Subpart Ce - Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators

§60.30e Scope.

This subpart contains emission guidelines and compliance times for the control of certain designated pollutants from hospital/medical/infectious waste incinerator(s) (HMIWI) in accordance with sections 111 and 129 of the Clean Air Act and subpart B of this part. The provisions in these emission guidelines supersede the provisions of §60.24(f) of subpart B of this part.

§60.31e Definitions.

Terms used but not defined in this subpart have the meaning given them in the Clean Air Act and in subparts A, B, and Ec of this part.

§60.32e Designated facilities.

(a) Except as provided in paragraphs (b) through (h) of this section, the designated facility to which the guidelines apply is each individual HMIWI:

(1) For which construction was commenced on or before June 20, 1996, or for which modification was commenced on or before March 16, 1998.

(2) For which construction was commenced after June 20, 1996 but no later than December 1, 2008, or for which modification is commenced after March 16, 1998 but no later than April 6, 2010.

(b) A combustor is not subject to this subpart during periods when only pathological waste, low-level radioactive waste, and/or chemotherapeutic waste (all defined in §60.51c) is burned, provided the owner or operator of the combustor:

(1) Notifies the Administrator of an exemption claim; and

(2) Keeps records on a calendar quarter basis of the periods of time when only pathological waste, low-level radioactive waste, and/or chemotherapeutic waste is burned.

(c) Any co-fired combustor (defined in §60.51c) is not subject to this subpart if the owner or operator of the co-fired combustor:

(1) Notifies the Administrator of an exemption claim;

(2) Provides an estimate of the relative weight of hospital waste, medical/infectious waste, and other fuels and/or wastes to be combusted; and

(3) Keeps records on a calendar quarter basis of the weight of hospital waste and medical/infectious waste combusted, and the weight of all other fuels and wastes combusted at the co-fired combustor.

(d) Any combustor required to have a permit under Section 3005 of the Solid Waste Disposal Act is not subject to this subpart.

(e) Any combustor which meets the applicability requirements under subpart Cb, Ea, or Eb of this part (standards or guidelines for certain municipal waste combustors) is not subject to this subpart.

(f) Any pyrolysis unit (defined in §60.51c) is not subject to this subpart.

(g) Cement kilns firing hospital waste and/or medical/infectious waste are not subject to this subpart.

(h) Physical or operational changes made to an existing HMIWI unit solely for the purpose of complying with emission guidelines under this subpart are not considered a modification and do not result in an existing HMIWI unit becoming subject to the provisions of subpart Ec (see §60.50c).

(i) Beginning September 15, 2000, or on the effective date of an EPA approved operating permit program under Clean Air Act title V and the implementing regulations under 40 CFR part 70 in the State in which the unit is located, whichever date is later, designated facilities subject to this subpart shall operate pursuant to a permit issued under the EPA-approved operating permit program.

(j) The requirements of this subpart as promulgated on September 15, 1997, shall apply to the designated facilities defined in paragraph (a)(1) of this section until the applicable compliance date of the requirements of this subpart, as amended on October 6, 2009. Upon the compliance date of the requirements of this subpart, designated facilities as defined in paragraph (a)(1) of this section are no longer subject to the requirements of this subpart, as promulgated on September 15, 1997, but are subject to the requirements of this subpart, as amended on October 6, 2009.

(k) The authorities listed under §60.50c(i) shall be retained by the Administrator and not be transferred to a state.

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51402, Oct. 6, 2009; 76 FR 18412, Apr. 4, 2011]

§60.33e Emissions guidelines.

(a) For approval, a State plan shall include the requirements for emissions limits at least as protective as the following requirements, as applicable:

(1) For a designated facility as defined in §60.32e(a)(1) subject to the emissions guidelines as promulgated on September 15, 1997, the requirements listed in Table 1A of this subpart, except as provided in paragraph (b) of this section.

(2) For a designated facility as defined in §60.32e(a)(1) subject to the emissions guidelines as amended on October 6, 2009, the requirements listed in Table 1B of this subpart, except as provided in paragraph (b) of this section.

(3) For a designated facility as defined in §60.32e(a)(2), the more stringent of the requirements listed in Table 1B of this subpart and Table 1A of subpart Ec of this part.

(b) For approval, a State plan shall include the requirements for emissions limits for any small HMIWI constructed on or before June 20, 1996, which is located more than 50 miles from the boundary of the nearest Standard Metropolitan Statistical Area (defined in §60.31e) and which burns less than 2,000 pounds per week of hospital waste and medical/infectious waste that are at least as protective as the requirements in paragraphs (b)(1) and (b)(2) of this section, as applicable. The 2,000 lb/week limitation does not apply during performance tests.

(1) For a designated facility as defined in §60.32e(a)(1) subject to the emissions guidelines as promulgated on September 15, 1997, the requirements listed in Table 2A of this subpart.

(2) For a designated facility as defined in §60.32e(a)(1) subject to the emissions guidelines as amended on October 6, 2009, the requirements listed in Table 2B of this subpart.

(c) For approval, a State plan shall include the requirements for stack opacity at least as protective as the following, as applicable:

(1) For a designated facility as defined in §60.32e(a)(1) subject to the emissions guidelines as promulgated on September 15, 1997, the requirements in §60.52c(b)(1) of subpart Ec of this part.

(2) For a designated facility as defined in §60.32e(a)(1) subject to the emissions guidelines as amended on October 6, 2009 and a designated facility as defined in §60.32e(a)(2), the requirements in §60.52c(b)(2) of subpart Ec of this part.

[74 FR 51403, Oct. 6, 2009]

§60.34e Operator training and qualification guidelines.

For approval, a State plan shall include the requirements for operator training and qualification at least as protective as those requirements listed in §60.53c of subpart Ec of this part. The State plan shall require compliance with these requirements according to the schedule specified in §60.39e(e).

§60.35e Waste management guidelines.

For approval, a State plan shall include the requirements for a waste management plan at least as protective as those requirements listed in §60.55c of subpart Ec of this part.

§60.36e Inspection guidelines.

(a) For approval, a State plan shall require each small HMIWI subject to the emissions limits under §60.33e(b) and each HMIWI subject to the emissions limits under §60.33e(a)(2) and (a)(3) to undergo an initial equipment inspection that is at least as protective as the following within 1 year following approval of the State plan:

(1) At a minimum, an inspection shall include the following:

(i) Inspect all burners, pilot assemblies, and pilot sensing devices for proper operation; clean pilot flame sensor, as necessary;

(ii) Ensure proper adjustment of primary and secondary chamber combustion air, and adjust as necessary;

(iii) Inspect hinges and door latches, and lubricate as necessary;

(iv) Inspect dampers, fans, and blowers for proper operation;

(v) Inspect HMIWI door and door gaskets for proper sealing;

(vi) Inspect motors for proper operation;

(vii) Inspect primary chamber refractory lining; clean and repair/replace lining as necessary;

(viii) Inspect incinerator shell for corrosion and/or hot spots;

(ix) Inspect secondary/tertiary chamber and stack, clean as necessary;

(x) Inspect mechanical loader, including limit switches, for proper operation, if applicable;

(xi) Visually inspect waste bed (grates), and repair/seal, as appropriate;

(xii) For the burn cycle that follows the inspection, document that the incinerator is operating properly and make any necessary adjustments;

(xiii) Inspect air pollution control device(s) for proper operation, if applicable;

(xiv) Inspect waste heat boiler systems to ensure proper operation, if applicable;

(xv) Inspect bypass stack components;

(xvi) Ensure proper calibration of thermocouples, sorbent feed systems and any other monitoring equipment; and

(xvii) Generally observe that the equipment is maintained in good operating condition.

(2) Within 10 operating days following an equipment inspection all necessary repairs shall be completed unless the owner or operator obtains written approval from the State agency establishing a date whereby all necessary repairs of the designated facility shall be completed.

(b) For approval, a State plan shall require each small HMIWI subject to the emissions limits under §60.33e(b) and each HMIWI subject to the emissions limits under §60.33e(a)(2) and (a)(3) to undergo an equipment inspection annually (no more than 12 months following the previous annual equipment inspection), as outlined in paragraph (a) of this section.

(c) For approval, a State plan shall require each small HMIWI subject to the emissions limits under §60.33e(b)(2) and each HMIWI subject to the emissions limits under §60.33e(a)(2) and (a)(3) to undergo an initial air pollution control device inspection, as applicable, that is at least as protective as the following within 1 year following approval of the State plan:

(1) At a minimum, an inspection shall include the following:

(i) Inspect air pollution control device(s) for proper operation, if applicable;

(ii) Ensure proper calibration of thermocouples, sorbent feed systems, and any other monitoring equipment; and

(iii) Generally observe that the equipment is maintained in good operating condition.

(2) Within 10 operating days following an air pollution control device inspection, all necessary repairs shall be completed unless the owner or operator obtains written approval from the State agency establishing a date whereby all necessary repairs of the designated facility shall be completed.

(d) For approval, a State plan shall require each small HMIWI subject to the emissions limits under §60.33e(b)(2) and each HMIWI subject to the emissions limits under §60.33e(a)(2) and (a)(3) to undergo an air pollution control device inspection, as applicable, annually (no more than 12 months following the previous annual air pollution control device inspection), as outlined in paragraph (c) of this section.

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51403, Oct. 6, 2009]

§60.37e Compliance, performance testing, and monitoring guidelines.

(a) Except as provided in paragraph (b) of this section, for approval, a State plan shall include the requirements for compliance and performance testing listed in §60.56c of subpart Ec of this part, with the following exclusions:

(1) For a designated facility as defined in §60.32e(a)(1) subject to the emissions limits in §60.33e(a)(1), the test methods listed in §60.56c(b)(7) and (8), the fugitive emissions testing requirements under §60.56c(b)(14) and (c)(3), the CO CEMS requirements under §60.56c(c)(4), and the compliance requirements for monitoring listed in §60.56c(c)(5)(ii) through (v), (c)(6), (c)(7), (e)(6) through (10), (f)(7) through (10), (g)(6) through (10), and (h).

(2) For a designated facility as defined in §60.32e(a)(1) and (a)(2) subject to the emissions limits in §60.33e(a)(2) and (a)(3), the annual fugitive emissions testing requirements under §60.56c(c)(3), the CO CEMS requirements under §60.56c(c)(4), and the compliance requirements for monitoring listed in §60.56c(c)(5)(ii) through (v), (c)(6), (c)(7), (e)(6) through (10), (f)(7) through (10), and (g)(6) through (10). Sources subject to the emissions limits under §60.33e(a)(2) and (a)(3) may, however, elect to use CO CEMS as specified under §60.56c(c)(4) or bag leak detection systems as specified under §60.57c(h).

(b) Except as provided in paragraphs (b)(1) and (b)(2) of this section, for approval, a State plan shall require each small HMIWI subject to the emissions limits under §60.33e(b) to meet the performance testing requirements listed in §60.56c of subpart Ec of this part. The 2,000 lb/week limitation under §60.33e(b) does not apply during performance tests.

(1) For a designated facility as defined in §60.32e(a)(1) subject to the emissions limits under §60.33e(b)(1), the test methods listed in §60.56c(b)(7), (8), (12), (13) (Pb and Cd), and (14), the annual PM, CO, and HCl emissions testing requirements under §60.56c(c)(2), the annual fugitive emissions testing requirements under §60.56c(c)(3), the CO CEMS requirements under §60.56c(c)(4), and the compliance requirements for monitoring listed in §60.56c(c)(5) through (7), and (d) through (k) do not apply.

(2) For a designated facility as defined in §60.32e(a)(2) subject to the emissions limits under §60.33e(b)(2), the annual fugitive emissions testing requirements under §60.56c(c)(3), the CO CEMS requirements under §60.56c(c)(4), and the compliance requirements for monitoring listed in §60.56c(c)(5)(ii) through (v), (c)(6), (c)(7), (e)(6) through (10), (f)(7) through (10), and (g)(6) through (10) do not apply. Sources subject to the emissions limits under §60.33e(b)(2) may, however, elect to use CO CEMS as specified under §60.56c(c)(4) or bag leak detection systems as specified under §60.57c(h).

(c) For approval, a State plan shall require each small HMIWI subject to the emissions limits under §60.33e(b) that is not equipped with an air pollution control device to meet the following compliance and performance testing requirements:

(1) Establish maximum charge rate and minimum secondary chamber temperature as site-specific operating parameters during the initial performance test to determine compliance with applicable emission limits.

(2) Following the date on which the initial performance test is completed or is required to be completed under §60.8, whichever date comes first, ensure that the designated facility does not operate above the maximum charge rate or below the minimum secondary chamber temperature measured as 3-hour rolling averages (calculated each hour as the average of the previous 3 operating hours) at all times. Operating parameter limits do not apply during performance tests. Operation above the maximum charge rate or below the minimum secondary chamber temperature shall constitute a violation of the established operating parameter(s).

(3) Except as provided in paragraph (c)(4) of this section, operation of the designated facility above the maximum charge rate and below the minimum secondary chamber temperature (each measured on a 3-hour rolling average) simultaneously shall constitute a violation of the PM, CO, and dioxin/furan emissions limits.

(4) The owner or operator of a designated facility may conduct a repeat performance test within 30 days of violation of applicable operating parameter(s) to demonstrate that the designated facility is not in violation of the applicable emissions limit(s). Repeat performance tests conducted pursuant to this paragraph must be conducted under process and control device operating conditions duplicating as nearly as possible those that indicated a violation under paragraph (c)(3) of this section.

(d) For approval, a State plan shall include the requirements for monitoring listed in §60.57c of subpart Ec of this part for HMIWI subject to the emissions limits under §60.33e(a) and (b), except as provided for under paragraph (e) of this section.

(e) For approval, a State plan shall require small HMIWI subject to the emissions limits under §60.33e(b) that are not equipped with an air pollution control device to meet the following monitoring requirements:

(1) Install, calibrate (to manufacturers' specifications), maintain, and operate a device for measuring and recording the temperature of the secondary chamber on a continuous basis, the output of which shall be recorded, at a minimum, once every minute throughout operation.

(2) Install, calibrate (to manufacturers' specifications), maintain, and operate a device which automatically measures and records the date, time, and weight of each charge fed into the HMIWI.

(3) The owner or operator of a designated facility shall obtain monitoring data at all times during HMIWI operation except during periods of monitoring equipment malfunction, calibration, or repair. At a minimum, valid monitoring data shall be obtained for 75 percent of the operating hours per day for 90 percent of the operating hours per calendar quarter that the designated facility is combusting hospital waste and/or medical/infectious waste.

(f) The owner or operator of a designated facility as defined in §60.32e(a)(1) or (a)(2) subject to emissions limits under §60.33e(a)(2), (a)(3), or (b)(2) may use the results of previous emissions tests to demonstrate compliance with the emissions limits, provided that the conditions in paragraphs (f)(1) through (f)(3) of this section are met:

(1) The designated facility's previous emissions tests must have been conducted using the applicable procedures and test methods listed in §60.56c(b) of subpart Ec of this part. Previous emissions test results obtained using EPA-accepted voluntary consensus standards are also acceptable.

(2) The HMIWI at the designated facility shall currently be operated in a manner (e.g., with charge rate, secondary chamber temperature, etc.) that would be expected to result in the same or lower emissions than observed during the previous emissions test(s), and the HMIWI may not have been modified such that emissions would be expected to exceed (notwithstanding normal test-to-test variability) the results from previous emissions test(s).

(3) The previous emissions test(s) must have been conducted in 1996 or later.

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51403, Oct. 6, 2009]

§60.38e Reporting and recordkeeping guidelines.

(a) Except as provided in paragraphs (a)(1) and (a)(2) of this section, for approval, a State plan shall include the reporting and recordkeeping requirements listed in §60.58c(b) through (g) of subpart Ec of this part.

(1) For a designated facility as defined in §60.32e(a)(1) subject to emissions limits under §60.33e(a)(1) or (b)(1), excluding §60.58c(b)(2)(ii) (fugitive emissions), (b)(2)(viii) (NO_X reagent), (b)(2)(xvii) (air pollution control device inspections), (b)(2)(xviii) (bag leak detection system alarms), (b)(2)(xix) (CO CEMS data), and (b)(7) (siting documentation).

(2) For a designated facility as defined in §60.32e(a)(1) or (a)(2) subject to emissions limits under §60.33e(a)(2), (a)(3), or (b)(2), excluding §60.58c(b)(2)(xviii) (bag leak detection system alarms), (b)(2)(xix) (CO CEMS data), and (b)(7) (siting documentation).

(b) For approval, a State plan shall require the owner or operator of each HMIWI subject to the emissions limits under §60.33e to:

(1) As specified in §60.36e, maintain records of the annual equipment inspections that are required for each HMIWI subject to the emissions limits under §60.33e(a)(2), (a)(3), and (b), and the annual air pollution control device inspections that are required for each HMIWI subject to the emissions limits under §60.33e(a)(2), (a)(3), and (b)(2), any required maintenance, and any repairs not completed within 10 days of an inspection or the timeframe established by the State regulatory agency; and

(2) Submit an annual report containing information recorded under paragraph (b)(1) of this section no later than 60 days following the year in which data were collected. Subsequent reports shall be sent no later than 12 calendar months following the previous report (once the unit is subject to permitting requirements under Title V of the Act, the owner or operator must submit these reports semiannually). The report shall be signed by the facilities manager.

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51404, Oct. 6, 2009]

§60.39e Compliance times.

(a) Each State in which a designated facility is operating shall submit to the Administrator a plan to implement and enforce the emissions guidelines as specified in paragraphs (a)(1) and (a)(2) of this section:

(1) Not later than September 15, 1998, for the emissions guidelines as promulgated on September 15, 1997.

(2) Not later than October 6, 2010, for the emissions guidelines as amended on October 6, 2009.

(b) Except as provided in paragraphs (c) and (d) of this section, State plans shall provide that designated facilities comply with all requirements of the State plan on or before the date 1 year after EPA approval of the State plan, regardless of whether a designated facility is identified in the State plan inventory required by §60.25(a) of subpart B of this part.

(c) State plans that specify measurable and enforceable incremental steps of progress towards compliance for designated facilities planning to install the necessary air pollution control equipment may allow compliance on or before the date 3 years after EPA approval of the State plan (but not later than September 16, 2002), for the emissions guidelines as promulgated on September 15, 1997, and on or before the date 3 years after approval of an amended State plan (but not later than October 6, 2014), for the emissions guidelines as amended on October 6, 2009). Suggested measurable and enforceable activities to be included in State plans are:

(1) Date for submitting a petition for site-specific operating parameters under §60.56c(j) of subpart Ec of this part.

(2) Date for obtaining services of an architectural and engineering firm regarding the air pollution control device(s);

(3) Date for obtaining design drawings of the air pollution control device(s);

(4) Date for ordering the air pollution control device(s);

(5) Date for obtaining the major components of the air pollution control device(s);

(6) Date for initiation of site preparation for installation of the air pollution control device(s);

(7) Date for initiation of installation of the air pollution control device(s);

(8) Date for initial startup of the air pollution control device(s); and

(9) Date for initial compliance test(s) of the air pollution control device(s).

(d) State plans that include provisions allowing designated facilities to petition the State for extensions beyond the compliance times required in paragraph (b) of this section shall:

(1) Require that the designated facility requesting an extension submit the following information in time to allow the State adequate time to grant or deny the extension within 1 year after EPA approval of the State plan:

(i) Documentation of the analyses undertaken to support the need for an extension, including an explanation of why up to 3 years after EPA approval of the State plan is sufficient time to comply with the State plan while 1 year after EPA approval of the State plan is not sufficient. The documentation shall also include an evaluation of the option to transport the waste offsite to a commercial medical waste treatment and disposal facility on a temporary or permanent basis; and

(ii) Documentation of measurable and enforceable incremental steps of progress to be taken towards compliance with the emission guidelines.

(2) Include procedures for granting or denying the extension; and

(3) If an extension is granted, require expeditious compliance with the emissions guidelines on or before the date 3 years after EPA approval of the state plan (but not later than September 16, 2002), for the emissions guidelines as promulgated on September 15, 1997, and on or before the date 3 years after EPA approval of an amended state plan (but not later than October 6, 2014), for the emissions guidelines as amended on October 6, 2009.

(e) For approval, a State plan shall require compliance with §60.34e - Operator training and qualification guidelines and §60.36e - Inspection guidelines by the date 1 year after EPA approval of a State plan.

(f) The Administrator shall develop, implement, and enforce a plan for existing HMIWI located in any State that has not submitted an approvable plan within 2 years after September 15, 1997, for the emissions guidelines as promulgated on September 15, 1997, and within 2 years after October 6, 2009 for the emissions guidelines as amended on October 6, 2009. Such plans shall ensure that each designated facility is in compliance with the provisions of this subpart no later than 5 years after September 15, 1997, for the emissions guidelines as promulgated on September 15, 1997, and no later than 5 years after October 6, 2009 for the emissions guidelines as amended on October 6, 2009.

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51404, Oct. 6, 2009; 76 FR 18412, Apr. 4, 2011]

Table 1A to Subpart Ce of Part 60 - Emissions Limits for Small, Medium, and Large HMIWI at Designated Facilities as Defined in §60.32e(a)(1)

[60 FR 65414, Dec. 19, 1995, as amended at 74 FR 51405, Oct. 6, 2009; 76 FR 18412, Apr. 4, 2011]

Table 1B to Subpart Ce of Part 60 - Emissions Limits for Small, Medium, and Large HMIWI at Designated Facilities as Defined in §60.32e(a)(1) and (a)(2)

[74 FR 51406, Oct. 6, 2009]

Table 2A to Subpart Ce of Part 60 - Emissions Limits for Small HMIWI Which Meet the Criteria Under §60.33e(b)(1)

[74 FR 51407, Oct. 6, 2009]

Table 2B to Subpart Ce of Part 60 - Emissions Limits for Small HMIWI Which Meet the Criteria Under §60.33e(b)(2)

[74 FR 51407, Oct. 6, 2009]