[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]


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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.

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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 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

[[Page 35932]]

the current status, please visit us online at http://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.
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    \1\ https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities.
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    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

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

           Table 1--Questionnaire Data Collection Form Design
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             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


