At the end of 2019, the U.S. EPA (Environmental Protection Agency) proposed amending the current control measure regulations involving Ethylene Oxide (ETO) emission standards for commercial sterilization facilities.

The hazardous chemicals amendment would help reduce the cancer-causing ETO toxic chemical emissions and other toxic substances at facilities emitting higher concentrations.

The increased risk can result in adverse health effects due to short and long-term human exposure to the harmful chemical at or nearby commercial sterilization facilities.

The U.S. EPA was responding to a Washington DC federal judge’s ruling that requires the agency to forego any more delays in its updating of outdated rules that failed to follow the Clean Air Act enacted for disease control. In 2016, the judge gave the agency three years to follow mandated compliance to minimize health risks.

However, legislators and environmental advocates are pushing back against the recommendation that attempts to use air testing control measures to minimize residential and occupational exposure.

Advocates, the Illinois EPA, and health care providers say that the harmful chemical amendments are not enough to protect human health and risk of cancer against inhalation ETO exposure. The failure to protect especially affects residents living nearby ethylene oxide factories that use or manufacture the product.

What is Ethylene Oxide (ETO)?

Ethylene Oxide a highly toxic, flammable chemical utilized in the manufacturing of ethylene glycol. The formulated ethylene glycol compound is used in many products, including antifreeze, pharmaceutical medications, adhesives, polyurethane foam, solvents, textiles, and detergents. At room temperature, ETO has a sweet odor before and after the production of ethylene glycol.

The toxic ETO chemical has also been used for ethylene oxide sterilization of medical devices, surgical tools, medical equipment, and other medical products. Although state regulators and the Illinois Environmental Protection Agency have long known that ethylene oxide and concentrated levels of ethylene glycol can create devastating problems in the human body, including cancer and non-Hodgkin lymphoma.

State Officials and OSHA (Occupational Safety and Health Administration) recommend strict limitations on ETO exposure from releases of airborne toxins that could result in serious health issues, including breast cancer.

This federal agency says that acute (short-term) exposure or release ethylene oxide could cause nausea, headaches, difficulty in breathing, vomiting, and other adverse health effects.

The EPA states that long-term ETO exposure can cause devastating chronic conditions, including genetic mutations, congenital disabilities, chemical allergic reactions, neurological problems, brain damage, and other catastrophic health effects. Research on humans and laboratory animal studies have shown that ETO is a human carcinogen associated with long-term and short-term exposure to Ethylene Oxide.

Better Control of ETO Omissions

The U.S. Environmental Protection Agency recommended the proposed rule to tighten controls on ETO emissions better and reduce cancer risks from about 2000 cases per million individuals exposed during their life down to 300 cases or less.

Many state regulators want to make changes to reduce cancer risks caused by air pollution at unacceptable levels, including ETO. The proposed amendments were formed years after the EPA denied there was a risk or concern about exposure to the chemical in either a liquid or gas form.

Unfortunately, the recommended amendments still leave the citizens of many communities exposed to excessive levels of heightened cancer risks that could be up to three times higher than the acceptable levels regulated by the EPA.

In addition to contamination through air pollution, humans might require medical care after direct contact, including skin contact with the harmful chemical.

The dangerous side effects and human carcinogen health risks involved in the use of Ethylene Oxide have mostly been hidden from public view. In 2016, the agency conducted an ongoing study of problems associated with the use of ethylene oxide. The results identified that the hazardous substances were fifty times more carcinogenic than previously believed.

Elevated ETO Risk and Serious Harm

By 2018, the EPA agency published the updated National Air Toxics Assessment risk value that identified the severe harm caused by Ethylene Oxide emissions. The hazardous chemicals study revealed higher than acceptable levels of risk for developing cancer for individuals living and working around hazardous chemicals at commercial sterilization facilities.

Federal law requires the U.S. EPA to review and update air testing standards involving dangerous chemicals that cause adverse health effects every eight years. However, even today, the agency has not been able to maintain that schedule concerning ETO toxicity and how it affects the local environment.

The agency’s periodic report found that many facilities were releasing Ethylene Oxide gas through leaky equipment, storage tanks, and vents. However, the report revealed that the air quality was measured in and around the facility’s perimeter only.

The air quality was not monitored past the company’s boundaries, where the toxic chemical might have spread into the neighboring community.

This limiting monitoring regulation directly opposes the 2015 EPA-initiated monitoring required around petroleum refineries where toxic level measurements reached out well past the company’s fence line.

Although the Environmental Protection Agency knew that Ethylene Oxide gas and liquids were human carcinogens as early as 2014, it took until December 2016 to classify the chemical as a cancer-causing agent.

Evidence from the agency has come to light that long-term exposure to the toxic chemical through hazardous air pollution elevates the potential risk of developing nervous system disorders and cancer by compromising white blood cells.

Some of the diseases associated with the poisonous substance include lymphocytic leukemia, myeloma, non-Hodgkin lymphoma, and breast cancer in females.

The Clean Air Act Acceptable ETO Levels

As a part of the Clean Air Act, the U.S. Congress classified Ethylene Oxide as a “hazardous air pollutant” or “air toxic” substance. To follow the law, the EPA must regulate toxic air levels by restricting the amount of pollution an industrial company can emit.

However, ambiguity in the law allows the U.S. EPA not to set the ambient standard, nor must the agency specifically define an acceptable level of ethylene oxide exposure from emissions.

Not All Ethylene Oxide Plants Are Affected by New Changes

An industry organization, the Ethylene Oxide Panel of the American Chemistry Council, reviewed the proposal recommendations made by the Environmental Protection Agency.

Unfortunately, many of the amendments to the existing rules to reduce ETO emissions and occupational exposure nationwide would not apply to numerous chemical plants throughout the United States. The failure in the law could place unsuspecting victims living in nearby communities in harm’s way.

FDA vs. EPA Guidance on Safe ETO Levels

In late 2019, the Food and Drug Administration (FDA) warned that closing companies producing or using Ethylene Oxide could risk the lives of patients. Many hospital procedures, including those that use hip replacement equipment and pacemakers, require the chemical for sterilization, even though ethylene oxide causes cancer.

Without proper decontamination of their much-needed equipment or devices, the patients could be subjected to severe or life-threatening infections.

In response to state authorities mandating the cut of Ethylene Oxide emissions, the State of Illinois environmental protection agency shuttered a sterilizing facility. The State of Michigan and the Georgia environmental protection division also temporarily closed ETO manufacturing companies due to ethylene oxide exposure concerns.

Many Communities Are Affected

In 2018, the U.S. EPA released the 2014 National Air Toxics Assessment based on air emission levels in 2014. The assessment works as a useful screening tool to help determine the potential adverse effects of pollutants to public health.

To better understand the cancer risks within your region or area, the EPA provides additional information through a research map based on estimated risks involving chemical exposure to ETO toxicity and the spread of emissions in the air, including Ethylene Oxide.

Although the total nationwide emissions of air chemical toxins are on the decline, many local communities still face serious challenges. The federal government continues to estimate the long-term risks of breathing ETO contaminated air. The EPA is working with state and regional industries by reviewing the Clean Air Act regulations and air toxics emission standards to provide recommendations on improving environmental quality.

The EPA is also planning to take an in-depth look at commercial sterilization facilities’ toxic ETO emission standards at chemical plants. The human services agency’s goal is to decrease adverse health effects and better control air pollution through expansive air testing and improve the protection of public health and occupational safety through optimized national emission standards.