Respondent Activity | (A) Hours per Occurrence | (B) Occurrences/ Respondent/Year | (C) Hours/ Respondent/ Year (A x B) | (D) Respondents/ Year1 | (E) Technical Hours/Year (C x D) |
(F) Managerial Hours/Year (E x 0.05) |
(G) Clerical Hours/Year (E x 0.10) |
(H) Cost/ Year2 | Notes | Original Basis for Time Estimates: | May 2019 NAICS-code specific ($/hr) (updated4/13/20) | 2019 rate x 2.1 (for 110% increase) | Multiplier | Total Number of Facilities to Cover | |
1. APPLICATIONS (Not Applicable) | technical | $44.60 | $93.66 | 2.1 | 61 | ||||||||||
2. SURVEY AND STUDIES (Not Applicable) | managerial | $71.37 | $149.88 | ||||||||||||
3. ACQUISITION, INSTALLATION, AND UTILIZATION OF TECHNOLOGY AND SYSTEMS (Not Applicable) | clerical | $20.78 | $43.64 | ||||||||||||
4. REPORT REQUIREMENTS | |||||||||||||||
A. Read Instructions | |||||||||||||||
EtO Commercial Sterilization facilities | 4 | 1 | 4 | 61 | 244 | 12 | 24.4 | $25,746 | |||||||
B. Required Activities | |||||||||||||||
i. Complete and submit survey spreadsheet tabs, as follows: | |||||||||||||||
EtO Commercial Sterilization facilities | |||||||||||||||
Facility Details | 4.5 | 1 | 4.5 | 61 | 275 | 14 | 27.45 | $28,965 | |||||||
Room Area | 13.5 | 1 | 13.5 | 61 | 824 | 41 | 82.35 | $86,894 | |||||||
EtO & EG Storage | 1.5 | 1 | 1.5 | 61 | 92 | 5 | 9.15 | $9,655 | |||||||
Sterilizer Chambers | 25.5 | 1 | 25.5 | 61 | 1,556 | 78 | 155.55 | $164,133 | |||||||
Aeration | 7.5 | 1 | 7.5 | 61 | 458 | 23 | 45.75 | $48,274 | |||||||
APCD Summary | 4.5 | 1 | 4.5 | 61 | 275 | 14 | 27.45 | $28,965 | |||||||
APCD Details | 3 | 1 | 3 | 61 | 183 | 9 | 18.3 | $19,310 | |||||||
EtO Monitoring | 16.5 | 1 | 16.5 | 61 | 1,007 | 50 | 100.65 | $106,204 | |||||||
Miscellaneous | 1.5 | 1 | 1.5 | 61 | 92 | 5 | 9.15 | $9,655 | |||||||
Additional Info | 1.5 | 1 | 1.5 | 61 | 92 | 5 | 9.15 | $9,655 | |||||||
Attachments | 10 | 1 | 10 | 61 | 610 | 31 | 61 | $64,366 | |||||||
Certification | 0.2 | 1 | 0.2 | 61 | 12 | 1 | 1.22 | $1,287 | |||||||
C. Create Information (Included in 4B) | |||||||||||||||
D. Gather Existing Information (Included in 4B) | |||||||||||||||
E. Write Report (Not Applicable) | |||||||||||||||
5. RECORDKEEPING REQUIREMENTS (Not applicable) | |||||||||||||||
TOTAL ANNUAL LABOR BURDEN AND COST | 5,716 | 286 | 572 | $603,107 | |||||||||||
Total Labor: | 6,573 | ||||||||||||||
Avg. hr./facility: | 108 | Avg. $/facility: | $9,887 | ||||||||||||
ANNUAL CAPITAL COSTS (Not Applicable) | |||||||||||||||
ANNUALIZED CAPITAL COSTS (Not Applicable) | 90% of respondents will make a CBI claim and have to mail in their survey | ||||||||||||||
TOTAL ANNUAL COSTS (O&M)3 | $920 | 7 | media | ||||||||||||
TOTAL ANNUALIZED COSTS (Annualized capital + O&M costs) | $920 | 9.75 | |||||||||||||
TOTAL LABOR AND O&M COSTS | $604,027 | ||||||||||||||
1. The number of respondents per year is based on the facility counts listed in Section 4(a) of the Supporting Statement. | |||||||||||||||
2. Based on mean hourly wages in Bureau of Labor Statistics, April 2020 National Industry-Specific Occupational Employment and Wage Estimates for NAICS code 339100—Medical Supplies and Equipment Manufacturing, available at https://www.bls.gov/oes/current/naics4_339100.htm#11-0000. Final loaded labor rates are: Technical: $93.66/hour (SOC 17-2000: Engineers), Managerial: $149.88/hour (SOC 11-1021: General and Operations Managers), Clerical: $43.64/hour (SOC 43-0000: Office and Administrative Support Occupations); all labor rates include 110 percent increase to account for fringe benefits and overhead expenses). | |||||||||||||||
3. Postage costs for mailing survey responses to the EPA are estimated at $9.75 for Federal Express letter-size envelope flat rate (1 per respondent). The costs of digital media (CD, DVD, or flash drive) are estimated to be $7 each. | |||||||||||||||
Tab Name | Table Name | Average No. of Units | No. of Questions | ||||||||||||
Count | UOM | ||||||||||||||
Facility Details | Table 4. Facility Buildings | 2 | Buildings | 10 | |||||||||||
Room Area | Table 1. Characteristics of Room Areas | 6 | Room Areas | 11 | |||||||||||
Room Area | Table 2. Natural Draft Openings (NDO) | 2 | NDOs | 10 | |||||||||||
Room Area | Table 3. Leak Checks of Components in EtO Service | 6 | Checks | 17 | |||||||||||
Room Area | Table 4. Room Area Controls | 8 | Room Area Controls | 27 | |||||||||||
EtO & EG Storage | D. Ethylene Glycol (EG) Tanks | 1 | Tanks | 31 | |||||||||||
Sterilizer Chambers | Table 2. Sterilizer Chamber Operation and Monitoring Characteristics | 7 | Sterilizer Chambers | 51 | |||||||||||
Sterilizer Chambers | Table 3. Control Characteristics for Sterilizer Chambers | 6 | Controls for Sterilizer Chambers | 64 | |||||||||||
Sterilizer Chambers | Table 5. Vacuum Pumps | 6 | Pumps | 10 | |||||||||||
Aeration | Table 1. Aeration that Occurs in Separate Unit (Aeration Room & Aeration Cell/Chamber) | 5 | Aeration Room & Cell/Chamber | 45 | |||||||||||
Aeration | Table 2. Aeration that Occurs within Sterilizer Chamber | 2 | Aeration within Sterilizer Chamber | 4 | |||||||||||
APCD Summary | Table 1. APCD Characteristics | 4 | APCDs | 16 | |||||||||||
APCD Details | Table 1. Wet Scrubber & Glygen Absorber Unit | 1 | Wet Scrubber & Glygen Absorber Units | 11 | |||||||||||
APCD Details | Table 3. Catalytic Oxidizer & Balancer/Abator | 1 | Catalytic Oxidzer & Balancer/Abator | 26 | |||||||||||
EtO Monitoring | Table 1. Personal Monitoring (Badges) for EtO | 44 | Personal Monitors | 11 | |||||||||||
EtO Monitoring | Table 2. Room Area Monitoring for EtO | 4 | Room Area Monitors | 9 | |||||||||||
Miscellaneous | K. Unique Cycles and EtO Reduction | 1 | Unique Cycle and EtO Reduction | 13 | |||||||||||
Additional Info | N/A | 9 | Additional Information (rows of data) | 3 | |||||||||||
Attachments | N/A | 10 | Attachments | N/A |
Agency Activity | (A) EPA Hours/ Occurrence | (B) Occurrences/ Respondent/Year | (C) EPA Hours/Respondent/Year (A x B) | (D) Respondents/Year1 | (E) EPA Technical Hours/Year (C x D) | (F) EPA Managerial Hours/Year (E x 0.05) | (G) EPA Clerical Hours/Year (E x 0.1) | (H) Cost, $/Year2 | Basis for Time Estimates | Total Number of Facilities to Cover | |||
Develop/revise questionnaire spreadsheets and instructions | N/A | N/A | N/A | N/A | N/A | N/A | N/A | $0 | Using the exisitng survey | 61 | |||
Develop survey webpage | N/A | N/A | N/A | N/A | N/A | N/A | N/A | $0 | Using the existing webpage | ||||
Answer respondent questions via phone, email, and/or frequently asked questions posted on webpage3 | 1 | 1 | 1 | 15 | 15 | 1 | 2 | $1,002 | |||||
Analyze requests for confidentiality4 | 1 | 1 | 1 | 55 | 55 | 3 | 5 | $3,605 | Majority of the initial ICR respondents included at least 1 data element as CBI | ||||
Review and analyze responses (including follow-up) | 20 | 1 | 20 | 61 | 1220 | 61 | 122 | $80,122 | Initially review the form for completeness, compile/consolidate results into the access database, export and perform reviews. Assume that we will have to go back to each facility with at least one question. Also, it has taken significant time in the past to map the coordinates provided in google earth to confirm that stack params, building placement is reasonable. | ||||
Analyze previous emissions test, performance test or engineering study data5 | 4 | 4 | 16 | 6 | 98 | 5 | 10 | $6,410 | |||||
Total Annual Hours/Cost | 1,388 | 69 | 139 | $91,139 | |||||||||
Total Labor: | 1,596 | ||||||||||||
Expenses (O&M)6 | |||||||||||||
Computer storage of data | $1,440 | $6/GB/mo x 10 GB x 24 mos | P&P part 1 was 6 GB | ||||||||||
Total O&M Expenses | $1,440 | ||||||||||||
TOTAL ANNUAL LABOR BURDEN AND COST | $92,579 | ||||||||||||
1. The number of respondents per year is based on the facility counts listed in Section 4 of the Supporting Statement. | |||||||||||||
2. Based on GS Scale 2020: Technical/GS 13-1: $36.75/hour, Managerial/GS 15-1: $51.08/hour, Clerical/GS 7-1: $17.42/hour. All agency labor rates have been scaled a multiplier of 1.6 to account for overhead and fringe benefit costs. | |||||||||||||
3. Assumes that 25 percent of the facilities will have questions. | |||||||||||||
4. Assumes that 90 percent of facilities will have confidential data. | |||||||||||||
5. Assumes that 10 percent of facilities will have performance test, emissions test, or other engineering study provided as an attachment to the ICR requiring additional review . Assume 1 hour to perform additional analyses of these attachments. | |||||||||||||
6. Data storage at $6/GB/month assuming 10 GB data for 24 months. | |||||||||||||
2020 rate | Multiplier | 2020 rate | |||||||||||
Technical (GS-13, step 1) | 36.75 | 1.6 | 58.80 | ||||||||||
Managerial (GS-15, step 1) | 51.08 | 1.6 | 81.73 | ||||||||||
Clerical (GS-7, step 1) | 17.42 | 1.6 | 27.87 |
https://www.bls.gov/oes/current/naics4_339100.htm#11-0000 | ||
SOC | Desc | Wage |
17-2000 | Engineers | $44.60 |
11-1021 | General and Operations Managers | $71.37 |
43-0000 | Office and Administrative Support Occupations | $20.78 |
GS Rates | ||
https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/20Tables/html/GS_h.aspx |
Table Name | No. of Question | Average No. of Units | Expected No. of Responses | Notes | Hours for responses By Tab | Hours for responses By Table | Expected Time for number of questions | ||||
Count | UOM | Assumes rate of 50 questions per 1.5 hour | |||||||||
Table 1. Facility Information | 12 | N/A | 12 | All columns/rows completed | 1.5 | 1.5 | 0-50 | ||||
Table 2. Parent Company Information | 8 | N/A | 8 | All columns/rows completed | 1.5 | 3 | 51-100 | ||||
Table 3. Facility Documents | N/A | -- | N/A, accounted for in Attachments | 4.5 | 101-150 | ||||||
Table 4. Facility Buildings | 10 | 2 | Buildings | 20 | All columns completed for the average number of units | 1.5 | k | 6 | 151-200 | ||
Table 5. Facility-level Data | 9 | N/A | 42 | All columns completed for all 5 reporting years | 1.5 | 7.5 | 201-250 | ||||
Table 6. Materials Sterilized with EtO | 5 | 4 | types of materials | 20 | All columns completed | 1.5 | x | 9 | 251-300 | ||
Table 7. Materials Sterilized with Non-EtO Techniques and Approaches | 4 | 2 | types of materials | 8 | All columns completed | 1.5 | k | 10.5 | 301-350 | ||
Facility Details | 110 | 4.5 | 9 | k | 12 | 351-400 | |||||
Table 1. Characteristics of Room Areas | 11 | 6 | Room Areas | 66 | All columns completed for the average number of units | 3 | k | 13.5 | 401-450 | ||
Table 2. Natural Draft Openings (NDO) | 10 | 2 | NDOs | 20 | All columns completed for the average number of units | 1.5 | k | 15 | 451-500 | ||
Table 3. Leak Checks of Components in EtO Service | 17 | 6 | Checks | 102 | All columns completed for the average number of units | 4.5 | x | 16.5 | 501-550 | ||
Table 4. Room Area Controls | 27 | 8 | Room Area Controls | 216 | All columns completed for the average number of units | 7.5 | 18 | 551-600 | |||
Room Area | 404 | 13.5 | 16.5 | k | 19.5 | 601-650 | |||||
C. EtO Drum and Container Storage | 13 | 12 | All columns/rows completed | 1.5 | x | 21 | 651-700 | ||||
D. Ethylene Glycol (EG) Tanks | 31 | 1 | Tanks | 31 | All columns completed for the average number of units | 1.5 | 22.5 | 701-750 | |||
EtO & EG Storage | 43 | 1.5 | 3 | k | 24 | 751-800 | |||||
Table 1. Summary for Sterilizer Chambers | 1 | N/A | 1 | All columns/rows completed | 1.5 | k | 25.5 | 801-850 | |||
Table 2. Sterilizer Chamber Operation and Monitoring Characteristics | 51 | 7 | Sterilizer Chambers | 357 | All columns completed for the average number of units | 12 | |||||
Table 3. Control Characteristics for Sterilizer Chambers | 64 | 6 | Controls for Sterilizer Chambers | 384 | All columns completed for the average number of units | 12 | k | ||||
Table 4. Control Characteristics for Sterilizer Chambers (continued) | 24 | 3 | Controls for Sterilizer Chambers | 72 | All columns completed for the average number of units | 3 | x | ||||
Table 5. Vacuum Pumps | 10 | 6 | Pumps | 60 | All columns completed for the average number of units | 3 | k | ||||
Sterilizer Chambers | 874 | 25.5 | 31.5 | k | |||||||
Table 1. Aeration that Occurs in Separate Unit (Aeration Room & Aeration Cell/Chamber) | 45 | 5 | Aeration Room & Cell/Chamber | 225 | All columns completed for the average number of units | 7.5 | |||||
Table 2. Aeration that Occurs within Sterilizer Chamber | 4 | 2 | Aeration within Sterilizer Chamber | 8 | All columns completed for the average number of units | 1.5 | x | ||||
Table 3. Movement of Sterilized Products through the Facility | 3 | N/A | 3 | All columns/rows completed | 1.5 | k | |||||
Aeration | 236 | 7.5 | 10.5 | ||||||||
Table 1. APCD Characteristics | 16 | 4 | APCDs | 64 | All columns completed for the average number of units | 3 | x | ||||
Table 2. Emissions and CEMS | 10 | 4 | APCDs | 40 | All columns completed for the average number of units | 1.5 | k | ||||
APCD Summary | 104 | 4.5 | 4.5 | ||||||||
Table 1. Wet Scrubber & Glygen Absorber Unit | 11 | 1 | Wet Scrubber & Glygen Absorber Units | 11 | All columns completed for the average number of units | 1.5 | k | ||||
Table 2. Dry-bed Scrubber | 21 | 1 | Dry-bed Scrubbers | 21 | All columns completed for the average number of units | 1.5 | |||||
Table 3. Catalytic Oxidizer & Combination Water Balancer/Catalytic Oxidizer | 26 | 1 | Catalytic Oxidzer & Balancer/Abator | 26 | All columns completed for the average number of units | 1.5 | |||||
Table 4. Thermal Oxidizer | 11 | 1 | Thermal Oxidizer | 11 | All columns completed for the average number of units | 1.5 | x | ||||
Table 5. Other APCDs | 7 | 0 | APCDs | 0 | All columns completed for the average number of units | k | |||||
APCD Details | 69 | 3 | 6 | k | |||||||
Table 1. Personal Monitoring (Badges) for EtO | 11 | 44 | Personal Monitors | 484 | All columns completed for the average number of units | 15 | |||||
Table 2. Room Area Monitoring for EtO | 9 | 4 | Room Area Monitors | 36 | All columns completed for the average number of units | 1.5 | x | ||||
Table 3. Other Monitoring for EtO | 3 | 1 | Other Monitors | 3 | All columns completed for the average number of units | 1.5 | k | ||||
EtO Monitoring | 523 | 16.5 | 18 | k | |||||||
J. Wastewater | 12 | 1 | Wastewater Treatment | 12 | All columns completed for the average number of units | 1.5 | |||||
K. Unique Cycles and EtO Reduction | 13 | 1 | Unique Cycle and EtO Reduction | 13 | All columns completed for the average number of units | 1.5 | x | ||||
Table 1. EtO and Facility Operation | 7 | N/A | 7 | All columns/rows completed | 1.5 | x | k | ||||
Table 2. Standalone Non-Colocated Warehouse, Distribution Center, or Enclosed Building for Sterilized Products | 4 | 2 | number of locations | 8 | All columns completed | 1.5 | |||||
Table 3. Alternative Sterilization | 2 | 2 | number of alternative methods | 4 | All columns completed | 1.5 | |||||
Miscellaneous | 44 | 1.5 | 6 | + | k | ||||||
Additional Info | 3 | 9 | Additional Information (rows of data) | 27 | All columns completed for the average number of units | 1.5 | 1.5 | ||||
Attachments | 10 | Attachments | 10 | Number of attachments | 10 | 10 |
Tab | Table Name | No. of Questions | Data Source / Assumptions | Altair Richmond, VA |
Altair Memphis, TN |
Altair Atlanta, GA |
BD Covington GA |
BD Madison GA |
BD Columbus, NE |
BD Sandy, UT |
Cosmed Franklin, NJ |
Cosmed Linden, NJ |
Cosmed Eerie, PA |
Elite Spice Hanover, MD |
Elite Spice Jessup, MD |
Elite Spice Sparks, NV |
Medline Salisbury, NC |
Medline Howell, MI |
Medline Waukegan, IL |
Medline Yuma, ZA |
Medtronic North Haven, CT |
Medtronic Villalba, PR |
Medtronic Miami Lakes, FL |
Medtronic Jacksonville, FL |
Medtronic Juncos, PR |
Medtronic Fridley, MN |
Medtronic Coon Rapids, MN |
Midwest Laredo, TX |
Midwest Jackson, MO |
Sterigenics Queensbury, NY |
Sterigenics Charlotte, NC |
Sterigenics Atlanta, GA |
Sterigenics Grand Prairie, TX |
Sterigenics Santa Teresa, NM |
Sterigenics SLCUT |
Sterigenics LAGifford, CA |
Sterigenics Ontario, CA |
Sterigenics LA50CA |
Steris Northborough, MA |
Steris South Plainfield, NJ |
Steris Spartanburg, SC |
Steris Minneapolis, MN |
Steris Grand Prairie, TX |
Steris El Paso, TX #1 |
Steris El Paso, TX #2 |
Steris San Diego, CA |
Steris Temecula, CA |
MIN | MAX | AVG | MODE | MEDIAN | Expected Responses | |||
Facility Details | Table 1. Facility Information | 12 | responses to questions | 11 | 11 | 11 | 11 | 11 | 11 | 12 | 12 | 11 | 11 | 12 | 12 | 12 | 12 | 12 | 11 | 11 | 12 | 12 | 11 | 12 | 12 | 12 | 11 | 11 | 11 | 12 | 12 | 12 | 12 | 12 | 11 | 12 | 12 | 11 | 12 | 11 | 11 | 12 | 11 | 11 | 11 | 11 | 11 | 11 | 12 | 11.4772727272727 | 11 | 11 | 12 | All | ||
Facility Details | Table 2. Parent Company Information | 8 | responses to questions | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 0 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 0 | 8 | 7.81818181818182 | 8 | 8 | 8 | All | ||
Facility Details | Table 3. Facility Documents | 5 | N/A, Accounted for in the Attachments Tab | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | n/a | N/A | ||||||||
Facility Details | Table 4. Facility Buildings | 10 | No. of buildings (i.e., rows completed in the table) | 4 | 4 | 4 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 2 | 3 | 1 | 4 | 3 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 4 | 1.52272727272727 | 1 | 1 | 20 | assumes all columns completed for 2 buildings (i.e., rows) | ||
Facility Details | Table 5. Facility-level Data | 9 | 5 years worth of data; responses to questions | 41 | 41 | 41 | 41 | 41 | 41 | 39 | 21 | 38 | 34 | 38 | 39 | 39 | 33 | 32 | 38 | 28 | 42 | 42 | 42 | 42 | 42 | 30 | 42 | 42 | 42 | 38 | 38 | 37 | 38 | 37 | 37 | 37 | 38 | 38 | 42 | 42 | 42 | 42 | 42 | 42 | 42 | 42 | 42 | 21 | 42 | 38.7954545454545 | 42 | 41 | 42 | All | ||
Facility Details | Table 6. Materials Sterilized with EtO | 5 | No. of sterilized products with EtO | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | 20 | assumes each facility has 4 products sterilized with EtO | |||||||
Facility Details | Table 7. Materials Sterilized with Non-EtO Techniques and Approaches | 4 | No. of sterilized products with non-EtO | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | 8 | assumes each facility has 2 products sterilized with non-EtO | |||||||
Room Area | Table 1. Characteristics of Room Areas | 11 | No. of rooms (i.e., rows completed in the table) | 7 | 6 | 7 | 9 | 12 | 9 | 8 | 3 | 3 | 4 | 1 | 1 | 1 | 2 | 2 | 6 | 3 | 15 | 3 | 1 | 5 | 2 | 3 | 1 | 15 | 19 | 12 | 6 | 5 | 6 | 8 | 12 | 3 | 5 | 6 | 8 | 5 | 7 | 8 | 4 | 6 | 4 | 3 | 5 | 1 | 19 | 5.93181818181818 | 3 | 5 | 66 | assumes all columns completed for 6 rooms (i.e., rows) | ||
Room Area | Table 2. Natural Draft Openings (NDO) | 10 | No. of rooms (i.e., rows completed in the table) | 1 | 1 | 0 | 6 | 9 | 0 | 1 | 2 | 3 | 1 | 1 | 1 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 15 | 19 | 0 | 1 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 4 | 6 | 4 | 4 | 3 | 3 | 5 | 0 | 19 | 2.36363636363636 | 0 | 1 | 20 | assumes all columns completed for 2NDOs (i.e., rows) | ||
Room Area | Table 3. Leak Checks of Components in EtO Service | 17 | No. of rooms (i.e., rows completed in the table) | 5 | 5 | 5 | 20 | 31 | 0 | 13 | 10 | 2 | 8 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 11 | 3 | 0 | 5 | 2 | 3 | 1 | 0 | 0 | 10 | 6 | 5 | 6 | 6 | 12 | 3 | 5 | 6 | 5 | 7 | 7 | 12 | 7 | 8 | 7 | 2 | 7 | 0 | 31 | 5.63636363636364 | 0 | 5 | 102 | assumes all columns completed for 6 checks (i.e., rows) | ||
Room Area | Table 4. Room Area Controls | 27 | No. of rooms (i.e., rows completed in the table) | 7 | 5 | 7 | 9 | 12 | 9 | 8 | 3 | 3 | 4 | 1 | 1 | 1 | 2 | 2 | 6 | 0 | 15 | 3 | 1 | 5 | 1 | 3 | 1 | 27 | 40 | 12 | 6 | 5 | 6 | 8 | 12 | 3 | 5 | 6 | 10 | 7 | 11 | 25 | 13 | 15 | 9 | 6 | 5 | 0 | 40 | 7.72727272727273 | 1 | 6 | 216 | assumes all columns completed for 8 control devices (i.e., rows) | ||
EtO & EG Storage | C. EtO Drum and Container Storage | 13 | responses to questions | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 11 | 11 | 11 | 12 | 12 | 11 | 12 | 12 | 12 | 5 | 12 | 12 | 11 | 11 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 5 | 12 | 11.7045454545455 | 12 | 12 | 13 | All | ||
EtO & EG Storage | D. Ethylene Glycol (EG) Tanks | 31 | No. of tanks (i.e., rows completed in the table) | 5 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 2 | 4 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 2 | 0 | 1 | 2 | 3 | 1 | 0 | 0 | 5 | 0.954545454545455 | 0 | 1 | 31 | assumes all columns completed for 1 tank | ||
Sterilizer Chambers | Table 1. Summary for Sterilizer Chambers | 1 | response to question | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | All | ||
Sterilizer Chambers | Table 2. Sterilizer Chamber Operation and Monitoring Characteristics | 51 | No. of chambers (i.e., rows completed in the table) | 4 | 2 | 3 | 5 | 7 | 3 | 6 | 3 | 4 | 4 | 2 | 2 | 1 | 3 | 1 | 10 | 3 | 4 | 23 | 0 | 2 | 13 | 10 | 2 | 10 | 13 | 11 | 9 | 10 | 5 | 14 | 10 | 8 | 9 | 6 | 4 | 7 | 6 | 12 | 10 | 4 | 6 | 9 | 6 | 0 | 23 | 6.5 | 4 | 6 | 357 | assumes all columns completed for 7 chambers | ||
Sterilizer Chambers | Table 3. Control Characteristics for Sterilizer Chambers | 64 | No. of chambers (i.e., rows completed in the table) | 4 | 2 | 3 | 0 | 7 | 3 | 6 | 3 | 4 | 4 | 2 | 2 | 1 | 3 | 1 | 10 | 0 | 4 | 24 | 0 | 0 | 13 | 10 | 2 | 10 | 13 | 11 | 9 | 10 | 5 | 14 | 10 | 8 | 9 | 6 | 4 | 7 | 6 | 12 | 10 | 4 | 6 | 9 | 6 | 0 | 24 | 6.29545454545455 | 4 | 6 | 384 | assumes all columns completed for 6 control devices | ||
Sterilizer Chambers | Table 4. Control Characteristics for Sterilizer Chambers (continued) | 24 | No. of chambers (i.e., rows completed in the table) | 4 | 2 | 3 | 0 | 7 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 0 | 2 | 24 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 9 | 0 | 5 | 7 | 0 | 0 | 3 | 0 | 4 | 7 | 6 | 12 | 0 | 4 | 6 | 9 | 6 | 0 | 24 | 3.25 | 0 | 2 | 72 | assumes all columns completed for 3 control devices | ||
Sterilizer Chambers | Table 5. Vacuum Pumps | 10 | No. of chambers (i.e., rows completed in the table) | 4 | 2 | 3 | 0 | 7 | 3 | 12 | 3 | 4 | 4 | 1 | 1 | 1 | 3 | 1 | 10 | 3 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 10 | 25 | 11 | 9 | 10 | 5 | 14 | 10 | 8 | 10 | 6 | 4 | 7 | 6 | 15 | 10 | 8 | 18 | 9 | 6 | 0 | 25 | 6.06818181818182 | 0 | 4.5 | 60 | assumes all columns completed for 6 vacuum pumps | ||
Aeration | Table 1. Aeration that Occurs in Separate Unit (Aeration Room & Aeration Cell/Chamber) | 45 | No. of aeration rooms (i.e., rows completed in the table) | 7 | 2 | 3 | 9 | 13 | 3 | 6 | 3 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 2 | 1 | 4 | 20 | 0 | 1 | 13 | 11 | 2 | 39 | 20 | 5 | 3 | 1 | 1 | 2 | 14 | 1 | 2 | 2 | 2 | 1 | 9 | 3 | 0 | 13 | 1 | 0 | 2 | 0 | 39 | 5.11363636363636 | 1 | 2 | 225 | assumes all columns completed for 5 aeration rooms | ||
Aeration | Table 2. Aeration that Occurs within Sterilizer Chamber | 4 | No. of aeration rooms within sterilization chamber (i.e., rows completed in the table) | 0 | 1 | 0 | 0 | 0 | 3 | 6 | 0 | 4 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 20 | 0 | 2 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 4 | 0 | 0 | 7 | 0 | 0 | 10 | 0 | 0 | 9 | 0 | 0 | 20 | 1.95454545454545 | 0 | 0 | 8 | assumes all columns completed for 2 aeration rooms with sterilizer chamber | ||
Aeration | Table 3. Movement of Sterilized Products through the Facility | 3 | responses to questions | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 3 | 3 | 1 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 3 | 3 | 3 | 3 | 0 | 3 | 2.68181818181818 | 3 | 3 | 3 | all | ||
APCD Summary | Table 1. APCD Characteristics | 16 | No. of APCDs (i.e., rows completed in the table) | 3 | 2 | 3 | 1 | 1 | 1 | 3 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 2 | 5 | 2 | 4 | 26 | 0 | 1 | 14 | 10 | 4 | 4 | 4 | 2 | 5 | 4 | 2 | 2 | 3 | 2 | 3 | 2 | 2 | 3 | 2 | 1 | 12 | 4 | 8 | 11 | 1 | 0 | 26 | 3.81818181818182 | 2 | 2 | 64 | assumes all columns completed for 4 APCDs | ||
APCD Summary | Table 2. Emissions and CEMS | 10 | No. of APCDs (i.e., rows completed in the table) | 3 | 2 | 3 | 1 | 1 | 1 | 3 | 1 | 4 | 2 | 1 | 1 | 1 | 2 | 2 | 1 | 2 | 4 | 26 | 0 | 1 | 14 | 10 | 4 | 4 | 4 | 2 | 5 | 4 | 2 | 2 | 3 | 2 | 3 | 2 | 2 | 3 | 2 | 1 | 12 | 4 | 8 | 11 | 1 | 0 | 26 | 3.79545454545455 | 2 | 2 | 40 | assumes all columns completed for 4 APCDs | ||
APCD Details | Table 1. Wet Scrubber & Glygen Absorber Unit | 11 | No. of Wet Scrubber & Glygen Absorber (i.e., rows completed in the table) | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 0 | 3 | 1 | 0 | 12 | 2 | 8 | 11 | 0 | 0 | 12 | 1.47727272727273 | 0 | 1 | 11 | assumes all columns completed for 1 wet scrubber | ||
APCD Details | Table 2. Dry-bed Scrubber | 21 | No. dry-bed scrubber (i.e., rows completed in the table) | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0.340909090909091 | 0 | 0 | 21 | assumes all columns completed for 1 dry-bed scrubbers | ||
APCD Details | Table 3. Catalytic Oxidizer & Combination Water Balancer/Catalytic Oxidizer | 26 | No. of CatOx & Balancer/Absorber (i.e., rows completed in the table) | 1 | 1 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 15 | 0 | 1 | 0 | 10 | 2 | 0 | 0 | 1 | 2 | 1 | 1 | 1 | 0 | 1 | 2 | 1 | 2 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 15 | 1.27272727272727 | 0 | 1 | 26 | assumes all columns completed for 1 catox | ||
APCD Details | Table 4. Thermal Oxidizer | 11 | No. of ThermOx (i.e., rows completed in the table) | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 0.386363636363636 | 0 | 0 | 11 | assumes all columns completed for 1 thermox | ||
APCD Details | Table 5. Other APCDs | 7 | No. of Other APCD (i.e., rows completed in the table) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0.045454545454546 | 0 | 0 | 0 | assumes 0 other | ||
EtO Monitoring | Table 1. Personal Monitoring (Badges) for EtO | 11 | No. of Unique ID (i.e., rows of data) | 8 | 8 | 14 | 18 | 18 | 20 | 20 | 10 | 14 | 17 | 44 | 31 | 8 | 13 | 15 | 20 | 5 | 6 | 4 | 0 | 1 | 12 | 18 | 6 | 10 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 90 | 101 | 121 | 185 | 136 | 187 | 262 | 236 | 97 | 0 | 262 | 44.4318181818182 | 20 | 20 | 484 | assumes all columns completed for 44 personal monitoring locations | ||
EtO Monitoring | Table 2. Room Area Monitoring for EtO | 9 | No. of rooms areas monitored | 0 | 0 | 0 | 9 | 9 | 9 | 8 | 3 | 8 | 4 | 4 | 5 | 2 | 2 | 2 | 6 | 3 | 10 | 0 | 1 | 5 | 1 | 3 | 1 | 15 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 5 | 7 | 8 | 3 | 6 | 4 | 3 | 5 | 0 | 19 | 4.04545454545455 | 0 | 3 | 36 | assumes all columns completed for 4 room area monitors | ||
EtO Monitoring | Table 3. Other Monitoring for EtO | 3 | No. of responses | 0 | 0 | 0 | 3 | 0 | 3 | 3 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 0 | 3 | 1.27272727272727 | 0 | 0 | 1 | assumes 1 response | ||
Miscellaneous | J. Wastewater | 12 | No. of responses | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0.409090909090909 | 0 | 0 | 12 | assumes all columns completed for 1 wastewater point | ||
Miscellaneous | K. Unique Cycles and EtO Reduction | 13 | No. of responses | 1 | 1 | 1 | 0 | 3 | 0 | 3 | 1 | 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 2 | 1 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 3 | 0.886363636363636 | 1 | 1 | 13 | assumes all columns completed for 1 unique cycle entry | ||
Miscellaneous | Table 1. EtO and Facility Operation | 7 | No. of responses | 6 | 6 | 6 | 6 | 6 | 5 | 6 | 6 | 5 | 6 | 5 | 5 | 5 | 5 | 5 | 0 | 6 | 5 | 6 | 5 | 6 | 6 | 6 | 6 | 6 | 6 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 0 | 6 | 5.25 | 6 | 6 | 7 | all | ||
Miscellaneous | Table 2. Standalone Non-Colocated Warehouse, Distribution Center, or Enclosed Building for Sterilized Products | 4 | No. of standalone non-colocated warehouse | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | 8 | assumes each facility sends products to 2 standalone non-colocated warehouses | |||||||
Miscellaneous | Table 3. Alternative Sterilization | 2 | No. of alternative sterilization methods | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | n/a (new in v5.5.1) | 4 | assumes each facility has 2 applicable alternative sterilization methods on their products | |||||||
Additional Info | N/A | 3 | No. of responses | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 57 | 25 | 58 | 8 | 8 | 10 | 0 | 0 | 0 | 0 | 18 | 3 | 5 | 23 | 5 | 19 | 23 | 40 | 43 | 3 | 6 | 9 | 3 | 3 | 15 | 3 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 58 | 9.13636363636364 | 0 | 3 | 27 | assumes all columns completed for 9 rows | ||
Attachments | N/A | 18 | No. of Attachments | 12 | 13 | 20 | 19 | 14 | 34 | 16 | 9 | 9 | 0 | 15 | 16 | 11 | 17 | 19 | 22 | 13 | 29 | 5 | 2 | 11 | 10 | 6 | 9 | 9 | 10 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 10 | 9 | 11 | 10 | 9 | 10 | 9 | 11 | 11 | 0 | 34 | 10.4090909090909 | 2 | 10 | 10 | assume 10 attachments per facility |
File Type | application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
File Modified | 0000-00-00 |
File Created | 0000-00-00 |