California Proposition 65: Updates for Ethylene Oxide

By: Sarah D’Mello, Senior Product Safety Specialist

 

OEHHA, The Office of Environmental Health Hazard Assessment released a draft document in early 2023 regarding ethylene oxide.

 

Read more about the proposed changes and learn how to participate in the public comment period below.

 

Cancer Inhalation Unit Risk Factor

 

The Office of Environmental Health Hazard Assessment (OEHHA) released a draft document outlining the carcinogenicity data and updated cancer inhalation unit risk factor (IUR) for ethylene oxide.

 

Cancer IURs are used in the Air Toxics Hot Spots Program to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen.

 

The public comment period will end on May 22, 2023. Comments can be submitted online.

 

Updated to the No Significant Risk Level

 

OEHHA is proposing to update the No Significant Risk Level (NSRL) for ethylene oxide. The proposed updated NSRL for ethylene oxide is 0.058 micrograms per day.

 

The updated NSRL reflects the current scientific information available for ethylene oxide. Exposures at or below the NSRL are exempt from the warning and discharge requirements of Proposition 65.

 

OEHHA must receive comments on the proposed regulation by May 23, 2023. Comments can be submitted here.

 

It is strongly recommended to submit comments electronically rather than in paper form.

 

What is Prop 65?

 

Proposition 65 (Prop 65) is a California law officially known as the  Safe Drinking Water and Toxic Enforcement Act of 1986.

 

Under the law, business are required to warn people about exposure to chemicals that cause cancer, birth defects or other reproductive harm. Penalties for non-compliance with Prop 65 can be as high as $2,500 per violation.

 

Dell Tech can help you identify if your product(s) contain any of the 900 chemicals outlined in Prop 65, review and update labels as required. Learn more about US Chemical Labelling Requirements here.

 

For More Information, Contact Client Services:

Kim Samela

kim@delltech.com

519-858-5021

 

Sources:

The Office of Environmental Health Hazard Assessment (OEHHA). (2023, April 7). Notice of Public Comment Period and Workshops on a Draft Cancer Inhalation Unit Risk for Ethylene Oxide. Oehha.ca.gov. Retrieved April 10, 2023, from https://oehha.ca.gov/air/crnr/notice-public-comment-period-and-workshops-draft-cancer-inhalation-unit-risk-ethylene-oxide

The Office of Environmental Health Hazard Assessment (OEHHA). (2023, April 7). Updated No Significant Risk Level for Ethylene Oxide. Oehha.ca.gov. Retrieved April 10, 2023, from https://oehha.ca.gov/proposition-65/crnr/updated-no-significant-risk-level-ethylene-oxide

 

 


Dell Tech has provided professional, confidential consulting services to the specialty chemical 

industry in Canada, the USA, Europe, and Asia for the last 40 years.

Contact us today for more information.

 

www.delltech.com

 

SHARE:

Recent Posts

image

PMRA Data Protection in Canada: Exclusive vs. Compensable Data Explained

In Canada, pesticide data protection is a critical component of the regulatory framework administered by the Pest Management Regulatory Agency (PMRA). Health Canada, as the federal agency responsible for pesticide…
image

DHPID Updates for GMP Inspections

Recently last year in October 2025, Health Canada released an update to the Drug and Health Product Inspection Database (DHPID) which now supports the search of inspection results by Site License…
image

CEPA Compliance Cosmetics Canada: Guidelines You Shouldn’t Miss

Cosmetic regulation in Canada is evolving, and enforcement is catching up. A Cosmetic Notification Form alone is no longer enough. In the past two years, Environment and Climate Change Canada…

Have Questions About Regulatory Compliance?

If you’re unsure what your next steps should be, check our frequently asked questions page or contact us today.