-analysis-unregulated-contaminants. This is an EPA method for the analysis PFAS in drinking water using SPE and LC/MS/MS and is to be used to measure 25 PFAS during UCMR 5 (11Cl-PF3OUdS, 8:2 FTS, 4:2 FTS, 6:2 FTS, ADONA, 9Cl-PF3ONS, HFPO-DA (GenX), NFDHA, PFEESA, PFMPA, PFMBA, PFBS, PFBA, PFDA, PFDoA, PFHpS, PFHpA, PFHxS, PFHxA, PFNA, PFOS, PFOA, PFPeS, PFPeA, and PFUnA).

(iii) EPA Method 537.1 “Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS),” Version 2.0, March 2020, EPA/600/R-20/006. Available at https://www.epa.gov/dwanalyticalmethods/analytical-methods-developed-epa-analysis-unregulated-contaminants. This is an EPA method for the analysis of PFAS in drinking water using SPE and LC/MS/MS and is to be used to measure four PFAS during UCMR 5 (NEtFOSAA, NMeFOSAA, PFTA, and PFTrDA).

2. Alternative Methods From American Public Health Association—Standard Methods (SM)

The following methods are from American Public Health—Standard Methods (SM), 800 I Street NW, Washington, DC 20001-3710.

(i) “Standard Methods for the Examination of Water & Wastewater,” 23rd edition (2017).

(a) SM 3120 B, “Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method.” This is a Standard Method for the analysis of metals in water and wastewater by emission spectroscopy using ICP and may be used for the analysis of lithium.

(ii) “Standard Methods Online,” approved 1999. Available for purchase at https://www.standardmethods.org.

(a) SM 3120 B, “Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method, Standard Methods Online,” revised December 14, 2020. This is a Standard Method for the analysis of metals in water and wastewater by emission spectroscopy using ICP and may be used for the analysis of lithium.

3. Methods From ASTM International

The following methods are from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.

(i) ASTM D1976-20, “Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy,” approved May 1, 2020. Available for purchase at https://www.astm.org/Standards/D1976.htm. This is an ASTM method for the analysis of elements in water by ICP-AES and may be used to measure lithium.

IV. Description of Final Rule and Summary of Responses to Public Comments

EPA published “Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meeting;” Proposed Rule, on March 11, 2021 (86 FR 13846, (USEPA, 2021g)). The UCMR 5 proposal identified three EPA analytical methods, and multiple alternative methods, to support water system monitoring for 30 UCMR 5 contaminants (29 PFAS and lithium) and detailed other potential changes relative to UCMR 4. Among the other changes reflected in the UCMR 5 proposal were the following: Requirement for water systems serving 3,300 to 10,000 people to monitor per AWIA requirements “subject to the availability of appropriations”; provisions for sampling frequency, timing, and locations; submission timeframe for GWRMPs; data reporting timeframes; and reporting requirements.

EPA received 75 sets of comments from 72 public commenters, including other federal agencies, state and local governments, utilities and utility stakeholder organizations, laboratories, academia, non-governmental organizations, and other interested stakeholders. After considering the comments, EPA developed the final UCMR 5 as described in Exhibit 3 of this preamble. Except as noted, the UCMR 5 final rule approach is consistent with the proposed rule. A track-changes version of the rule language, comparing UCMR 4 to UCMR 5, (“Revisions to 40 CFR 141.35 and 141.40” (USEPA, 2021h)), is included in the electronic docket listed in the ADDRESSES section of this preamble.

This section summarizes key aspects of this final rule and the associated comments received in response to the proposed rule. EPA has compiled all public comments and EPA's responses in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

Exhibit 3—Key Elements of Final UCMR 5
NumberTitle
CFR rule sectionDescription of sectionCorresponding preamble section
NumberTitle
40 CFR 141.40(a)(3)Contaminants in UCMR 5Maintains proposed list of 29 PFAS and lithium for monitoringIV.A
40 CFR 141.35(d), 40 CFR 141.40(a)(2)(ii), and 40 CFR 141.40(a)(4)(ii)Scope of UCMR 5 applicabilityRevises the scope of UCMR 5 to reflect that small CWSs and NTNCWSs serving 25 to 10,000 people will monitor (consistent with AWIA), if they are notified by the agencyIV.B
40 CFR 141.40(a)(i)(B)Sampling frequency and timingMaintains proposed sample frequency (four sample events for SW, two sample events for GW)IV.C
40 CFR 141.35(c)(3)Sampling locations and Ground Water Representative Monitoring Plans (GWRMPs)Maintains proposed flexibility for PWSs to submit a GWRMP proposal to EPAIV.D
40 CFR 141.35(c)(6)(ii) and 40 CFR 141.40(a)(5)(vi)Reporting timeframeMaintains proposed timeframe (“within 90 days from the sample collection date”) for laboratories to post and approve analytical results in EPA's electronic data reporting system (for review by the PWS). Maintains proposed timeframe (“30 days from when the laboratory posts the data to EPA's electronic data reporting system”) for PWSs to review, approve, and submit data to the state and EPAIV.E
40 CFR 141.35(e)Reporting requirementsRemoves one proposed data element, maintains 27 proposed data elements, and clarifies the use of state dataIV.F
40 CFR 141.40(a)(3)Minimum reporting levels (MRL)Maintains proposed MRLs for contaminantsIV.G

A. What contaminants must be monitored under UCMR 5?

1. This Final Rule

EPA is maintaining the proposed list of UCMR 5 contaminants and the methods associated with analyzing those contaminants (see Exhibit 4 of this preamble). Further information on the prioritization process, as well as contaminant-specific information ( e.g., source, use, production, release, persistence, mobility, health effects, and occurrence), that EPA used to select the analyte list, is contained in “Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021e). This Information Compendium can be found in the electronic docket listed in the ADDRESSES section of this preamble.

Exhibit 4—UCMR 5 Analytes
1 EPA Method 533 (Solid phase extraction (SPE) liquid chromatography/tandem mass spectrometry (LC/MS/MS)) (USEPA, 2019b).
2 EPA Method 537.1 Version 2.0 (Solid phase extraction (SPE) liquid chromatography/tandem mass spectrometry (LC/MS/MS)) (USEPA, 2020).
3 EPA Method 200.7 (Inductively coupled plasma-atomic emission spectrometry (ICP-AES)) (USEPA, 1994).
4 Standard Methods (SM) 3120 B (SM, 2017) or SM 3120 B-99 (SM Online, 1999).
5 ASTM International (ASTM) D1976-20 (ASTM, 2020).
Twenty-five Per- and Polyfluoroalkyl Substances (PFAS) using EPA Method 533 (SPE LC/MS/MS):
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS)perfluorodecanoic acid (PFDA).
1H, 1H, 2H, 2H-perfluorodecane sulfonic acid (8:2 FTS)perfluorododecanoic acid (PFDoA).
1H, 1H, 2H, 2H-perfluorohexane sulfonic acid (4:2 FTS)perfluoroheptanesulfonic acid (PFHpS).
1H, 1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS)perfluoroheptanoic acid (PFHpA).
4,8-dioxa-3H-perfluorononanoic acid (ADONA)perfluorohexanesulfonic acid (PFHxS).
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS)perfluorohexanoic acid (PFHxA).
hexafluoropropylene oxide dimer acid (HFPO-DA) (GenX)perfluorononanoic acid (PFNA).
nonafluoro‐3,6‐dioxaheptanoic acid (NFDHA)perfluorooctanesulfonic acid (PFOS).
perfluoro (2‐ethoxyethane) sulfonic acid (PFEESA)perfluorooctanoic acid (PFOA).
perfluoro‐3‐methoxypropanoic acid (PFMPA)perfluoropentanesulfonic acid (PFPeS).
perfluoro‐4‐methoxybutanoic acid (PFMBA)perfluoropentanoic acid (PFPeA).
perfluorobutanesulfonic acid (PFBS)perfluoroundecanoic acid (PFUnA).
perfluorobutanoic acid (PFBA)
Four Per- and Polyfluoroalkyl Substances (PFAS) using EPA Method 537.1 (SPE LC/MS/MS):
n-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA)perfluorotetradecanoic acid (PFTA).
n-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA)perfluorotridecanoic acid (PFTrDA).
One Metal/Pharmaceutical using EPA Method 200.7 (ICP-AES)or alternate SMor ASTM:
lithium

2. Summary of Major Comments and EPA Responses

Those who expressed an opinion about the proposed UCMR 5 analytes were supportive of EPA's inclusion of the 29 PFAS and lithium. Commenters expressed mixed opinions on the consideration of additional contaminants, particularly “aggregate PFAS,” Legionella pneumophilia, haloacetonitriles, and 1,2,3-trichloropropane. The major comments and EPA responses regarding these contaminants are summarized in the discussion that follows.

a. Aggregate PFAS Measure

EPA received multiple comments encouraging the agency to validate and include a total organic fluorine (TOF) and/or total oxidizable precursors (TOP) technique in UCMR 5 as a screening tool to determine “total PFAS.” EPA also received comments expressing concern for the limitations of the analytical methodologies, including a lack of sensitivity and specificity for PFAS using TOF.

EPA has not identified a complete, validated, peer-reviewed aggregate PFAS method with the appropriate specificity and sensitivity to support UCMR 5 monitoring. EPA's Office of Water and Office of Research and Development are currently developing and evaluating methodologies for broader PFAS analysis in drinking water, however, the measurement approaches are subject to significant technical challenges. The sensitivity of TOF is currently in the low μg/L range, as opposed to the low ng/L range of interest required for PFAS analysis in drinking water. TOF is also not specific to PFAS. TOP, while focusing on PFAS, is limited to measuring compounds that can be detected by LC/MS/MS and the technique requires two LC/MS/MS analyses; one before oxidation and one after oxidation. EPA is evaluating the TOP approach to understand the degree to which certain precursors are oxidized, and subsequently measurable by LC/MS/MS, as well as the degree to which PFAS that were measured in the pre-oxidation sample are still measured post-oxidation.

EPA is also monitoring progress by commercial laboratories and academia. In 2020 and 2021, EPA contacted commercial laboratories that advertised TOF capability, and these laboratories indicated that they had not yet commercialized the TOF method (see Appendix 4 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble). TOP has been more widely commercialized but is often used as an exploratory tool to estimate precursors.

In summary, there are still analytical challenges leading to uncertainties in the results using the TOF and TOP techniques. More research and method refinement are needed before a peer-reviewed validated method that meets UCMR quality control needs is available to address PFAS more broadly.

b. Legionella Pneumophila

Some comments supported EPA's proposal to not include Legionella pneumophila in UCMR 5, while others encouraged EPA to add it. EPA has decided not to include Legionella pneumophila in the final UCMR 5.

Under EPA's Surface Water Treatment Rule (SWTR), EPA established NPDWRs for Giardia, viruses, Legionella, turbidity and heterotrophic bacteria and set maximum contaminant level goals of zero for Giardia lamblia, viruses and Legionella pneumophila (54 FR 27486, June 29, 1989 (USEPA, 1989)). EPA is currently examining opportunities to enhance protection against Legionella pneumophila through revisions to the suite of Microbial and Disinfection Byproduct (MDBP) rules. In addition to the SWTR, the MDBP suite includes the Stage 1 and Stage 2 Disinfectants and Disinfection Byproduct Rules; the Interim Enhanced Surface Water Treatment Rule; and the Long Term 1 Enhanced Surface Water Treatment Rule.

As stated in the conclusions from EPA's third “Six-Year Review of Drinking Water Standards” (82 FR 3518, January 11, 2017 (USEPA, 2017)), “EPA identified the following NPDWRs under the SWTR as candidates for revision, because of the opportunity to further reduce residual risk from pathogens (including opportunistic pathogens such as Legionella ) beyond the risk addressed by the current SWTR.” In accordance with the dates in the Settlement Agreement between EPA and Waterkeeper Alliance ( Waterkeeper Alliance, Inc. v. U.S. EPA, No. 1:19-cv-00899-LJL (S.D.N.Y. Jun. 1, 2020)), the agency anticipates signing a proposal for revisions to the MDBP rules and a final action on the proposal by July 31, 2024 and September 30, 2027, respectively. EPA has concluded that UCMR 5 data collection for Legionella pneumophila would not be completed in time to meaningfully inform MDBP revision and that UCMR 5 data for Legionella pneumophila would soon lack significance because it would not reflect conditions in water systems after any regulatory revisions become effective (because water quality would be expected to change as a result of PWSs complying with such regulatory revisions).

EPA estimates that Legionella pneumophila monitoring under UCMR 5 would have added $10.5 million in new expenses for large PWSs, $20 million in new expenses for the agency for small system monitoring, and $0.5 million in new expenses for small PWSs and states over the 5-year UCMR period. Because the data would not be available in time to inform MDBP regulatory revisions and because MDBP revisions could change the presence of Legionella pneumophila in drinking water distribution systems ( Legionella occurrence may change, for example, if the required minimum disinfectant residual concentration is higher following MDBP revisions), EPA concluded that the expense of this monitoring is not warranted given the limited utility of the data.

c. Haloacetonitriles

Some commenters agreed with EPA's rationale for not including the four unregulated haloacetonitrile disinfection byproducts (DBPs) in UCMR 5, while others encouraged EPA to include them. EPA has decided not to include haloacetonitrile DBPs in the final UCMR 5.

As was the case with Legionella pneumophila, EPA has concluded that UCMR 5 data collection for haloacetonitriles would not be completed in time to meaningfully inform MDBP revision and that UCMR 5 data would not reflect conditions in water systems after any regulatory revisions become effective (haloacetonitrile occurrence may change, for example, if the required minimum disinfectant residual concentration is higher following MDBP revisions).

As with Legionella pneumophila, inclusion of haloacetonitriles in UCMR 5 would introduce significant monitoring and reporting complexity and cost compared to the sampling design for PFAS and lithium. If haloacetonitriles were to be added to UCMR 5, most of the additional expenses would be borne by large PWSs (for analysis of their samples) and EPA (for analysis of samples from small PWSs). EPA estimates this would result in $13 million in new expenses for large PWSs, $19 million in new expenses for the agency, and $0.5 million in new expenses for small PWSs and states over the 5-year UCMR period.

Because the data would not be available in time to inform MDBP regulatory revisions and because MDBP revisions could change the presence of haloacetonitriles in drinking water distribution systems, EPA concluded that the expense of this monitoring is not warranted given the limited utility of the data.

d. 1,2,3-Trichloropropane

EPA received some comments that support the agency's proposed decision to not include 1,2,3-trichloropropane (1,2,3-TCP) monitoring in UCMR 5, and others recommending that 1,2,3-TCP be included. EPA concluded that appropriate analytical methods are not currently available to support additional UCMR data collection ( i.e., above and beyond the data collection under UCMR 3 (USEPA, 2019c)).

Several commenters suggested that EPA consider analytical methods to monitor for 1,2,3-trichloropropane at lower levels. They suggested, for example, that the agency use California method SRL-524M (California DHS, 2002), which is prescribed by the state for compliance monitoring at 0.005 μg/L (5 ng/L). EPA has reviewed SRL 524M and determined that the associated quality control (QC) and IDC criteria do not meet the EPA's needs for drinking water analysis. See also EPA's “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

Occurrence data collected during UCMR 3 (77 FR 26072, May 2, 2012 (USEPA, 2012)) for 1,2,3-trichloropropane may be found at https://www.epa.gov/dwucmr/occurrence-data-unregulated-contaminant-monitoring-rule#3.

B. What is the UCMR 5 sampling design?

1. This Final Rule

EPA has utilized up to three different tiers of contaminant monitoring, associated with three different “lists” of contaminants, in past UCMRs. EPA designed the monitoring tiers to reflect the availability and complexity of analytical methods, laboratory capacity, sampling frequency, and cost. The Assessment Monitoring tier is the largest in scope and is used to collect data to determine the national occurrence of “List 1” contaminants for the purpose of estimating national population exposure. Assessment Monitoring has been used in the four previous UCMRs to collect occurrence data from all systems serving more than 10,000 people and a representative sample of 800 smaller systems. Consistent with AWIA, the Assessment Monitoring approach was redesigned for UCMR 5 and reflects the plan, subject to additional appropriations being made available for this purpose, that would require all systems serving 3,300 or more people and a representative sample of systems serving 25 to 3,299 people to perform monitoring (USEPA, 2021a). The population-weighted sampling design for the nationally representative sample of small systems (used in previous UCMR cycles to select 800 systems serving 25 to 10,000 people and used in UCMR 5 to select 800 systems serving 25 to 3,299 people) calls for the sample to be stratified by water source type (ground water or surface water), service size category, and state (where each state is allocated a minimum of two systems in its State Monitoring Plan). The allowable margin of error at the 99 percent confidence level is ±1 percent for an expected contaminant occurrence of 1 percent at the national level. Assessment Monitoring is the primary tier used for contaminants and generally relies on analytical methods that use more common techniques that are expected to be widely available. EPA has used an Assessment Monitoring tier for 72 contaminants and contaminant groups over the course of UCMR 1 through UCMR 4. The agency is exclusively requiring Assessment Monitoring in UCMR 5. This monitoring approach yields the most complete set of occurrence data to support EPA's decision making.

2. Summary of Major Comments and EPA Responses

Many commenters expressed support for the increase in small system Assessment Monitoring, with no opposition to the inclusion of all PWSs serving 3,300 to 10,000 people in UCMR 5. The U.S. Small Business Administration asked that EPA clarify small-system responsibilities in the event of inadequate EPA funding to fully support the envisioned monitoring.

Recognizing the uncertainty in funding from year-to-year, the agency will implement a “monitor if notified” approach for PWSs serving 25 to 10,000 people. In 2022, EPA will notify the approximately 6,000 small PWSs tentatively selected for the expanded UCMR 5 (all PWSs serving 3,300 to 10,000 people and a statistically-based, nationally representative set of 800 PWSs serving 25 to 3,299 people) of their anticipated UCMR 5 monitoring requirements; that initial notification will specify that monitoring is conditioned on EPA having sufficient funds and will be confirmed in a second notification. Upon receiving appropriations for a particular year, EPA will determine the number of small PWSs whose monitoring is covered by the appropriations, and notify the included small PWSs of their upcoming requirements at least six months prior to their scheduled monitoring. EPA has made minor edits to 40 CFR 141.35 and 40 CFR 141.40 for consistency with this approach.

Additionally, to ensure that EPA has access to a nationally representative set of small-system data, even in the absence of sufficient appropriations to support the planned monitoring by small systems, a statistically-based nationally representative set of 800 PWSs will also be selected from among the PWSs serving 25 to 10,000 people. An updated description of the statistical approach for the nationally representative samples for UCMR 5 is available in the docket as “Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update” (USEPA 2021a).

To minimize the impact of the final rule on small systems (those serving 25 to 10,000 people), EPA pays for their sample kit preparation, sample shipping fees, and sample analysis. Large systems (those serving more than 10,000 people) pay for all costs associated with their monitoring. Exhibit 5 of this preamble shows a summary of the estimated number of PWSs subject to monitoring.

Exhibit 5—Systems Expected To Participate in UCMR 5 Monitoring
List 1 chemicals
1 EPA pays for all analytical costs associated with monitoring at small systems.
2 Counts for small PWSs serving 3,300-10,000 people are approximate.
3 Large system counts are approximate.
4 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
System size (number of people served)National sample: Assessment monitoring designTotal number of systems per size category
List 1 chemicals
Small Systems1 (25-3,299)800 randomly selected systems (CWSs and NTNCWSs)4 800
Small Systems12 (3,300-10,000)All systems (CWSs and NTNCWSs) subject to the availability of appropriations4 5,147
Large Systems3 (10,001 and over)All systems (CWSs and NTNCWSs)4,364
Total10,311

C. What is the sampling frequency and timing?

1. This Final Rule

This final rule maintains the proposed sampling frequency and timeframe for Assessment Monitoring. On a per-system basis, the anticipated number of samples collected by each system is consistent with sample collection during prior UCMR cycles (although, as described elsewhere in this document, the number of water systems expected to participate in UCMR 5 is significantly greater under this final rule per AWIA). Water systems will be required to collect samples based on the typical UCMR sampling frequency and timeframe as follows: For surface water, ground water under the direct influence of surface water, and mixed locations, sampling will take place for four consecutive quarters over the course of 12 months (total of 4 sampling events). Sampling events will occur three months apart. For example, if the first sample is taken in January, the second will then occur anytime in April, the third will occur anytime in July, and the fourth will occur anytime in October. For ground water locations, sampling will take place twice over the course of 12 months (total of 2 sampling events). Sampling events will occur five to seven months apart. For example, if the first sample is taken in April, the second sample will then occur anytime in September, October, or November.

EPA, in conjunction with the states, will initially determine schedules (year and months of monitoring) for large water systems. Thereafter, large PWSs will have an opportunity to modify this initial schedule for planning purposes or other reasons ( e.g., to spread costs over multiple years, if a sampling location will be closed during the scheduled month of monitoring, etc.). EPA will schedule and coordinate small system monitoring (for PWSs serving 3,300 to 10,000 people and for the nationally representative sample of smaller PWSs) by working closely with partnering states. State Monitoring Plans provide an opportunity for states to review and revise the initial sampling schedules developed by EPA (see discussion of State Monitoring Plans in Section III.D of this preamble).

2. Summary of Major Comments and EPA Responses

EPA received two comments recommending that the agency reduce the sampling frequency for both ground water (GW) and surface water (SW) systems, including a suggestion that UCMR 5 require only one sample per system. EPA concluded that less frequent data collection would affect the integrity of the data and result in insufficient data to fulfill the needs envisioned by the 1996 SDWA Amendments, particularly with regard to supporting the Administrator's regulatory determinations and drinking water regulation development. Maintaining the proposed sampling frequency allows the resulting contaminant data to be analyzed for temporal variability, in addition to between-system variability. These analyses are not possible with a single-sample structure. When making regulatory determinations, EPA evaluates the number of systems (and populations) with means or single measured values above health levels of concern, as both values provide important information.

EPA acknowledges that based on UCMR 3 (77 FR 26072, May 2, 2012 (USEPA, 2012)) data, the correlation between results from multiple sample events can be high; however, the approach suggested by commenters would yield less accurate data for several reasons. EPA's assessment of sampling frequency using UCMR 3 and UCMR 4 data (see Appendix 2 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble) shows that for both SW and GW systems, there are numerous cases where occurrence is notably different between sample events. Focusing first on UCMR 3 results for PWS with SW sources, the number of sample points at which PFOS was measured at or above the MRL was 108 percent greater when considering multiple sample events, versus only considering the first sample event. There were multiple occasions where the results from the first sample event were below the health-based reference concentration while subsequent results were above it. Looking at UCMR 3 results for PWSs with GW sources, PFOS was measured at or above the MRL at 26 percent more sample points in the second sample event relative to the first. Similar to the UCMR 3 results for SW systems, there were multiple occasions where the second result from a GW system exceeded the reference concentration while the first result did not.

Some commenters suggested that between-system variability is much greater for PFAS than within-system variability. While it may be less than between-system variability, within-system variability can still be important. Shifting to a single sample prevents reasonable assessments of within-system variability and limits the ability to observe between-system variability estimates. This would then drastically reduce the ability to characterize uncertainty.

Additionally, although the provisions of AWIA could include the addition of approximately 5,200 more PWSs to UCMR 5 relative to earlier cycles and thus capture more spatial variation in the resulting dataset, it is important to note that spatial variation is different than temporal or seasonal variation. Capturing more of one does not diminish the influence of the others on national occurrence data and reducing the frequency of sampling eliminates the possibility of analyzing the resulting data for temporal variation. In addition, statistical means based on two measurements have considerably less error than a single measurement per system, and provide a more robust dataset for future regulatory decisions. Having more than one sample event also greatly reduces the chance of underestimating the true proportion of occurrence of the contaminant in drinking water ( i.e., exposure).

Regarding monitoring frequency and burden, EPA notes that the agency allows large GW systems the opportunity to reduce monitoring burden by using approved representative entry points (40 CFR 141.35(c)(3)) as described in Section IV.D of this preamble. Representative monitoring plans will result in fewer samples and thus time and cost savings to the PWS. Consecutive systems with multiple connections from a particular wholesaler are also permitted to choose one entry point as representative, thus reducing burden.

D. Where are the sampling locations and what is representative monitoring?

1. This Final Rule

Consistent with past UCMR cycles, sample collection for UCMR 5 contaminants will take place at the entry point to the distribution system (EPTDS). As during past UCMRs and as described in 40 CFR 141.35(c)(3) of this preamble, this final rule will allow large ground water systems (or large surface water systems with ground water sources) that have multiple ground water EPTDSs to request approval to sample at representative monitoring locations rather than at each ground water EPTDS. GWRMPs approved under prior UCMRs may be used for UCMR 5, presuming no significant changes in the configuration of the ground water EPTDSs since the prior approval. Water systems that intend to use a previously approved plan must send EPA a copy of the approval documents received under prior UCMRs from their state (if reviewed by the state) or EPA.

Relative to the rules for prior UCMR cycles, this final rule provides greater flexibility to PWSs in submitting GWRMPs to EPA. Plans must be submitted to EPA six months prior to the PWS's scheduled sample collection, instead of by a specified date; those PWSs scheduled to collect samples in 2024 or 2025 will have significant additional time to develop and propose representative plans. PWSs, particularly those scheduled for sample collection in 2023, are encouraged to submit proposals for a new GWRMP by December 31, 2022, to allow time for review by EPA and, as appropriate, the state. EPA will work closely with the states to coordinate the review of GWRMPs in those cases where such review is part of the state's Partnership Agreement. Changes to inventory data in SDWARS that impact a PWS's representative plan before or during the UCMR sampling period must be reported within 30 days of the change. EPA will collaborate with small systems (particularly those with many ground water locations) to develop a GWRMP when warranted, recognizing that EPA pays for the analysis of samples from small systems.

2. Summary of Major Comments and EPA Responses

EPA received multiple comments regarding GWRMPs and representative sampling for wholesale systems and consecutive connections. Generally, commenters supported the continued use of GWRMPS and the use of previously approved monitoring plans. An additional supporting document, titled, “Instructions for Preparing a Ground Water Representative Monitoring Plan for the Unregulated Contaminant Monitoring Rule,” (USEPA, 2021j) has been placed in the electronic docket listed in the ADDRESSES section of this preamble.

Several commenters recommended that EPA not require monitoring by consecutive systems that purchase 100 percent of their water from wholesale systems that are already subject to UCMR 5 monitoring. They requested that EPA instead require wholesalers to identify the PWSIDs of consecutive systems receiving water from the wholesaler, and that EPA rely on wholesaler monitoring in lieu of monitoring by the consecutive systems. EPA has decided to require monitoring by consecutive systems to conduct monitoring in accordance with UCMR 5. Previous UCMR data demonstrate that wholesalers and purchasers can have different analytical results (see Appendix 3 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble). For example, pairing the results from wholesaler to consecutive connections for 190 manganese results from UCMR 4 (81 FR 92666, December 20, 2016 (USEPA, 2016)), one-third of the results are higher at the wholesaler and one-third of the results are higher at the consecutive connection, with one-third of all results being comparable [±0.4 μg/L]. The agency therefore elected to maintain the proposed approach in which all eligible consecutive systems must monitor, irrespective of monitoring being conducted by the wholesale system from which they purchase drinking water.

E. How long do laboratories and PWSs have to report data?

1. This Final Rule

EPA is maintaining the revised reporting timeframes for laboratories and PWSs as proposed. For UCMR 5, laboratories have 90 days (versus 120 days in prior UCMR cycles) from the sample collection date to post and approve analytical results in SDWARS for PWS review. Large PWSs have 30 days (versus 60 days in prior UCMR cycles) to review and approve the analytical results posted to SDWARS. As with the UCMR 4 requirements, data will be considered approved and available for state and EPA review if the PWS takes no action within their allotted review period.

In the proposed rule for UCMR 5, EPA noted that multiple states have expressed an interest in earlier access to UCMR data (see Docket ID No. EPA-HQ-OW-2020-0530). EPA believes that the shorter timeframes for posting and approving data are feasible and reasonable based on our experience with UCMR reporting to date.

2. Summary of Major Comments and EPA Responses

Commenters generally agreed with the revised timeframes for laboratories to post and approve analytical results in SDWARS. The 90-day laboratory timeframe makes UCMR results more readily available to interested stakeholders and states. Some commenters supported the timely reporting of data by laboratories to ensure that PWSs have adequate time to reconcile QC issues, especially those that may require a PWS to resample. Some expressed concerns that the revised timeframe could be challenging for laboratories. Some suggested that the shorter timeframe be conditioned on consistent functionality and availability of SDWARS.

Commenters generally agreed with the changes in the timeframes for large PWSs to review and approve analytical results posted to SDWARS, though several requested that EPA maintain the 60-day review period.

EPA has observed that many laboratories are routinely posting data to SDWARS within 90 days of sample collection and that many large PWSs are approving and submitting data within 30 days of their laboratory posting the data. Judging by reporting for 2020 monitoring under UCMR 4 (81 FR 92666, December 20, 2016 (USEPA, 2016)), more than 75 percent of laboratories posted and approved data within 90 days, and more than 85 percent of large PWSs who chose to act on their data, did so within 30 days of the laboratory posting it. During UCMR 3 and UCMR 4, less than half of large PWSs chose to actively review and approve their data, as opposed to letting the results default to “approved” status after the review period. The many large PWSs that have routinely chosen to not review and approve their data will not be impacted by the revised timeframe for PWS data review for UCMR 5. See also Appendix 5 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

EPA does not anticipate functionality or availability issues with SDWARS during UCMR 5 but is prepared to make case-by-case exceptions for reporting timeframes should significant issues occur with the reporting system.

F. What are the reporting requirements for UCMR 5?

1. This Final Rule

Today's final rule removes 1 of the proposed data elements (“Direct Potable Reuse Water Information”) and maintains the 27 others described in the proposed rule. EPA has updated some of the data-element definitions for clarity and consistency in the reporting requirements. Please see Table 1 of 40 CFR 141.35(e) of this preamble for the complete list of data elements, definitions and drop-down options that will be provided in the data reporting system.

2. Summary of Major Comments and EPA Responses

a. Data Elements

EPA received multiple comments on the proposed contaminant-specific data elements, with some commenters questioning the quality, reliability, and utility of some of the data that would be provided to the agency per the proposed data element requirements. Several commenters requested that EPA include rationale explaining the intended use of such data. EPA has updated the data elements for clarity ( e.g., clarifying treatment types, and abbreviations for them; adding the treatment option “NMT = not modified after testing”) and has provided additional rationale (including describing how the information could impact regulatory decision making and risk-management strategies) in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), available in the UCMR 5 public docket (see the ADDRESSES section of this preamble). EPA acknowledges the data collected will have some limitations but believes that the collection of the information is still valuable. In addition, EPA notes the modest burden associated with the collection.

b. Reporting State Data

EPA received several comments suggesting that PWSs be permitted to submit occurrence data collected under state-based monitoring, in lieu of conducting UCMR 5 monitoring, to reduce the monitoring burden. In those cases where the monitoring required by a state is aligned with the requirements of UCMR 5, PWSs may be able to conduct PFAS monitoring that meets the needs of their state and UCMR 5, with the understanding that UCMR 5 requirements must be met. This includes the requirement that PFAS samples be analyzed by a UCMR 5-approved laboratory using EPA Method 533 and Method 537.1. EPA offers flexibility for PWSs to reschedule their UCMR 5 monitoring, and PWSs may do so to coordinate it with their state-required monitoring. PWSs wishing to conduct “dual purpose” monitoring ( i.e., concurrently meeting the state and UCMR 5 needs) may contact their state or EPA, as appropriate, if there are questions about whether the state and UCMR 5 requirements are being met.

G. What are the UCMR 5 Minimum Reporting Levels (MRLs) and how were they determined?

1. This Final Rule

EPA is maintaining the proposed minimum reporting levels for the UCMR 5 contaminants. EPA establishes MRLs to ensure consistency in the quality of the information reported to the agency. As defined in 40 CFR 141.40(a)(5)(iii) of this preamble, the MRL is the minimum quantitation level that, with 95 percent confidence, can be achieved by capable analysts at 75 percent or more of the laboratories using a specified analytical method. More detailed explanation of the MRL calculation is in the “Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator” (USEPA, 2010), available at ( https://www.epa.gov/dwanalyticalmethods/lowest-concentration-minimum-reporting-level-lcmrl-calculator ).

EPA requires each laboratory interested in supporting UCMR analyses to demonstrate that they can reliably make quality measurements at or below the established MRL to ensure that high quality results are being reported by participating laboratories. EPA established the proposed MRLs in 40 CFR 141.40(a)(3), Table 1 of this preamble, for each analyte/method by obtaining data from at least three laboratories that performed “lowest concentration minimum reporting level” (LCMRL) studies. The results from these laboratory LCMRL studies can be found in the “UCMR 5 Laboratory Approval Manual” (USEPA, 2021f), available in the electronic docket (see the ADDRESSES section of this preamble).

The multiple laboratory LCMRLs were then processed through a statistical routine to derive an MRL that, with 95 percent confidence, is predicted to be attainable by 75 percent of laboratories using the prescribed method. EPA considers these to be the lowest reporting levels that can practically and consistently be achieved on a national basis (recognizing that individual laboratories may be able to measure at lower levels).

2. Summary of Major Comments and EPA Responses

Some commenters recommended that EPA establish lower MRLs for the 29 PFAS in UCMR 5. MRLs used for the UCMR program are based on calculations that account for the ability of laboratories to report accurate and precise measurements with a specific statistical confidence. Based on the results from multiple laboratories that participated in MRL-setting studies, EPA concluded that the proposed MRLs represent the lowest feasible levels for a national MRL measure. Sensitivity ( i.e., quantitation limit) may improve with time, experience, and instrumentation advances.

H. What are the requirements for laboratory analysis of field reagent blank samples?

1. This Final Rule

EPA initially proposed that laboratories analyze all field reagent blank (FRB) samples, along with the corresponding field samples, to reduce the possibility of invalidating a positive field sample result ( i.e., a field sample result at or above the MRL) because of FRB hold times being exceeded.

2. Summary of Major Comments and EPA Responses

EPA did not receive any comments expressing concerns with the laboratory approval process; however, the agency did receive a comment on the FRB sample analysis criteria, suggesting that the agency not require analysis of every FRB sample. EPA Method 537.1 and Method 533, used for PFAS analysis, require collection of a corresponding FRB sample from each unique sampling location for each sampling event. The methods require that the FRB be analyzed if there is a positive result for a PFAS analyte in a corresponding field sample. Based on further consideration, EPA is now providing laboratories with discretion as to whether they analyze every FRB sample proactively or only those associated with positive field sample results. This is with the understanding that laboratories must analyze field samples promptly enough such that the corresponding FRB analyses, if needed, may be completed within the prescribed hold time. Compliance with the method hold-time requirements, and other provisions of the methods, is a condition of maintaining laboratory approval. EPA is studying the possibility of extending the FRB hold times for EPA Method 537.1 and Method 533, and will communicate the results of the studies with the approved laboratories.

I. How will EPA support risk communication for UCMR 5 results?

EPA received comments requesting that the agency develop and provide risk communication materials to support interpretation and characterization of UCMR 5 results. EPA intends to publish a “reference concentration” summary document with available EPA health values; provide a template for PWSs to consider using in communicating with their customers about the detection of PFAS in drinking water; and provide other supporting material as risk-related information becomes available.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. A full analysis of potential costs associated with this action, the “Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5),” (USEPA, 2021b) ICR Number 2040-0304, is also available in the docket (Docket ID No. EPA-HQ-OW-2020-0530). A summary of the ICR can be found in Section I.C of this preamble.

B. Paperwork Reduction Act (PRA)

The information collection activities in this final rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document (USEPA, 2021b) that EPA prepared has been assigned EPA ICR number ICR 2683.02. You can find a copy of the ICR in the docket for this final rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.

The information that EPA will collect under this final rule fulfills the statutory requirements of Section1445(a)(2) of SDWA, as amended in 1996, 2018, and 2019. The data will describe the source of the water, location, and test results for samples taken from public water systems (PWSs) as described in 40 CFR 141.35(e). The information collected will support EPA's decisions as to whether or not to regulate particular contaminants under SDWA. Reporting is mandatory. The data are not subject to confidentiality protection.

The 5-year UCMR 5 period spans 2022-2026. UCMR 5 sample collection begins in 2023 and continues through 2025. Since ICRs cannot be approved by OMB for a period longer than three years pursuant to 5 CFR 1320.10, the primary analysis in the ICR only covers the first three years of the UCMR 5 period ( i.e., 2022-2024). Prior to expiration of the initial UCMR 5 ICR, EPA will seek to extend the ICR and thus receive approval to collect information under the PRA in the remaining two years of the UCMR 5 period (2025-2026).

EPA received several comments regarding cost and burden of the proposed rule. Those comments recommended that EPA provide more accurate cost estimates. EPA's response is detailed more fully in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.

EPA has reviewed and, as appropriate, revised the cost and burden figures for UCMR 5; this includes using updated unit cost estimates for sample analysis. The annual burden and cost estimates described in this section are based on the implementation assumptions described in Section III of this preamble, among them the inclusion of all systems serving 3,300 to 10,000 people and a representative sample of smaller systems. As such, those estimates represent an upper bound. If EPA does not receive the necessary appropriations in one or more of the collections years—and thus collects data from fewer small systems—the actual costs would be lower than those estimated here. In general, burden hours were calculated by:

1. Determining the activities that PWSs and states would complete to comply with UCMR activity;

2. Estimating the number of hours per activity;

3. Estimating the number of respondents per activity; and

4. Multiplying the hours per activity by the number of respondents for that activity.

Respondents/affected entities: The respondents/affected entities are small PWSs (those serving 25 to 10,000 people); large PWSs (those serving 10,001 to 100,000 people); very large PWSs (those serving more than 100,000 people); and states.

Respondent's obligation to respond: Mandatory (40 CFR 141.35).

Estimated number of respondents: Respondents to UCMR 5 include 5,947 small PWSs, 4,364 large PWSs, and the 56 primacy agencies (50 States, one Tribal nation, and five Territories) for a total of 10,367 respondents.

Frequency of response: The frequency of response varies across respondents and years. Across the initial 3-year ICR period for UCMR 5, small PWSs will sample an average of 2.8 times per PWS ( i.e., number of responses per PWS); large PWSs will sample and report an average of 3.2 times per PWS; and very large PWSs will sample and report an average of 3.7 times per PWS.

Total estimated burden: 48,469 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $9,404,007 annualized capital or operation & maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

For purposes of assessing the impacts of this final rule on small entities, EPA considered small entities to be PWSs serving 25 to 10,000 people. As required by the RFA, EPA proposed using this alternative definition in the Federal Register (63 FR 7606, February 13, 1998 (USEPA, 1998a)), sought public comment, consulted with the Small Business Administration (SBA) Office of Advocacy, and finalized the alternative definition in the Consumer Confidence Reports rulemaking (63 FR 44512, August 19, 1998 (USEPA, 1998b)). As stated in that document, the alternative definition applies to this regulation.

Exhibit 6—Number of Publicly- and Privately-Owned Small Systems Subject to UCMR 5 1
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
2 PWS counts were adjusted to display as whole numbers in each size category.
System size (number of people served)Publicly-ownedPrivately-ownedTotal 2
Ground Water
500 and under42126168
501 to 3,300320121441
3,301 to 10,0002,3345412,875
Subtotal Ground Water2,6967883,484
Surface Water (and Ground Water Under the Direct Influence of Surface Water)
500 and under91120
501 to 3,30012645171
3,301 to 10,0001,7625102,272
Subtotal Surface Water1,8975662,463
Total of Small Water Systems4,5931,3545,947

The basis for the UCMR 5 RFA certification is as follows: For the 5,947 small water systems that EPA anticipates will be affected, per the planned monitoring, the average annual cost for complying with this final rule represents an average of 0.02 percent of system revenues. The average yearly cost to small systems to comply with UCMR 5 over the 5-year period of 2022-2026, is approximately $0.3 million. EPA anticipates that approximately one third of the 5,947 small PWSs will collect samples in each of three years (2023, 2024, and 2025).

PWS costs are attributed to the labor required for reading about UCMR 5 requirements, monitoring, reporting, and record keeping. The estimated average annual burden across the 5-year UCMR 5 implementation period of 2022-2026 is 1.3 hours at $52 per small system. By assuming all costs for laboratory analyses, shipping and quality control for small entities, EPA incurs the entirety of the non-labor costs associated with UCMR 5 small system monitoring, or 96 percent of total small system testing costs. Exhibit 7 and Exhibit 8 of this preamble present the estimated economic impacts in the form of a revenue test for publicly- and privately-owned systems.

Exhibit 7—UCMR 5 Relative Cost Analysis for Small Publicly-Owned Systems [2022-2026] 1
System size (number of people served)Annual number of systems impacted 2Average annual hours per systemAverage annual cost per systemSBREFA criteria- revenue test 3 (%)
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
2 PWS counts were adjusted to display as whole numbers in each size category. Includes the publicly-owned portion of small systems subject to UCMR 5.
3 Costs are presented as a percentage of median annual revenue for each size category.
Ground Water Systems
500 and under81.0$40.650.09
501 to 3,300641.143.370.02
3,301 to 10,0004671.349.920.01
Surface Water (and Ground Water Under the Direct Influence of Surface Water) Systems
500 and under21.454.390.07
501 to 3,300251.456.190.02
3,301 to 10,0003531.557.390.004
Exhibit 8—UCMR 5 Relative Cost Analysis for Small Privately-Owned Systems [2022-2026] 1
System size (number of people served)Annual number of systems impacted 2Average annual hours per systemAverage annual cost per systemSBREFA criteria- revenue test 3 (%)
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people).
2 PWS counts were adjusted to display as whole numbers in each size category. Includes the privately-owned portion of small systems subject to UCMR 5.
3 Costs are presented as a percentage of median annual revenue for each size category.
Ground Water Systems
500 and under251.0$40.650.48
501 to 3,300241.1$43.370.03
3,301 to 10,0001081.3$49.920.004
Surface Water (and Ground Water Under the Direct Influence of Surface Water) Systems
500 and under21.4$54.390.11
501 to 3,30091.4$56.190.02
3,301 to 10,0001021.5$57.390.004

Up to 9.4 percent of all small systems ( i.e., up to 5,947 small PWSs serving 25 to 10,000 people) will participate in UCMR 5 if EPA receives the necessary appropriations to support its plan. EPA has determined that participating small systems will experience an average impact of 0.02 percent of revenues. This accounts for small PWSs familiarizing themselves with the regulatory requirements; reading sampling instructions; traveling to the sampling location; collecting and shipping the samples; and maintaining their records. The 5,947 small PWSs are comprised of all 5,147 systems serving between 3,300 and 10,000 people, and the representative group of 800 systems serving between 25 and 3,299 people; the remainder of small systems will not participate in UCMR 5 monitoring and will not be impacted.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action along with a description of the very minor impacts are previously addressed in this section. Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA has attempted to reduce impacts by assuming all costs for analyses of the samples, and for shipping the samples from small systems to laboratories contracted by EPA to analyze the UCMR 5 samples (the cost of shipping is included in the cost of each analytical method). EPA has historically set aside $2.0 million each year from the Drinking Water State Revolving Fund (DWSRF) with its authority to use DWSRF monies for the purposes of implementing this provision of SDWA. EPA anticipates drawing on these and additional funds, if available, to implement the plan and carry out the expanded UCMR monitoring approach outlined in AWIA. We have therefore concluded that this action will have no significant impact on any directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action implements mandate(s) specifically and explicitly set forth in SDWA Section 1445(a)(2), Monitoring Program for Unregulated Contaminants.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

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

This action has Tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized Tribal governments, nor preempt Tribal law. As described previously in this document, this final rule requires monitoring by all large PWSs. Information in the SDWIS/Fed water system inventory indicates there are approximately 27 large Tribal PWSs (serving 10,001 to 40,000 people). EPA estimates the average annual cost to each of these large PWSs, over the 5-year rule period, to be $1,783. This cost is based on a labor component (associated with the collection of samples), and a non-labor component (associated with shipping and laboratory fees). As planned, UCMR 5 is expected to also require monitoring by all small PWSs serving 3,300 to 10,000 people and a nationally representative sample of small PWSs serving 25 to 3,299 people. Information in the SDWIS/Fed water system inventory indicates there are approximately 75 small Tribal PWSs (serving 3,300 to 10,000 people). EPA estimates that less than 2 percent of small Tribal systems serving 25 to 3,299 people will be selected as part of the nationally representative sample. EPA estimates the average annual cost to small Tribal systems over the 5-year rule period to be $52. Such cost is based on the labor associated with collecting a sample and preparing it for shipping. All other small-PWS expenses (associated with shipping and laboratory fees) are paid by EPA.

EPA consulted with Tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation, titled, “Summary of the Tribal Coordination and Consultation Process for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” is provided in the electronic docket listed in the ADDRESSES section of this preamble.

As required by section 7(a), the EPA's Tribal Consultation Official has certified that the requirements of the executive order have been met in a meaningful and timely manner. A copy of the certification is included in the docket for this action.

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

EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern such an environmental health risk or safety risk.

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

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. This is a national drinking water occurrence study that was submitted to OMB for review.

I. National Technology Transfer and Advancement Act (NTTAA)

This action involves technical standards. EPA has identified options that involve using analytical methods developed by the agency and three major voluntary consensus method organizations to support UCMR 5 monitoring. The voluntary consensus method organizations are Standard Methods for the Examination of Water and Wastewater, and ASTM International. EPA identified acceptable consensus method organization standards for the analysis of lithium. A summary of each method along with how the method specifically applies to UCMR 5 can be found in Section III.I of this preamble.

All of these standards are reasonably available for public use. EPA methods are free for download on the agency's website. The methods in the Standard Methods for the Examination of Water and Wastewater 23rd edition are consensus standards, available for purchase from the publisher, and are commonly used by the drinking water laboratory community. The methods in the Standard Methods Online are consensus standards, available for purchase from the publisher's website, and are commonly used by the drinking water laboratory community. The methods from ASTM International are consensus standards, are available for purchase from the publisher's website, and are commonly used by the drinking water laboratory community.

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

EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. Background information regarding EPA's consideration of Executive Order 12898 in the development of this final rule is provided in Section III.F of this preamble, and an additional supporting document, titled, “Summary of Environmental Justice Considerations for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” has been placed in the electronic docket listed in the ADDRESSES section of this preamble.

K. Congressional Review Act (CRA)

This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

VI. References

(i) ASDWA. 2013. Insufficient Resources for State Drinking Water Programs Threaten Public Health: An Analysis of State Drinking Water Programs' Resources and Needs. December 2013. Available at https://www.asdwa.org/asdwa-reports/.

(ii) ASTM. 2020. ASTM D1976-20— Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy. ASTM, 100 Barr Harbor Drive, West Conshohocken, PA, 19428. Approved May 1, 2020. Available for purchase at https://www.astm.org/Standards/D1976.htm.

(iii) California DHS. 2002. California Department of Health Services. Determination of 1,2,3-Trichloropropane in Drinking Water by Purge and Trap Gas Chromatography/Mass Spectrometry. Division of Drinking Water and Environmental Management, Sanitation and Radiation Laboratories Branch, Berkeley, CA. Available at https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/123-tcp/tcp_by_pt_gcms.pdf.

(iv) Settlement Agreement, Waterkeeper Alliance, Inc. v. U.S. EPA, No. 1:19-cv-00899-LJL (S.D.N.Y. Jun. 1, 2020).

(v) SM. 2017. 3120B—Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method. Standard Methods for the Examination of Water and Wastewater, 23rd edition. American Public Health Association, 800 I Street NW, Washington, DC 20001-3710.

(vi) SM Online. 1999. 3120B-99—Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method (Editorial Revisions, 2020). Standard Methods Online. Available for purchase at http://www.standardmethods.org.

(vii) USEPA. 1989. National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule.Federal Register . Vol. 54, No. 124, p. 27486, June 29, 1989.

(viii) USEPA. 1994. EPA Method 200.7—Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry, Revision 4.4. Office of Research and Development, Cincinnati, OH. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma.

(ix) USEPA. 1998a. National Primary Drinking Water Regulations: Consumer Confidence Reports; Proposed Rule. Federal Register . Vol. 63, No. 30, p. 7606, February 13, 1998.

(x) USEPA. 1998b. National Primary Drinking Water Regulation: Consumer Confidence Reports; Final Rule. Federal Register . Vol. 63, No. 160, p. 44512, August 19, 1998.

(xi) USEPA. 2010. Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator. EPA 815-R-11-001. Office of Water. December 2010. Available at https://www.epa.gov/dwanalyticalmethods.

(xii) USEPA. 2011. Exposure Factors Handbook 2011 Edition (Final Report). U.S. EPA, Washington, DC, EPA/600/R-09/052F. Office of Research and Development, Washington, DC. September 2011. Available at https://www.epa.gov/expobox/about-exposure-factors-handbook.

(xiii) USEPA. 2012. Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems; Final Rule. Federal Register . Vol. 77, No. 85, p. 26072, May 2, 2012.

(xiv) USEPA. 2016. Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems and Announcement of Public Meeting. Federal Register . Vol. 81, No. 244, p. 92666, December 20, 2016.

(xv) USEPA. 2017. National Primary Drinking Water Regulations; Announcement of the Results of EPA's Review of Existing Drinking Water Standards and Request for Public Comment and/or Information on Related Issues. Federal Register . Vol. 82, No. 7, p. 3518, January 11, 2017.

(xvi) USEPA. 2018. Method Development for Unregulated Contaminants in Drinking Water: Public Meeting and Webinar. EPA 815-A-18-001. Office of Water. June 2018. Available at https://www.epa.gov/dwanalyticalmethods.

(xvii) USEPA. 2019a. Development of the Proposed Unregulated Contaminant Monitoring Rule for the Fifth Monitoring Cycle (UCMR 5). Presentation Slides. EPA 815-A-19-001. Office of Water. Available at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.

(xviii) USEPA. 2019b. EPA Method 533—Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry. EPA 815-B-19-020. Office of Water, Cincinnati, OH. November 2019. Available at https://www.epa.gov/dwanalyticalmethods.

(xix) USEPA. 2019c. Appendix C: 1,2,3-Trichloropropane in Regulatory Determination 4 Support Document for Selected Contaminants from the Fourth Drinking Water Contaminant Candidate List (CCL 4). EPA 815-R-19-006. Docket ID EPA-HQ-OW-2019-0583. Available at https://www.regulations.gov.

(xx) USEPA. 2020. EPA Method 537.1—Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS). Version 2.0. EPA/600/R-20/006. Office of Research and Development, Cincinnati, OH. March 2020. Available at https://www.epa.gov/dwanalyticalmethods.

(xxii) USEPA. 2021a. Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update. EPA 815-B-21-012. Office of Water. December 2021.

(xxiii) USEPA. 2021b. Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5). EPA 815-B-21-008. Office of Water. December 2021.

(xxiv) USEPA. 2021c. Revisions to the Unregulated Contaminant Monitoring Rule for the Fifth Monitoring Cycle (UCMR 5): Public Meeting and Webinar. Presentation Slides. EPA 815-A-21-001. Office of Water. April 2021. Available at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.

(xxv) USEPA. 2021d. Drinking Water Contaminant Candidate List 5—Draft. Federal Register . Vol. 86, No. 135 p. 37948, July 19, 2021.

(xxvi) USEPA. 2021e. Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5). EPA 815-B-21-009. Office of Water. December 2021.

(xxvii) USEPA. 2021f. UCMR 5 Laboratory Approval Manual. EPA 815-B-21-010. Office of Water. December 2021.

(xxviii) USEPA. 2021g. Revisions to the Unregulated Contaminant Monitoring Rule for Public Water Systems and Announcement of Public Meeting; Proposed Rule and Notice of Public Meeting. Federal Register . Vol. 86, No. 46, p. 13846, March 11, 2021.

(xxix) USEPA. 2021h. Revisions to 40 CFR 141.35 and 141.40. EPA 815-B-21-011. Office of Water. December 2021. Available in EPA's public docket (under Docket ID No. EPA-HQ-OW-2020-0530) at https://www.regulations.gov.

(xxx) USEPA. 2021i. Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal. EPA 815-R-21-008. Office of Water. December 2021.

(xxi) USEPA. 2021j. Instructions for Preparing a Ground Water Representative Monitoring Plan for the Unregulated Contaminant Monitoring Rule. EPA 815-B-21-013. Office of Water. December 2021.

List of Subjects in 40 CFR Part 141

Environmental protection, Chemicals, Incorporation by reference, Indian—lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply.

Michael S. Regan,

Administrator.

For the reasons set forth in the preamble, EPA amends 40 CFR part 141 as follows:

PART 141—NATIONAL PRIMARY DRINKING WATER REGULATIONS

1. The authority citation for part 141 continues to read as follows:

Authority:

42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

Subpart D—Reporting and Recordkeeping

2. Amend §141.35 as follows:

a. In paragraph (a), revise the fourth sentence;

b. In paragraph (c)(1), remove the text “December 31, 2017” and add, in its place the text “December 31, 2022”;

c. Revise paragraphs (c)(2), (c)(3)(i) through (iii), (c)(4), (c)(5)(i), and (c)(6)(ii);

d. In paragraph (d)(2), revise the first, second, and third sentences; and

f. Revise paragraph (e).

The revisions read as follows:

§141.35 Reporting for unregulated contaminant monitoring results.

(a) * * * For the purposes of this section, PWS “population served” is the retail population served directly by the PWS as reported to the Federal Safe Drinking Water Information System (SDWIS/Fed). * * *

* * * * *

(c) * * *

(2) Sampling location inventory information. You must provide your inventory information by December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. You must submit, verify, or update data elements 1-9 (as defined in Table 1 of paragraph (e) of this section) for each sampling location, or for each approved representative sampling location (as specified in paragraph (c)(3) of this section) regarding representative sampling locations. If this information changes, you must report updates, including new sources, and sampling locations that are put in use before or during the UCMR sampling period, to EPA's electronic data reporting system within 30 days of the change.

(3) * * *

(i) Qualifications. Large PWSs that have EPA- or State-approved representative EPTDS sampling locations from a previous UCMR cycle, or as provided for under 40 CFR 141.23(a)(1), 40 CFR 141.24(f)(1), or 40 CFR 141.24(h)(1), may submit a copy of documentation from your State or EPA that approves your representative sampling plan. PWSs that do not have an approved representative EPTDS sampling plan may submit a proposal to sample at representative EPTDS(s) rather than at each individual EPTDS if: You use ground water as a source; all of your well sources have either the same treatment or no treatment; and you have multiple EPTDSs from the same source ( i.e., same aquifer). You must submit a copy of the existing or proposed representative EPTDS sampling plan, as appropriate, at least six months prior to your scheduled sample collection, as specified in paragraph (b)(1) of this section. If changes to your inventory that impact your representative plan occur before or during the UCMR sampling period, you must report updates within 30 days of the change.

(ii) Demonstration. If you are submitting a proposal to sample at representative EPTDS(s) rather than at each individual EPTDS, you must demonstrate that any EPTDS that you propose as representative of multiple wells is associated with a well that draws from the same aquifer as the wells it will represent. The proposed well must be representative of the highest annual volume and most consistently active wells in the representative array. If that representative well is not in use at the scheduled sampling time, you must select and sample an alternative representative well. You must submit the information defined in Table 1, paragraph (e) of this section for each proposed representative sampling location. You must also include documentation to support your proposal that the specified wells are representative of other wells. This documentation can include system-maintained well logs or construction drawings indicating that the representative well(s) is/are at a representative depth, and details of well casings and grouting; data demonstrating relative homogeneity of water quality constituents ( e.g., pH, dissolved oxygen, conductivity, iron, manganese) in samples drawn from each well; and data showing that your wells are located in a limited geographic area ( e.g., all wells within a 0.5 mile radius) and/or, if available, the hydrogeologic data indicating the ground water travel time between the representative well and each of the individual wells it represents ( e.g., all wells within a five-year time of travel delineation). Your proposal must be sent in writing to EPA, as specified in paragraph (b)(1) of this section.

(iii) Approval. EPA or the State (as specified in the Partnership Agreement reached between the State and EPA) will review your proposal and coordinate any necessary changes with you. Your plan will not be final until you receive written approval from EPA, identifying the final list of EPTDSs where you will be required to monitor.

(4) Contacting EPA if your PWS has not been notified of requirements. If you believe you are subject to UCMR requirements, as defined in 40 CFR 141.40(a)(1) and (a)(2)(i), and you have not been contacted by either EPA or your State by April 26, 2022, you must send a letter to EPA, as specified in paragraph (b)(1) of this section. The letter must be from your PWS Official and must include an explanation as to why the UCMR requirements are applicable to your system along with the appropriate contact information. A copy of the letter must also be submitted to the State as directed by the State. EPA will make an applicability determination based on your letter, and in consultation with the State when necessary and will notify you regarding your applicability status and required sampling schedule. However, if your PWS meets the applicability criteria specified in 40 CFR 141.40(a)(2)(i), you are subject to the UCMR monitoring and reporting requirements, regardless of whether you have been contacted by the State or EPA.

(5) * * *

(i) General rescheduling notification requirements. Large systems may independently change their monitoring schedules up to December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. After this date has passed, if your PWS cannot sample according to your assigned sampling schedule ( e.g., because of budget constraints, or if a sampling location will be closed during the scheduled month of monitoring), you must mail or email a letter to EPA, as specified in paragraph (b)(1) of this section, prior to the scheduled sampling date. You must include an explanation of why the samples cannot be taken according to the assigned schedule, and you must provide the alternative schedule you are requesting. You must not reschedule monitoring specifically to avoid sample collection during a suspected vulnerable period. You are subject to your assigned UCMR sampling schedule or the schedule that you revised on or before December 31, 2022, unless and until you receive a letter from EPA specifying a new schedule.

* * * * *

(6) * * *

(ii) Reporting schedule. You must require your laboratory, on your behalf, to post and approve the data in EPA's electronic data reporting system, accessible at https://www.epa.gov/dwucmr, for your review within 90 days from the sample collection date (sample collection must occur as specified in 40 CFR 141.40(a)(4)). You then have 30 days from when the laboratory posts and approves your data to review, approve, and submit the data to the State and EPA via the agency's electronic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting approved data, the data will be considered approved by you and available for State and EPA review.

* * * * *

(d) * * *

(2) Sampling location inventory information. You must provide your inventory information by December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. If this information changes, you must report updates, including new sources, and sampling locations that are put in use before or during the UCMR sampling period, to EPA's electronic data reporting system within 30 days of the change, as specified in paragraph (b)(1) of this section. * * *

(e) Data elements. Table 1 defines the data elements that must be provided for UCMR monitoring.

Table 1 to Paragraph (e)—Unregulated Contaminant Monitoring Reporting Requirements
Data elementDefinition
1. Public Water System Identification (PWSID) CodeThe code used to identify each PWS. The code begins with the standard 2-character postal State abbreviation or Region code; the remaining 7 numbers are unique to each PWS in the State. The same identification code must be used to represent the PWS identification for all current and future UCMR monitoring.
2. Public Water System NameUnique name, assigned once by the PWS.
3. Public Water System Facility Identification CodeAn identification code established by the State or, at the State's discretion, by the PWS, following the format of a 5-digit number unique within each PWS for each applicable facility (i.e., for each source of water, treatment plant, distribution system, or any other facility associated with water treatment or delivery). The same identification code must be used to represent the facility for all current and future UCMR monitoring.
4. Public Water System Facility NameUnique name, assigned once by the PWS, for every facility ID ( e.g., Treatment Plant).
5. Public Water System Facility TypeThat code that identifies that type of facility as either: CC = Consecutive connection. SS = Sampling station. TP = Treatment plant. OT = Other.
6. Water Source TypeThe type of source water that supplies a water system facility. Systems must report one of the following codes for each sampling location:
SW = Surface water (to be reported for water facilities that are served entirely by a surface water source during the 12-month period).
GU = Ground water under the direct influence of surface water (to be reported for water facilities that are served all or in part by ground water under the direct influence of surface water at any time during the 12-month sampling period), and are not served at all by surface water during this period.
MX = Mixed water (to be reported for water facilities that are served by a mix of surface water, ground water, and/or ground water under the direct influence of surface water during the 12-month period).
GW = Ground water (to be reported for water facilities that are served entirely by a ground water source during the 12-month period).
7. Sampling Point Identification CodeAn identification code established by the State, or at the State's discretion, by the PWS, that uniquely identifies each sampling point. Each sampling code must be unique within each applicable facility, for each applicable sampling location (i.e ., entry point to the distribution system). The same identification code must be used to represent the sampling location for all current and future UCMR monitoring.
8. Sampling Point NameUnique sample point name, assigned once by the PWS, for every sample point ID ( e.g., Entry Point).
9. Sampling Point Type CodeA code that identifies the location of the sampling point as: EP = Entry point to the distribution system.
10. Disinfectant TypeAll of the disinfectants/oxidants that have been added prior to and at the entry point to the distribution system. Please select all that apply:
PEMB = Permanganate.
HPXB = Hydrogen peroxide.
CLGA = Gaseous chlorine.
CLOF = Offsite generated hypochlorite (stored as a liquid form).
CLON = Onsite generated hypochlorite.
CAGC = Chloramine (formed with gaseous chlorine).
CAOF = Chloramine (formed with offsite hypochlorite).
CAON = Chloramine (formed with onsite hypochlorite).
CLDB = Chlorine dioxide.
OZON = Ozone.
ULVL = Ultraviolet light.
OTHD = All other types of disinfectant/oxidant.
NODU = No disinfectant/oxidant used.
11. Treatment InformationTreatment information associated with the sample point. Please select all that apply.
CON = Conventional (non-softening, consisting of at least coagulation/sedimentation basins and filtration).
SFN = Softening.
RBF = River bank filtration.
PSD = Pre-sedimentation.
INF = In-line filtration.
DFL = Direct filtration.
SSF = Slow sand filtration.
BIO = Biological filtration (operated with an intention of maintaining biological activity within filter).
UTR = Unfiltered treatment for surface water source.
GWD = Groundwater system with disinfection only.
PAC = Application of powder activated carbon.
GAC = Granular activated carbon adsorption (not part of filters in CON, SFN, INF, DFL, or SSF).
AIR = Air stripping (packed towers, diffused gas contactors).
POB = Pre-oxidation with chlorine (applied before coagulation for CON or SFN plants or before filtration for other filtration plants).
MFL = Membrane filtration.
IEX = Ionic exchange.
DAF = Dissolved air floatation.
CWL = Clear well/finished water storage without aeration.
CWA = Clear well/finished water storage with aeration.
ADS = Aeration in distribution system (localized treatment).
OTH = All other types of treatment.
NTU = No treatment used.
DKN = Do not know.
12. Sample Collection DateThe date the sample is collected, reported as 4-digit year, 2-digit month, and 2-digit day (YYYYMMDD).
13. Sample Identification CodeAn alphanumeric value up to 30 characters assigned by the laboratory to uniquely identify containers, or groups of containers, containing water samples collected at the same sampling location for the same sampling date.
14. ContaminantThe unregulated contaminant for which the sample is being analyzed.
15. Analytical Method CodeThe identification code of the analytical method used.
16. Extraction Batch Identification CodeLaboratory assigned extraction batch ID. Must be unique for each extraction batch within the laboratory for each method. For CCC samples report the Analysis Batch Identification Code as the value for this field. For methods without an extraction batch, leave this field null.
17. Extraction DateDate for the start of the extraction batch (YYYYMMDD). For methods without an extraction batch, leave this field null.
18. Analysis Batch Identification CodeLaboratory assigned analysis batch ID. Must be unique for each analysis batch within the laboratory for each method.
19. Analysis DateDate for the start of the analysis batch (YYYYMMDD).
20. Sample Analysis TypeThe type of sample collected and/or prepared, as well as the fortification level. Permitted values include: CCCL = MRL level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants.
CCCM = Medium level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants.
CCCH = High level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants.
FS = Field sample; sample collected and submitted for analysis under this final rule.
LFB = Laboratory fortified blank; an aliquot of reagent water fortified with known quantities of the contaminants and all preservation compounds.
LRB = Laboratory reagent blank; an aliquot of reagent water treated exactly as a field sample, including the addition of preservatives, internal standards, and surrogates to determine if interferences are present in the laboratory, reagents, or other equipment.
LFSM = Laboratory fortified sample matrix; a UCMR field sample with a known amount of the contaminant of interest and all preservation compounds added.
LFSMD = Laboratory fortified sample matrix duplicate; duplicate of the laboratory fortified sample matrix.
QCS = Quality control sample; a sample prepared with a source external to the one used for initial calibration and CCC. The QCS is used to check calibration standard integrity.
FRB = Field reagent blank; an aliquot of reagent water treated as a sample including exposure to sampling conditions to determine if interferences or contamination are present from sample collection through analysis.
21. Analytical Result—SignA value indicating whether the sample analysis result was: (<) “less than” means the contaminant was not detected, or was detected at a level below the Minimum Reporting Level. (=) “equal to” means the contaminant was detected at the level reported in “Analytical Result— Measured Value.”
22. Analytical Result—Measured ValueThe actual numeric value of the analytical results for: Field samples; laboratory fortified matrix samples; laboratory fortified sample matrix duplicates; and concentration fortified.
23. Additional ValueRepresents the true value or the fortified concentration for spiked samples for QC Sample Analysis Types (CCCL, CCCM, CCCH, QCS, LFB, LFSM, and LFSMD).
24. Laboratory Identification CodeThe code, assigned by EPA, used to identify each laboratory. The code begins with the standard two-character State postal abbreviation; the remaining five numbers are unique to each laboratory in the State.
25. Sample Event CodeA code assigned by the PWS for each sample event. This will associate samples with the PWS monitoring plan to allow EPA to track compliance and completeness. Systems must assign the following codes:
SE1, SE2, SE3, and SE4—Represent samples collected to meet UCMR Assessment Monitoring requirements; where “SE1” and “SE2” represent the first and second sampling period for all water types; and “SE3” and “SE4” represent the third and fourth sampling period for SW, GU, and MX sources only.
26. Historical Information for Contaminant Detections and TreatmentA yes or no answer provided by the PWS for each entry point to the distribution system. Question: Have you tested for the contaminant in your drinking water in the past? YES = If yes, did you modify your treatment and if so, what types of treatment did you implement? Select all that apply.
PAC = Application of powder activated carbon.
GAC = Granular activated carbon adsorption (not part of filters in CON, SFN, INF, DFL, or SSF).
IEX = Ionic exchange.
NRO = Nanofiltration and reverse osmosis.
OZN = Ozone.
BAC = Biologically active carbon.
MFL = Membrane filtration.
UVL = Ultraviolet light.
OTH = Other.
NMT = Not modified after testing.
NO = Have never tested for the contaminant.
DK = Do not know.
27. Potential PFAS SourcesA yes or no answer provided by the PWS for each entry point to the distribution system. Question: Are you aware of any potential current and/or historical sources of PFAS that may have impacted the drinking water sources at your water system?
YES = If yes, select all that apply:
MB = Military base.
FT = Firefighting training school.
AO = Airport operations.
CW = Car wash or industrial launderers.
PS = Public safety activities ( e.g., fire and rescue services).
WM = Waste management.
HW = Hazardous waste collection, treatment, and disposal.
UW = Underground injection well.
SC = Solid waste collection, combustors, incinerators.
MF = Manufacturing.
FP = Food packaging.
TA = Textile and apparel ( e.g., stain- and water-resistant, fiber/thread, carpet, house furnishings, leather).
PP = Paper.
CC = Chemical.
PR = Plastics and rubber products.
MM = Machinery.
CE = Computer and electronic products.
FM = Fabricated metal products (e.g., nonstick cookware).
PC = Petroleum and coal products.
FF = Furniture.
OG = Oil and gas production.
UT = Utilities (e.g ., sewage treatment facilities).
CT = Construction (e.g ., wood floor finishing, electrostatic painting).
OT = Other.
NO = Not aware of any potential current and/or historical sources.
DK = Do not know.

Subpart E—Special Regulations, Including Monitoring Regulations and Prohibition on Lead Use

3. Amend §141.40 as follows:

a. In paragraph (a) introductory text, remove the text “December 31, 2015” and add in its place the text “February 1, 2021 or subsequent corrections from the State”;

b. Revise paragraphs (a)(2)(ii) introductory text, (a)(2)(ii)(A), and (a)(3);

c. In paragraph (a)(4)(i) introductory text, remove the text “December 31, 2017” and add in its place the text “December 31, 2022”;

d. Revise paragraphs (a)(4)(i)(A) through (C), (a)(4)(ii) introductory text, and the first sentence in paragraph (a)(4)(ii)(A);

e. Remove paragraph (a)(4)(iii);

f. In paragraph (a)(5)(ii), revise the fifth and sixth sentences;

g. Revise paragraph (a)(5)(iii) introductory text;

h. Remove and reserve paragraph (a)(5)(iv); and

i. Revise paragraphs (a)(5)(v) and (vi) and paragraph (c).

The revisions read as follows:

§141.40 Monitoring requirements for unregulated contaminants.

(a) * * *

(2) * * *

(ii) Small systems. EPA will provide sample containers, provide pre-paid air bills for shipping the sampling materials, conduct the laboratory analysis, and report and review monitoring results for all small systems selected to conduct monitoring under paragraphs (a)(2)(ii)(A) through (C) of this section. If you own or operate a PWS (other than a transient non-community water system) that serves a retail population of 10,000 or fewer people and you are notified of monitoring requirements by the State or EPA, you must monitor as follows:

(A) Assessment Monitoring. You must monitor for the contaminants on List 1 per table 1 to paragraph (a)(3) if you are notified by your State or EPA that you are part of the State Monitoring Plan for Assessment Monitoring.

* * * * *

(3) Analytes to be monitored. Lists 1, 2, and 3 contaminants are provided in table 1 to paragraph (a)(3):

Table 1 to Paragraph(a)(3)—UCMR Contaminant List
1—Contaminant2—CASRN3—Analytical methods a4—Minimum reporting level b5—Sampling location c6—Period during which sample collection to be completed
Column headings are:
1—Contaminant: The name of the contaminant to be analyzed.
2—CASRN (Chemical Abstracts Service Registry Number) or Identification Number: A unique number identifying the chemical contaminants.
3—Analytical Methods: Method numbers identifying the methods that must be used to test the contaminants.
4—Minimum Reporting Level (MRL): The value and unit of measure at or above which the concentration of the contaminant must be measured using the approved analytical methods. If EPA determines, after the first six months of monitoring that the specified MRLs result in excessive resampling, EPA will establish alternate MRLs and will notify affected PWSs and laboratories of the new MRLs. N/A is defined as non-applicable.
5—Sampling Location: The locations within a PWS at which samples must be collected.
6—Period During Which Sample Collection to be Completed: The time period during which the sampling and testing will occur for the indicated contaminant.
a The analytical procedures shall be performed in accordance with the documents associated with each method, see paragraph (c) of this section.
b The MRL is the minimum concentration of each analyte that must be reported to EPA.
c Sampling must occur at your PWS's entry points to the distribution system (EPTDSs), after treatment is applied, that represent each non-emergency water source in routine use over the 12-month period of monitoring. Systems that purchase water with multiple connections from the same wholesaler may select one representative connection from that wholesaler. The representative EPTDS must be a location within the purchaser's water system. This EPTDS sampling location must be representative of the highest annual volume connections. If the connection selected as the representative EPTDS is not available for sampling, an alternate highest volume representative connection must be sampled. See 40 CFR 141.35(c)(3) for an explanation of the requirements related to the use of representative GW EPTDSs.
List 1: Assessment Monitoring
Per- and Polyfluoroalkyl Substances (PFAS)
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS)763051-92-9EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
1H, 1H, 2H, 2H-perfluorodecane sulfonic acid (8:2 FTS)39108-34-4EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
1H, 1H, 2H, 2H-perfluorohexane sulfonic acid (4:2 FTS)757124-72-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
1H, 1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS)27619-97-2EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
4,8-dioxa-3H-perfluorononanoic acid (ADONA)919005-14-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS)756426-58-1EPA 5330.002 µg/LEPTDS1/1/2023-12/31/2025
hexafluoropropylene oxide dimer acid (HFPO-DA) (GenX)13252-13-6EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
nonafluoro‐3,6‐dioxaheptanoic acid (NFDHA)151772-58-6EPA 5330.02 µg/LEPTDS1/1/2023-12/31/2025
perfluoro (2‐ethoxyethane) sulfonic acid (PFEESA)113507-82-7EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoro‐3‐methoxypropanoic acid (PFMPA)377-73-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluoro‐4‐methoxybutanoic acid (PFMBA)863090-89-5EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorobutanesulfonic acid (PFBS)375-73-5EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorobutanoic acid (PFBA)375-22-4EPA 5330.005 µg/LEPTDS1/1/2023-12/31/2025
perfluorodecanoic acid (PFDA)335-76-2EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorododecanoic acid (PFDoA)307-55-1EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoroheptanesulfonic acid (PFHpS)375-92-8EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoroheptanoic acid (PFHpA)375-85-9EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorohexanesulfonic acid (PFHxS)355-46-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorohexanoic acid (PFHxA)307-24-4EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluorononanoic acid (PFNA)375-95-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluorooctanesulfonic acid (PFOS)1763-23-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluorooctanoic acid (PFOA)335-67-1EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluoropentanesulfonic acid (PFPeS)2706-91-4EPA 5330.004 µg/LEPTDS1/1/2023-12/31/2025
perfluoropentanoic acid (PFPeA)2706-90-3EPA 5330.003 µg/LEPTDS1/1/2023-12/31/2025
perfluoroundecanoic acid (PFUnA)2058-94-8EPA 5330.002 µg/LEPTDS1/1/2023-12/31/2025
n-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA)2991-50-6EPA 537.10.005 µg/LEPTDS1/1/2023-12/31/2025
n-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA)2355-31-9EPA 537.10.006 µg/LEPTDS1/1/2023-12/31/2025
perfluorotetradecanoic acid (PFTA)376-06-7EPA 537.10.008 µg/LEPTDS1/1/2023-12/31/2025
perfluorotridecanoic acid (PFTrDA)72629-94-8EPA 537.10.007 µg/LEPTDS1/1/2023-12/31/2025
Metal/Pharmaceutical
Lithium7439-93-2EPA 200.7, SM 3120 B, ASTM D1976-209 µg/LEPTDS1/1/2023-12/31/2025
List 2: Screening Survey
ReservedReservedReservedReservedReservedReserved
List 3: Pre-Screen Testing
ReservedReservedReservedReservedReservedReserved

(4) * * *

(i) * * *

(A) Sample collection period. You must collect the samples in one continuous 12-month period for List 1 Assessment Monitoring, and, if applicable, for List 2 Screening Survey, or List 3 Pre-Screen Testing, during the timeframe indicated in column 6 of table 1 to paragraph (a)(3) of this section. EPA or your State will specify the month(s) and year(s) in which your monitoring must occur. As specified in 40 CFR 141.35(c)(5), you must contact EPA if you believe you cannot collect samples according to your schedule.

(B) Frequency. You must collect the samples within the timeframe and according to the frequency specified by contaminant type and water source type for each sampling location, as specified in table 2 to this paragraph (a)(4)(i)(B). For the second or subsequent round of sampling, if a sample location is non-operational for more than one month before and one month after the scheduled sampling month ( i.e., it is not possible for you to sample within the window specified in table 2), you must notify EPA as specified in 40 CFR 141.35(c)(5) to reschedule your sampling.

Table 2 to Paragraph ( )(4)( )(B)—Monitoring Frequency by Contaminant and Water Source Types
Contaminant typeWater source typeTimeframeFrequency 1
1 Systems must assign a sample event code for each contaminant listed in Table 1. Sample event codes must be assigned by the PWS for each sample event. For more information on sample event codes see 40 CFR 141.35(e) Table 1.
List 1 ContaminantsSurface water, Mixed, or GWUDI12 monthsYou must monitor for four consecutive quarters. Sample events must occur three months apart. (Example: If first monitoring is in January, the second monitoring must occur any time in April, the third any time in July, and the fourth any time in October).
Ground water12 monthsYou must monitor twice in a consecutive 12-month period. Sample events must occur 5-7 months apart. (Example: If the first monitoring event is in April, the second monitoring event must occur any time in September, October, or November.)

(C) Location. You must collect samples for each List 1 Assessment Monitoring contaminant, and, if applicable, for each List 2 Screening Survey, or List 3 Pre-Screen Testing contaminant, as specified in table 1 to paragraph (a)(3) of this section. Samples must be collected at each sample point that is specified in column 5 and footnote c of table 1 to paragraph (a)(3) of this section. If you are a GW system with multiple EPTDSs, and you request and receive approval from EPA or the State for sampling at representative EPTDS(s), as specified in 40 CFR 141.35(c)(3), you must collect your samples from the approved representative sampling location(s).

* * * * *

(ii) Small systems. If you serve a population of 10,000 or fewer people and are notified that you are part of the State Monitoring Plan, you must comply with the requirements specified in paragraphs (a)(4)(ii)(A) through (H) of this section. If EPA or the State informs you that they will be collecting your UCMR samples, you must assist them in identifying the appropriate sampling locations and in collecting the samples.

(A) Sample collection and frequency. You must collect samples at the times specified for you by the State or EPA. Your schedule must follow both the timing of monitoring specified in table 1 to paragraph (a)(3) of this section, List 1, and, if applicable, List 2, or List 3, and the frequency of monitoring in table 2 to paragraph (a)(4)(i)(B) of this section.

* * * * *

(5) * * *

(ii) * * * To participate in the UCMR Laboratory Approval Program, the laboratory must register and complete the necessary application materials by August 1, 2022. Correspondence must be addressed to: UCMR Laboratory Approval Coordinator, USEPA, Technical Support Center, 26 West Martin Luther King Drive, (MS 140), Cincinnati, Ohio 45268; or emailed to EPA at: UCMR_Lab_Approval@epa.gov.

(iii) Minimum Reporting Level. The MRL is defined by EPA as the quantitation limit achievable, with 95 percent confidence, by 75 percent of laboratories nationwide, assuming the use of good instrumentation and experienced analysts.

* * * * *

(v) Method defined quality control. You must ensure that your laboratory analyzes Laboratory Fortified Blanks and conducts Laboratory Performance Checks, as appropriate to the method's requirements, for those methods listed in column 3 in table 1 to paragraph (a)(3) of this section. Each method specifies acceptance criteria for these QC checks.

(vi) Reporting. You must require your laboratory, on your behalf, to post and approve these data in EPA's electronic data reporting system, accessible at https://www.epa.gov/dwucmr, for your review within 90 days from the sample collection date. You then have 30 days from when the laboratory posts and approves your data to review, approve, and submit the data to the State and EPA, via the agency's electronic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting approved data, the data will be considered approved by you and available for State and EPA review.

* * * * *

(c) Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at U.S. Environmental Protection Agency, Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004, (202) 566-1744, email Docket-customerservice@epa.gov, or go to https://www.epa.gov/dockets/epa-docket-center-reading-room, and is available from the sources indicated elsewhere in this paragraph. The material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) U.S. Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004; telephone: (202) 566-1744.

(i) Method 200.7, “Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Revision 4.4, EMMC Version, 1994. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma.

(ii) Method 537.1, “Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” Version 2.0, 2020. Available at https://www.epa.gov/water-research/epa-drinking-water-research-methods.

(iii) Method 533, “Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” November 2019, EPA 815-B-19-020. Available at https://www.epa.gov/dwanalyticalmethods.

(2) American Public Health Association, 800 I Street NW, Washington, DC 20001-3710; telephone: (202) 777-2742; email: comments@apha.org; www.apha.org.

(i) “Standard Methods for the Examination of Water & Wastewater,” 23rd edition (2017).

(A) SM 3120 B, “Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method.”

(B) [Reserved]

(ii) “Standard Methods Online,” approved 1999; https://www.standardmethods.org.

(A) SM 3120 B, “Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method,” revised December 14, 2020.

(B) [Reserved]

(3) ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959; telephone: (610) 832-9500; email: service@astm.org; www.astm.org.

(i) ASTM D1976-20, “Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy,” approved May 1, 2020.

(ii) [Reserved]

[FR Doc. 2021-27858 Filed 12-23-21; 8:45 am]

BILLING CODE 6560-50-P

2024-05-13T05:00:00Z

EPA Final Rule: NESHAP for Primary Copper Smelting

This action finalizes the residual risk and technology review (RTR) conducted for the Primary Copper Smelting major source category regulated under national emission standards for hazardous air pollutants (NESHAP). This action also finalizes the technology review for the Primary Copper Smelting area source NESHAP. The final amendments for the major source NESHAP include particulate matter (PM) emission standards as a surrogate for metal hazardous air pollutants (HAP) other than mercury (primarily lead and arsenic) for anode refining point sources, process fugitive emissions from roofline vents, Hoboken converter process fugitive capture systems where they combine with anode refining point sources, and new converters. We are also finalizing emission standards for previously unregulated HAP including mercury, benzene, toluene, hydrogen chloride (HCl), chlorine, polycyclic aromatic hydrocarbons (PAH), and dioxins and furans (D/F). In addition, we are taking final action in the major source NESHAP to establish work practice standards for bypass stacks, and add a new emissions limit for lead and emissions control design standards to minimize process fugitive emissions at facilities with flash furnaces and Peirce-Smith converters. Final amendments for both the major source NESHAP and the area source NESHAP include removing exemptions and associated provisions for periods of startup, shutdown, and malfunction (SSM), specifying that the emission standards apply at all times, and requiring electronic reporting of performance test results and notification of compliance reports.

DATES: This final rule is effective May 13, 2024, except for changes to §63.14, which are effective July 15, 2024. This final rule is published in the Federal Register May 13, 2024, page 41648.

View final rule.

§63.14 Incorporations by reference.
(f)(1) and (i)(95), (105), and (110)RevisedView text
(o)AddedView text
§63.14 Incorporations by reference. (Effective July 15, 20240
(f)(1) and (i)(110)RevisedView text
(o) RevisedView text
Subpart QQQ - National Emission Standards for Hazardous Air Pollutants for Primary Copper Smelting
Entire subpartRevisedView text
§63.11147 What are the standards and compliance requirements for existing sources not using batch copper converters?
(b)(6), (c)(1) and (5), (d), and (e)RevisedView text
§63.11148 What are the standards and compliance requirements for existing sources using batch copper converters?
(a)(1), (a)(3)(ii), (a)(4)(iv), (b)(1), (b)(2)(i), (b)(4), (c)(2) and (4), (e)(3), (f)(1), (f)(4)(ii) and (iii), (f)(5), (g), and (h)RevisedView text
§63.11149 What are the standards and compliance requirements for new sources?
Entire sectionRevisedView text
§63.11151 What definitions apply to this subpart?
definition “Blowing”AddedView text
definition “Capture system”RevisedView text
§63.11152 Who implements and enforces this subpart?
(c) introductory textRevisedView text
undesignated paragraph after paragraph (c)(5)RemovedView text
(c)(6)AddedView text
Table 1 to Subpart EEEEEE of Part 63 - Applicability of General Provisions to Subpart EEEEEE
Entire tableRevisedView text

New Text

§63.14 Incorporations by reference. (Effective July 15, 20240

* * * * *

(f) * * *

(1) ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analyses [Part 10, Instruments and Apparatus], issued August 31, 1981, IBR approved for §§63.116(c); 63.116 and (h); 63.128(a); 63.145(i); 63.309(k); 63.365(b); 63.457(k); 63.490(g); 63.772(e) and (h); 63.865(b); 63.997(e); 63.1282(d) and (g); 63.1450(a), (b), and (e) through (g); 63.1625(b); table 5 to subpart EEEE; §§63.3166(a); 63.3360(e); 63.3545(a); 63.3555(a); 63.4166(a); 63.4362(a); 63.4766(a); 63.4965(a); 63.5160(d); table 4 to subpart UUUU; table 3 to subpart YYYY; §§63.7822(b); 63.7824(e); 63.7825(b); 63.8000(d); 63.9307(c); 63.9323(a); 63.9621(b) and (c)