Burden Calculation Tables

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Overview

Table 1
Table 2

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Sheet 1: Table 1

Table 1: Annual Respondent Burden and Cost – NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Renewal)
					121.46	148.45	60.23
Burden item	(A) Person hours per occurrence	(B) No. of occurrences per respondent per year	(C) Person hours per respondent per year (AxB)	(D) Respondents per year a	(E) Technical person-hours per year (CxD)	(F) Management person hours per year (Ex0.05)	(G) Clerical person hours per year (Ex0.1)	(H) Total Cost per year, $ b
1. Applications	N/A
2. Surveys and studies	N/A
3. Reporting Requirements
A. Familiarization with Regulatory Requirements	1	1	1	27	27	1.35	2.7	$3,642.45
B. Required Activities
i. Initial Performance Tests c
New	480	1	480	0	0	0	0	$0
Reconstructed	160	1	160	0	0	0	0	$0
Wastewater	160	1	160	0	0	0	0	$0
ii. Quality control plan for CMS c	60	1	60	0	0	0	0	$0
iii. Repeat performance test d	60	1	60	0	0	0	0	$0
C. Write reports
i. Notification of construction/reconstruction c	2	1	2	0	0	0	0	$0
ii. Notification of physical or operational changes c, e	8	3	24	27	648	32.4	64.8	$87,418.76
iii. Notification of actual startup c	2	1	2	0	0	0	0	$0
iv. Notification of initial performance test c	2	1	2	0	0	0	0	$0
v. Notification of applicability c	2	1	2	0	0	0	0	$0
vi. Notification of demonstration of CMS c	2	1	2	0	0	0	0	$0
vii. Notification of compliance status c	120	1	120	0	0	0	0	$0
viii. Pre-compliance report (with and without emission averaging implementation plan) c	180	1	180	0	0	0	0	$0
ix. Malfunction report f	40	2	80	27	2,160	108	216	$291,395.88
x. Semiannual summary report
a. No deviations g	8	2	16	24	384	19.2	38.4	$51,803.71
b. Deviations h	24	2	48	3	144	7.2	14.4	$19,426.39
xi. Leak detection and repair (LDAR) report i	432	2	864	27	23,328	1,166.4	2,332.8	$3,147,075.50
xii. Emissions averaging report j	20	2	40	3	120	6	12	$16,188.66
Subtotal for Reporting Requirements					30,833			$3,616,951
4. Recordkeeping requirements
A. Develop record system	40	1	40	0	0	0	0	$0
B. Train personnel	40	1	40	0	0	0	0	$0
C. Records for operating parameters for control devices k	1	365	365	27	9,855	492.75	985.5	$1,329,493.70
D. Records of malfunctions l	2	26	52	27	1,404	70.2	140.4	$189,407.32
E. Calibration of CMS m	16	1	16	27	432	21.6	43.2	$58,279.18
F. LDAR	See 3C
Subtotal for Recordkeeping Requirements					13,445			$1,577,180
TOTAL LABOR BURDEN AND COST (rounded) n					44,300			$5,190,000		1641	Hrs/Respondent
TOTAL CAPITAL AND O&M COST (rounded) n								$112,000		178	Hrs/Response
GRAND TOTAL (rounded) n								$5,300,000
Assumptions:
a We have assumed that the annual average number of respondents that will be subject to this rule will be 27. There will be no new additional sources during the next three years of this ICR.
b This ICR uses the following labor rates: $148.45 per hour for Executive, Administrative, and Managerial labor; $121.46 per hour for Technical labor, and $60.23 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2020, Table 2. Civilian Workers, by Occupational and Industry group. The rates are from column 1, Total Compensation. The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.
c We have assumed that there will be no new or reconstructed facilities during the next three years of this ICR, and these one-time initial requirements do not apply; however, the ICR estimates that all existing sources will have changes in their operations.
d We have assumed that 20 percent of new respondents would have to repeat initial performance tests due to failure. Since there are no new respondents estimated, no one is assumed to conduct a repeat test.
e We have assumed that each source will require an average of three processing changes each year over the next three years of this ICR.
f We have assumed that each respondent will take 40 hours two times per year to complete the startup, shutdown, malfunction reports.
g We have assumed that 90 percent of respondents will each take eight hours two times per year to complete the no deviation report.
h We have assumed that 10 percent of respondents will each take 24 hours two times per year to complete the deviation report.
i We have assumed that it will take each respondent 432 hours two times per year to complete the LDAR report.
j We have assumed that ten percent of respondents will each take 20 hours two times per year to complete the emissions averaging report.
k We have assumed that it will take each respondent 1 hour 365 times per year to record the operating parameters for control devices.
l We have assumed that it will take each respondent 2 hours 26 times per year to record the occurrence and duration of each malfunction.
m We have assumed that it will take each respondent 16 hours one time per year to record the calibration of CMS.
n Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.

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Sheet 2: Table 2

Table 2: Average Annual EPA Burden and Cost – NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Renewal)
					50.72	68.37	27.46
Activity	(A) EPA person hours per occurrence	(B) No. of occurrences per plant per year	(C) EPA person hours per plant per year (AxB)	(D) Plants per year a	(E) Technical person-hours per year (CxD)	(F) Management person hours per year (Ex0.05)	(G) Clerical person hours per year (Ex0.1)	(H) Cost, $ b
1. Required activities
i. Initial performance tests c	2	1	2	0	0	0	0	$0
ii. Repeat performance test d	24	1	24	0	0	0	0	$0
2. Report review - one time c
i. Notification of construction/reconstruction	2	1	2	0	0	0	0	$0
ii. Notification of actual startup	2	1	2	0	0	0	0	$0
iii. Notification of demonstration of CMS	2	1	2	0	0	0	0	$0
iv. Initial notification of applicability	2	1	2	0	0	0	0	$0
v. Notification of compliance status report	40	1	40	0	0	0	0	$0
vi. Pre-compliance report e
a. With emissions averaging f	20	1	20	0	0	0	0	$0
b. Without emissions averaging	4	1	4	0	0	0	0	$0
3. Report review - on-going
i. Semiannual summary report
a. No deviations g	2	2	4	24	96	4.8	9.6	$5,460.91
b. Deviations h	8	2	16	3	48	2.4	4.8	$2,730.46
ii. Notification of physical or operational changes i	8	3	24	27	648	32.4	64.8	$36,861.16
iii. Malfunction j	2	2	4	27	108	5.4	10.8	$6,143.53
iv. Leak detection and repair (LDAR) report k	8	2	16	27	432	21.6	43.2	$24,574.10
v. Emissions averaging report l	8	2	16	3	48	2.4	4.8	$2,730.46
TOTAL (rounded) m					1,590			$78,500
Assumptions:
a We have assumed that the average number of respondents that will be subject to this rule will be 27. There will be no new additional sources during the next three years of this ICR.
b This cost is based on the following hourly labor rates times a 1.6 benefits multiplication factor to account for government overhead expenses: $68.37 for Managerial, $50.72 for Technical and $27.46 Clerical. These rates are from the Office of Personnel Management (OPM) 2020 General Schedule which excludes locality rates of pay.
c We have assumed that there will be no new or reconstructed facilities during the next three years of this ICR, and these one-time initial requirements do not apply.
d We have assumed that 20 percent of respondents would have to repeat performance tests due to failure. Since there are no new respondents estimated, no one is assumed to conduct a repeat test.
e We have assumed that 50 percent of new facilities will submit a pre-compliance report.
f We have assumed that 10 percent of existing facilities will have to comply with emission averaging requirements; however, this is a one-time requirement; new facilities are not allowed to use emissions averaging.
g We have assumed that 90 percent of respondents will report no deviations.
h We have assumed that 10 percent of respondents will have to report deviations.
i We have assumed that each respondent will be required to submit the physical/operational changes three times per year over the next three-year period of this ICR.
j We have assumed that each respondent will report actions on malfunction that are consistent.
k We have assumed that each respondent will have to comply with the LDAR report two times per year.
l We have assumed that 10 percent of respondents will submit the emission averaging report.
m Totals have been rounded to 3 significant figures. Figures may not add exactly due to rounding.