Please see the message below from the USEPA. According to the EPA, ethylene 
oxide is no longer being used for pest control in museums, libraries, and for 
other archival materials. But in case you have been using it or plan to, note 
that EPA has acted to ban such uses due to health concerns and the availability 
of alternative treatments.

--Dan

Dan Wixted
he/him/his
Extension Support Specialist III

New York State Integrated Pest Management Program
Pesticide Safety Education
135 CALS Surge Facility
525 Tower Road
Ithaca, NY 14853
psep.cce.cornell.edu<http://psep.cce.cornell.edu/>
dj...@cornell.edu<mailto:dj...@cornell.edu>
607-255-7525

From: Pendley, Zachary <pendley.zach...@epa.gov>
Sent: Tuesday, January 14, 2025 4:25 PM
Subject: EPA Finalizes Protections for Workers and Communities from 
Cancer-Causing Ethylene Oxide Pollution


[EPA]<https://links-1.govdelivery.com/CL0/https:%2F%2Fwww.epa.gov%2F/1/01000194668cca4b-bd1afc68-90d0-4631-9933-35c1ac47d9e7-000000/XtmIVvIcowpTRe-Do2K4uc3qEYNPYIdx9BeBZjMPQ2s=388>
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EPA Finalizes Protections for Workers and Communities from Cancer-Causing 
Ethylene Oxide Pollution
WASHINGTON - Today, Jan. 14, the U.S. Environmental Protection Agency released 
the Interim Decision for Ethylene Oxide (EtO) - a pesticide used on 50 percent 
of all sterilized medical devices in the United States and on approximately 30 
percent of dried herbs and spices. EtO is known to cause cancer, including 
lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma and myeloma in 
people.  Workers who use EtO and people who work, live, or go to school or 
daycare near facilities that use EtO may breathe in emissions at levels that 
can increase cancer risk. The greatest risk is for people who work for their 
entire careers at facilities directly handling EtO with insufficient worker 
protections in place.
The Interim Decision includes mitigation measures that, in addition to the 
measures included in the 2024 EtO National Emissions Standards for Hazardous 
Air 
Pollutants<https://links-1.govdelivery.com/CL0/https:%2F%2Fwww.epa.gov%2Fnewsreleases%2Fepa-announces-final-rule-slash-toxic-emissions-ethylene-oxide-and-reduce-cancer-risk/1/01000194668cca4b-bd1afc68-90d0-4631-9933-35c1ac47d9e7-000000/bGFeawd0Spxx2XziMoDZ9a_BazCUEhJevZs5CB3u8Wc=388>
 (NESHAP), will reduce exposure to workers and nearby communities. Together, 
these two EPA actions provide a comprehensive approach to addressing EtO 
pollution concerns, including cancer risk, that will increase safety in 
communities and for workers while supporting ongoing supply chain needs for 
sterilized medical equipment. This decision advances President Biden's 
commitment to ending cancer as we know it as part of the Cancer Moonshot, as 
well as the Administration's commitment to securing environmental justice and 
protecting public health, including for communities that are most exposed to 
toxic chemicals.
"EPA continues to make important strides to protect people from dangerous 
chemicals like ethylene oxide," said Assistant Administrator for the Office of 
Chemical Safety and Pollution Prevention Michal Freedhoff. "These protections 
will reduce EtO exposures to workers and communities, while also ensuring that 
the chemical remains available to provide sterile life-saving medical supplies."
Ethylene Oxide
EPA regulates EtO's use as a pesticide under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). EtO has both antimicrobial uses, such 
as sterilization of medical devices, and conventional uses, such as fumigation 
of dried herbs and spices. In some instances, such as with sterilization of 
medical devices like surgical kits, EtO is the only available option, making it 
essential for protecting human health. Every 15 years, EPA evaluates potential 
human health and environmental effects associated with the use of a pesticide 
through the registration review process. As part of EtO's registration review, 
the agency assessed cancer risk from working in sterilization and health care 
facilities that use EtO, living in communities near EtO facilities, and 
consuming dried herbs and spices treated with EtO.
After a 75-day public comment period with over 60 stakeholder meetings with 
industry, other federal agencies, unions, and nonprofit organizations, EPA 
identified a broad set of protections under FIFRA that aim to reduce exposure 
to all EtO sterilization facility workers and to others who work, live, or go 
to school near sterilization facilities. Specifically, the Decision includes a 
reduced EtO concentration rate limit for new medical device sterilization 
cycles to reduce levels of exposure for workers; a lowered worker exposure 
limit of 0.5 ppm after three years, 0.25 ppm after five years, and 0.1 ppm 
after 10 years (compared to the current Occupational Safety and Health 
Administration standard of 1 ppm);  phased cancellation of the use of EtO on 
specific dried herbs and spices; and cancellation of the use of EtO when safer 
and effective alternatives are available.
Interim Decision
Some of the highlights of the Interim Decision include:
Commercial Sterilizers

  *   Lowered worker exposure limit of 0.5 ppm by 2028, 0.25 ppm by 2030, and 
0.1 ppm by 2035, as compared to the 1984 OSHA limit of 1 ppm. Any workers who 
could be exposed to concentrations of EtO above these limits would need to wear 
additional respiratory protection.
  *   Finalizing the ban of use for museum, library and archival materials; 
cosmetics; musical instruments; and beekeeping equipment.
  *   Immediate cancellation of the use of EtO for specific dried herbs and 
spices for which its use is not considered critical for food safety, and phased 
cancellation for specific dried herbs and spices for which EtO use is 
considered critical for food safety but have potential alternatives to EtO.
  *   Establishing a concentration limit of 600 mg/L for new medical device 
sterilization cycles within 10 years. If a device requires a concentration of 
EtO greater than 600 mg/L due to the device design, the facility must maintain 
records to justify the increased application rate.
  *   Separation of HVAC systems for areas where EtO is used and areas where 
EtO is not used, to reduce EtO exposure in areas such as offices.
  *   Requiring respirators to protect workers involved in certain high EtO 
exposure tasks, such as connecting and disconnecting EtO containers from 
sterilization process equipment.
  *   Continuous EtO concentration monitoring throughout sterilization 
facilities, including on-site storage facilities.
  *   Data requirements to monitor breathing zone worker exposure to EtO within 
commercial sterilization facilities and warehouses that store sterilized 
materials, both on and off-site.
Healthcare Facilities

  *   Require abatement devices for healthcare facilities that use more than 10 
lbs. of EtO/year by comparison - c commercial sterilizers typically release 
tons of EtO annually.
  *   Ventilation of EtO through exterior ventilation stacks to reduce exposure 
to healthcare facility workers. Exposure to communities from EtO used in 
healthcare facilities is expected to be minimal because the amount of EtO used 
at healthcare facilities is orders of magnitude lower than at commercial 
sterilization facilities.
Next Steps
EPA expects that registrants will submit label amendments that include the 
changes outlined in the Interim Decision within 60 days after publication. The 
agency plans to quickly review the label amendments so that products sold and 
distributed by registrants will include the changes outlined in the Interim 
Decision. The timing for implementation for individual mitigation measures 
ranges from two years to 10 years, taking into consideration the costs, 
technology availability, potential impacts to the medical device supply chain 
and other logistical elements. Additionally, EPA will issue a Data Call-In 
(DCI) to gather information on worker exposure. Specifically, the DCI will 
require submission of worker exposure data for commercial sterilizers and 
warehouses in order to understand the worker exposure impacts of complying with 
EPA's Clean Air Act EtO commercial sterilization NESHAP and implementing the 
mitigation measures identified in this Interim Decision. EPA will reevaluate 
this Interim Decision within eight years, earlier than the typical 15-year 
cycle, based on the submitted worker exposure data, in order to identify 
further opportunities to reduce EtO exposures.
To view all documents related to EtO's registration review, visit docket 
EPA-HQ-OPP-2013-0244<https://links-1.govdelivery.com/CL0/https:%2F%2Fgcc02.safelinks.protection.outlook.com%2F%3Furl=https%253A%252F%252Fwww.regulations.gov%252Fdocument%252FEPA-HQ-OPP-2013-0244-0044%26data=05%257C02%257CDunton.Cheryl%2540epa.gov%257C97c58fe3057042097e3508dd34d60a6b%257C88b378b367484867acf976aacbeca6a7%257C0%257C0%257C638724816109355414%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata=nSwY2kpHr%252Bel2npNT%252FeDMZLfbx%252ByU51e31NUcJ%252BlSnY%253D%26reserved=0/1/01000194668cca4b-bd1afc68-90d0-4631-9933-35c1ac47d9e7-000000/ZYD4dzQLsADgqf1Y0R3m8JTisCqd5XHJebmboQykF9A=388>.



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