§ 63.362 - Standards.

§ 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. If you own or operate an affected source, you must comply with the applicable requirement by the compliance date specified in § 63.360(gj). 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 sources Source type Sterilization chamber vent Aeration room vent Chamber 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]

[59 FR 62589, Dec. 6, 1994, as amended at 66 FR 55583, Nov. 2, 2001]

tables 1 through 5 to this subpart.

(b) Applicability of standards. The standards in paragraphs (c) through (k) of this section apply at all times. If using EtO CEMS to determine compliance with an applicable standard, this compliance demonstration is based on the previous 30-operating days of data. If using EtO CEMS to determine compliance with an applicable emission reduction standard in paragraphs (c) through (g) and (i) of this section for each operating day, you must determine the total inlet mass to and outlet mass from the control system using the procedures laid out in § 63.364(f) and appendix A to this subpart, and you must maintain the emission limit based on the inlet mass and the applicable emission reduction standard. If using EtO CEMS to determine compliance with an applicable emission reduction standard in paragraph (j) of this section, you must continuously comply with the requirements of that paragraph.

(c) SCV. You must comply with each applicable standard in table 1 to this subpart, and you must meet each applicable requirement specified in § 63.363. If a SCV is combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.

(d) ARV. You must comply with each applicable standard in table 2 to this subpart, and you must meet each applicable requirement specified in § 63.363. If an ARV is combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.

(e) CEV. You must comply with each applicable standard in table 3 to this subpart, and you must meet each applicable requirement specified in § 63.363. If a CEV is combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.

(f) Group 1 room air emissions. You must comply with the applicable standard in table 4 to this subpart, and you must meet each applicable requirement specified in § 63.363. If Group 1 room air emissions are combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section.

(g) Group 2 room air emissions. You must comply with the applicable standard in table 5 to this subpart, and you must meet each applicable requirement specified in § 63.363. If Group 2 room air emissions are combined with a stream from another emission source, you must comply with the appropriate emission standard as prescribed in paragraph (i) of this section. If you are required to limit the sterilization chamber concentration of EtO to 1 ppmv prior to opening the sterilization chamber door, you must meet the monitoring requirements specified in § 63.364(h).

(h) Capture systems. Room air emissions for which numerical limits are prescribed must be captured and routed under negative pressure to a control system. You may assume the capture system efficiency is 100 percent if both conditions in paragraphs (h)(1) and (2) of this section are met:

(1) The capture system meets the criteria in Method 204 of appendix M to 40 CFR part 51 for a PTE and directs all the exhaust gases from the enclosure to an add-on control system.

(2) All sterilization operations creating exhaust gases for which the compliance demonstration is applicable are contained within the capture system.

(i) Requirements for combined emission streams. When streams from two or more emission sources are combined, you must demonstrate compliance by either the approach specified in paragraph (i)(1) of this section or the approach specified in paragraph (i)(2) of this section in lieu of the applicable standards in paragraphs (c) through (g) of this section for the affected source. The combined emission stream limit is based on as 30-operating day rolling sum. In order to elect to comply with a combined emission streams limit, you must use a CEMS on each exhaust stack at the facility to determine compliance.

(1) Monitoring after emission streams are combined. You must follow requirements of paragraphs (i)(1)(i) through (iii) of this section to determine the applicable combined emission streams limitation and demonstrate compliance. Under this approach, you must first determine the 30-operating day rolling sum of mass inlet to the control system. Then, the emission limitation is determined by applying the most stringent emission reduction standard to the 30-operating day rolling sum of the inlet mass. You must maintain actual emissions at or below that rate. For example, suppose a facility controls all of its ARVs and CEVs with one control system and that the emission reduction standards that apply to the ARVs and CEVs are 99.9% and 99%, respectively. Further suppose that the mass of uncontrolled EtO emissions from the combined stream is 5 lb during the 30-operating day period. Under this approach, the facility would need to apply an emission reduction of 99.9% to the combined stream, resulting in an emission limit of 0.005 lb for the 30-operating day period.

(i) The combined emission streams limit for each 30-operating day period is determined daily by using equation 1 to this paragraph.

Where:

CES_Combined = The combined emission stream limit based upon monitoring after the emission streams are combined, in pounds.

M_30day = The 30-operating day total mass sent to controls for the combined emission stream (i.e., monitoring data at the inlet of the control system), as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “M_30day” as used in this equation is equivalent to the term “E_30day” as designated in equation A-3.

Max(ER) = The most stringent emission reduction standard specified in tables 1 through 5 of this subpart applicable to any of the constituent streams, in decimal format.

(ii) The 30-operating day rolling sum of emissions for the combined emission stream (i.e., monitoring data at the outlet of the control system) is calculated daily using equation A-3 and determined in accordance with appendix A to this subpart. For purposes of this section, this value is designated as E_Combined. If the combined emission stream is split between two or more control systems, further sum the 30-operating day rolling sum of emissions from each control system to obtain E_Combined.

(iii) Compliance with the combined emission streams limitation shall be determined by demonstrating that E_Combined, as calculated in accordance with paragraph (i)(1)(ii) of this section, for each 30-operating day period is at or below CES_Combined, as calculated in paragraph (i)(1)(i) of this section.

(2) Monitoring before emission streams are combined. You must follow requirements of paragraphs (i)(2)(i) through (iii) of this section to determine the applicable combined emission streams limitation and demonstrate compliance. Under this approach, you must first determine 30-operating day rolling sum of inlet mass to the control system for each component stream. Then, the emission limitation is determined by applying the applicable emission reduction standards to the 30-operating day rolling sum of each component stream and summing across the components. You must maintain actual emissions at or below that rate. For example, suppose a facility controls all of its ARVs and CEVs with one control system and that the emission reduction standards that apply to the ARVs and CEVs are 99.9% and 99%, respectively. Further suppose that during a 30-operating day period the mass of uncontrolled EtO emissions from the ARVs is 4 lb and the mass of uncontrolled EtO emissions from the CEVs is 1 lb. Under this approach, the facility would need to apply an emission reduction of 99.9% to the ARV stream and an emission reduction of 99% to the CEV stream, resulting in an emission limit of 0.014 lb for the 30-operating day period.

(i) The combined emission streams limit for each 30-operating day period is determined daily by using equation 2 to this paragraph.

Where:

CES_Streams = The combined emission stream limit based upon monitoring before the emission streams are combined, in pounds.

M_c,i = The 30-operating day total mass sent to controls for each non-SCV constituent emission stream (i.e., monitoring data at the inlet of the control system), as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “M_c,i” as used in this equation is equivalent to the term “E_30day” as designated in equation A-3.

ER_i = The applicable emission reduction standard from tables 2 through 5 of this subpart to each non-SCV constituent emission stream i.

i = Non-SCV constituent emission stream index.

n = Total number of non-SCV constituent emission streams.

M_c,j = The 30-operating day total mass sent to controls for each SCV emission stream, as determined in accordance with equation 10 of § 63.364(f)(1)(i)(C)(1).

ER_j = The applicable SCV emission reduction standard in table 1 to this subpart, in decimal format.

j = SCV emission stream index.

m = Total number of SCV emission streams.

(ii) The 30-operating day rolling sum emissions for the combined emission stream (i.e., monitoring data at the outlet of the control system) is calculated daily using equation A-3 and determined in accordance with appendix A to this subpart. For purposes of this section, this value is designated as E_Combined. If the combined emission stream is split between two or more control systems, then further sum the 30-operating day rolling sum emissions from each control system to obtain E_Combined.

(iii) Compliance with the combined emission streams limitation shall be determined by demonstrating that E_Combined, as calculated in accordance with paragraph (i)(2)(ii) of this section, for each 30-operating day period is at or below CES_Streams, as calculated paragraph (i)(2)(i) of this section.

(3) If room air emissions are both subject to an emission standard and split between two or more control systems, then these control systems must be treated as part of the same control system.

(j) Site-wide emission limitation. You may choose to comply with a site-wide emission limitation (SWEL) specified in this paragraph (j) in lieu of the applicable standards in paragraphs (c) through (g) of this section for the facility. The SWEL, which is calculated daily, is based on the previous 30 operating days of data. In order to elect to comply with a SWEL, you must utilize an EtO CEMS on each exhaust stack at the facility to determine compliance. The owner or operator may demonstrate compliance via one of the two SWEL approaches in lieu of the applicable standard(s) in paragraphs (c) through (g) of this section for the facility. If electing to comply with a SWEL, you must comply with paragraph (j)(3) of this section.

(1) SWEL based upon facility EtO use. If you elect to comply with a SWEL based upon facility EtO use, you must follow requirements of paragraphs (j)(1)(i) through (iii) of this section to determine the applicable SWEL and demonstrate compliance. Under this approach, you first determine the 30-operating day rolling sum of EtO use. The SWEL is determined by multiplying by 0.99 and then applying the required SCV percent emission reduction standard in table 1 to this subpart to the 30-operating day rolling sum of EtO usage. Then, for each CEMS at the outlet of the control systems at the facility, determine the 30-operating day rolling sum of emissions. Finally, determine the facility actual emissions by summing the 30-operating day rolling sums for each CEMS at the facility. You must maintain actual emissions at or below the SWEL.

(i) The SWEL for each 30-operating day period is determined daily by using equation 3 to this paragraph.

Where:

SWEL_Fac = SWEL based upon facility EtO use, in pounds.

M_Fac = Facility EtO use over the previous 30 operating days, in pounds, as determined in accordance with equation 11 of § 63.364(i)(2).

0.99 = Adjustment factor for EtO residual in sterilized product.

ER_SCV = The applicable SCV emission reduction standard in table 1 to this subpart, in decimal format.

(ii) The 30-operating day rolling sum of emissions are determined daily using equation 4 to this paragraph.

Where:

E_Fac = The total emissions from the facility over the previous 30-operating days, in pounds.

E_o,i = The 30-operating day rolling sum of emissions calculated at each exhaust stack, i, monitored by an EtO CEMS, as calculated using equation A-3 of appendix A to this subpart.

i = Exhaust stack index

n = Total number of exhaust stacks

(iii) Compliance with the SWEL based upon facility EtO usage shall be determined by demonstrating that E_Fac, as calculated in accordance with paragraph (j)(1)(ii) of this section, for each 30-operating day period is at or below the SWEL, as calculated paragraph (j)(1)(i) of this section.

(2) SWEL based upon emissions streams. If you elect to comply with a SWEL based upon emissions streams, you must follow requirements of paragraphs (j)(2)(i) through (iii) of this section to determine the applicable SWEL and demonstrate compliance. Under this approach, for each non-SCV affected source, you must determine the mass of EtO sent to controls and apply the applicable emission reduction standard. For each SCV affected source, you must determine the mass of EtO sent to controls as specified in § 63.364(f)(1)(i)(C)(1) and apply the applicable emission reduction standard. The SWEL is determined by summing across the result of this calculation for each affected source (both non-SCV and SCV). Then, for each CEMS at the outlet of the control system(s) at the facility, determine the 30-operating day rolling sum of emissions. Finally, determine the facility actual emissions by summing the 30-operating day rolling sums for each CEMS at the facility. You must maintain actual emissions at or below the SWEL.

(i) The SWEL for each 30-operating day period is determined daily by using equation 5 to this paragraph.

Where:

SWEL_Streams = SWEL based upon individual emissions streams, in pounds.

M_c,i = The 30-operating day total mass sent to controls (i.e., monitoring data at the inlet of the control system) for each non-SCV emission stream, as calculated using equation A-3 and determined in accordance with appendix A to this subpart. The term “M_c,i” as used in this equation is equivalent to the term “E_30day” as designated in equation A-3.

ER_i = The applicable emission reduction standard to each non-SCV emission stream, i, specified in tables 1 through 5 of this subpart, in decimal format.

i = Non-SCV emission streams index.

n = Total number of non-SCV emission streams.

M_c,j = The 30-operating day total mass sent to controls for each SCV emission stream, as determined in accordance with equation 10 in § 63.364(f)(1)(i)(C)(1).

ER_j = The applicable SCV emission reduction standard in table 1 to this subpart, in decimal format.

j = SCV emission stream index.

m = Total number of SCV emission streams.

(ii) The 30-operating day rolling sum of emissions are determined daily using equation 4 to this section.

(iii) Compliance with the SWEL based upon emission streams shall be determined by demonstrating that E_Fac, as calculated in accordance with paragraph (j)(2)(ii) of this section, for each 30-operating day period is at or below SWEL_Streams, as calculated in paragraph (j)(2)(i) of this section.

(3) Boundary. The boundary for this approach includes all affected sources at the facility.

(k) General duty. At all times, you must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.