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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

Stay on track with mobile off-road emission rules
2025-01-16T06:00:00Z

Stay on track with mobile off-road emission rules

Just like all-terrain tires, mobile emission regulations are built for paved and unpaved landscapes. The Environmental Protection Agency (EPA) sets federal emission standards for mobile sources, and the rules extend beyond vehicles on the road. The requirements also apply to off-road mobile sources, ranging from the humble lawnmower to imposing construction equipment.

While most requirements affect off-road vehicle, engine, and equipment manufacturers, certain rules apply to owners and operators. So, before you fire up the forklift or any other mobile off-road source, ensure your equipment complies.

What qualifies as a mobile off-road source?

Mobile sources, according to EPA, include vehicles, engines, and motorized equipment with exhaust and evaporative emissions. There are two types of mobile sources:

  • On-road sources, such as passenger and commercial vehicles; and
  • Off-road (or nonroad) sources, like chain saws, generators, and excavators.

Nonroad emission requirements are based on the source and emission system types.

EPA's mobile nonroad emission regulations
Nonroad sourceEmission systemRegulations (40 CFR)
AircraftExhaustPart 1031
Part 1065
Part 1068
Nonroad compression-ignition enginesExhaustPart 1039
Part 1065
Part 1068
Nonroad large spark-ignition enginesExhaust
Evaporative
Part 1048
Part 1065
Part 1068
LocomotivesExhaustPart 1033
Part 1065
Part 1068
Marine compression-ignition engines and vesselsExhaustPart 1042
Part 1065
Part 1068
Marine spark-ignition engines and vesselsExhaust
Evaporative
Part 1045
Part 1065
Part 1068
Nonroad recreational engines and vehiclesExhaust
Evaporative
Part 1051
Part 1065
Part 1068
Nonroad small spark-ignition engines (up to 19 kilowatts)Exhaust
Evaporative
Part 1054
Part 1065
Part 1068
Manufacturers must demonstrate that their nonroad equipment complies with EPA’s regulations to obtain a Certificate of Conformity. This certification allows manufacturers to produce and sell their products.

How do the regulations impact mobile nonroad source owners and operators?

The rules for owners and operators primarily relate to handling, maintaining, and rebuilding the emission-controlling components on nonroad vehicles, engines, and equipment.

Don’t tamper with emission controls

The regulation at 1068.101(b) bans owners, operators, and everyone else from impeding or removing emission controls from certified mobile nonroad vehicles, engines, and equipment. Examples include using software to increase emissions, removing emission control devices from equipment, and operating engines with incorrect fuel.

It also prohibits anyone from making, selling, or using defeat devices to bypass, impair, defeat, or disable emission controls.

Follow the manufacturer’s instructions

Manufacturers are required to provide emission-related installation and maintenance instructions as well as a warranty that the nonroad engine or equipment complies with EPA’s regulations. Owners and operators are responsible for maintaining the product (1068.110(e)).

Implement these actions to help ensure proper maintenance of your nonroad engine or equipment:

  • Follow the manufacturer’s emission-related installation and maintenance guidelines.
  • Operate the vehicle, engine, or equipment solely according to the manufacturer’s instructions.
  • Understand the terms of the manufacturer’s warranty. In addition to improper maintenance (like using an unauthorized service facility if applicable), other actions can void the warranty, such as using the engine or equipment outside its intended purposes stated by the manufacturer.

Rebuild engines according to the regulations

Anyone who installs or has a rebuilt engine installed in a regulated piece of nonroad equipment must confirm that the engine complies with 1068.120. These are some of the major requirements:

  • Only use a rebuilt engine that’s built/rebuilt to a certified configuration that meets the same or more stringent emission standards.
  • If you install an engine rebuilt by someone else, check all emission-related components per the original manufacturer’s recommended practice.
  • Keep required records for all rebuilt engines (except for certain spark-ignition engines with low total displacement) for at least two years.

Key to remember: EPA regulates emissions from all mobile sources, including off-road vehicles, engines, and equipment.

EHS Monthly Round Up - December 2024

EHS Monthly Round Up - December 2024

In this December 2024 roundup video, we’ll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

OSHA’s personal protective equipment in construction final rule takes effect January 13. Employers must ensure PPE is of safe design and construction for the work to be performed and properly fits employees.

OSHA extended the comment deadline to January 14 for its proposed heat illness prevention rule. This gives stakeholders two more weeks to review the proposal and comment on it. An informal public hearing on the rule is scheduled for June 16.

OSHA released its Fall 2024 regulatory agenda on December 13. Many final and proposed rulemakings have been pushed into the first half of 2025, and a few have been bumped into the third quarter of the year.

OSHA updated its arc flash guidance for employees working on energized electrical equipment. Arc flash incidents can ignite clothing, cause structural fires, and cause severe or fatal burns. The guidance covers protecting employees from arc flash hazards, common electrical work myths, establishing boundaries around arc flash hazards, and being aware of arc flash hazards.

Warehouse, delivery, and retail workers are at increased risk for injuries and illnesses during the holidays due to higher volumes of work to meet consumer demand. OSHA reminds employers to protect workers by ensuring they’re trained to recognize and prevent hazards.

And finally, turning to environmental news, EPA released its Fall 2024 regulatory agenda on December 13. It includes projected publication dates for several final and proposed rules that may impact industry compliance with air, land, and water regulations.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round Up - October 2024

EHS Monthly Round Up - October 2024

In this October 2024 roundup video, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

A Government Accountability Office report says OSHA can do more to protect warehouse and delivery workers from ergonomic injuries. The report recommends several steps for OSHA to consider, including ensuring compliance officers can easily obtain data on when musculoskeletal disorders occurred.

OSHA updated its inspection guidance for animal slaughtering and processing industries. Inspections will focus on several hazards, including sanitation, ergonomics, and machine guarding. Among other changes, compliance officers will conduct inspections during off-shift times and identify workplace activities that impact employees most at risk such as temporary employees.

OSHA urges workers involved in hurricane cleanup and recovery efforts to be mindful of hazards, especially those associated with restoring electricity, removing debris, and trimming trees. Proper training, experience, and familiarity with related equipment helps ensure worker safety.

And finally, turning to environmental news, EPA extended the 2024 Chemical Data Reporting deadline to November 22 due to technical difficulties with its electronic reporting tool. The 2024 report covers activities that occurred between calendar years 2020 and 2023.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round Up - May 2023

EHS Monthly Round Up - May 2023

In this monthly roundup video, we'll review the most impactful environmental, safety, and health news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript to take a deeper dive into the topics I’ll be covering today. With that said, let’s get started!

First, let’s take a look at what’s happening in safety and health. The week of May 1 marked the 10th annual Stand-Down to Prevent Falls in Construction. Employers were encouraged to have safety talks or demonstrations on the use of fall protection.

A new National Emphasis Program on fall prevention covers all industries, with a focus on construction and specific general industry activities. It took effect May 1; however, programmed inspections will begin after a 90-day outreach period.

With the start of lawn-care season, a recent OSHA case highlights some of the risks involved. The Agency found a lawn service contractor operating in Kentucky ignored safety requirements to save time.

A forklift operator suffered fatal injuries after falling into a recycling baler while trying to remove a jam. Investigators found a lack of training and communication were contributing factors.

In response to larger, more frequent wildfires, the state of Washington has proposed permanent wildfire smoke rules. They include year-round requirements for employers that will be in effect whenever there’s a risk that workers will be exposed to wildfire smoke.

And finally, turning to environmental news, EPA finalized changes to the new source performance standards for Automobile and Light Duty Truck Surface Coating Operations. The rule adds more emissions requirements for such operations.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round Up - January 2023

EHS Monthly Round Up - January 2023

In this monthly roundup video, we’ll review the most impactful environmental, safety, and health news.

Hi everyone! Welcome to the monthly roundup video, where we’ll review the most impactful environmental, safety, and health news. First, let’s take a look at what’s happening in safety and health.

If you haven’t already done so, now is the time to post your OSHA 300A Summary. Employers are required to post the Summary in a conspicuous place from February 1st through April 30th.

As required by law, OSHA increased its penalties for inflation in mid-January. Penalties went up 7.7 percent, effective January 17th.

Also in January, OSHA released its long-awaited Fall 2022 regulatory agenda. Along with numerous proposed rules in the works, three major final rules are slated for 2023 – COVID-19 in healthcare, Injury and Illness tracking, and an update to the hazard communication standard.

OSHA recently released two new letters of interpretation, which address exit signs and lockout/tagout. Specifically, OSHA states that the International Standards Organization emergency exit symbol can be located beside the mandatory EXIT text on an existing sign.

The second letter addresses the applicability of lockout/tagout and the maintenance and operations of cathodic protection rectifiers when working on pipelines.

New York’s Warehouse Worker Protection Act was signed into law in December and takes effect in late February. It protects warehouse distribution workers from undisclosed or unlawful work speed quotas and includes protections for workers who fail to meet these quotas.

In 2021, a worker died every 101 minutes from a work-related injury, according to the Bureau of Labor Statistics. A total of 5,190 fatal work injuries was recorded in the U.S. in 2021, an 8.9 percent increase over 2020.

Turning to environmental news, EPA automatically added nine per- and polyfluoroalkyl substances, or PFAS, to the Toxics Release Inventory, or TRI, list. Four PFAS were added since they are no longer claimed as confidential business information.

EPA released its Fall 2022 regulatory agenda in early January. Included are major regulations impacting the National Ambient Air Quality Standards, waters of the United States, and modifications to the Risk Management Program under the Clean Air Act.

There are also a number of rules related to the National Emission Standards for Hazardous Air Pollutants in various rule stages.

And finally, beginning with model year 2027, heavy-duty trucks will be required to meet clean air standards that are 80 percent more stringent than current requirements.

EPA says this final rule is aimed at reducing smog- and soot-forming emissions, increasing the life of governed vehicles by up to 250 percent, and increasing emissions warranty periods up to 450 percent.

Thanks for tuning in to the monthly news roundup!

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Most Recent Highlights In Transportation

EHS Monthly Round Up - January 2024

EHS Monthly Round Up - January 2024

In this monthly video, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll go over the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

Effective January 15, OSHA penalties increased 3.2 percent for inflation. Most penalties increased to $16,131. Willful and serious violations, however, increased to $161,323.

Construction workers aged 45 and older suffer more severe injuries and higher associated costs than other age groups. Most injuries are due to slips, trips, and falls.

Washington State updated its process safety management rules to better protect workers in petroleum refineries from the hazards of volatile chemicals. The rules take effect December 27, 2024.

Bloodborne pathogens topped the list of OSHA violations for the healthcare industry in 2023. Hazard Communication was the second most cited standard, followed by respiratory protection.

OSHA Region 2 launched a regional emphasis program that targets tree trimming, tree removal, and land clearing operations. Region 2 includes New York, New Jersey, Puerto Rico, and the U.S. Virgin Islands.

EPA continues to strengthen its regulation of per- and polyfluoroalkyl — or PFAS — substances. A new rule prevents facilities from using any of the 300+ inactive PFAS before EPA conducts a risk determination and, if necessary, regulates the activity.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round Up - August 2023

EHS Monthly Round Up - August 2023

In this monthly roundup video, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we'll review the most impactful environmental, health, and safety news. Please view the content links in the transcript to take a deeper dive into the topics I'll be covering today. With that said, let's get started!

In response to soaring temperatures across the country, OSHA issued a heat hazard alert reminding employers of their obligation to protect workers against heat illness. OSHA also ramped up enforcement activities in high-risk industries like construction and agriculture.

OSHA's annual Safe and Sound Week was held the week of August 7. It highlighted the importance of workplace safety and health programs. This year's focus was on mental health and well-being.

OSHA wants to know how you use your safety and health program to ensure a positive workplace safety culture. The agency has drawn up questions related to work safety values, safety messaging, and more, and will use your feedback to develop educational materials. November 30 is the deadline for comments.

Though the current hurricane season has been relatively quiet, it's important to be prepared as the height of the season approaches. Both OSHA and NIOSH have provided resources to help emergency responders, recovery workers, and employers prepare in advance for anticipated weather disasters.

Workplace deaths due to unintentional overdoses of fentanyl and methamphetamine continue to rise. In 2021, there were 464 such fatalities, a 19.6 percent increase over 2020.

And finally, turning to environmental news, receiving facilities will see increased user fees for the e-Manifest system in fiscal years 2024 and 2025. EPA sets these user fees based on how the manifest is submitted and processing costs for each manifest type. Using fully electronic waste manifests will cost significantly less.

Thanks for tuning in to the monthly news roundup. We'll see you next month!

EHS Monthly Roundup - March 2023

EHS Monthly Roundup - March 2023

This monthly video spotlights EHS news highlights from March 2023.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript to take a deeper dive into the topics I’ll be covering today. With that said, let’s get started!

First, let’s take a look at what’s happening in safety and health. OSHA revised its combustible dust national emphasis program. It adds several industries with a higher likelihood of having combustible dust hazards.

California’s Safety and Health Appeals Board says drinking water must be “as close as practicable” to outdoor employees.

The Pipeline and Hazardous Materials Safety Administration says that some forklift operators may be considered hazmat employees. If operators handle hazmat cargo, such as moving it from the truck to an aircraft, they need hazmat training.

OSHA posted a letter of interpretation that answers hazard communication questions related to lithium batteries. The agency says workers may be exposed to hazards during storage, handling, and maintenance activities.

Stand Up 4 Grain Safety Week was held the week of March 27. Employers were encouraged to hold toolbox talks or safety demonstrations related to grain handling and storage.

Turning to environmental news, EPA issued significant new use rules for chemical substances that were the subject of premanufacture notices. This change brings added reporting and recordkeeping.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round Up - September 2024

EHS Monthly Round Up - September 2024

In this September 2024 video, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

OSHA published its proposed heat illness rule on August 30. It applies to both indoor and outdoor work in general industry, construction, agriculture, and maritime. Comments on the proposal will be accepted until December 30. OSHA encourages both employers and workers to submit comments.

Fall protection for construction remained number one on OSHA’s list of Top 10 violations for the 14th year in a row. There was little movement among the other Top 10 entries, with Hazard Communication at number 2 and ladders at number 3.

OSHA may exclude volunteer emergency response organizations from its proposed emergency response rule. During the rule’s public comment period, the agency received numerous comments that raised serious economic feasibility concerns.

During its silica enforcement inspections, OSHA also found violations of the hazard communication, respiratory protection, and noise standards. Over 200 companies were targeted as part of the agency’s respirable crystalline silica emphasis program.

Employers can view workplace injury and illness trends using OSHA’s Severe Injury Report dashboard. This new online tool allows users to search the agency’s severe injury report database. Severe injuries and illnesses are those that result in inpatient hospitalization, amputation, or loss of an eye.

And finally, turning to environmental news, an EPA final rule impacts facilities that reclassify from major to area source status under the National Emission Standards for Hazardous Air Pollutants program. These facilities must continue to meet the major source emission standards for seven hazardous air pollutants.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round Up - April 2024

EHS Monthly Round Up - April 2024

In this monthly roundup video, we’ll review the most impactful environmental, safety, and health news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll go over the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

OSHA’s worker walkaround rule takes effect May 31st. It expands the criteria for who employees can authorize to act as their representative during an inspection.

Between 2015 and 2022, there were about 1,500 worker injuries involving food processing machinery. A new OSHA alert raises awareness of these hazards. It addresses hazard recognition, corrective measures, and workers’ rights.

The National Institute for Occupational Safety and Health (NIOSH) seeks stakeholder input on protecting outdoor workers from wildfire smoke. The agency intends to develop a hazard review document that provides recommendations to protect workers.

The Mine Safety and Health Administration published a final rule that lowers miners’ exposure to silica dust. It also revises the standard to reflect the latest advances in respiratory protection and practices.

OSHA released 2023 injury and illness data. The agency provides public access to this information in an effort to identify unsafe conditions and workplace hazards that may lead to injuries and illnesses.

And turning to environmental news, EPA finalized a rule to designate two widely used PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act, or CERCLA. The rule requires immediate release notifications for the two PFAS. It also gives EPA the authority to hold polluters responsible for contamination.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

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Most Recent Highlights In Safety & Health

EHS Monthly Roundup - February 2023

EHS Monthly Roundup - February 2023

This monthly video spotlights EHS news highlights from February 2023.

Hi everyone! Welcome to the monthly roundup video, where we’ll review the most impactful environmental, safety, and health news.

First, let’s take a look at what’s happening in safety and health. Machine guarding and hazard communication topped OSHA’s list of most frequently cited serious violations in fiscal year 2022. Over 1,300 citations were issued for machine guarding and over 1,800 were issued for HazCom.

Effective March 26, OSHA will cite certain types of violations as “instance-by-instance” citations, when inspectors identify high-gravity, serious violations specific to the following: falls, trenching, machine guarding, respiratory protection, permit required confined space, and lockout/tagout, as well as other-than-serious violations specific to recordkeeping.

California’s COVID-19 prevention non-emergency regulations, which require employers to protect workers from the hazards related to COVID-19, took effect February 3, and will remain in effect for two years.

A new OSHA fact sheet outlines measures to protect shipyard employees from the physical hazards of confined spaces. In the maritime sector, physical hazards in confined spaces can increase a worker’s risk of injury.

OSHA says it will withdraw its proposal to revoke Arizona’s State Plan. The state has taken measures to remain compliant with federal OSHA. However, OSHA continues to work closely with Arizona to address other state-plan concerns that weren’t part of its original withdrawal proposal.

And turning to environmental news, EPA issued a rule that finalizes first-time standards for inorganic hazardous air pollutants in miscellaneous coating manufacturing that will limit emissions and require effective controls. Final amendments include provisions for inorganic hazardous air pollutant standards for process vessels. The rule took effect February 22.

Thanks for tuning in to the monthly news roundup. We'll see you next month!

EHS Monthly Round Up - March 2024

EHS Monthly Round Up - March 2024

In this monthly roundup video, we’ll review the most impactful environmental, safety, and health news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll go over the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started! The Office of Management and Budget completed its review of OSHA’s worker walkaround final rule on March 20. The next step is publication in the Federal Register. The rule expands the criteria for who employees can authorize to act as their representative during an OSHA inspection.

Stand Up 4 Grain Safety Week was held the week of March 25. This annual event brings attention to hazards in the grain handling and storage industry and encourages employers to focus on safe work practices.

Over 100 people die in ladder-related deaths each year, and thousands more suffer disabling injuries. During Ladder Safety Month, which is held each March, the American Ladder Institute promotes ladder safety to decrease the number of injuries and fatalities.

Between 2010 and 2023, 11 miners drowned in incidents involving submerged mobile equipment. In response, the Mine Safety and Health Administration issued a safety alert. It recommends measures miners should take when operating equipment near water.

And finally, turning to environmental news, EPA finalized amendments to its Risk Management Program in an effort to improve safety at facilities that use and distribute hazardous chemicals. The rule seeks to improve chemical process safety; assist in planning for, preparing for, and responding to accidents; and increase public awareness of chemical hazards at regulated sites.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

EHS Monthly Round-Up - August 2024

EHS Monthly Round-Up - August 2024

In this August 2024 roundup, we'll review the most impactful environmental, health, and safety news.

Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!

Two State Plan agencies allegedly provided advance notice of workplace inspections to employers, a practice that’s prohibited under the Occupational Safety and Health Act. Now, lawmakers have requested that the Department of Labor’s acting secretary address the allegations and explain what challenges OSHA faces when monitoring and enforcing State Plan compliance.

A recent study shows jobs in agriculture, forestry, fishing, and hunting are among California’s most dangerous, accounting for the highest number of fatalities among full-time workers. Transportation and utilities jobs ranked second and construction was third.

Remote isolation of process equipment can quickly stop the release of hazardous materials, which can help prevent fatalities and injuries, limit facility damage, and better protect communities and the environment. A U.S. Chemical Safety Board study explores their use and makes recommendations for their utilization in chemical facilities.

A National Safety Council report explores the role of diversity, equity, and inclusion on work-related musculoskeletal disorders, or MSDs. MSDs are the most common workplace injury and often lead to worker disability, early retirement, and employment limitations.

And finally, turning to environmental news, EPA published a final rule that revises its hazardous waste export manifest regulations. All hazardous waste shipments and manifest-related reports will be managed electronically through the agency’s e-Manifest program.

Thanks for tuning in to the monthly news roundup. We’ll see you next month!

Section 404 permits: Does your project need a permit to fill?
2025-01-03T06:00:00Z

Section 404 permits: Does your project need a permit to fill?

Some commercial and industrial projects place materials (called fill) in a body of water for various reasons, such as building a facility, adding a road to a facility site, or installing intake and outfall pipes at a power plant. If the project affects any of the waters of the United States (WOTUS), you must first obtain a permit.

Section 404 of the Clean Water Act requires a permit to discharge dredged or fill material into any WOTUS (including wetlands). Before conducting any activities at your facility’s site, it’s crucial to find out whether your project requires a permit to fill.

What’s considered fill material?

The regulations at 40 CFR 232.2 define fill material as any material placed in WOTUS that:

  • Replaces any part of WOTUS with dry land, or
  • Changes the bottom elevation of WOTUS.

Fill material excludes trash and garbage. Common examples of fill material are:

  • Construction debris,
  • Materials used to create a structure/infrastructure,
  • Rock,
  • Sand, and
  • Soil.

Whenever fill material is dumped, placed, or deposited in WOTUS, a “discharge of fill material” occurs. Examples (according to 232.2) range from road fills to commercial and industrial site development fills.

The Environmental Protection Agency and the U.S. Army Corps of Engineers (USACE) jointly administer the Section 404 permit program. The USACE typically issues the permits unless a state or tribal program is authorized to issue them.

Does your project require a permit to fill?

To answer this question, you’ll need to address a few more questions:

1. Will fill materials enter WOTUS?

The first step is to determine whether Section 404 regulations cover any on-site waterbodies.

The Aquatic Resource Delineation Report is a required part of the permitting process. It identifies any on-site aquatic resources (i.e., waterbodies or wetlands) subject to permitting rules. Businesses typically hire consultants to develop the report.

If you need help figuring out the status of your aquatic resources, you can request the USACE to make a written jurisdictional determination of whether Section 404 rules apply to any on-site waterbodies or wetlands.

2. Is the planned discharge of fill exempt?

Not all fill discharges require a Section 404 permit. Examples include:

  • Conducting ongoing farming and ranching activities (such as minor drainage and harvesting);
  • Maintaining drainage ditches, dams, and levees; and
  • Building and maintaining irrigation ditches, farm and stock ponds, and farm and forest roads.

See 232.3 for the comprehensive list of discharge activities that don’t require a permit.

3. What impact will the fill discharge have?

The potential impact that your project will have on WOTUS determines the type of permit you need: general or individual.

General permits are issued for discharges that have only minimal adverse effects on WOTUS. They’re based on specific activities and typically require much less processing time, allowing projects to begin sooner. The types of general permits include:

  • Nationwide permits (authorize activities across the U.S.),
  • Regional general permits (authorize activities in a specific area), and
  • Programmatic general permits (authorize activities already regulated by existing state, local, or federal programs).

Individual permits are issued for discharges that may have significant impacts on WOTUS. They require case-by-case evaluations of each project.

When starting the Section 404 permitting process, keep these things in mind:

  • The permit requirements apply both to permanent and temporary projects, like using fills to access a work area for a limited time.
  • You can request to meet with the USACE before applying for a permit. It’s an informal meeting during which the USACE offers guidance and insights that could help reduce your application’s processing time.
  • Check with the state to identify any state-level permitting requirements.

Key to remember: If a project’s discharges of fill material could impact the waters of the United States, it may require a Section 404 permit under the Clean Water Act.

The next 5: EPA's latest step in chemical risk evaluations
2024-12-31T06:00:00Z

The next 5: EPA's latest step in chemical risk evaluations

Are the chemicals in your home and workplace safe? The Environmental Protection Agency (EPA) is working to answer this question with the recent launch of risk evaluations for five chemicals under the Toxic Substances Control Act (TSCA):

  • Acetaldehyde,
  • Acrylonitrile,
  • Benzenamine,
  • 4,4’-methylene bis(2-chloroaniline) (or MBOCA), and
  • Vinyl chloride.

EPA selected the chemicals through a rigorous process (under TSCA section 6(b)(1)(A)) that considers potential hazards, exposure levels, and other relevant factors. A critical component of this process is the prioritization of chemicals for risk evaluation.

The prioritization process is the cornerstone of EPA's TSCA implementation. It ensures that the agency's resources are directed toward chemicals with the greatest potential to cause harm. This systematic approach allows the agency to efficiently evaluate a vast number of existing chemicals and make informed decisions about their safety.

Prioritizing existing chemicals under TSCA can include up to seven stages:

  1. Approach to prioritization: EPA selects a prioritization approach that’s appropriate for the purposes of the evaluation.
  2. Candidate selection: In this stage, EPA identifies potential candidates for prioritization using a variety of sources, including industry reports, scientific studies, and public input.
  3. Initiation: Once the agency selects a candidate chemical, it initiates the prioritization process by gathering relevant information on the chemical's hazards, exposures, and potential risks.
  4. Screening review: During this stage, EPA conducts a screening-level risk assessment to evaluate the potential risks of the chemical.
  5. Proposed designation: Based on the screening review, the agency proposes a designation for the chemical as either high- or low-priority for further evaluation. Chemicals designated as High-Priority Substances enter the TSCA risk evaluation process.
  6. Final designation: After considering public comments, EPA finalizes the chemical’s designation.
  7. Revision of designation: EPA may revise the designation of a low-priority substance to high-priority if new information suggests that the chemical may present an unreasonable risk of injury to health or the environment.

Risk evaluation: Assessing unreasonable risks

Following prioritization, EPA immediately starts risk evaluations for chemicals designated as High-Priority Substances. The evaluations involve a comprehensive assessment of potential hazards, exposure pathways, and potential risks to human health and the environment. The goal is to determine whether a chemical presents an "unreasonable risk of injury to health or the environment."

If a risk evaluation identifies an unreasonable risk, EPA can take various regulatory actions under TSCA. These actions may include restrictions on the use, manufacture, or distribution of the chemical. The agency tailors the regulatory approach to the unique characteristics and risks of each chemical.

Key to remember: EPA recently announced the initiation of risk evaluations for five chemicals under TSCA. The chemicals were selected through a rigorous prioritization process that considers potential hazards, exposure levels, and other relevant factors.

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Most Recent Highlights In Human Resources

Agency adds new temporary hazardous waste storage, transfer codes
2024-12-30T06:00:00Z

Agency adds new temporary hazardous waste storage, transfer codes

The Environmental Protection Agency (EPA) has added new Management Method Codes to describe how hazardous waste will be managed after temporary storage and transfer. The codes are used for Biennial Hazardous Waste Reports and e-Manifests required by the Resource Conservation and Recovery Act (RCRA).

What are the changes?

The new “S Codes” are effective as of January 1, 2025. The S Codes will ultimately replace code H141 for Storage and Transfer for the RCRA Biennial Reports and e-Manifests. EPA will remove Code H141 from the Biennial Report and e-Manifest on January 1, 2027.

Hazardous waste handlers will use the S Codes on the Biennial Report Waste Generation and Management (GM) forms. The S Codes indicate that (a) hazardous waste was received to be stored or transferred and (b) the hazardous waste will later be managed by a final receiving facility using a specific method.

What are the new codes?

The new Management Method Codes include the following:

S CodeDescription
S010Stored and transferred for metals recovery
S011Stored and transferred for mercury recovery
S015Stored and transferred for deployment/deactivation of airbag waste
S020Stored and transferred for solvents recovery
S039Stored and transferred for other recovery or reclamation for reuse
S040Stored and transferred for incineration
S041Stored and transferred for open burning/open detonation
S042Stored and transferred for thermal desorption
S070Stored and transferred for chemical treatment
S081Stored and transferred for biological treatment
S090Stored and transferred for polymerization
S100Stored and transferred for physical treatment only
S110Stored and transferred for stabilization
S113Stored and transferred for stabilization to remove HW characteristics or to achieve delisting levels
S120Stored and transferred for comb. of chemical, biological, and/or physical TRT
S121Stored and transferred for neutralization only
S122Stored and transferred for evaporation
S129Stored and transferred for other treatment
S130Stored and transferred for surface impoundment that will be closed as landfill
S131Stored and transferred for land treatment or application
S132Stored and transferred for landfill (with prior treatment and/or stabilization)
S134Stored and transferred for deepwell or underground injection

When do the new codes apply?

Handlers may use the new S Codes on the 2025 Biennial Report GM form, on the 2026 Annual Report in some states, and for e-Manifests. While handlers may continue using code H141, EPA recommends shifting to S Codes before January 1, 2027, when code H141 will be removed.

Key to remember: EPA’s new S Codes for Biennial Reports and e-Manifests indicate how the final receiving facility will manage temporarily stored and transferred hazardous waste.

EPA's Fall 2024 regulatory agenda impacts air, land, water rules
2024-12-16T06:00:00Z

EPA's Fall 2024 regulatory agenda impacts air, land, water rules

The Environmental Protection Agency (EPA) published the Fall 2024 Semiannual Agenda of Regulatory and Deregulatory Actions on December 13, 2024. The agenda reveals the agency’s upcoming regulatory actions and where each action is in the rulemaking process.

The agenda includes major EPA updates, such as:

  • Finalizing a rule to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories to the Toxics Release Inventory as chemicals of special concern, making them subject to reporting (final rule expected August 2025);
  • Establishing greenhouse gas emission guidelines for existing fossil fuel-fired combustion turbine electric generating units (proposed rule expected February 2025);
  • Lowering the 2024 cellulosic biofuel volume and associated percentage standard requirements under the Renewable Fuel Standard program (final rule expected in March 2025);
  • Issuing renewal decisions for each of the six applications of hydrofluorocarbons (HFCs) prioritized under the HFC allowance allocation program starting in calendar year 2026 (final rule expected in July 2025); and
  • Proposing and finalizing regulations to control unreasonable risks from multiple chemical substances regulated under the Toxic Substances Control Act, like:
    • C. I. Pigment Violet 29 (proposed rule expected in April 2025),
    • N-methylpyrrolidone (final rule expected in August 2025), and
    • 1,4-dioxane (proposed rule expected in October 2025).

This article highlights some of the major rules we’re watching closely. You’ll want to review the entire agenda to learn about all the rulemakings on EPA’s docket. Please note that the agenda dates are tentative; they're when the agency seeks to publish the rulemakings in the Federal Register.

Final Rule Stage
Project Publication DateTitle
December 2024New Source Performance Standards (NSPS) and Emission Guidelines (EG) for Large Municipal Waste Combustors (MWCs)  
December 2024Removal of Affirmative Defense Provisions From Specified New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants
January 2025Water System Restructuring Assessment Rule
March 2025Regulatory Requirements for New HAP Additions to Part 63
July 2025Listing of Specific PFAS as Hazardous Constituents 
August 2025Clean Water Act Effluent Limitations Guidelines and Standards for the Meat and Poultry Products Point Source Category 
October 2025Revisions to Standards for the Open Burning/Open Detonation of Waste Explosives
November 2025Stationary Combustion Turbines New Source Performance Standards (NSPS) Technology Review
Proposed Rule Stage
Projected publication date of Notice of Proposed RulemakingTitle
December 2024Reconsideration of Standards of Performance for New, Reconstructed and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review 
January 2025National Emission Standards for Hazardous Air Pollutants for the Polyether Polyols Production Industry
March 2025Clean Water Act Effluent Limitations Guidelines and Standards for PFAS Manufacturers Under the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category
April 2025Phasedown of Hydrofluorocarbons: Reconsideration of Technology Transitions Final Rule Under the American Innovation and Manufacturing Act of 2020 
May 2025National Emission Standards for Hazardous Air Pollutants: Stationary Combustion Turbines; Amendments 
June 2025Improving Recycling and Management of Renewable Energy Wastes: Universal Waste Regulations for Solar Panels and Lithium Batteries
June 2025PFAS Requirements in NPDES Permit Applications
June 2025Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management Under the Toxic Substances Control Act (TSCA) 
November 2025Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems
November 2025Revise/Update the Standards of Performance and Emission Guidelines for Municipal Solid Waste Landfills 
Pre-Rule Stage
Projected publication date or other actionTitle
December 2024 (Notice of Proposed Rulemaking)Lead Wheel Weights; Regulatory Investigation Under the Toxic Substances Control Act (TSCA)
January 2025 (End Review)610 Review of Standards of Performance for New Residential Wood Heathers, New Residential Hydronic Heaters and Forced-Air Furnaces
January 2025 (Advanced Notice of Proposed Rulemaking Comment Period End)Regulatory Investigation of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine ("6PPD") and its Transformation Product, 6PPD-quinone Under the Toxic Substances Control Act (TSCA)
Key to remember: EPA’s Fall 2024 regulatory agenda includes upcoming actions with possible impacts on industry compliance with air, land, and water rules.
New chemical review: What are the 5 possible results?
2024-12-11T06:00:00Z

New chemical review: What are the 5 possible results?

Before a new chemical substance can enter the marketplace, it first travels through the New Chemicals Review Program. Section 5 of the Toxic Substances Control Act (TSCA) requires the Environmental Protection Agency (EPA) to review new chemicals for any unreasonable risk of injury they may pose to human or environmental health. The agency determines (a) whether the substances can enter the marketplace and (b) if they require restrictions to manage any unreasonable risk.

To manufacture (including import) a chemical for commercial purposes that’s not on the TSCA Chemical Substance Inventory (i.e., a new chemical), you have to submit a premanufacture notice (PMN) to EPA. In December 2024, EPA finalized the new chemicals review rule. It clarifies that when you submit a PMN, you may not manufacture the new chemical substance until the agency issues a safety determination and completes any associated actions (like developing rules to limit its use).

Start the PMN process by conducting your own review! Evaluate and prepare for the possible determinations EPA will make for your new chemical substance.

Safety determinations

Submitting a PMN sparks the beginning of the new chemicals review process. EPA completes the review process by making one of five possible safety determinations for the new chemical.

It’s important to note that three types of determinations fall under the scope of Section 5(e) actions. If EPA makes any determination under Section 5(e), it must issue a Section 5(e) order with requirements that limit or ban the manufacture, processing, distribution in commerce, use, or disposal of the new chemical. Examples include toxicity testing, personal protective equipment for exposed workers, and environmental release restrictions.

Let’s take a look at each one.

Section 5(a)(3)(C): Not likely to present an unreasonable risk

In the most straightforward scenario, EPA can find that the new chemical isn’t likely to pose an unreasonable risk.

In this case, the agency will notify you and publish its findings in the Federal Register. Once you receive the Section 5(a)(3)(C) notice from EPA, you may begin manufacturing the new chemical substance, even if the applicable review period isn’t over.

Section 5(f): Presents an unreasonable risk

The agency may find that a new chemical presents an unreasonable risk of injury.

It will use Section 5(f) to limit or ban the manufacture, processing, distribution in commerce, use, or disposal of the new chemical through either:

  • A proposed rule that takes immediate effect, or
  • An issued order.

Section 5(e): Insufficient information

The agency may determine that it doesn’t have enough information to make a “reasoned evaluation” of the new chemical’s impact on health and the environment.

EPA will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.

Section 5(e): May present an unreasonable risk

If EPA doesn’t have enough information, it can alternatively determine that the new chemical poses an unreasonable risk due to insufficient information.

The agency will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.

Section 5(e): Presents unreasonable risk due to quantity

On the other hand, EPA may determine that the new chemical will be produced in substantial quantities that could (a) be released in large amounts to the environment or (b) result in significant human exposure.

EPA will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.

Regulatory action

In December 2024, EPA finalized changes to the rule for new chemical reviews. It clarifies that the agency must make one of five statutory determinations for each PMN, significant new use notice, and microbial commercial activity notice it receives.

The final rule also:

  • Eliminates full review exemptions for per- and polyfluoroalkyl substances (or PFAS) as well as for persistent, bioaccumulative, and toxic (PBT) chemicals if environmental releases of or potentially unreasonable exposures to PBT chemicals are expected;
  • Clarifies the information required in new chemical notices;
  • Changes EPA’s procedures for reviewing notices with incomplete information or errors;
  • Updates the application form on the EPA Central Data Exchange; and
  • Streamlines the suspension request process for submitters.

Key to remember: EPA reviews each new chemical and makes one of five possible safety determinations that dictate both if and how the substance can enter the marketplace.

Chemical management: Minimizing risks, maximizing compliance
2024-12-10T06:00:00Z

Chemical management: Minimizing risks, maximizing compliance

In 2022, the National Institute for Occupational Safety and Health (NIOSH) reported a staggering 658,000 workers were exposed to harmful chemicals, resulting in 839 fatalities. These statistics highlight the significant health and safety risks that an unexpected exposure to a hazardous chemical, or a substantial threat of a hazardous substance release, can pose to workers, organizations, and communities. A thorough understanding of chemical management regulations is crucial to ensure potential hazardous exposures are minimized.

Hazard communication (HazCom)

OSHA’s HazCom standard (29 CFR 1910.1200) is designed to inform workers about chemical hazards and how to protect themselves.

Key definitions: A "hazardous chemical" is any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, or other hazards not that may not be classified but still pose a serious danger.

Indicators: Any workplace where hazardous chemicals are used, stored, or processed needs a hazard communication program. Labels, safety data sheets (SDSs), and employee training are essential components.

Training requirements: Training must cover how to read and understand labels, the purpose and location of SDSs, and specific protective measures when handling hazardous chemicals. Training must be provided upon initial assignment and updated whenever new chemical hazards are introduced.

Hazardous materials (Hazmat)

The DOT’s hazmat regulations (DOT 49 CFR Parts 171-180) include substances that, if transported improperly, can harm people, property, or the environment. By correctly handling and moving these materials, organizations can avoid accidents and safeguard both public health and the environment.

Key definitions: A "hazardous material" is any substance or material capable of posing an unreasonable risk when transported in commerce. This can include flammable, toxic, and reactive substances.

Indicators: Activities involving the loading, unloading, and handling of hazardous materials require adherence to hazmat regulations. This requirement also applies to organizations that make or maintain packaging, or a part of packaging, that's marked or sold as suitable for transporting hazardous materials commercially.

Training requirements: Workers handling hazmat must undergo specific training on material classification, safe handling, emergency response, and transportation. Training must be provided within 90 days of initial assignment and a refresher at least once every three years. Training must also be documented and retained for a minimum of three years.

Hazardous waste (Hazwaste)

The EPA’s hazwaste regulations (40 CFR Parts 260-299) refer to any waste material that could potentially harm the environment or human health if not managed correctly. Additionally, many states have hazardous waste requirements beyond EPA regulations.

Key Definitions: Hazardous waste includes materials classified as toxic, ignitable, corrosive, or reactive, based on specific criteria.

Indicators: Managing hazardous waste follows the material’s entire lifecycle including the generation, transportation, treatment, storage, and disposal, known as "cradle-to-grave." Requirements are based on the quantity of waste generated.

Training requirements: Employees involved in hazardous waste management must receive training on waste handling, storage, labeling, and disposal procedures. Annual training requirements are based on generator quantity status.

Hazardous waste operations and emergency response (HAZWOPER)

OSHA’s HAZWOPER standard (29 CFR 1910.120) protects workers involved in hazardous waste management and emergency response. HAZWOPER covers a wide range of activities, including cleanup operations and responses to hazardous substance releases.

Key definitions: A hazardous substance is any material that can harm health and safety if released into the environment. In the context of HAZWOPER, this includes materials that pose risks in emergencies, such as spills, leaks, or other uncontrolled releases.

Indicators: Workers and organizations tasked with hazardous waste cleanup, spill response, and emergency operations require specialized training, equipment, and procedures.

Training requirements: HAZWOPER training is intensive and includes specific requirements depending on job roles. Training levels include 24-hour, 40-hour, and 8-hour refresher courses for different exposure risks. Employees learn about hazardous substance properties, emergency response procedures, PPE use, and decontamination processes.

Process Safety Management (PSM)

OSHA’s PSM standard (29 CFR 1910.119) aims to prevent accidental chemical releases that could seriously harm employees or the environment by including safety measures, risk assessments, and employee training to ensure safe operations. It is especially important in industries handling highly hazardous chemicals including facilities with high-risk chemical processes.

Key definitions: OSHA defines a "highly hazardous chemical" as any substance that poses a significant risk of causing serious harm to people, property, or the environment due to its toxic, reactive, flammable, or explosive properties.

Indicators: Any workplace handling large volumes of hazardous chemicals or using complex chemical processes including chemicals that are specifically listed by OSHA in appendix A of the standard, are present in quantities above specified thresholds, or exhibit properties that make them likely to cause a major incident.

Training requirements: PSM training covers safe operating procedures, hazard analysis, and incident investigation for employees involved in high-risk processes. Training must be provided at initial assignment and a refresher at least once every three years.

Key to remember: Chemical management is a complex task. Understanding what regulatory requirements apply will ensure compliance as well as minimize the chance for dangerous incidents.

Deadliest chemical disaster still haunts, decades later
2024-12-03T06:00:00Z

Deadliest chemical disaster still haunts, decades later

December 2024 marks the 40th anniversary of one of history’s worst industrial incidents — the release of a deadly gas at a chemical plant in Bhopal, India. This incident, along with another in West Virginia in 1985, spurred U.S. legislative and regulatory action. However, some might say that work is not finished.

Think of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986, the EPA Risk Management Program (RMP) standard, and the OSHA Process Safety Management (PSM) standard, for example. You’ll find roots to the Bhopal disaster.

What happened in Bhopal?

It was late on December 2, 1984, at a chemical facility. A faulty valve leaked water into a tank of methyl isocyanate (or MIC). This prompted a violent reaction inside the tank. History tells us that at about 1:00 a.m. on that fateful December 3, the failure of a safety valve triggered a massive release. A dense, lethal cloud of MIC and other chemicals drifted over the city of Bhopal.

By dawn, thousands of residents were dead, along with birds, dogs, cows, and other animals. The injured flocked to hospitals in overwhelming numbers. A lack of information about just what the chemicals were, however, compounded the catastrophe.

India officials reported half a million or more chemical exposures. Estimates vary, but as many as 10,000 people perished in the initial few days. Tens of thousands died prematurely in the decades to follow, according to sources.

What happened in West Virginia?

In August 1985, a chemical release in Institute, West Virginia, showed Americans that a “Bhopal-like” incident could happen here. Aldicarb oxime and other chemicals released from the facility, and over 125 residents landed in the hospital. Again, a lack of available chemical information was noteworthy. Many U.S. citizens began to fear they faced catastrophic risks.

What happened next?

In the wake of the incidents, Congress enacted laws:

Together, they required EPA and OSHA to issue regulations to:

  • Increase community chemical emergency preparedness,
  • Require companies to report worst-case release scenarios,
  • Require companies to develop RMPs and PSM programs to protect communities and workers, respectively.

Congress also established the Chemical Safety and Hazard Investigation Board (CSB) to investigate chemical incidents and recommend measures to prevent them. Despite these actions, the U.S. continues to experience serious chemical incidents. A visit to the CSB or National Response Center (NRC) websites reveals countless incident reports since 1990. A look at the 2024 data finds:

CSB video

Ten years ago, on the 30th anniversary of the Bhopal disaster, CSB posted a six-minute video explaining how the tragedy occurred. The video also examines more recent U.S. incidents. It emphasizes what more could be done to prevent similar incidents.

CSB investigations around the time of the video found deficiencies in design and PSM, similar to those uncovered in Bhopal! CSB Chairperson Rafael Moure-Eraso argued: “Process safety management regulations are in need of reform. There must be more emphasis on preventing the occurrence of major chemical accidents through safer design. Responding to emergencies and punishing people after the fact are not enough.”

Push for regulatory reform

Another headline-making incident in April 2013 involved a massive explosion of ammonium nitrate at a fertilizer storage/distribution facility in West, Texas. It fatally injured 12 volunteer firefighters and two members of the public and caused hundreds of injuries. The incident prompted the Executive Order on Improving Chemical Facility Safety and Security (EO 13650) on August 1, 2013. The order directed the federal government to:

  • Improve operational coordination with state and local partners;
  • Enhance federal agency coordination and information sharing;
  • Modernize policies, regulations, and standards; and
  • Work with stakeholders to identify best practices.

The feds held listening sessions and issued a flurry of fact sheets, alerts, and enforcement policy changes (See here and here.). Note that the RMP regulation at 40 CFR 68 was eventually amended this year on March 11, 2024. The PSM standard remains unchanged, despite a request for information on December 9, 2013. In an about-face, Congress allowed the Chemical Facility Anti-Terrorism Standards program (at 6 CFR 27) to expire on July 28, 2023, but many in Congress and industry would like to see its return.

Key to remember

This month marks the 40th anniversary of the Bhopal chemical disaster. It sparked the U.S. Congress to take steps back then to prevent such a disaster from occurring here. Those actions did not spell the end to all chemical disasters in the U.S. In response, a renewed push for regulatory reforms popped up in the last decade.

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