Attachment- EPA Determination

S7.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

+?4

PRO

December 2021
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
Recipients of this Determination:

1.

Andersen Sterilizers, 3154 Caroline Drive, Haw River, NC 27258

2.

Boston Scientific Corporation, 8 Industrial Drive, Coventry, RI 02816

3.

ETO Sterilization -Plant #2, 2500 Brunswick Avenue, Linden, NJ 07036

4.

Fuchs North America, 3800 Hampstead Mexico Road, Hampstead, MD 21074

5.

International Sterilization Laboratory, 217 Sampey Road, Groveland, FL 34736

6.

Isomedix Operations, Inc., 1435 Isomedix Place, El Paso, TX 79936

7.

Isomedix Operations, Inc., 1175 Isuzu Parkway, Grand Prairie, TX 75050

8.

Isomedix Operations, Inc., 435 Whitney Street, Northborough, MA 01532

9.

LEMCO Ardmore, 3204 Hale Road, Ardmore, OK 73401

10.

Long Island Sterilization, 175 Wireless Boulevard, Hauppauge, NY 11788

11.

Medline Industries, 1160 South Northpoint Boulevard, Waukegan, IL 60085

12. Parter Medical Products mc, 17115 Kingsview Avenue, Carson, CA 90746
13. Professional Contract Sterilization, Inc., 40 Myles Standish Boulevard, Taunton, MA 02780
14.

Sterigenics U.S. LLC, 2971 Olympic Industrial Court SE, Suite 116, Atlanta, GA 30339

15.

Sterigenics US, LLC, 18021 Withers Cove Park Drive, Charlotte, NC 28278

16.

Sterigenics U.S. LLC, 1302 Avenue T, Grand Prairie, TX 75050

17.

Sterigenics US, LLC, 687 Wanamaker Avenue, Ontario, CA 91761

18.

Sterigenics US LLC, 84 Park Road, Queensbury, NY 12804

19.

Sterigenics -Salt Lake City Facility, 5725 West Harold Gaily Drive, Salt Lake City, UT 84116

20.

Sterigenics -Santa Teresa, NM, 2400 Airport Road, Santa Teresa, NM 88008

Internet: https://www.epa.gov/toxics-release -inventory -tri -program

21.

Sterigenics US, Inc., 4900 Gifford Avenue, Vernon, CA 90058

22. Sterilization Services of Tennessee, 2396 Florida Street, Memphis, TN 38109
23. STERIS Inc., 380 90th Avenue Northwest, Coon Rapids, MN 55433
24.

Steris, Inc., 43425 Business Park Drive, Temecula, CA 92590

25.

Steris Isomedix Services mc, 7685 Saint Andrews Avenue, San Diego, CA 92154

26.

Steris Isomedix Services mc, 3459 5 Clinton Avenue, South Plainfield, NJ 07080

27.

STERIS-Isomedix Services, 2072 Southport Road, Spartanburg, SC 29306

28. Steritec, Inc., 1705 Enterprise Street, Athens, TX 75751
29.

Trinity Sterile, Inc., 201 Kiley Drive, Salisbury, MD 21801

Pursuant to the Emergency Planning and Community Right -to -Know Act (EPCRA) Section 313(b)(2),
the U.S. Environmental Protection Agency (EPA) is extending Toxics Release Inventory (TRI) reporting
requirements to the facilities identified herein for ethylene oxide and, where specified, ethylene glycol.
The requirement that the EPA is applying to these facilities requires the submission of certain chemical
data if the facility manufactures, processes, or otherwise uses the chemical in amounts exceeding the
respective threshold. Additional materials and information supporting this determination are available in
the docket: EPA -HQ -OPPT -202 1-0693.

This determination is organized as follows:
Recipients of this Determination ............................................................................................................ 1

2
I. BACKGROUND AND AUTHORITY
REQUIREMENTS
TO
PARTICULAR
APPLY
TRI
REPORTING
TO
DETERMINATION
II.
4
FACILITIES UNDER 31 3(b)(2)
III. CONSEQUENCES OF THIS DECISION: REPORTING AND RECOIWKEEPING UNDER
7
EPCRA SECTION 3 13(a)
9
IV. FOR FURTHER INFORMATION CONTACT
9
V. SIGNATURE
APPENDIX A. FACTORS FOR EXTENDING REPORTING REQUIREMENTS TO THE
Appendix A: 1
IDENTIFIED FACILITIES
Appendix B:
APPENDIX B. REFERENCES
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I. BACKGROUND AND AUTHORITY
A. Toxics Release Inventory Reporting Requirement

EPCRA Section 313 requires owners and operators of covered facilities to submit certain data to the
EPA TRI on the releases of listed toxic chemicals annually. See EPCRA § 313, 42 U.S.C. § 11023; 40
CFR 372. For a general overview of TRI, please visit the EPA website (https://www.epa.gov/tri). In
2

addition, the Pollution Prevention Act (PPA) of 1990 requires owners and operators of TRI -covered
facilities to report on additional waste management (i.e., recycling, treatment, and energy recovery) and
source reduction activities for these toxic chemicals. See PPA § 6607, 42 U.S.C. § 13106.
Specifically, EPCRA Section 3 13(a) requires any facility covered by a rule or determination under
EPCRA Section 313(b) to report to TRI data on chemicals that it manufactures, processes, or otherwise
uses in quantities exceeding the listed chemical's respective reporting threshold. See EPCRA § 3 13(a),
42 U.S.C. § 11023(a) ("[t]he owner or operator of afacility subject to the requirements ofthis section
shall complete a toxic chemical release form as published under [EPCRA Section 313(g)] for each toxic
chemical listed under [EPCRA Section 313(c)] that was manufactured, processed, or otherwise used in
quantities exceeding the toxic chemical threshold quantity established by [EPCRA Section 313(f)]
during the preceding calendar year at such facility."). Thus, the owners or operators of such facilities are
required to determine, each year, whether the facility meets the reporting thresholds for TRI chemicals.
The owner or operator of each facility must conduct a threshold analysis for such chemical(s) and
submit a TRI reporting form for the chemical(s) should the reporting threshold be exceeded for the given
chemical(s).
Pursuant to 40 CFR 372.5, if the owner and operator of a facility are different persons, only one of them
needs to report under 40 CFR 372.30, or provide a notice under 40 CFR 372.45, for each toxic chemical
in a mixture or trade name product distributed from the facility. However, if neither submits a report or
provides notice, the EPA will hold both persons liable under EPCRA Section 325(c), except as provided
in 40 CFR 372.3 8(e) and 3 72.45(g).
B. Anolication to Additional Facilities Under EPCRA Section 31 3(b(2

EPCRA Section 313(b)(2) provides the EPA with the authority to extend the reporting requirements of
EPCRA Section 313(a) to additional facilities per the Administrator's discretion:
may apply the requirements of [EPCRA
The Administrator, on [their] own motion
Section 313(a)] 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.
.

.

.

,

Using this authority, the EPA may subject any particular facility to TRI reporting requirements for listed
chemicals if the Administrator decides that such action is warranted based on the statutory factors
provided in EPCRA Section 313(b)(2). Following such a determination, the facility is then subject to the
TRI reporting requirements in EPCRA Section 313(a), regardless of its industry sector or number of
full-time employee equivalents. See EPCRA § 313(a), (b)(1)-(2), 42 U.S.C. § 11023(a), (b)(1)-(2); 40
CFR 372.
C. Entities Covered by this Determination

The EPA Administrator is issuing this determination to apply TRI requirements to the facilities listed in
Table 1 for ethylene oxide (CASRN: 75-21-8) and, where noted, ethylene glycol (CASRN: 107-21-1).
The EPA rationale supporting this determination for each facility is outlined in Section II and Appendix
3

A, below.

This determination applies to the entire facility for each facility identified in Table 1, including all
establishments. A Tifi reporting facility can be comprised of multiple establishments-distinct and
separate economic units-located on a single site (or contiguous or adjacent sites) if those
establishments are owned or operated by the same person (e.g., individual, trust, firm, joint stock
company, corporation).
For the purposes of this determination, please refer to the definitions in EPCRA Section 329 and 40 CFR
372.3. Specifically, a few important definitions include:

Establishment means an economic unit, generally at a single physical location, where business is
conducted or where services or industrial operations are performed.
Facility means all buildings, equipment, structures, and other stationary items which are located
on a single site or on contiguous or adjacent sites and which are owned or operated by the same
person (or by any person which controls, is controlled by, or under common control with such
person). A facility may contain more than one establishment.

Person means any individual, trust, firm, joint stock company, corporation (including a
government corporation), partnership, association, State, municipality, commission, political
subdivision of a State, or interstate body.
A TRI reporting facility can be comprised of multiple establishments-distinct and separate economic
units-located on a single site (or contiguous or adjacent sites) if those establishments are owned or
operated by the same person (e.g., individual, trust, firm, joint stock company, corporation). This
determination applies to the entire facility for each facility identified in Table 1, including all

establishments.
II. DETERMINATION TO APPLY Tifi REPORTING REQUIREMENTS TO PARTICULAR
FACILITIES UNDER 313(b)(2)

EPCRA Section 313(b)(2) provides that the EPA may subject a facility to the TRI reporting
requirements of EPCRA Section 313(a) "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."
The purpose of TRI is to provide governments and the public, including residents of communities
surrounding covered facilities, with information on the releases and other waste management activities
of listed toxic chemicals. After considering the factors for each facility as presented in Appendix A
including the toxicity of the chemicals, the facility's proximity to population centers (including the
number of schools and children under the age of five), the facility's history of releases (as determined
through past TRI reporting), and other factors the EPA Administrator deems appropriate (including
concerns for facility workers and potential environmental justice concerns), and the EPA estimates for
-

potential ethylene oxide quantities manufactured, processed, or otherwise used on -site 1 -the EPA has
determined that applying TRI reporting requirements to the facilities in Table 1 for ethylene oxide (and
ethylene glycol, when noted) is warranted under EPCRA Section 313(b)(2). The EPA believes the
public would benefit from increased information disclosure related to releases of these chemicals at
these facilities. Therefore, pursuant to the EPA Administrator's authority under EPCRA Section 313(b),
the EPA hereby determines that it is appropriate to apply the requirements of EPCRA 313 to the
facilities in Table 1 to the TRI reporting requirements for ethylene oxide (and ethylene glycol, when
noted).

______

__________

¯

2500 Brunswick
Sterilization -Plant Avenue
#2

Linden

ETO

_____________

________

__________________

__________________________

_______________________

_____________

___________________

TABLE 1. Facilities to whom this determination applies.
Facility Name
City
Street Address
State ZIP Code
Andersen
3154 Caroline Drive Haw River
NC
27258
Sterilizers
Boston Scientific 8 Industrial Drive
Coventry
RI
02816
Corporation

NJ

07036

¯

3800 Hampstead

MD

21074

¯

34736

¯

______

_____________

Mexico Road
217 Sampey Road

Hampstead

Groveland

_________

Fuchs North
America
International
Sterilization

_____________

________

__________________

__________________________

_______________________

¯

FL

Chemical(s)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide

(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)

____________________

__________

______

_____________

___________________

Laboratory

Isomedix

1435 Isomedix Place El Paso

TX

79936

¯

75050

¯

01532

¯

73401

¯

_________

_____

____________

__________________

Operations, Inc.

Isomedix
Operations, Inc.

1175 Isuzu Parkway

Grand Prairie

_____________

________

__________________

__________________________

_______________________

TX

Isomedix

Northborough MA

LEMCO

3204 Hale Road

Ardmore

__________

______

_____________

___________________

Operations, Inc.

435 Whitney Street

OK
_________

_____

____________

_________________

Ardmore

Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)

EPA does not believe that EPCRA Section 3 I 3(b)(2) requires that a facility culTently meet the TRI reporting thresholds for
this determination to be warranted. However, EPA does believe that considering the quantity of ethylene oxide or ethylene
glycol potentially manufactured, processed, or otherwise used on -site is appropriate in determining whether this action is
warranted.

5

11788

¯

60085

¯

_________

_____

Waukegan

IL

¯

________
_____________________

________________________

_________________

____________

Sterilization
Medline
Industries

NY

Hauppauge
____________

175 Wireless
Boulevard
1160 South
Northpoint
Boulevard

Long Island

Avenue

Professional

40 Myles Standish
Boulevard

Contract
Sterilization, Inc.

90746

¯

02780

¯

_________

Products Inc

CA

Carson
_____

17115 Kingsview
____________

Parter Medical

MA

Taunton

________
_______________________

__________________________

_________________

_____________

¯

2971 Olympic
Industrial Court SE,
Suite 116

GA

¯

28278

¯

_____________

30339

_______________________

__________________________

________

Atlanta

_________________

Sterigenics U.S.
LLC

Charlotte

18021 Withers Cove
Park Drive

Sterigenics US,
LLC

NC

_____________
_______________________

__________________________

_________________

________

¯

Sterigenics U.S.
LLC

Grand Prairie

1302 Avenue T

75050

TX

¯

_____________
_______________________

__________________________

_________________

________

¯

Ontario

687 Wanamaker

Sterigenics US,
LLC

91761

CA

¯

Avenue

______________
_______________________

__________________________

_________________

_______

¯

12804

NY

Queensbury

84 Park Road

Sterigenics US
LLC

¯

______________
_______________________

__________________________

_________________

_______

¯

Salt Lake
City

Sterigenics Salt 5725 West Harold
Lake City Facility Gatty Drive
-

84116

UT

¯

_______________________

__________________________

__________________

______________

_______

¯

Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-2 11)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)

2400 Airport Road

Sterigenics -Santa
Teresa, NM

Santa Teresa

88008

NM

Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
'Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)
Ethylene glycol
(CASRN: 107-211)
Ethylene oxide
(CASRN: 75-21-8)

¯

4900 Gifford
Avenue

Sterigenics US,
Inc.

_____________

_______

__________________

__________________________

_______________________

¯

90058

CA

Vernon

¯

2396 Florida Street

Memphis

____________

38109

TN

Steris Isomedix
Services Inc

_____________

_______

_________

____________

92590

San Diego

_________

_____

_______________

Drive
7685 Saint Andrews

CA

____________

Steris, Inc.

55433

MN
_____

380 90th Avenue
Coon Rapids
Northwest
43425 Business Park Temecula

_______________

STERIS Inc.

__________________

__________________________

_______________________

Sterilization
Services of
Tennessee

_______

_________________

________________________

_____________________

¯

CA

92154

Avenue

¯

¯

¯

¯

_____________

________

__________________

__________________________

_______________________

¯

Steris Isomedix
Services Inc

3459 5 Clinton
Avenue

South
Plainfield

NJ

07080

¯

_____________

________

__________________

__________________________

_______________________

¯

SC

29306

Athens

TX

75751

¯

21801

¯

_________

______

______________

1705 Enterprise
Street
201 Kiley Drive

Trinity Sterile,

Spartanburg

_____________

_____________________

2072 Southport
Road

________________

STERISIsomedix
Services
Steritec, Inc.

Salisbury

MD
_________

_____

____________

_________________

Inc.

Ethylene oxide
(CASRN: 75-21-8)
Ethylene oxide
(CASRN: 75-21-8)

Nothing in this determination should be read as limiting the scope of the "facility" subject to this
determination to a single establishment listed in Table 1, should additional buildings, equipment, or sites
on adjacent and/or contiguous land with a common operator or operator also fall within the scope of the
facility. See EPCRA § 329(4), 42 U.S.C. § 11049(4); 40 CFR 372.3.
III. CONSEQUENCES OF THIS DECISION: REPORTING AND RECORDKEEPING UNDER

EPCRA SECTION 3 13(a)

The EPA decision to apply the requirements of EPCRA to these facilities makes the owner and operator
7

of each facility specified in Table 1 subject to TRI reporting requirements under EPCRA Section 313.
See EPCRA § 313, 42 U.S.C. § 110023; 40 CFR 372. If that facility subsequently manufactures,
processes, or otherwise uses ethylene oxide (or ethylene glycol, where noted) above the activity
thresholds, EPCRA Section 313(a) would require the facility's current owner or operator to report for
that chemical pursuant to the statute and the EPA implementing regulations. Nothing in this
determination alters the requirements of ECPRA Sections 313(a) and 313(g) or requires an owner or
operator to report if the facility does not meet the chemical activity threshold requirements in ECPRA
Section 313(f) or 40 CFR 372, subpart. B. This determination under EPCRA Section 31 3(b)(2) applies
the TRI reporting requirements in EPCRA Section 313(a) to the facilities listed in Table 1, without
regard to their industry sector (i.e., North American Industry Classification System (NAICS) code) or
the number of full-time employee -equivalents.
A. Conseauences of Failing to Comnlv with EPCRA Section 313(a

Failure to comply with any reporting requirements of EPCRA Section 313 is a violation of EPCRA and
could subject you to civil and administrative penalties under EPCRA Section 325. EPCRA § 325, 42
U.S.C. § 11045; 40 C.F.R. pt. 19 (implementing civil penalties adjustments). Each day a facility fails to
meet any of the requirements constitutes a separate violation of the specific requirement. Submission of
false information to the EPA or knowing failure to file an EPCRA Section 313 report may also be
subject to criminal penalties under 18 U.S.C. § 1001.
B. Panerwork Reduction Act Notice

The current collection of information under the EPA TRI regulations is approved by the Office of
Management and Budget (0MB) under the Paperwork Reduction Act, 44 U.S.C. § 3501 et seq. See
0MB Control No. 2070-02 12. The EPA is currently revising its information collection request (ICR) for
the TRI regulations to account for potential reporting by additional facilities under EPCRA Section
313(b)(2), specifically ethylene oxide -using facilities (some of which also include ethylene gylcol,
where noted). These revisions are currently pending approval with 0MB. The normal clearance
procedures under the PRA require agencies to provide a 60 -day public comment opportunity before
submitting an ICR to 0MB for review and approval. The 0MB review and approval process involves
another mandated 30 days for additional public conmient. The 60 -day public comment period for
collecting information under this discretionary authority began on November 15, 2021. See Proposed
Revisions to an Existing Collection: Toxic Chemical Release Reporting, 86 Fed. Reg. 63025.
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 0MB control number. The annual public burden related
to the Form R is estimated to be 35.7 hours per response for a facility filing a report on one chemical.
The annual public burden related to the Form A is estimated to average 21.96 hours per response for a
facility filing a report on one chemical. Under the PRA, burden is defined at 5 CFR 1320.3(b). Send
comments on the Agency's need for this information, the accuracy of the provided burden estimates and
any suggested methods for minimizing respondent burden to the Regulatory Support Division Director,
U.S. Environmental Protection Agency (282 IT), 1200 Pennsylvania Ave., NW, Washington, D.C.
20460. Include the 0MB control number in any correspondence. Do not send the completed TRI form to
this address.
While the EPA cannot enforce recordkeeping from entities subject to this determination pursuant to its

TRI regulations until 0MB has approved the ICR, the EPA reminds covered entities that persons subject
to the statutory reporting and recordkeeping requirements in EPCRA Sections 313(a) and 313(g) are
nevertheless subject to enforcement under EPCRA Section 325(c)(1) should they fail to comply with
those requirements. See 5 CFR 1320.6(e) (observing that penalties protections under 5 CFR 1320.6(a)
do not "preclude the imposition of a penalty on a person for failing to comply with a collection of
information that is imposed on the person by statute"). The EPA anticipates that 0MB will approve the
ICR in Spring 2022.
IV. FOR FURTHER INFORMATION CONTACT

For technical information contact: Stephanie Griffin, Data Collection Branch, Data Gathering and
Analysis Division (7410M), Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Permsylvania Ave., NW, Washington, DC 20460-0001; telephone number: (202) 5641463; email address: griflinstephanie@epa.gov.
For general TRI support and contacts, see the TRI Program Contacts webpage:
https://www.epa.gov/toxics -release -inventory -tri -program/forms/tri -prograrn -contacts.
V. SIGNATURE

Under the authority of EPCRA Section 313(b)(2) the United States Environmental Protection Agency
hereby issues this Determination to take effect on the date of my signature
Dated:

DEC 162021

Michael S. Regan,

Administrator.

Enclosures:
Appendix A: Factors for Extending Reporting Requirements to the Identified Facilities
Appendix B: References