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06/13/2024

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89 FR 24090 National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review

...

89 FR 24090 National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review

RegSense Environmental Protection Agency (EPA)Rulemaking Air Programs Final Rule Environmental Air Quality English Focus Area Air Programs USA

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 63

Emission source	Existing or new?	EtO use	Standards	CAA section
¹ MACT floor.
² Beyond-the-Floor (BTF) standard.
³ To assure compliance with the emission limit, we are requiring each facility to operate area sources with these emissions in accordance with the PTE requirements of EPA Method 204 of appendix M to 40 CFR part 51.
⁴ Owners and operators may also apply for an alternative means of emission limitation under CAA section 112(h)(3).
SCV	Existing and new	At least 30 tpy	99.99 percent emission reduction	112(f)(2).
		At least 10 tpy but less than 30 tpy	99.9 percent emission reduction	112(f)(2).
		At least 10 tpy	99.9 percent emission reduction	112(d)(6).
		At least 1 but less than 10 tpy	99.8 percent emission reduction	112(f)(2) and 112(d)(6).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
ARV	Existing	At least 30 tpy	99.9 percent emission reduction	112(f)(2).
		At least 10 tpy but less than 30 tpy	99.6 percent emission reduction	112(f)(2).
		At least 10 tpy	99.6 percent emission reduction	112(d)(6).
		At least 1 but less than 10 tpy	99 percent emission reduction	112(d)(5).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
	New	At least 30 tpy	99.9 percent emission reduction	112(f)(2).
		At least 10 tpy	99.9 percent emission reduction	112(d)(6).
		At least 1 but less than 10 tpy	99 percent emission reduction	112(d)(5).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
CEVs at major source facilities	Existing and new	N/A	99.94 percent emission reduction ¹	112(d)(2) and 112(d)(3).
CEVs at area source facilities	Existing and new	At least 400 tpy	99.9 percent emission reduction	112(f)(2).
		At least 60 but less than 400 tpy	99.9 percent emission reduction	112(f)(2).
		Less than 60 tpy	99 percent emission reduction	112(d)(5).
Group 1 room air emissions at major sources	Existing and new	N/A	97 percent emission reduction	112(d)(2) and 112(d)(3).
Group 1 room air emissions at area sources	Existing and new	At least 40 tpy	98 percent emission reduction ³	112(f)(2).
		Less than 40 tpy	80 percent emission reduction ³	112(d)(5).
Group 2 room air emissions at major sources	Existing and new	N/A	86 percent emission reduction	112(d)(2) and 112(d)(3).
Group 2 room air emissions at area sources	Existing	At least 20 tpy	98 percent emission reduction ³	112(f)(2).
		At least 4 but less than 20 tpy	80 percent emission reduction ³	112(f)(2).
		Less than 4 tpy	Lower the EtO concentration within each sterilization chamber to 1 ppm before the chamber can be opened ⁴	112(d)(5).
	New	At least 20 tpy	98 percent emission reduction ³	112(f)(2).
		At least 4 but less than 20 tpy	80 percent emission reduction ³	112(f)(2).
		Less than 4 tpy	80 percent emission reduction ³	112(d)(5).

Requirement	Number of facilities w/costs associated with new requirements	Total capital investment	Total annual costs
¹ This includes the 88 facilities that are currently operating, as well as two planned facilities that are expected to start operating within the next few years.
² This includes $763,000 of one-time annual costs for reading the rule and developing record systems.
Permanent total enclosure	28	$77,500,000	$8,280,000
Additional control devices	83	187,000,000	43,000,000
Monitoring and testing	89	48,100,000	19,400,000
Recordkeeping and reporting	¹ 90		² 2,600,000
Total	¹ 90	313,000,000	74,000,000

	Current cancer risks— actual emissions	Current cancer risks— allowable emissions	Cancer risks after implementation of final amendments
¹ The MIR or maximum individual lifetime cancer risk is defined as the increase in estimated cancer risk associated with a 70-year lifetime of continuous exposure at the highest concentration of HAP where people are likely to live.
² Ranges in values account for if all facilities were performing at the level of the standards (high end) to considering facilities that are currently performing better than the standards (low end).
Maximum Individual Risk (MIR) ¹	6,000-in-1 million	8,000-in-1 million ³	100-in-1 million.
Number of People with Cancer Risks >100-in-1 million	19,000	260,000	0.
Number of People with Cancer Risks ≥1-in-1 million	8.5 million	62 million	700,000 to 1.4 million. ²
Estimated Annual Cancer Incidence (cases per year)	0.9	8	0.1 to 0.2. ²

Industrial category	NESHAP	NAICS ¹ code
¹ North American Industry Classification System.
Surgical and Medical Instrument Manufacturing	40 CFR part 63, subpart O	339112
Surgical Appliance and Supplies Manufacturing	40 CFR part 63, subpart O	339113
Pharmaceutical Preparation Manufacturing	40 CFR part 63, subpart O	325412
Spice and Extract Manufacturing	40 CFR part 63, subpart O	311942
Dried and Dehydrated Food Manufacturing	40 CFR part 63, subpart O	311423
Packaging and Labeling Services	40 CFR part 63, subpart O	561910

Existing and new sources subcategory (in any consecutive 12-month period) ¹	Sterilization chamber vent (SCV)	Aeration room vent (ARV)	Chamber exhaust vent (CEV) ²
¹ Determined on a rolling 12-month basis.
² The CEV emission source was included in the original standard but was later eliminated from the 40 CFR part 63, subpart O regulation in 2001.
Sources using 10 tons or more of EtO	99 percent emission reduction (see 40 CFR 63.362(c))	1 part per million (ppm) maximum outlet concentration or 99 percent emission reduction (see 40 CFR 63.362(d))	No control.
Sources using 1 ton or more of EtO but less than 10 tons of EtO	99 percent emission reduction (see 40 CFR 63.362(c))	No control	No control.
Sources using less than 1 ton of EtO	No control required; minimal recordkeeping requirements apply (see 40 CFR 63.367(c)).)	No control required; minimal recordkeeping requirements apply (see 40 CFR 63.367(c)).)	No control required; minimal recordkeeping requirements apply (see 40 CFR 63.367(c)).).

Emission source	Existing or new?	EtO use	Standards	CAA section
¹ To assure compliance with the emission limit, we proposed requiring each facility to operate areas with these emissions in accordance with the PTE requirements of EPA Method 204 of appendix M to 40 CFR part 51.
SCV	Existing and new	At least 40 tpy	99.94 percent emission reduction	112(f)(2).
		At least 10 tpy but less than 40 tpy	99.94 percent emission reduction	112(f)(2).
		At least 10 tpy	99.94 percent emission reduction	112(d)(6).
		At least 1 but less than 10 tpy	99.8 percent emission reduction	112(f)(2) and 112(d)(6).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
ARV	Existing	At least 10 tpy	99.6 percent emission reduction	112(d)(6).
		At least 1 but less than 10 tpy	99 percent emission reduction	112(d)(5).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
	New	At least 10 tpy	99.9 percent emission reduction	112(d)(6).
		At least 1 but less than 10 tpy	99 percent emission reduction	112(d)(5).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
CEV	Existing and new	At least 10 tpy	3.2E-4 lb/h	112(d)(2) and (3).
		At least 1 but less than 10 tpy	99.9 percent emission reduction	112(d)(5).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
Group 1 room air emissions	Existing and new	N/A	1.3E-3 lb/h ¹	112(d)(2) and 112(d)(3).
Group 1 room air emissions at area sources	Existing and new	N/A	1.3E-3 lb/h ¹	112(d)(5).
Group 2 room air emissions at major sources	Existing and new	N/A	2.8E-3 lb/h ¹	112(d)(2) and 112(d)(3).
Group 2 room air emissions at area sources	Existing	At least 20 tpy Less than 20 tpy	2.8E-3 lb/h ¹ Follow either the Cycle Calculation Approach or the Bioburden/Biological Indicator Approach to achieve sterility assurance in accordance with ISO 11135:2014 (July 15, 2014) and ISO 11138-1:2017 (March 2017)	112(f)(2). 112(d)(5).
	New	N/A	2.8E-3 lb/h ¹	112(d)(5).

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
MACT Floor	99.94 percent emission reduction	$830,000	$176,000	2.4E-2 [480 lb/yr]	$735,000 [$370/lb].
1	99.95 percent emission reduction	184,000	65,500	2.0E-4 [0.4 lb/year]	328,000,000 [$164,000/lb].
2	99.96 percent emission reduction	184,000	66,200	2.0E-4 [0.4 lb/year]	331,000,000 [$166,000/lb].

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
¹ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the chamber is opened, as well as preparing and submitting the necessary paperwork to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs ( i.e., annualized capital costs plus annual costs) in the analysis.
1	99 percent emission reduction	$1,750,000	$740,000	3.84 [7,680 lb/year]	193,000 [$96/lb]
2	BMP (estimated 20 percent emission reduction)	0	$3,560,000 (one-time annual cost) ¹	0.796 [1,590 lb/year]	$4,470,000 [$2,240/lb]

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
¹ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs ( i.e., annualized capital costs plus annual costs) in the analysis.
1	99 percent emission reduction	$553,000	$142,000	0.99 [1,980 lb/year]	$144,000 [$72/lb]
2	BMP (estimated 20 percent emission reduction)	0	$80,000 (one-time annual cost) ¹	0.20 [400 lb/year]	$400,000 [$200/lb]

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
MACT floor	90 percent emission reduction	$830,000	$176,000	0.168 [336 lb/year]	$1,050,000 [$525/lb].
1	95 percent emission reduction	553,000	129,000	2.80E-2 [56.0 lb/year]	$4,610,000 [$2,300/lb].
2	97 percent emission reduction	461,000	113,000	1.12E-2 [22.4 lb/year]	$10,100,000 [$5,040/lb].

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
¹ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs ( i.e., annualized capital costs plus annual costs) in the analysis.
1	80 percent emission reduction	$91,000,000	$12,900,000	3.66 [7,320 lb/year]	$3,530,000 [$1,770/lb].
2	BMP (estimated 20 percent emission reduction)	$0	$5,040,000 (one-time annual cost) ¹	1.13 [2,260 lb/year]	$4,460,000 [$2,230/lb].

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
¹ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs ( i.e., annualized capital costs plus annual costs) in the analysis.
1	80 percent emission reduction	$922,000	$192,000	0.288 [576 lb/year]	$666,000 [$333/lb].
2	BMP (estimated 20 percent emission reduction)	0	$80,000 (one-time annual cost) ¹	7.20E-2 [144 lb/year]	$1,110,000 [$556/lb].

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
¹ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs ( i.e., annualized capital costs plus annual costs) in the analysis.
1	80 percent emission reduction	$236,000,000	$32,700,000	1.10 [2,200 lb/year]	$29,700,000 [$14,900/lb].
2	BMP (estimated 20 percent emission reduction)	0	$5,440,000 (one-time annual cost) ¹	0.311 [622 lb/year]	$17,500,000 [$8,750/lb].

Option	Proposed standard	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
¹ This includes the cost for testing to verify that the new sterilization process will lower the in-chamber EtO concentration to 1 ppm before the chamber is opened, as well as re-submitting to FDA for approval. It is expected that facilities will only incur this cost once and it is assumed to be incurred in the first year of compliance, but it is treated as an annual cost for the purposes of estimating total annual costs ( i.e., annualized capital costs plus annual costs) in the analysis.
1	80 percent emission reduction	$1,840,000	$332,000	3.6E-2 [72 lb/year]	$9,170,000 [$4,560/lb].
2	BMP (estimated 20 percent emission reduction)	0	$40,000 (one-time annual cost) ¹	9.1E-3 [18 lb/year]	$4,375,000 [$2,190/lb].

Number of facilities ¹	Maximum individual cancer risk (in 1 million) ²	Estimated population at increased risk of cancer		Estimated annual cancer incidence (cases per year)	Maximum chronic noncancer TOSHI	Maximum screening acute noncancer hazard quotient (HQ)
>100-in-1 million	≥1-in-1 million
¹ Number of facilities evaluated in the risk analysis.
² Maximum individual excess lifetime cancer risk due to HAP emissions from the source category.
³ As part of the risk assessment for the proposed rulemaking, there were 86 facilities in the Commercial Sterilization Facilities source category in operation and 11 research and development facilities, for a total of 97 facilities. To exercise caution with respect to this source category, we included research facilities in our assessment because there was a lack of certainty over whether these were true research facilities, for which CAA section 112(c)(7) requires that a separate category be established. However, EtO use at these facilities tends to be very low (less than 1 tpy), and these facilities had low risk.
97 ³	6,000	18,000	8,300,000	0.9	0.04	0.002 (REL).

Table 23—Comparison at Baseline and CAA Section 112( )(2), (3), and (5) Post-Control of Demographics of Populations With Cancer Risk Greater Than or Equal to 1-in-1 Million Living Within 10 km of Facilities That Were Assessed
Demographic group	Nationwide	Total population living within 10 km of EtO facilities	Cancer risk ≥ 1-in-1 million
Baseline	Post-control
Notes:
• Nationwide population and demographic percentages are based on the Census Bureau's (Census) 2015-2019 American Community Survey (ACS) 5-year block group averages. Total population count within 10 km is based on 2010 Decennial Census block population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.
• The sum of individual populations with a demographic category may not add up to total due to rounding.
Total Population	328M	17.3M	5.3M	3.2M
Number of Facilities		88	75	70
Race and Ethnicity by Percent [Number of People]
White	60 percent [197M]	40 percent [6.9M]	40 percent [2.1M]	40 percent [1.3M]
African American	12 percent [40M]	13 percent [2.3M]	15 percent [770K]	16 percent [520K]
Native American	0.7 percent [2M]	0.3 percent [51K]	0.3 percent [17K]	0.3 percent [9K]
Hispanic or Latino (includes white and nonwhite)	19 percent [62M]	36 percent [6.2M]	39 percent [2.1M]	38 percent [1.2M]
Other and Multiracial	8 percent [27M]	11 percent [1.9M]	7 percent [350K]	6 percent [190K]
Income by Percent [Number of People]
Below Poverty Level	13 percent [44M]	15 percent [2.5M]	16 percent [840K]	16 percent [520K]
Above Poverty Level	87 percent [284M]	85 percent [14.8M]	84 percent [4.5M]	84 percent [2.7M]
Education by Percent [Number of People]
Over 25 and without a High School Diploma	12 percent [40M]	16 percent [2.7M]	18 percent [960K]	18 percent [590K]
Over 25 and with a High School Diploma	88 percent [288M]	84percent [14.6M]	82 percent [4.3M]	82 percent [2.7M]
Linguistically Isolated by Percent [Number of People]
Linguistically Isolated	5 percent [18M]	10 percent [1.8M]	11 percent [570K]	11 percent [360K]

Table 24—Comparison at Baseline and CAA Section 112( )(2), (3), and (5) Post-Control of Demographics of Populations With Cancer Risk Greater Than or Equal to 50-in-1 Million Living Within 10 km of Facilities That Were Assessed
Demographic group	Nationwide	Total population living within 10 km of EtO facilities	Cancer risk ≥ 50-in-1 million
Baseline	Post-control
Notes:
• Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group averages. Total population count within 10 km is based on 2010 Decennial Census block population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.
• The sum of individual populations with a demographic category may not add up to total due to rounding.
• To account for the uncertainty of demographics estimates in smaller populations, any population values of 100 persons or less have been shown simply as “<100.”
Total Population	328M	17.3M	124,000	23,000
Number of Facilities		88	38	23
Race and Ethnicity by Percent [Number of People]
White	60 percent [197M]	40 percent [6.9M]	31 percent [39K]	30 percent [7K]
African American	12 percent [40M]	13 percent [2.3M]	43 percent [54K]	13 percent [2.9K]
Native American	0.7 percent [2M]	0.3 percent [51K]	0.1 percent [190]	0.1 percent [<100]
Hispanic or Latino (includes white and nonwhite)	19 percent [62M]	36 percent [6.2M]	22 percent [27K]	56 percent [13K]
Other and Multiracial	8 percent [27M]	11 percent [1.9M]	3 percent [3.9K]	2 percent [400]
Income by Percent [Number of People]
Below Poverty Level	13 percent [44M]	15 percent [2.5M]	22 percent [28K]	29 percent [6.6K]
Above Poverty Level	87 percent [284M]	85 percent [14.8M]	78 percent [96K]	71 percent [17K]
Education by Percent [Number of People]
Over 25 and without a High School Diploma	12 percent [40M]	16 percent [2.7M]	17 percent [21K]	21 percent [5K]
Over 25 and with a High School Diploma	88 percent [288M]	84 percent [14.6M]	83 percent [103K]	79 percent [18K]
Linguistically Isolated by Percent [Number of People]
Linguistically Isolated	5 percent [18M]	10 percent [1.8M]	9 percent [11K]	30 percent [6.9K]

Table 25—Comparison at Baseline and CAA Section 112( )(2), (3), and (5) Post-Control of Demographics of Populations With Cancer Risk Greater Than 100-in-1 Million Living Within 10 km of Facilities That Were Assessed
Demographic group	Nationwide	Total population living within 10 km of EtO facilities	Cancer risk > 100-in-1 million
Baseline	Post-control
Notes:
• Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group averages. Total population count within 10 km is based on 2010 Decennial Census block population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.
• The sum of individual populations with a demographic category may not add up to total due to rounding.
• To account for the uncertainty of demographics estimates in smaller populations, any population values of 100 persons or less have been shown simply as “<100.”
Total Population	328M	17.3M	19,000	3,900
Number of Facilities		88	16	13
Race and Ethnicity by Percent [Number of People]
White	60 percent [197M]	40 percent [6.9M]	40 percent [7.7K]	25 percent [1K]
African American	12 percent [40M]	13 percent [3M]	31 percent [5.9K]	6 percent [200]
Native American	0.7 percent [2M]	0.3 percent [51K]	0.1 percent [<100]	0 percent [0]
Hispanic or Latino (includes white and nonwhite)	19 percent [62M]	36 percent [6.2M]	26 percent [4.9K]	68 percent [2.6K]
Other and Multiracial	8 percent [27M]	11 percent [1.9M]	3 percent [500]	1 percent [<100]
Income by Percent [Number of People]
Below Poverty Level	13 percent [44M]	15 percent [2.5M]	25 percent [4.7K]	38 percent [1.4K]
Above Poverty Level	87 percent [284M]	85 percent [14.8M]	75 percent [14K]	62 percent [2.4K]
Education by Percent [Number of People]
Over 25 and without a High School Diploma	12 percent [40M]	16 percent [2.7M]	18 percent [3.5K]	22 percent [900]
Over 25 and with a High School Diploma	88 percent [288M]	84 percent [14.6M]	82 percent [16K]	78 percent [3K]
Linguistically Isolated by Percent [Number of People]
Linguistically Isolated	5 percent [18M]	10 percent [1.8M]	16 percent [3K]	44 percent [1.7K]

Table 26—Comparison of Demographics for Populations With Cancer Risk Greater Than or Equal to 1-in-1 Million Living Within 10 km of Sterilizer Facilities After Implementation of Various Components of the Final Standards
Demographic group	Nationwide	Cancer risk ≥1-in-1 million
Post-control CAA section 112(d)(2), (3), and (5) standards	Residual risk standards (CAA section 112(f)(2))
Notes:
• Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group averages. Total population count within 10 km is based on 2010 Decennial Census block population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.
• The sum of individual populations with a demographic category may not add up to total due to rounding.
Total Population	328M	3.2M	700K
Number of Facilities with Pop. Above Cancer Level		70	67
Race and Ethnicity by Percent [Number of People]
White	60 percent [197M]	40 percent [1.3M]	40 percent [280K]
African American	12 percent [40M]	16 percent [520K]	18 percent [130K]
Native American	0.7 percent [2M]	0.3 percent [9K]	0.2 percent [2.2K]
Hispanic or Latino (includes white and nonwhite)	19 percent [62M]	38 percent [1.2M]	34 percent [240K]
Other and Multiracial	8 percent [27M]	6 percent [190K]	8 percent [53K]
Income by Percent [Number of People]
Below Poverty Level	13 percent [44M]	16 percent [520K]	15 percent [100K]
Above Poverty Level	87 percent [284M]	84 percent [7M]	85 percent [600K]
Education by Percent [Number of People]
> 25 w/o a HS Diploma	12 percent [40M]	18 percent [590K]	15 percent [110K]
> 25 w/HS Diploma	88 percent [288M]	82 percent [2.7M]	85 percent [590K]
Linguistically Isolated by Percent [Number of People]
Linguistically Isolated	5 percent [18M]	11 percent [360K]	11 percent [80K]

Emission source	Existing or new?	EtO use	Standards	CAA section
¹ This standard is different from what was proposed.
² To assure compliance with the emission limit, we are requiring each facility to operate areas with these emissions in accordance with the PTE requirements of EPA Method 204 of appendix M to 40 CFR part 51.
SCV	Existing and new	At least 10 tpy	99 percent emission reduction	Current standard.
		At least 1 but less than 10 tpy	99 percent emission reduction	Current standard.
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
ARV	Existing and new	At least 10 tpy	99 percent emission reduction	Current standard.
		At least 1 but less than 10 tpy	99 percent emission reduction	112(d)(5).
		Less than 1 tpy	99 percent emission reduction	112(d)(5).
CEV at major sources	Existing and new	N/A	99.94 percent emission reduction ¹	112(d)(2) and 112(d)(3).
CEV at area sources	Existing and new	N/A	99 percent emission reduction ¹	112(d)(5).
Group 1 room air emissions at major sources	Existing and new	N/A	97 percent emission reduction ¹²	112(d)(2) and 112(d)(3).
Group 1 room air emissions at area sources	Existing and new	N/A	80 percent emission reduction ¹²	112(d)(5).
Group 2 room air emissions at major sources	Existing and new	N/A	86 percent emission reduction ¹²	112(d)(2) and 112(d)(3).
Group 2 room air emissions at area sources	Existing	N/A	Lower the EtO concentration within each sterilization chamber to 1 ppm before the chamber can be opened. ¹	112(d)(5).
	New	N/A	80 percent emission reduction ¹²	112(d)(5).

	Inhalation cancer risk		Population cancer risk
Maximum individual risk (in 1 million)	Risk driver	Cancer incidence (cases per year)	>100-in-1 million	≥1-in-1 million
¹ Ranges in values account for if all facilities were performing at the level of the standards (high end) to considering facilities that are currently performing better than the standards (low end).
Actual Emissions Baseline Risk	6,000	ethylene oxide	0.9	19,000	8,500,000
Allowable Emissions Baseline Risk	8,000	ethylene oxide	8	260,000	62,000,000
Post-control Risk	100	ethylene oxide	¹ 0.1-0.2	0	¹ 700,000-1,380,000

Option	Standard evaluated	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
1	99.9 percent emission reduction	$1,840,000	$752,000	1.14 [2,280 lb]	$661,000 [$330/lb].
2	99.6 percent emission reduction	0	0	0	N/A.

Option	Standard evaluated	Total capital investment ($)	Total annual costs ($/yr)	EtO emission reductions (tpy)	Cost effectiveness ($/ton EtO)
1	99.9 percent emission reduction	$523,000	$136,000	1.02 [2,040 lb]	$134,000 [$67/lb].
2	99.6 percent emission reduction	348,000	106,000	0.68 [1,360 lb]	158,000 [$79/lb].

Emission source	Facility EtO use	Number of facilities with this affected source	Number of facilities appearing to achieve final standard ¹	Compliance timeframe
¹ The phrase “appearing to achieve” is used (as opposed to “achieving”) to account for uncertainties in the data. A notable example is the SCVs where, for a given facility, the emission reduction on the first evacuation may not high enough to ensure that the standard is being met across all evacuations. Another uncertainty is the fraction of EtO going to each emission stream. In some instances, there is facility-specific information available, and in others, there is no information available and default fractions are applied as a result.
SCV	At least 30 tpy	38	19	Two years.
	At least 10 but less than 30 tpy	9	9	Two years.
	At least 1 but less than 10 tpy	18	16	Two years.
	Less than 1 tpy	23	22	Three years.
ARV	At least 30 tpy	36	12	Two years.
	At least 10 but less than 30 tpy	5	5	Three years.
	At least 1 but less than 10 tpy	10	7	Three years.
	Less than 1 tpy	4	2	Three years.
CEVs at major source facilities	N/A	0	N/A	Three years.
CEVs at area source facilities	At least 60 tpy	25	12	Two years.
	Less than 60 tpy	15	8	Three years.
Group 1 room air emissions at major sources	N/A	0	N/A	Three years.
Group 1 room air emissions at area sources	At least 40 tpy	36	16	Two years.
	Less than 40 tpy	38	7	Three years.
Group 2 room air emissions at major sources	N/A	1	0	Three years.
Group 2 room air emissions at area sources	At least 20 tpy	44	17	Two years.
	At least 4 but less than 20 tpy	13	1	Two years.
	Less than 4 tpy	27	27	Three years.

Demographic group	Nationwide	Cancer risk ≥50-in-1 million post-control
CAA section 112(d)(2), (3), and (5) standards	Residual risk standards (112(f)(2))
Notes:
• Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group averages. Total population count within 10 km is based on 2010 Decennial Census block population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.
• The sum of individual populations with a demographic category may not add up to total due to rounding.
• To account for the uncertainty of demographics estimates in smaller populations, any population values of 100 persons or less have been shown simply as “<100”.
Total Population	328M	23,000	170
Number of Facilities with Pop. Above Cancer Level		23	11
Race and Ethnicity by Percent [Number of People]
White	60 percent [197M]	30 percent [7K]	12 percent [<100]
African American	12 percent [40M]	13 percent [2.9K]	11 percent [<100]
Native American	0.7 percent [2M]	0.1 percent [190]	0.3 percent [<100]
Hispanic or Latino (includes white and nonwhite)	19 percent [62M]	56 percent [13K]	76 percent [130]
Other and Multiracial	8 percent [27M]	2 percent [400]	0.4 percent [<100]
Income by Percent [Number of People]
Below Poverty Level	13 percent [44M]	29 percent [6.6K]	30 percent [<100]
Above Poverty Level	87 percent [284M]	71 percent [17K]	70 percent [120]
Education by Percent [Number of People]
>25 w/o a HS Diploma	12 percent [40M]	21 percent [5K]	31 percent [<100]
>25 w/HS Diploma	88 percent [288M]	79 percent [18K]	69 percent [120]
Linguistically Isolated by Percent [Number of People]
Linguistically Isolated	5 percent [18M]	30 percent [6.9K]	47 percent [<100]

Demographic group	Nationwide	Cancer risk >100-in-1 million
CAA section 112(d)(2), (3), and (5) post-control	Residual risk controls
Notes:
• Nationwide population and demographic percentages are based on Census' 2015-2019 ACS 5-year block group averages. Total population count within 10 km is based on 2010 Decennial Census block population.
• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.
• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.
• The sum of individual populations with a demographic category may not add up to total due to rounding.
• To account for the uncertainty of demographics estimates in smaller populations, any population values of 100 persons or less have been shown simply as “<100”.
Total Population	328M	3,900	0
Number of Facilities with Pop. Above Cancer Level		13	0
Race and Ethnicity by Percent [Number of People]
White	60 percent [197M]	25 percent [1K]
African American	12 percent [40M]	6 percent [200]
Native American	0.7 percent [2M]	0 percent [0]
Hispanic or Latino (includes white and nonwhite)	19 percent [62M]	68 percent [2.6K]
Other and Multiracial	8 percent [27M]	1 percent [<100]
Income by Percent [Number of People]
Below Poverty Level	13 percent [44M]	38 percent [1.4K]
Above Poverty Level	87 percent [284M]	62 percent [2.4K]
Education by Percent [Number of People]
>25 w/o a HS Diploma	12 percent [40M]	22 percent [900]
>25 w/HS Diploma	88 percent [288M]	78 percent [3K]
Linguistically Isolated by Percent [Number of People]
Linguistically Isolated	5 percent [18M]	44 percent [1.7K]

Potential interferent gas ¹	Approximate concentration (balance N ₂ )
¹ Any of these specific gases can be tested at a lower level if the manufacturer has provided reliableness for limiting or scrubbing that gas to a specified level in CEMS field installations.
CO ₂	1% ± 0.2% CO ₂ .
CH ₄	20 ± 5 ppm.
H ₂ O	5% ± 1% H ₂ O. ¹
N ₂	Balance. ¹


Date of Test
Analyzer type
Model Number
Serial Number
Span
Test Organization
Test Personnel

Test	Units	EtO zero and reference gas concentrations in terms of percent of span ^a				Section
Zero	Low level	Mid-level	High level
^a Reference gas concentration must be NIST traceable. (See section 7.1)
^b High-level is required. For DS calibration drift option, choose a concentration that yields a value in this range at the analyzer.
Calibration Drift	% Of Span		NA		^b 80-100	11.5
Measurement Error	% Of Span	NA	20-30	50-60	80-100	11.4

n−1 ^a	t-value	n−1 ^a	t-value	n−1 ^a	t-value
^a The value n is the number of independent pairs of measurements. Either discrete (independent) measurements in a single run or run averages can be used.
1	12.71	11	2.201	21	2.080
2	4.303	12	2.179	22	2.074
3	3.182	13	2.160	23	2.069
4	2.776	14	2.145	24	2.064
5	2.571	15	2.131	25	2.060
6	2.447	16	2.120	26	2.056
7	2.365	17	2.110	27	2.052
8	2.306	18	2.101	28	2.048
9	2.262	19	2.093	29	2.045
10	2.228	20	2.086	30	2.042

Source:			Date:
CEMS:			Location:
Serial Number:			Span:
Run number	Reference gas value (ppbv)	CEMS response (ppbv)	Difference— low (ppbv)	Difference— low (ppbv)	Difference— low (ppbv)
1
2
3
4
5
6
7
8
9
Mean Difference—ppbv
Measurement Error—%

Source/Location:
CEMS:
Instrument Serial Number:
Instrument Span:
Day	Date	Time	Reference gas value (ppbv)	CEMS response (ppbv)	Difference (ppbv)	Percent of span
Zero Gas
1			0
2			0
3			0
4			0
5			0
6			0
7			0
High-Level Gas
1
2
3
4
5
6
7


Facility Name:	Date:	Time:
Unit(s) Tested:	Personnel:
Analyzer Make and Mode
Serial Number
Calibration Span

Q _probe (lpm)	Q _spike (lpm)	DF ¹	MC _native
Pre	Post	Avg.	C _spike²	MC _spike³
¹ DF must be less than or equal to 10%.
² C _spike = Actual EtO concentration of the spike gas, ppbv.
³ MC _spike = Measured EtO concentration of the spiked sample at the target level, ppbv.











					Average
					SD

Audit point	Audit range
1 (Mid-Level)	50 to 60% of span value.
2 (High-Level)	80 to 100% of span value.

For each . . .	For which . . .	You must . . .	You must comply with the standard . . .
¹ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after December 6, 1996.
² If using EtO CEMS to determine compliance, this standard is based on the previous 30 operating days of data.
³ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after April 7, 2025.
⁴ The standard applies if the facility has used less than 1 tpy of EtO within all consecutive 12-month periods after April 6, 2026.
⁵ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after startup.
⁶ The standard applies if the facility is not expected to meet or exceed 1 tpy of EtO use within one year after startup. Afterwards, the standard applies if the facility has used less than 1 tpy of EtO within all consecutive 12-month periods after startup.
1. Existing SCV	a. Facility EtO use is at least 10 tpy	i. Continuously reduce EtO emissions by 99 percent ¹	Until April 6, 2026.
	b. Facility EtO use is at least 1 tpy but less than 10 tpy	i. Continuously reduce EtO emissions by 99 percent ¹	Until April 6, 2026.
		ii. Continuously reduce EtO emissions by 99.8 percent	No later than April 6, 2026.
	c. Facility EtO use is at least 30 tpy	i. Continuously reduce EtO emissions by 99.99 percent	No later than April 6, 2026.
	d. Facility EtO use is at least 10 tpy but less than 30 tpy	i. Continuously reduce EtO emissions by 99.9 percent	No later than April 6, 2026.
	e. Facility EtO use is less than 1 tpy	i. Continuously reduce EtO emissions by 99 percent	No later than April 5, 2027.
2. New SCV	a. Initial startup is on or before April 5, 2024, and facility EtO use is at least 30 tpy	i. Continuously reduce EtO emissions by 99.99 percent	No later than April 5, 2024.
	b. Initial startup is on or before April 5, 2024, and facility EtO use is at least 10 tpy but less than 30 tpy	i. Continuously reduce EtO emissions by 99.9 percent	No later than April 5, 2024.
	c. Initial startup is on or before April 5, 2024, and facility EtO use is at least 1 tpy but less than 10 tpy	i. Continuously reduce EtO emissions by 99.8 percent	No later than April 5, 2024.
	d. Initial startup is on or before April 5, 2024, and facility EtO use is less than 1 tpy	i. Continuously reduce EtO emissions by 99 percent	No later than April 5, 2024.
	e. Initial startup is after April 5, 2024, and facility EtO use is at least 30 tpy	i. Continuously reduce EtO emissions by 99.99 percent	Upon startup of the source.
	f. Initial startup is after April 5, 2024, and facility EtO use is at least 10 tpy but less than 30 tpy	i. Continuously reduce EtO emissions by 99.9 percent	Upon startup of the source.
	g. Initial startup is after April 5, 2024, and facility EtO use is at least 1 tpy but less than 10 tpy	i. Continuously reduce EtO emissions by 99.8 percent	Upon startup of the source.
	h. Initial startup is after April 5, 2024, and facility EtO use is less than 1 tpy	i. Continuously reduce EtO emissions by 99 percent	Upon startup of the source.

For each . . .	For which . . .	You must . . .	You must comply with the standard . . .
¹ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after December 6, 1996.
² If using CEMS to determine compliance, this standard is based on a rolling 30-operating day average.
³ The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after April 7, 2025.
⁴ The standard applies if the facility has used less than 10 tpy of EtO within all consecutive 12-month periods after April 6, 2026.
⁵ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after startup.
⁶ The standard applies if the facility is not expected to meet or exceed 10 tpy of EtO use within one year after startup. Afterwards, the standard applies if the facility has used less than 10 tpy of EtO within all consecutive 12-month periods after startup.
1. Existing ARV	a. Facility EtO use is at least 10 tpy	i. Continuously reduce EtO emissions by 99 percent ¹	Until April 6, 2026.
	b. Facility EtO use is at least 30 tpy	i. Continuously reduce EtO emissions by 99.9 percent	No later than April 6, 2026.
	c. Facility EtO use is at least 10 tpy but less than 30 tpy	i. Continuously reduce EtO emissions by 99.6 percent	No later than April 6, 2026.
	d. Facility EtO use is less than 10 tpy	i. Continuously reduce EtO emissions by 99 percent	No later than April 5, 2027.
2. New ARV	a. Initial startup is on or before April 5, 2024, and facility EtO use is at least 10 tpy	i. Continuously reduce EtO emissions by 99.9 percent	No later than April 5, 2024.
	b. Initial startup is on or before April 5, 2024, and facility EtO use is less than 10 tpy	i. Continuously reduce EtO emissions by 99 percent	No later than April 5, 2024.
	c. Initial startup is after April 5, 2024, and facility EtO use is at least 10 tpy	i. Continuously reduce EtO emissions by 99.9 percent	Upon startup of the source.
	d. Initial startup is after April 5, 2024, and facility EtO use is less than 10 tpy	i. Continuously reduce EtO emissions by 99 percent	Upon startup of the source.

For each . . .	For which . . .	You must . . .	You must comply with the standard . . .
¹ If using CEMS to determine compliance, this standard is based on a rolling 30-operating day average.
² The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after April 7, 2025.
³ The standard applies if the facility has used less than 60 tpy of EtO within all consecutive 12-month periods after April 6, 2026.
⁴ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after startup.
⁵ The standard applies if the facility is not expected to meet or exceed 60 tpy of EtO use within one year after startup. Afterwards, the standard applies if the facility has used less than 60 tpy of EtO within all consecutive 12-month periods after startup.
1. Existing CEV at a major source facility	a. Not applicable	i. Continuously reduce EtO emissions by 99.94 percent ¹	No later than April 5, 2027.
2. Existing CEV at an area source facility	a. Facility EtO use is at least 60 tpy	i. Continuously reduce EtO emissions by 99.9 percent	No later than April 6, 2026.
	b. Facility EtO use is less than 60 tpy	i. Continuously reduce EtO emissions by 99 percent	No later than April 5, 2027.
3. New CEV at a major source facility	a. Initial startup is on or before April 5, 2024	i. Continuously reduce EtO emissions by 99.94 percent ¹	No later than April 5, 2024.
	b. Initial startup is after April 5, 2024	i. Continuously reduce EtO emissions by 99.94 percent ¹	Upon startup of the source.
4. New CEV at an area source facility	a. Initial startup is on or before April 5, 2024, and facility EtO use is at least 60 tpy	i. Continuously reduce EtO emissions by 99.9 percent	No later than April 5, 2024.
	b. Initial startup is on or before April 5, 2024, facility EtO use is less than 60 tpy	i. Continuously reduce EtO emissions by 99 percent	No later than April 5, 2024.
	c. Initial startup is after April 5, 2024, and facility EtO use is at least 60 tpy	i. Continuously reduce EtO emissions by 99.9 percent	Upon startup of the source.
	d. Initial startup is after April 5, 2024, facility EtO use is less than 60 tpy	i. Continuously reduce EtO emissions by 99 percent	Upon startup of the source.

For each . . .	For which . . .	You must . . .	You must comply with the requirement(s) . . .
¹ This standard is based on a rolling 30-operating day average.
² The standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after April 7, 2025.
³ The standard applies if the facility has used less than 4 tpy of EtO within all consecutive 12-month periods after April 6, 2026.
⁴ The standard applies if the facility is expected to meet or exceed the specified EtO use within one year after startup. Afterwards, the standard applies if the facility has met or exceeded the specified EtO use within any consecutive 12-month period after startup.
⁵ The standard applies if the facility is not expected to meet or exceed 20 tpy of EtO use within one year after startup. Afterwards, the standard applies if the facility has used less than 20 tpy of EtO within all consecutive 12-month periods after startup.
1. Existing collection of Group 2 room air emissions at a major source facility	a. Not applicable	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. Also, ii. Continuously reduce EtO emissions by 86 percent ¹	No later than April 5, 2027.
2. Existing collection of Group 2 room air emissions at an area source facility	a. Facility EtO use is at least 20 tpy	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. ² Also, ii. Continuously reduce EtO emissions by 98 percent ¹²	No later than April 6, 2026.
	b. Facility EtO use is at least 4 tpy but less than 20 tpy	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. ² Also, ii. Continuously reduce EtO emissions by 80 percent ¹²	No later than April 6, 2026.
	c. Facility EtO use is less than 4 tpy	Lower the EtO concentration within each sterilization chamber to 1 ppm before the chamber can be opened ³	No later than April 5, 2027.
3. New collection of Group 2 room air emissions at a major source facility	a. Initial startup is on or before April 5, 2024	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. Also, ii. Continuously reduce EtO emissions by 86 percent ¹	No later than April 5, 2024.
	b. Initial startup is after April 5, 2024	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. Also, ii. Continuously reduce EtO emissions by 86 percent ¹	Upon startup of the source.
4. New collection of Group 2 room air emissions at an area source facility	a. Initial startup is on or before April 5, 2024, and facility EtO use is at least 20 tpy	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. ⁵ Also, ii. Continuously reduce EtO emissions by 98 percent ¹⁵	No later than April 5, 2024.
	b. Initial startup is on or before April 5, 2024, and facility EtO use is less than 20 tpy	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. ⁶ Also, ii. Continuously reduce EtO emissions by 80 percent ¹⁶	No later than April 5, 2024.
	c. Initial startup is after April 5, 2024, and facility EtO use is at least 20 tpy	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. ⁵ Also, ii. Continuously reduce EtO emissions by 98 percent ¹⁵	Upon startup of the source.
	d. Initial startup is after April 5, 2024, and facility EtO use is less than 20 tpy	i. Operate all areas of the facility that contain Group 2 room air emissions with PTE, with all exhaust gas streams being captured and routed to a control system. ⁶ Also, ii. Continuously reduce EtO emissions by 80 percent ¹⁶	Upon startup of the source.