Proposed Information Collection Request; Comment Request; Information Collection; Effort for Ethylene Oxide Commercial Sterilization Facilities, 35931-35933 [2020-12728]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices members shall be associated with small, rural public water systems; and five members are from the general public. The current list of members is available on the EPA’s NDWAC website at https:// www.epa.gov/ndwac under ‘‘NDWAC roster.’’ The Council typically will meet in person once each year and may hold a second meeting, either in person or by video/teleconference, during the year. Members also may be asked to participate in ad hoc workgroups to develop policy recommendations, advice letters, and reports to address specific program issues. Member Nominations: Any interested person and/or organization may nominate qualified individuals for membership. Interested candidates may self-nominate. The EPA values and welcomes diversity. In an effort to obtain nominations of diverse candidates, the EPA encourages nominations of women and men of all racial and ethnic groups. All nominations will be fully considered, but applicants need to be aware of the specific representation required by the SDWA: State and local agencies concerned with water hygiene and public water supply (two vacancies in 2020); private organizations or groups demonstrating an active interest in the field of water hygiene and public water supply (three vacancies in 2020—of which one will be associated with small, rural public water systems); and the general public (one vacancy in 2021). The EPA may also consider nominations received through this solicitation in the event of unplanned vacancies on the Council. Other criteria used to evaluate nominees will include: • Demonstrated experience with drinking water issues at the national, state, or local level; • Excellent interpersonal, oral, and written communication and consensusbuilding skills; • Willingness to commit time to the Council and demonstrated ability to work constructively on committees; • Absence of financial conflicts of interest; • Absence of appearance of a lack of impartiality; and • Background and experience that would help members contribute to the diversity of perspectives on the Council, e.g., geographic, economic, social, cultural, educational backgrounds, professional affiliations, and other considerations. Nominations must include a resume, which provides the nominee’s background, experience, and educational qualifications, as well as a brief statement (one page or less) VerDate Sep<11>2014 17:43 Jun 11, 2020 Jkt 250001 describing the nominee’s interest in serving on the Council and addressing the other criteria previously described. Nominees are encouraged to provide any additional information that they think would be useful for consideration, such as: Availability to participate as a member of the Council; and how the nominee’s background, skills, and experience would contribute to the diversity of the Council. Nominees should be identified by name, occupation, position, current business address, email address, and telephone number. The DFO will use the email address provided for the nominee to acknowledge receipt of nominations. Persons selected for membership will receive compensation for travel and a nominal, daily compensation (if appropriate) while attending meetings. All selected candidates will be designated as Special Government Employees (SGEs) and will be required to submit the ‘‘Confidential Financial Disclosure Form for Environmental Protection Agency Special Government Employees’’ (EPA Form 3110–48). This confidential form provides information to the EPA’s ethics officials, to determine whether there is a conflict between the SGE’s public duties and their private interests, including an appearance of a loss of impartiality as defined by federal laws and regulations. The form may be viewed and downloaded through the ‘‘Ethics requirements’’ link on the EPA’s website at https://www.epa.gov/ndwac. Other sources, in addition to this Federal Register announcement, may also be utilized in the solicitation of nominees. To help the EPA in evaluating the effectiveness of its outreach efforts, please tell us how you learned of this opportunity. Jennifer L. McLain, Director, Office of Ground Water and Drinking Water. [FR Doc. 2020–12727 Filed 6–11–20; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OAR–2019–0178; FRL–10010–58– OAR] Proposed Information Collection Request; Comment Request; Information Collection; Effort for Ethylene Oxide Commercial Sterilization Facilities Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 35931 The U.S. Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ‘‘Information Collection Effort for Ethylene Oxide Commercial Sterilization Facilities’’ (EPA ICR No. 2623.01, OMB Control No. 2060–NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comment on specific aspects of the proposed information collection as described below. This is a request for approval of a new collection. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. DATES: Comments must be submitted on or before August 11, 2020. ADDRESSES: Submit your comments, referencing Docket ID No. EPA–HQ– OAR–2019–0178, online using https:// www.regulations.gov/ (our preferred method) or by email to a-and-r-docket@ epa.gov. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room was closed to public visitors on March 31, 2020, to reduce the risk of transmitting COVID–19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via https:// www.regulations.gov or email, as there is a temporary suspension of mail delivery to the EPA, and no hand deliveries are currently accepted. The EPA’s policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. FOR FURTHER INFORMATION CONTACT: Mr. Matthew Witosky, Sector Policies and Programs Division (E143–05), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541–2865; email address: witosky.matthew@ epa.gov. SUPPLEMENTARY INFORMATION: Supporting documents explaining in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at https:// www.regulations.gov/. The telephone number for the Docket Center is (202) 566–1742. For additional information about EPA’s Docket Center services and SUMMARY: E:\FR\FM\12JNN1.SGM 12JNN1 jbell on DSKJLSW7X2PROD with NOTICES 35932 Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices the current status, please visit us online at https://www.epa.gov/dockets. Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to (1) evaluate whether the proposed collection of information is necessary for the proper performance of Agency functions; (2) evaluate the accuracy of the Agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on responders, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, the EPA will issue another Federal Register document to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO) Commercial Sterilization and Fumigation Operations were finalized in December 1994 (59 FR 62585) at 40 CFR part 63, subpart O. The NESHAP establishes emission standards for both major and area sources that use at least 1 ton of EtO in sterilization or fumigation operations in each 12-month period. The standards require existing and new major sources to control emissions to the level achievable by the maximum achievable control technology and require existing and new area sources to control emissions using generally available control technology. The current standards address EtO emissions originating at two of the three major emissions sources: The sterilization chamber vent and the aeration room vent. The third major EtO emissions source is the chamber exhaust vent (CEV), and while the 1994 NESHAP regulated emissions from CEVs, relevant standards were later removed due to safety concerns (66 FR 55577, November 2, 2001). To fulfill its requirements under sections 112(d) and 112(f) of the Clean Air Act (CAA), the EPA completed a residual risk and technology review for the NESHAP in 2006 and concluded, at that time, that no revisions to the standards were necessary (71 FR 17712, April 7, 2006). VerDate Sep<11>2014 17:43 Jun 11, 2020 Jkt 250001 More recently, in 2016, the EPA released its updated Integrated Risk Information System value for EtO, which indicated that cancer risks from EtO were significantly higher than previously understood. Subsequently, the National Air Toxics Assessment (NATA) released in August 2018, identified EtO emissions as a potential concern in several areas across the country. The latest NATA estimates that EtO significantly contributes to potential elevated cancer risks in some census tracts across the U.S. (less than 1 percent of the total number of tracts). Further investigation revealed commercial sterilization using EtO as a source category contributing to some of these risks, which has led the EPA to evaluate, in greater depth, potential options to reduce emissions of EtO from the source category. Over the past year, the EPA has been gathering additional information to evaluate opportunities to reduce EtO emissions through potential rule revisions and more immediate emission reduction steps. The goal of the data gathering efforts is to better understand the emissions sources, measurement and monitoring techniques, and available control technologies and their associated efficiencies. These data gathering efforts also included an advance notice of proposed rulemaking (ANPRM) and a CAA section 114 questionnaire requesting facility-specific data on process controls and operational practices that may reduce the amount of EtO released into the ambient air. The EPA published the ANPRM on December 12, 2019 (84 FR 67889). In the ANPRM, the EPA solicited comments on a range of issues including the modeling file and EtO annual usage, control of fugitive emissions, CEV control and safety considerations, other point source control options, and small business considerations. The public comments on the ANPRM were due on February 10, 2020, and comments received are available in the docket (https:// www.regulations.gov/). Alongside the ANPRM, the EPA exercised its authority under section 114(a) of the CAA to initiate a questionnaire to gather information from nine companies in December 2019. The instructions and questionnaire were posted to the EPA web page 1 where they were accessed by facilities. Facilities were required to provide electronic responses within 60 days or by February 6, 2020. Facility responses to the initial questionnaire 1 https://www.epa.gov/stationary-sources-airpollution/ethylene-oxide-emissions-standardssterilization-facilities. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 have been collected and compiled to create a source category database. While these data gathering efforts have been successful in identifying process controls and operational practices as possible methods for reducing the amount of EtO released into the ambient air, there are still several important information gaps that should be filled prior to any future rulemaking activity. In reviewing the December 2019 questionnaire results, the EPA found that each EtO commercial sterilization facility’s equipment, equipment configuration, processes, and pace of technological advancement is unique. The most recent sector-level data collected by the EPA was completed over 25 years ago for the development of the original NESHAP and is now outdated. The combined data from this ICR and the December 2019 questionnaire will enable the EPA to obtain an updated, comprehensive, and consistent dataset. The combined results provide the EPA with the most information possible to achieve its objectives of reducing EtO emissions and informing potential rule revisions. Therefore, the EPA is now contemplating exercising its authority under section 114(a) of the CAA to broaden its data collection efforts through this new ICR to include all facilities subject to 40 CFR part 63, subpart O. The data collected through this new ICR, as well as the initial questionnaire, would enable the EPA to have a complete understanding of all emissions, emissions sources, processes, and control technologies in use at EtO sterilization facilities nationwide, providing the most robust foundation for a potential future rulemaking. Based on the EPA’s knowledge of EtO sterilization facilities, an estimated 108 facilities have been identified within the EtO commercial sterilization source category. If OMB approves this new ICR, respondents not included in the initial questionnaire would be required to complete the questionnaire under the authority of section 114 of the CAA. The EPA anticipates issuing the CAA section 114 letters by December 2020. These letters would require owners or operators to complete and submit the questionnaire within 90 days from the date they receive the letter from the EPA. The ICR process, including the instructions and questionnaire, would be identical to the questionnaire that was initiated in December 2019. The instructions for the questionnaire are an Adobe portable document format (PDF), and the questionnaire is a Microsoft Excel workbook that is available in the docket. The questionnaire contains 14 worksheets. Each worksheet has one or E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices 35933 more tables designed to collect specific information as detailed in Table 1. TABLE 1—QUESTIONNAIRE DATA COLLECTION FORM DESIGN Tab name Description of data Introduction ............. Terms ...................... Facility Details ......... Room Area .............. EtO & EG Storage .. Sterilizer Chambers Aeration ................... APCD Summary ..... APCD Details .......... EtO Monitoring ........ Miscellaneous ......... Additional Info ......... Documents .............. Introduction and instructions for completing and submitting the questionnaire. Definitions or explanations of technical terms. Information about facility registrations, ownership, general characteristics, facility-level data. Characteristics, inventory of components, and control of individual room areas where EtO is used or emitted. Questions regarding EtO storage in drums and containers, and ethylene glycol (EG) tanks. Operation, monitoring, and control characteristics of sterilizer chambers, including chamber exhaust vents. Details of aeration equipment. Information about all air pollution control devices operated by the facility. Details regarding air pollution control devices such as scrubbers, catalytic oxidizers, thermal oxidizers, and others. Information about workspace monitoring, personal monitoring, room monitoring conducted by facility. Questions regarding facility’s wastewater treatment and other items of EtO commercial sterilization operation. Extra space to provide any additional information requested within the questionnaire. Designated fields for reporter to attach documents requested throughout the questionnaire (e.g., facility diagram; process flow diagrams; air permit; permit application documents; startup, shutdown, malfunction plan; EtO calculations and supporting information; performance tests; engineering tests; parametric monitoring; standard operating procedures; EtO monitoring results; documentation of studies done on quantifying EtO residuals in your products; and other process and instrumentation diagrams). Reporter’s information and certification for completing and submitting the questionnaire. jbell on DSKJLSW7X2PROD with NOTICES Certification ............. As described in the instructions and the questionnaire, facilities may claim certain data as CBI in their response. There is a cell in each worksheet to indicate whether the worksheet contains CBI and if so, each cell containing data being claimed as CBI should be shaded red. It should be noted that CAA section 114(c) exempts emissions data from claims of confidentiality, and emissions data provided may be made available to the public. Emissions data should not be marked confidential. A definition of what the EPA considers emissions data is provided in 40 CFR 2.301(a)(2)(i). Facilities claiming CBI must submit both a non-confidential and confidential version of their response. All nonconfidential responses to the ICR would be submitted to the EPA via email or on a thumb drive, CD–ROM, or DVD through the U.S. mail. All confidential responses to the ICR would be submitted on a thumb drive, CD–ROM, or DVD to the EPA through the U.S. mail. Non-confidential information collected from this ICR will be made available to the public. Any information designated as confidential by an ICR respondent that the EPA subsequently determines to constitute CBI or a trade secret under the EPA’s CBI regulations at 40 CFR part 2, subpart B, will be protected pursuant to those regulations and, for trade secrets, under 18 U.S.C. 1905. If no claim of confidentiality accompanies the information when it is received by the EPA, it may be made available to the public by the EPA without further notice pursuant to the EPA regulations at 40 CFR 2.203. Form numbers: None. VerDate Sep<11>2014 17:43 Jun 11, 2020 Jkt 250001 Respondents/affected entities: Facilities subject to 40 CFR part 63, subpart O. Respondent’s obligation to respond: Responses to the ICR are mandatory under the authority of section 114 of the CAA. Estimated number of respondents: 66 (total). Frequency of response: Once. Total estimated burden: The estimated cumulative respondent burden is 6,201 hours. The estimated cumulative Agency burden to administer this ICR is 1,727 hours. Burden is defined at 5 CFR 1320.03(b). Total estimated cost: The estimated cumulative costs to respondents is $569,967, including $995 operation and maintenance costs for media and postage for submitting questionnaires containing CBI. The estimated cumulative Agency costs is $100,049 including $1,440 operation and maintenance costs for data storage. Dated: June 5, 2020. Penny Lassiter, Director, Sector Policies and Programs Division. [FR Doc. 2020–12728 Filed 6–11–20; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3395–N] Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee— July 22, 2020 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (‘‘Committee’’) will be held on Wednesday, July 22, 2020. This meeting will focus on the home use of noninvasive positive pressure ventilation in patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). We are seeking the MEDCAC’s recommendations regarding the characteristics that define those patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). DATES: Meeting Date: The virtual meeting will be held on Wednesday, July 22, 2020 from 8:00 a.m. until 4:30 p.m., Eastern Daylight Time (EDT). SUMMARY: E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35931-35933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12728]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2019-0178; FRL-10010-58-OAR]


Proposed Information Collection Request; Comment Request; 
Information Collection; Effort for Ethylene Oxide Commercial 
Sterilization Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency (EPA) is planning to 
submit an information collection request (ICR), ``Information 
Collection Effort for Ethylene Oxide Commercial Sterilization 
Facilities'' (EPA ICR No. 2623.01, OMB Control No. 2060-NEW) to the 
Office of Management and Budget (OMB) for review and approval in 
accordance with the Paperwork Reduction Act (PRA). Before doing so, the 
EPA is soliciting public comment on specific aspects of the proposed 
information collection as described below. This is a request for 
approval of a new collection. An agency may not conduct or sponsor and 
a person is not required to respond to a collection of information 
unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before August 11, 2020.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2019-0178, online using https://www.regulations.gov/ (our preferred 
method) or by email to [email protected]. Out of an abundance of 
caution for members of the public and our staff, the EPA Docket Center 
and Reading Room was closed to public visitors on March 31, 2020, to 
reduce the risk of transmitting COVID-19. Our Docket Center staff will 
continue to provide remote customer service via email, phone, and 
webform. We encourage the public to submit comments via https://www.regulations.gov or email, as there is a temporary suspension of 
mail delivery to the EPA, and no hand deliveries are currently 
accepted.
    The EPA's policy is that all comments received will be included in 
the public docket without change including any personal information 
provided, unless the comment includes profanity, threats, information 
claimed to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Mr. Matthew Witosky, Sector Policies 
and Programs Division (E143-05), U.S. Environmental Protection Agency, 
Research Triangle Park, NC 27711; telephone number: (919) 541-2865; 
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents explaining in detail 
the information that the EPA will be collecting are available in the 
public docket for this ICR. The docket can be viewed online at https://www.regulations.gov/. The telephone number for the Docket Center is 
(202) 566-1742. For additional information about EPA's Docket Center 
services and

[[Page 35932]]

the current status, please visit us online at https://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting 
comments and information to enable it to (1) evaluate whether the 
proposed collection of information is necessary for the proper 
performance of Agency functions; (2) evaluate the accuracy of the 
Agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) enhance the quality, utility, and clarity of the information 
to be collected; and (4) minimize the burden of the collection of 
information on responders, including through the use of appropriate 
automated electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses. The EPA will consider the comments 
received and amend the ICR as appropriate. The final ICR package will 
then be submitted to OMB for review and approval. At that time, the EPA 
will issue another Federal Register document to announce the submission 
of the ICR to OMB and the opportunity to submit additional comments to 
OMB.
    Abstract: The National Emission Standards for Hazardous Air 
Pollutants (NESHAP) for Ethylene Oxide (EtO) Commercial Sterilization 
and Fumigation Operations were finalized in December 1994 (59 FR 62585) 
at 40 CFR part 63, subpart O. The NESHAP establishes emission standards 
for both major and area sources that use at least 1 ton of EtO in 
sterilization or fumigation operations in each 12-month period. The 
standards require existing and new major sources to control emissions 
to the level achievable by the maximum achievable control technology 
and require existing and new area sources to control emissions using 
generally available control technology. The current standards address 
EtO emissions originating at two of the three major emissions sources: 
The sterilization chamber vent and the aeration room vent. The third 
major EtO emissions source is the chamber exhaust vent (CEV), and while 
the 1994 NESHAP regulated emissions from CEVs, relevant standards were 
later removed due to safety concerns (66 FR 55577, November 2, 2001). 
To fulfill its requirements under sections 112(d) and 112(f) of the 
Clean Air Act (CAA), the EPA completed a residual risk and technology 
review for the NESHAP in 2006 and concluded, at that time, that no 
revisions to the standards were necessary (71 FR 17712, April 7, 2006).
    More recently, in 2016, the EPA released its updated Integrated 
Risk Information System value for EtO, which indicated that cancer 
risks from EtO were significantly higher than previously understood. 
Subsequently, the National Air Toxics Assessment (NATA) released in 
August 2018, identified EtO emissions as a potential concern in several 
areas across the country. The latest NATA estimates that EtO 
significantly contributes to potential elevated cancer risks in some 
census tracts across the U.S. (less than 1 percent of the total number 
of tracts). Further investigation revealed commercial sterilization 
using EtO as a source category contributing to some of these risks, 
which has led the EPA to evaluate, in greater depth, potential options 
to reduce emissions of EtO from the source category.
    Over the past year, the EPA has been gathering additional 
information to evaluate opportunities to reduce EtO emissions through 
potential rule revisions and more immediate emission reduction steps. 
The goal of the data gathering efforts is to better understand the 
emissions sources, measurement and monitoring techniques, and available 
control technologies and their associated efficiencies.
    These data gathering efforts also included an advance notice of 
proposed rulemaking (ANPRM) and a CAA section 114 questionnaire 
requesting facility-specific data on process controls and operational 
practices that may reduce the amount of EtO released into the ambient 
air. The EPA published the ANPRM on December 12, 2019 (84 FR 67889). In 
the ANPRM, the EPA solicited comments on a range of issues including 
the modeling file and EtO annual usage, control of fugitive emissions, 
CEV control and safety considerations, other point source control 
options, and small business considerations. The public comments on the 
ANPRM were due on February 10, 2020, and comments received are 
available in the docket (https://www.regulations.gov/). Alongside the 
ANPRM, the EPA exercised its authority under section 114(a) of the CAA 
to initiate a questionnaire to gather information from nine companies 
in December 2019. The instructions and questionnaire were posted to the 
EPA web page \1\ where they were accessed by facilities. Facilities 
were required to provide electronic responses within 60 days or by 
February 6, 2020. Facility responses to the initial questionnaire have 
been collected and compiled to create a source category database. While 
these data gathering efforts have been successful in identifying 
process controls and operational practices as possible methods for 
reducing the amount of EtO released into the ambient air, there are 
still several important information gaps that should be filled prior to 
any future rulemaking activity.
---------------------------------------------------------------------------

    \1\ https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities.
---------------------------------------------------------------------------

    In reviewing the December 2019 questionnaire results, the EPA found 
that each EtO commercial sterilization facility's equipment, equipment 
configuration, processes, and pace of technological advancement is 
unique. The most recent sector-level data collected by the EPA was 
completed over 25 years ago for the development of the original NESHAP 
and is now outdated. The combined data from this ICR and the December 
2019 questionnaire will enable the EPA to obtain an updated, 
comprehensive, and consistent dataset. The combined results provide the 
EPA with the most information possible to achieve its objectives of 
reducing EtO emissions and informing potential rule revisions.
    Therefore, the EPA is now contemplating exercising its authority 
under section 114(a) of the CAA to broaden its data collection efforts 
through this new ICR to include all facilities subject to 40 CFR part 
63, subpart O. The data collected through this new ICR, as well as the 
initial questionnaire, would enable the EPA to have a complete 
understanding of all emissions, emissions sources, processes, and 
control technologies in use at EtO sterilization facilities nationwide, 
providing the most robust foundation for a potential future rulemaking. 
Based on the EPA's knowledge of EtO sterilization facilities, an 
estimated 108 facilities have been identified within the EtO commercial 
sterilization source category. If OMB approves this new ICR, 
respondents not included in the initial questionnaire would be required 
to complete the questionnaire under the authority of section 114 of the 
CAA. The EPA anticipates issuing the CAA section 114 letters by 
December 2020. These letters would require owners or operators to 
complete and submit the questionnaire within 90 days from the date they 
receive the letter from the EPA. The ICR process, including the 
instructions and questionnaire, would be identical to the questionnaire 
that was initiated in December 2019. The instructions for the 
questionnaire are an Adobe portable document format (PDF), and the 
questionnaire is a Microsoft Excel workbook that is available in the 
docket. The questionnaire contains 14 worksheets. Each worksheet has 
one or

[[Page 35933]]

more tables designed to collect specific information as detailed in 
Table 1.

           Table 1--Questionnaire Data Collection Form Design
------------------------------------------------------------------------
             Tab name                        Description of data
------------------------------------------------------------------------
Introduction......................  Introduction and instructions for
                                     completing and submitting the
                                     questionnaire.
Terms.............................  Definitions or explanations of
                                     technical terms.
Facility Details..................  Information about facility
                                     registrations, ownership, general
                                     characteristics, facility-level
                                     data.
Room Area.........................  Characteristics, inventory of
                                     components, and control of
                                     individual room areas where EtO is
                                     used or emitted.
EtO & EG Storage..................  Questions regarding EtO storage in
                                     drums and containers, and ethylene
                                     glycol (EG) tanks.
Sterilizer Chambers...............  Operation, monitoring, and control
                                     characteristics of sterilizer
                                     chambers, including chamber exhaust
                                     vents.
Aeration..........................  Details of aeration equipment.
APCD Summary......................  Information about all air pollution
                                     control devices operated by the
                                     facility.
APCD Details......................  Details regarding air pollution
                                     control devices such as scrubbers,
                                     catalytic oxidizers, thermal
                                     oxidizers, and others.
EtO Monitoring....................  Information about workspace
                                     monitoring, personal monitoring,
                                     room monitoring conducted by
                                     facility.
Miscellaneous.....................  Questions regarding facility's
                                     wastewater treatment and other
                                     items of EtO commercial
                                     sterilization operation.
Additional Info...................  Extra space to provide any
                                     additional information requested
                                     within the questionnaire.
Documents.........................  Designated fields for reporter to
                                     attach documents requested
                                     throughout the questionnaire (e.g.,
                                     facility diagram; process flow
                                     diagrams; air permit; permit
                                     application documents; startup,
                                     shutdown, malfunction plan; EtO
                                     calculations and supporting
                                     information; performance tests;
                                     engineering tests; parametric
                                     monitoring; standard operating
                                     procedures; EtO monitoring results;
                                     documentation of studies done on
                                     quantifying EtO residuals in your
                                     products; and other process and
                                     instrumentation diagrams).
Certification.....................  Reporter's information and
                                     certification for completing and
                                     submitting the questionnaire.
------------------------------------------------------------------------

    As described in the instructions and the questionnaire, facilities 
may claim certain data as CBI in their response. There is a cell in 
each worksheet to indicate whether the worksheet contains CBI and if 
so, each cell containing data being claimed as CBI should be shaded 
red. It should be noted that CAA section 114(c) exempts emissions data 
from claims of confidentiality, and emissions data provided may be made 
available to the public. Emissions data should not be marked 
confidential. A definition of what the EPA considers emissions data is 
provided in 40 CFR 2.301(a)(2)(i). Facilities claiming CBI must submit 
both a non-confidential and confidential version of their response. All 
non-confidential responses to the ICR would be submitted to the EPA via 
email or on a thumb drive, CD-ROM, or DVD through the U.S. mail. All 
confidential responses to the ICR would be submitted on a thumb drive, 
CD-ROM, or DVD to the EPA through the U.S. mail. Non-confidential 
information collected from this ICR will be made available to the 
public. Any information designated as confidential by an ICR respondent 
that the EPA subsequently determines to constitute CBI or a trade 
secret under the EPA's CBI regulations at 40 CFR part 2, subpart B, 
will be protected pursuant to those regulations and, for trade secrets, 
under 18 U.S.C. 1905. If no claim of confidentiality accompanies the 
information when it is received by the EPA, it may be made available to 
the public by the EPA without further notice pursuant to the EPA 
regulations at 40 CFR 2.203.
    Form numbers: None.
    Respondents/affected entities: Facilities subject to 40 CFR part 
63, subpart O.
    Respondent's obligation to respond: Responses to the ICR are 
mandatory under the authority of section 114 of the CAA.
    Estimated number of respondents: 66 (total).
    Frequency of response: Once.
    Total estimated burden: The estimated cumulative respondent burden 
is 6,201 hours. The estimated cumulative Agency burden to administer 
this ICR is 1,727 hours. Burden is defined at 5 CFR 1320.03(b).
    Total estimated cost: The estimated cumulative costs to respondents 
is $569,967, including $995 operation and maintenance costs for media 
and postage for submitting questionnaires containing CBI. The estimated 
cumulative Agency costs is $100,049 including $1,440 operation and 
maintenance costs for data storage.

    Dated: June 5, 2020.
Penny Lassiter,
Director, Sector Policies and Programs Division.
[FR Doc. 2020-12728 Filed 6-11-20; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.