International Sterilization Laboratory

Groveland, FL

Comment Period Now Open for
Proposed Ethylene Oxide Rules

May 2023 Fact Sheet

Introduction

The U.S. Environmental Protection Agency is reaching out
to residents surrounding commercial sterilizers that
release high levels of the chemical - ethylene oxide (EtO)
into the air, including International Sterilization
Laboratory (ISL) located at 217 Sampey Road in
Groveland.

EtO is a colorless, odorless gas that is primarily used for
sterilization purposes. Inhalation of EtO at elevated levels
over a lifetime can increase a person's risk of getting
cancer. However, single-day exposures to the
concentrations found in residential communities are not
an immediate threat to an individual's health.

The EPA is sharing this information because communities
have a right to know about emissions that could affect
their health and well-being. The EPA will host a virtual community meeting on Thursday, June 15th to provide
residents an opportunity to learn more about EtO and how to submit comments to the proposed rule and
decision. Please follow the instructions in the blue box above to register for the meeting.

The EPA proposed new rules to limit EtO emissions from commercial sterilizers and is seeking input from the
public on the rules. In the interim, the Agency is working with ISL and other commercial sterilizers across the
country to find ways they can voluntarily implement early emission controls to reduce risk. The comment
period for the proposed rule closes on June 27, 2023. During that time, any person can provide comments
to the Agency about any aspect of the proposed rules. To learn more about the proposed rules and how to
comment, please visit www.epa.gov/eto.

The EPA's Proposed Rules

In April 2023, EPA issued proposals that are expected to reduce risks in communities and for workers. The EPA
has proposed new set of rules and decision to limit EtO emissions from commercial sterilizers and is seeking
input from the public:

1. Reducing EtO Emissions from Commercial Sterilizers: The EPA proposed to strengthen

emission standards for the 86 commercial sterilizers that are currently operating across the country as
well as for new sterilizers. These requirements, if finalized, will reduce the amount of EtO emitted
from commercial sterilizers by 80 percent and will reduce risk in nearby communities to levels below
the CAA benchmark for elevated risk. The comment period for the commercial sterilizer proposed rule

I

xvEPA



Virtual Public Meeting

Thursday, June 15, 2023

Community Meeting: 7:00 - 9:00 p.m.
Call-in No: (646) 828-7666
Webinar ID: 160 386 6856

Register for the virtual meeting here:

-------
closes on June 27, 2023. During that time, you can provide comments to the Agency about any aspect
of the proposed rule. To learn more about the proposed rule and how to comment, please visit
www.e pa .gov/eto.

2. Reducing Risk to Workers in the Sterilization Industry: The EPA proposed a broad set of new

protections under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that will reduce risk
for all workers who use EtO to sterilize things and for others who work, live, or go to school near
sterilization facilities. The comment period for the FIFRA proposed decision closes on June 27, 2023.
During that time, you can provide comments to the Agency about any aspect of the proposed
protections under FIFRA. To learn more about the proposed decision and how to comment, please
visit www.epa.gov/eto.

Please visit www.epa.gov/eto for additional information, including a link to view EPA's August 10th National
Public Webinar, location-specific maps, information about individual commercial sterilizers, and health risks
for residents and workers.

Background

The EPA has regulated EtO emissions for 30 years, however in 2016, new scientific information revealed that EtO
is more toxic than previously understood. This prompted the EPA to conduct nationwide analyses and intensive
data collection, which has revealed that certain communities near commercial sterilizers could have elevated
cancer risks due to lifetime exposures to EtO.

The EPA has determined that portions of Groveland neighborhoods in the vicinity of ISL may have an estimated
lifetime cancer risk at or above 100 in a million. A lifetime cancer risk of 100 in a million means that, if 1 million
people were exposed to this level of EtO in the air 24 hours a day for 70 years, 100 people would be expected to
develop cancer from that exposure. The risk gradually increases as you get closer to the facility, reaching an
estimated maximum of 200 in a million in areas closest to ISL.



Contact Information:

If you or someone you know would like to be added to EPA's distribution list to receive future
updates, please contact Region4EtO@epa.gov or 1-800-241-1754.

V 	 /

2

-------