[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Notices]
[Pages 73764-73766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28067]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0693; FRL-9157-01-OCSPP]


EPA Administrator Determination Extends TRI Reporting 
Requirements to Certain Contract Sterilization Facilities; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
extension of the Toxics Release Inventory (TRI) reporting requirements 
to certain contract sterilization facilities under its discretionary 
authority through the Emergency Planning and Community Right-to-Know 
Act (EPCRA). Pursuant to this authority, EPA decided to extend the 
reporting requirements for ethylene oxide releases and other waste 
management activities to 29 contract sterilization facilities; and to 
extend the reporting requirements for ethylene glycol to 16 of those 
facilities. EPA is applying this discretionary authority in response to 
concerns over potential health effects of ethylene oxide exposure and 
in support of the public's right-to-know.

FOR FURTHER INFORMATION CONTACT: Stephanie Griffin, Data Gathering and 
Analysis Division, Office of Pollution Prevention and Toxics, (7410M), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-1463; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    The determination, signed by the Administrator on December 16, 2021 
(Ref. 1), is directed to the 29 specific facilities identified in Unit 
II.A. of this document. This determination may also be of interest to 
the general public and users of TRI data, including researchers, non-
profit organizations in the environmental and public health sectors, 
and state and local governments. Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. What is the Agency's authority for taking this action?

    EPA made this determination pursuant to EPCRA section 313(b)(2), 
[42 U.S.C. 11023], which provides EPA with the authority to extend the 
reporting requirements of EPCRA section 313 to any particular facility 
at the Administrator's discretion:

    The Administrator, on [their] own motion . . . , may apply the 
requirements of [EPCRA section 313] to the owners and operators of 
any particular facility that manufactures, processes, or otherwise 
uses a toxic chemical listed under [EPCRA section 313(c)] if the 
Administrator determines that such action is warranted on the basis 
of toxicity of the toxic chemical, proximity to other facilities 
that release the toxic chemical or to population centers, the 
history of releases of such chemical at such facility, or such other 
factors as the Administrator deems appropriate.

C. How can I get copies of this document and other related information?

    The docket for this determination, identified by docket 
identification (ID) number EPA-HQ-OPPT-2021-0693, is available at 
http://www.regulations.gov. Due to the public health concerns related 
to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed 
to visitors with limited exceptions. The staff continues to provide 
remote customer service via email, phone, and webform. For the latest 
status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

D. What action is the Agency taking?

    Pursuant to EPCRA section 313(b)(2), the EPA Administrator signed a 
determination on December 16, 2021 that extended TRI reporting 
requirements to 29 facilities for ethylene oxide and, in 16 cases, for 
ethylene glycol (Ref. 1). After considering facility-specific factors 
including chemical toxicity, proximity to population centers, the 
facility's history of chemical releases, and other factors the EPA 
Administrator deems appropriate (such as potential environmental 
justice concerns), the EPA believes the public would benefit from 
increased information disclosure related to the releases of ethylene 
oxide (and in some cases, ethylene glycol) at these facilities. This 
discretionary authority extends TRI reporting requirements to 
facilities identified by the Administrator if they manufacture, 
process, or otherwise use the TRI toxic chemical over the respective 
activity threshold over the course of a year, regardless of the 
facility's industry sector (i.e., North American Industry 
Classification System (NAICS) code) or number of full-time employee-
equivalents. Going forward, EPCRA section 313(a) will require these 
facilities to report to TRI if they meet TRI reporting thresholds for 
on-site activities involving ethylene oxide or ethylene glycol over the 
course of a year.

E. Why is the Agency taking this action?

    Ethylene oxide is a flammable, colorless gas used to sterilize 
equipment, such as medical equipment, among other manufacturing 
applications, including the manufacture of ethylene glycol. In December 
2016, EPA's Integrated Risk Information System (IRIS) Program updated 
its cancer assessment for ethylene oxide and characterized the chemical 
as

[[Page 73765]]

``carcinogenic to humans'' by the inhalation route of exposure (Ref. 
2).
    Congress established the TRI to further the public's right to know 
about chemical releases from certain facilities in their communities. 
However, not all facilities are currently subject to TRI reporting 
requirements (see 40 CFR part 372). EPA recognizes and shares the 
public's concerns about the harmful effects of ethylene oxide on human 
health and the environment, so the Agency exercised its authority under 
EPCRA section 313(b)(2) to increase the information available to the 
public on releases of ethylene oxide and ethylene glycol from certain 
sterilization facilities that were not currently subject to TRI 
reporting requirements.

F. What are the estimated incremental impacts of this action?

    This determination extends TRI reporting requirements to 29 
facilities for ethylene oxide, and to 16 of those facilities for 
ethylene glycol. While this action does not directly require facilities 
to report to TRI or use EPA's TRI reporting forms, these facilities may 
ultimately submit up to 45 TRI reporting forms pursuant to EPCRA 
section 313(a) and 40 CFR part 372, if chemical activity reporting 
thresholds are met for those chemicals over the course of a year. 45 
TRI reporting forms would result in estimated incremental impacts of up 
to $107,408 annually across all affected entities. There are no 
annualized operation or maintenance costs. All affected entities have 
annual cost impacts of less than 1%.

II. Background

A. Which facilities does this determination apply to?

    The Administrator's determination extends the TRI reporting 
requirements in EPCRA section 313 to the following facilities, for the 
indicated chemicals. The Agency has created a separate docket for each 
facility, which includes any correspondence between EPA and the 
facility on this matter:

    1. Andersen Sterilizers, 3154 Caroline Drive, Haw River, NC 
27258; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-
0694.
    2. Boston Scientific Corporation, 8 Industrial Drive, Coventry, 
RI 02816; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-
1); Docket ID: EPA-HQ-OPPT-2021-0696.
    3. ETO Sterilization-Plant #2, 2500 Brunswick Avenue, Linden, NJ 
07036; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-1); 
Docket ID: EPA-HQ-OPPT-2021-0697.
    4. Fuchs North America, 3800 Hampstead Mexico Road, Hampstead, 
MD 21074; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-
2021-0698.
    5. International Sterilization Laboratory, 217 Sampey Road, 
Groveland, FL 34736; Ethylene oxide (CASRN: 75-21-8); Docket ID: 
EPA-HQ-OPPT-2021-0699.
    6. Isomedix Operations, Inc., 1435 Isomedix Place, El Paso, TX 
79936; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-
0700.
    7. Isomedix Operations, Inc., 1175 Isuzu Parkway, Grand Prairie, 
TX 75050; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-
1); Docket ID: EPA-HQ-OPPT-2021-0701.
    8. Isomedix Operations, Inc., 435 Whitney Street, Northborough, 
MA 01532; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-
2021-0702.
    9. LEMCO Ardmore, 3204 Hale Road, Ardmore, OK 73401; Ethylene 
oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-0703.
    10. Long Island Sterilization, 175 Wireless Boulevard, 
Hauppauge, NY 11788; Ethylene oxide (CASRN: 75-21-8); Docket ID: 
EPA-HQ-OPPT-2021-0704.
    11. Medline Industries, 1160 South Northpoint Boulevard, 
Waukegan, IL 60085; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol 
(107-21-1); Docket ID: EPA-HQ-OPPT-2021-0705.
    12. Parter Medical Products Inc, 17115 Kingsview Avenue, Carson, 
CA 90746; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-
2021-0707.
    13. Professional Contract Sterilization, Inc., 40 Myles Standish 
Boulevard, Taunton, MA 02780; Ethylene oxide (CASRN: 75-21-8), 
Ethylene glycol (107-21-1); Docket ID: EPA-HQ-OPPT-2021-0708.
    14. Sterigenics-Salt Lake City Facility, 5725 West Harold Gatty 
Drive, Salt Lake City, UT 84116; Ethylene oxide (CASRN: 75-21-8), 
Ethylene glycol (107-21-1); Docket ID: EPA-HQ-OPPT-2021-0714.
    15. Sterigenics U.S. LLC, 2971 Olympic Industrial Court SE, 
Suite 116, Atlanta, GA 30339; Ethylene oxide (CASRN: 75-21-8), 
Ethylene glycol (107-21-1); Docket ID: EPA-HQ-OPPT-2021-0709.
    16. Sterigenics U.S. LLC, 1302 Avenue T, Grand Prairie, TX 
75050; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-1); 
Docket ID: EPA-HQ-OPPT-2021-0711.
    17. Sterigenics U.S. LLC, 84 Park Road, Queensbury, NY 12804; 
Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-1); Docket 
ID: EPA-HQ-OPPT-2021-0713.
    18. Sterigenics U.S., Inc., 4900 Gifford Avenue, Vernon, CA 
90058; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-1); 
Docket ID: EPA-HQ-OPPT-2021-0716.
    19. Sterigenics U.S., LLC, 18021 Withers Cove Park Drive, 
Charlotte, NC, 28278, Ethylene oxide (CASRN: 75-21-8), Ethylene 
glycol (107-21-1), EPA-HQ-OPPT-2021-0710.
    20. Sterigenics U.S., LLC, 687 Wanamaker Avenue, Ontario, CA 
91761; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol (107-21-1); 
Docket ID: EPA-HQ-OPPT-2021-0712.
    21. Sterigenics-Santa Teresa, NM, 2400 Airport Road, Santa 
Teresa, NM 88008; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol 
(107-21-1); Docket ID: EPA-HQ-OPPT-2021-0715.
    22. Sterilization Services of Tennessee, 2396 Florida Street, 
Memphis, TN 38109; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol 
(107-21-1); Docket ID: EPA-HQ-OPPT-2021-0717.
    23. Steris Inc., 380 90th Avenue Northwest, Coon Rapids, MN 
55433; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-
0718.
    24. Steris Isomedix Services Inc, 7685 Saint Andrews Avenue, San 
Diego, CA 92154; Ethylene oxide (CASRN: 75-21-8), Ethylene glycol 
(107-21-1); Docket ID: EPA-HQ-OPPT-2021-0720.
    25. Steris Isomedix Services Inc, 3459 S Clinton Avenue, South 
Plainfield, NJ 07080; Ethylene oxide (CASRN: 75-21-8), Ethylene 
glycol (107-21-1); Docket ID: EPA-HQ-OPPT-2021-0721.
    26. Steris, Inc., 43425 Business Park Drive, Temecula, CA 92590; 
Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-0719.
    27. Steris-Isomedix Services, 2072 Southport Road, Spartanburg, 
SC 29306; Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-
2021-0722.
    28. Steritec, Inc., 1705 Enterprise Street, Athens, TX 75751; 
Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-0723.
    29. Trinity Sterile, Inc., 201 Kiley Drive, Salisbury, MD 21801; 
Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-0724.

B. How did EPA select these facilities?

    In identifying these facilities, EPA considered a variety of data 
available on ethylene oxide usage and releases, including historical 
TRI data and data reported to other EPA programs. Information available 
to EPA suggests these contract sterilization facilities use the highest 
amounts of ethylene oxide in this sector.
    EPA believes that these facilities are likely to exceed the 10,000 
pounds per year ``otherwise used'' TRI reporting threshold for ethylene 
oxide. While EPA's discretionary authority to extend TRI reporting 
requirements to specific facilities is not limited to facilities that 
currently meet the TRI reporting thresholds, EPA determined that it is 
appropriate to consider the quantity of ethylene oxide or ethylene 
glycol potentially manufactured, processed, or otherwise used on-site 
when evaluating whether reporting requirements should be extended to 
certain facilities. In addition, EPA reviewed previous TRI reporting 
forms to identify which facilities may also be likely to exceed the 
chemical activity reporting thresholds for ethylene glycol.
    EPA also considered other factors enumerated in EPCRA section 
313(b)(2) in the identifying these facilities, including the 
facilities' proximity to a population center (e.g., the density of the 
population, including children,

[[Page 73766]]

living near the facilities) and other factors the Administrator deems 
are appropriate (e.g., proximity of the facilities to nearby schools 
and communities, especially those with potential environmental justice 
concerns).

C. Did EPA conduct any outreach to facilities prior to this action?

    In October 2021, EPA sent letters to 31 facilities providing notice 
that EPA was considering exercising this discretionary authority. These 
letters also provided the facilities with the opportunity to respond or 
provide any additional information before EPA made its determination.
    EPA received communications from 19 facilities. Some included 
inquiries on the scope of the discretionary authority under EPCRA 
section 313(b)(2) and TRI reporting; others acknowledged that the 
facility would be prepared to submit any TRI reporting forms to EPA 
should they be required by EPCRA section 313(a) and 40 CFR part 372. 
All communications with facilities under this authority have been 
uploaded to facility-specific dockets, which are listed in Unit II.A.
    Additionally, one facility indicated that they no longer conduct 
any ethylene oxide sterilization on-site, they have sold their previous 
sterilization establishment, and all sterilization activity has been 
contracted out-of-state. A separate facility also provided information 
to EPA regarding the size of and technology used in their operations to 
support their claim of using very low levels of ethylene oxide such 
that they would be unlikely to ever meet TRI reporting thresholds. 
After reviewing this information, EPA decided not to extend reporting 
requirements to these two facilities. Those facilities and their 
dockets are listed below:

    1. Andersen Scientific, 1001 Aviation Parkway, Suite 600, 
Morrisville, NC 27560; Ethylene oxide (CASRN: 75-21-8); Docket ID: 
EPA-HQ-OPPT-2021-0695.
    2. NovoSci Corporation, 2021 Airport Road, Conroe, TX 77301; 
Ethylene oxide (CASRN: 75-21-8); Docket ID: EPA-HQ-OPPT-2021-0706.

D. What reporting may be required under EPCRA section 313(a) and 40 CFR 
part 372 following the Administrator's determination under EPCRA 
section 313(b)(2)?

    EPCRA requires reporting to provide information on releases and 
other waste management of TRI chemicals. This information is used by 
the public and assists EPA and other regulatory agencies in determining 
whether future regulations are needed. Among other data elements, 
facilities must report (1) the quantities of routine and accidental 
releases; (2) releases resulting from catastrophic or other one-time 
events of TRI chemicals; (3) the maximum amount (in ranges) of the TRI 
chemical on-site during the calendar year; and (4) the amount contained 
in wastes managed on-site or transferred off-site. Facilities reporting 
to TRI must submit either a Form R for each chemical, or a Form A 
Certification Statement for applicable chemicals. Form R is the 
standard TRI reporting form. Form A Certification Statement is a 
simplified certification form available to facilities to report on 
chemicals for which the facility neither (1) manufactures, processes, 
or otherwise uses above one million pounds; nor (2) exceeds 500 pounds 
for total quantities released or otherwise managed as waste on-site and 
quantities transferred off-site for waste management. More information 
on the data reported on TRI reporting forms, including instructions for 
reporting facilities, can be found in the current TRI Reporting Forms 
and Instructions (Ref. 3).
    Under EPCRA section 313(a) and 40 CFR part 372, the facilities 
listed in this notice may be required to submit TRI reporting forms for 
ethylene oxide (and ethylene glycol, where noted) if they manufacture, 
process, or otherwise use the chemical above the respective activity 
thresholds in 40 CFR 372.25. Reporting on ethylene oxide and ethylene 
glycol would begin with Reporting Year 2022, and Reporting Year 2022 
forms from these facilities will be due to EPA by July 1, 2023. This 
reporting requirement will continue to apply for each subsequent 
reporting year where the facility's chemical activities meet or exceed 
the respective activity threshold.

III. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

    1. U.S. EPA. Determination of the Administrator of the 
Environmental Protection Agency Under the Emergency Planning and 
Community Right-to-Know Act Section 313(b)(2) to Apply the 
Requirements of EPCRA Section 313 to Certain Contract Sterilization 
Facilities. December 16, 2021.
    2. U.S. EPA. Evaluation of the Inhalation Carcinogenicity of 
Ethylene Oxide (EPA/635/R-16/350Fa). December 2016. Available at 
https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1025tr.pdf.
    3. U.S. EPA. Toxic Chemical Release Inventory Reporting Forms 
and Instructions. Available at https://www.epa.gov/tri/rfi.

    Authority: 42 U.S.C. 11023.

    Dated: December 21, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-28067 Filed 12-27-21; 8:45 am]
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