EPA’s Discretionary Authority to Extend TRI Reporting Requirements to Certain EtO Facilities
Under the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313(b)(2), the EPA Administrator has the discretionary authority to extend Toxics Release Inventory (TRI) reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of chemical releases at the facility, or other factors the Administrator deems appropriate.
What action is EPA taking?
In October 2021, EPA notified 31 facilities that it was considering exercising this authority to extend TRI reporting requirements to those facilities for ethylene oxide (EtO). Some of the facilities were also being considered for ethylene glycol.
In December 2021, EPA issued a decision extending TRI reporting requirements to 29 out of the 31 facilities. Read the Federal Register notice announcing this decision.
Why did EPA decide to exercise this authority for these 29 facilities?
EPA shares the public’s concerns about EtO’s harmful effects on human health and the environment. EPA is also concerned about potential EtO exposure to workers in facilities that use EtO and in the communities—including historically underserved communities—located adjacent to these facilities. Additionally, because their bodies are still growing, children are expected to be more susceptible to the toxic effects of EtO.
In making its determination for these 29 facilities, EPA considered a variety of EtO data. EPA believes these 29 facilities use the highest amounts of EtO in the contract sterilization sector and are among those facilities that do not currently report to TRI. EPA also believes the public would benefit from increased information disclosure related to releases of these chemicals at these facilities.
EPA considered the toxicity of EtO and ethylene glycol, which is produced using EtO. Ethylene oxide and ethylene glycol have been on the TRI toxic chemical list since its creation in 1987.
EPA also considered these facilities’ proximity to a population center (e.g., the number of people, including children under the age of five, living near the facilities), their history of releases of ethylene oxide and ethylene glycol (e.g., past receipt of TRI reporting forms on ethylene oxide and ethylene glycol from these facilities), and other factors the Administrator deemed appropriate (e.g., proximity of the facilities to nearby schools and communities, especially those communities with potential environmental justice concerns, health concerns for facility workers, and whether facilities handled a significant volume of EtO or ethylene glycol).
How will EPA proceed?
EPA published a Federal Register notice announcing the Administrator’s determination and has notified these facilities of its decision. The 29 facilities are now subject to TRI reporting requirements for EtO (and, in some cases, ethylene glycol). Like other facilities subject to EPCRA’s statutory reporting and recordkeeping requirements, these facilities should begin tracking their chemical activities and releases and other waste management quantities in January 2022 and, if appropriate, submit TRI data beginning in 2023.
Which facilities were selected for addition to the TRI reporting requirements?
EPA has extended the TRI reporting requirements to 29 out of the 31 facilities initially considered. These 29 facilities are listed below.
Correspondence with each of the selected facilities will be available soon in separate dockets at www.regulations.gov. A list of the facilities included in this determination is below.
Parter Medical Products Inc, Carson, CA - Determination Letter (pdf)
Sterigenics US, Inc., Vernon, CA - Determination Letter (pdf)
Sterigenics US, LLC, Ontario, CA - Determination Letter (pdf)
Steris Services Inc, San Diego, CA - Determination Letter (pdf)
Steris, Inc., Temecula, CA - Determination Letter (pdf)
International Sterilization Laboratory, Groveland, FL - Determination Letter (pdf)
Sterigenics U.S. LLC, Atlanta, GA - Determination Letter (pdf)
Medline Industries, Waukegan, IL - Determination Letter (pdf)
Isomedix Operation, Inc., Northborough, MA - Determination Letter (pdf)
Professional Contract Sterilization, Inc., Taunton, MA - Determination Letter (pdf)
Fuchs North America, Hampstead, MD - Determination Letter (pdf)
Trinity Sterile, Inc., Salisbury, MD - Determination Letter (pdf)
STERIS Inc., Coon Rapids, MN - Determination Letter (pdf)
Sterigenics US, LLC, Charlotte, NC - Determination Letter (pdf)
Andersen Products, Inc., Haw River, NC - Determination Letter (pdf)
ETO Sterilization-Plant #2, Linden, NJ - Determination Letter (pdf)
Steris Isomedix Services Inc, South Plainfield, NJ - Determination Letter (pdf)
Sterigenics-Santa Teresa, NM, Santa Teresa, NM - Determination Letter (pdf)
Long Island Sterilization, Hauppauge, NY - Determination Letter (pdf)
Sterigenics US LLC, Queensbury, NY - Determination Letter (pdf)
LEMCO Ardmore, Ardmore, OK - Determination Letter (pdf)
Boston Scientific Corporation, Coventry, RI - Determination Letter (pdf)
STERIS-Isomedix Services, Spartanburg, SC - Determination Letter (pdf)
Sterilization Services of Tennessee, Memphis, TN - Determination Letter (pdf)
Steritec, Inc., Athens, TX - Determination Letter (pdf)
Isomedix Operations, Inc., El Paso, TX - Determination Letter (pdf)
Isomedix Operations, Inc., Grand Prairie, TX - Determination Letter (pdf)
Sterigenics U.S. LLC, Grand Prairie, TX - Determination Letter (pdf)
Sterigenics -Salt Lake City Facility, Salt Lake City, UT - Determination Letter (pdf)
Why did EPA choose not to exercise this authority for the remaining two facilities?
EPA elected not to exercise this authority to extend TRI reporting requirements to two facilities.
One facility—NovoSci Corporation (Conroe, Texas)—sold the establishment previously used for sterilization and informed EPA that no sterilization work is currently done at the facility. The other facility—Andersen Scientific (Morrisville, North Carolina)—informed EPA that their facility uses EtO in low quantities far below the amount that would trigger TRI reporting (the facility uses 90-100 lbs/year compared to the TRI reporting threshold of 10,000 lbs/year) due to their sterilization technology, scale of operations, and niche client base.
Based on these facts, EPA decided that extending TRI reporting requirements to these facilities was not warranted at this time.
Andersen Scientific, Morrisville, NC - Determination Letter (pdf)
Novosci Corporation, Conroe, TX - Determination Letter (pdf)