[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24862-24863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09794]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2019-0178; FRL-10023-89-OMS]


Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; Ethylene Oxide Commercial Sterilization 
Facilities National Emission Standards for Hazardous Air Pollutants 
(NESHAP) Technology Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) has submitted 
an information collection request (ICR), Ethylene Oxide Commercial 
Sterilization Facilities National Emission Standards for Hazardous Air 
Pollutants (NESHAP) Technology Review (EPA ICR Number 2623.01, OMB 
Control Number 2060-NEW), to the Office of Management and Budget (OMB) 
for review and approval in accordance with the Paperwork Reduction Act 
(PRA). This is a request for approval of a new collection. Public 
comments were previously requested via the Federal Register on June 12, 
2020, during a 60-day comment period. This notice allows for an 
additional 30 days for public comments. A complete description of the 
ICR is provided below, including its estimated burden and cost to the 
public. 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: Additional comments may be submitted on or before June 9, 2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OAR-2019-0178, online using www.regulations.gov (our preferred 
method), by email to a-and-r-docket@epa.gov, or by mail to: EPA Docket 
Center, Environmental Protection Agency, Mail Code 28221T, 1200 
Pennsylvania Ave. NW, Washington, DC 20460. 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.
    Submit written comments and recommendations to OMB for the proposed 
information collection within 30 days of publication of this notice to 
www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function.

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 the current status, please visit us online at https://www.epa.gov/dockets.
    Abstract: The NESHAP for EtO Commercial Sterilization and 
Fumigation Operations were finalized in December 1994 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 any 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 EPA completed a residual risk and 
technology review for the NESHAP in 2006 and, at that time, concluded 
that the risk under existing standards were acceptable and provided an 
ample margin of safety. More recently, in 2016, the EPA released its 
updated Integrated Risk Information System unit risk estimate 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 
an important risk driver in several areas across the country. Further 
investigation revealed the EtO Commercial Sterilization source category 
contributes 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.
    Since 2019, the EPA has been gathering additional information to 
evaluate opportunities to reduce EtO emissions through potential rule 
revisions and more immediate emission

[[Page 24863]]

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 efforts have included an advance notice of proposed 
rulemaking (ANPRM) requesting facility-specific data on process 
controls and operational practices as well as a CAA section 114 
questionnaire that was distributed to 9 companies engaged in EtO 
commercial sterilization. The instructions and questionnaire were 
posted to the EPA web page where they were accessed by facilities. 
Electronic responses were required within 60 days or by February 6, 
2020. While these data gathering efforts have been successful, there 
are still several important information gaps that should be filled 
prior to any final rulemaking activity. Therefore, the EPA is now 
exercising its authority under section 114(a) of the CAA to broaden its 
data collection efforts to include all facilities subject to 40 CFR 
part 63, subpart O that were not involved in the December 2019 
questionnaire. The data collected through the initial questionnaire and 
this new ICR 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 a robust 
foundation for a final rulemaking.
    Form numbers: Main Questionnaire; Supplement 1 (as needed); 
Supplement 2 (as needed); Supplement 3 (as needed).
    Respondents/affected entities: Facilities subject to 40 CFR part 
63, subpart O that are not included in the initial December 2019 
questionnaire.
    Respondent's obligation to respond: Responses to the ICR are 
mandatory under the authority of section 114 of the CAA. All 
respondents are required to fill out the main questionnaire, while 
Supplements 1, 2, and 3 may be filled out as needed.
    Estimated number of respondents: 61 (total).
    Frequency of response: This is a one-time questionnaire.
    Total estimated burden: 6,573 hours (per year). Burden is defined 
at 5 CFR 1320.03(b)
    Total estimated cost: $604,027 (per year), includes $920 annualized 
capital or operation & maintenance costs.
    Changes in the estimates: This is a new collection. Therefore, 
there is no change in burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-09794 Filed 5-7-21; 8:45 am]
BILLING CODE 6560-50-P


