Proposed Information Collection Request; Comment Request; Information Collection; Effort for Ethylene Oxide Commercial Sterilization Facilities
| Citation | 85 FR 35931 |
| Record Number | 2020-12728 |
| Published date | 12 June 2020 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 85 Issue 114 (Friday, June 12, 2020)
[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 [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 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
[[Page 35933]]
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
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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.
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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
