EPA Launches Community Engagement Efforts on New Ethylene Oxide Risk Information

The EPA recently announced its plans to engage and inform communities, states, Tribes, Territories, and stakeholders about up-to-date information on the risks posed by air emissions of ethylene oxide (EtO) from commercial sterilizers, as well as EPA’s efforts to address these risks. EPA is releasing new information on specific facilities where lifetime risk levels are the highest to people who live nearby and is encouraging impacted communities to participate in a series of public engagements to learn more. Later this year, EPA expects to propose an air pollution regulation to protect public health by addressing EtO emissions at commercial sterilizers.

 

EPA analysis indicates that the air near facilities does not exceed short-term health benchmarks. However, the concern is that a lifetime of exposure to EtO emissions could lead to long-term health impacts if some of these facilities continue to emit at the current levels. EPA is working with these facilities to take appropriate steps to reduce emissions.

 

“Today, EPA is taking action to ensure communities are informed and engaged in our efforts to address ethylene oxide, a potent air toxic posing serious health risks with long-term exposure,” said EPA Administrator Michael S. Regan. “Under my watch, EPA will do everything we can to share critical information on exposure risk to the people who need and deserve this information, and to take action to protect communities from pollution.”

 

EPA is taking a phased outreach approach to engage the American public on this issue. This includes detailed web material with risk information for high-risk communities and a national public webinar taking place on August 10 from 8:00 to 9:30PM Eastern. EPA will be following this national level outreach with community specific engagements starting with communities where the risk is the highest.

 

 

EPA is continuing to gain access to more information about EtO, and to refine its scientific understanding of the risks it poses. Later in 2022, EPA will release additional, national-level information about the risks that EtO creates to those who work in EtO facilities, as well as those who spend time near them.  

 

Medical sterilization is a critical function that ensures a safe supply of medical devices for patients and hospitals. EPA is committed to addressing the pollution concerns associated with EtO in a comprehensive way that ensures facilities can operate safely in communities while also providing sterilized medical supplies.

 

Since 2018, EPA has been working with federal partners, communities, states, Tribes, and stakeholders to reduce the risks posed by EtO exposure. Recently, EPA collected information in support of a Clean Air Act regulation to control EtO from commercial sterilizers. EPA used updated EtO emissions information from commercial sterilizers to estimate the increased risk of cancer related to the EtO emitted from almost 100 commercial sterilizers.  The agency found elevated risks at or above 100 in a million in residential areas at 23 of those sterilizers. Long-term exposure to high concentrations of EtO can increase the lifetime risk of getting cancer.

 

The agency is sharing this risk information so that communities located near the highest-risk commercial sterilizers, and members of the public concerned about EtO exposure, have up-to-date information about emissions and health risks from EtO and can make informed decisions. EPA expects to propose an air pollution regulation later this year to protect public health by addressing EtO emissions at commercial sterilizers. This regulation will rely on the best available science and proven air pollution controls. At the same time, EPA will release proposed limits on how EtO can be used within sterilization facilities with the goal of reducing risks to workers who handle EtO and those who are exposed in other ways like working or attending school near a facility. The Agency is working with state and local governments, Territories, Tribes, facilities, and other partners to identify and implement near-term steps to reduce this pollution as soon as possible. 

 

View the list of sterilizers with elevated risk.

 

In addition to the community outreach, EPA continues to take significant action to address EtO and advance critical EtO research. These actions include:

Ethylene oxide, a colorless gas, is used to sterilize devices that cannot be sterilized using steam or radiation, such as some medical and dental equipment. According to the Food and Drug Administration, EtO is currently used to treat approximately 50% of sterile medical devices, about 20 billion medical devices annually. EtO is the only safe and effective sterilization method currently available for some devices. However, EPA is working to reduce EtO emissions and FDA is looking to identify alternatives to EtO.  

 

EtO is also produced in large volumes at some chemical manufacturing facilities. In the U.S., it is primarily used to make other chemicals that are used to make a range of products, including antifreeze, textiles, plastics, detergents, and adhesives. EtO is also used to sterilize some food products and spices. 

To stay up to date on the latest activities and actions related to EtO, please visit our website. 

 

 

Practical approaches for sampling engineered nanomaterials (ENMs) in the workplace are outlined in a new NIOSH technical report. ENMs, the report explains, are “a diverse group of materials that have at least one dimension in the size range of 100 nanometer (nm) or less.” ENMs are potentially hazardous because some substances have been found to be more toxic in microscale forms than at larger scales. As ENM production is increasing and these materials are being incorporated into more products, NIOSH has identified “a clear need to develop, implement, and apply a suitable strategy for occupational risk assessment and management” of ENMs.

 

To support an ENM management strategy, the report outlines steps for conducting workplace sampling of three types of ENMs that have NIOSH recommended exposure limits: airborne carbon nanotubes and nanofibers (CNTs and CNFs), silver, and titanium dioxide (TiO₂). Another section of the report discusses recommendations for exposure sampling of ENMs lacking NIOSH RELs. Since no single instrument or analytical technique can assess occupational exposure for all ENMs, NIOSH recommends combinations of instruments and measurement techniques to collect data to characterize ENM exposures.

 

Studies in rats and mice have shown that inhalation of CNTs and CNFs, silver nanoparticles, and TiO₂ nanomaterials causes a range of health effects that particularly impact lung function. Occupational exposures to CNTs and CNFs in workers are also “associated with biomarkers of early effect for fibrosis, inflammation, oxidative stress, and cardiovascular responses,” the report states.

 

The report can be downloaded for free from NIOSH’s website.

 

 

The Oregon Department of Environmental Quality issued eight penalties totaling $184,545 in June for various environmental violations. A detailed list of violations and resulting penalties is at https://ordeq.org/enforcement.

 

Fines ranged from $2,250 to $114,089. Alleged violations include a winery discharging wastewater to a creek tributary without a permit, a hazardous waste landfill improperly disposing of corrosive waste, and a gas station failing to submit required annual air quality reports.

 

DEQ issued civil penalties to the following organizations:

 

In addition to the penalties listed above, DEQ also issued a revised penalty to the Port of Morrow in June for additional violations involving overapplication of wastewater containing nitrogen to agricultural fields in the Lower Umatilla Basin. DEQ issued the original penalty in January. The additional violations increase the fine by $800,000, from $1.3 million to $2.1 million.

 

Organizations or individuals must either pay the fines or file an appeal within 20 days of receiving notice of the penalty. They may be able to offset a portion of a penalty by funding a supplemental environmental project that improves Oregon’s environment. Learn more about these projects at https://ordeq.org/sep.

 

Penalties may also include orders requiring specific tasks to prevent ongoing violations or additional environmental harm.

 

A federal workplace safety investigation into a Jan. 19, 2022, ammonia leak that hospitalized two workers and led to the evacuation of about 50 workers at a Canton poultry processing plant found their employer might have prevented the incident by ensuring required safety standards were followed.

 

Inspectors with OSHA found the uncontrolled temperature and pressure conditions on an ammonia refrigeration system contributed to the release of ammonia. Liquid and vapor ammonia were dispersed in the air and engulfed the emergency exit doors that discharged outside. In addition to the hospitalized workers, one worker was treated on the scene.

 

OSHA issued nine serious citations for inadequately implementing and maintaining the process safety management program for controlling anhydrous ammonia hazards in industrial refrigeration systems. Specifically, the employer failed to:

 

OSHA has proposed $110,630 in penalties.

 

“The failures identified in this case are inexcusable,” said OSHA Area Office Director Joshua Turner in Atlanta-East. “This incident should serve as a reminder to employers of their legal obligation to maintain a complete and up-to-date process safety management program, and ensure workers are trained on the dangers of hazardous chemicals and the importance of following safety precautions.”

 

Exposure to harmful substances in the workplace increased from 379 workers affected in 2019 to 448 workers affected in 2020, the Bureau of Labor Statistics reports.

 

Pilgrim’s Pride Corp. in one of the world’s largest poultry and pork producers with approximately 58,000 workers at locations in 14 U.S. states, the United Kingdom, Mexico, Puerto Rico and Europe.

 

 

The Washington Department of Ecology issued $631,000 in penalties of $1,000 or more from April through June 2022. A detailed list of the violations and resulting penalties can be viewed here.

 

Ecology works with thousands of businesses and individuals to help them comply with state laws. Penalties are issued in cases where non-compliance continues after Ecology has provided technical assistance or warnings, or for particularly serious violations.

 

The money owed from penalties may be reduced from the issued amount due to settlement or court rulings. Funds collected go to the state’s general fund or to dedicated pollution prevention accounts.

 

Ecology strives to protect, preserve and enhance Washington’s environment and promote wise management for current and future generations. When someone pollutes Washington’s land, air or waters, Ecology enforces state and federal regulations in hopes of changing behavior and deterring future violations.

 

The Massachusetts Department of Environmental Protection (MassDEP) has assessed a $13,500 penalty to the Aquarion Water Company of Massachusetts for violating drinking water regulations during the operation of its community public water system in the Town of Oxford. Aquarion owns the Oxford public water system and operates and maintains four wells and three water treatment plants in town and distributes drinking water to 6,130 customers.

 

Potassium hydroxide is added to the drinking water at the Oxford water treatment plants to increase the water's pH for corrosion control purposes. The pH of undiluted potassium hydroxide ranges from 10 to 13; solutions with pH values at or above 11 can cause skin and eye irritations and possible exacerbation of skin disorders.

 

On June 21, 2021, the company notified MassDEP that a customer on Depot Road reported "slippery" water while showering, resulting in a skin rash. The company immediately investigated and found the pH at the customer's home and in other parts of the system to be 10, but as high as 11 at one location in the distribution system. The company immediately took corrective measures by issuing a reverse-911 call to affected customers and flushing the distribution lines to reduce the elevated pH in the drinking water. Normal pH levels of the drinking water in the Oxford system range from 7 to 7.5.

 

The elevated pH in the distribution system was determined to be caused by an overfeed of potassium hydroxide at the North Main Street water treatment plant. The overfeed was due to a malfunction of a valve that allowed approximately eight gallons of undiluted potassium hydroxide to flow into a pipe at the water treatment plant. The pH probe at the water treatment plant failed to detect the elevated pH from the chemical slug in the pipe, activate the alarm system and shut down pumps to prevent unsafe drinking water from being delivered to the customers. The valve and pH probe at the North Main Street treatment plant were subsequently replaced.

 

Under a consent order signed with MassDEP, the company must pay the penalty and hire a third-party company to conduct a comprehensive evaluation of all existing critical chemical feed systems at Aquarion's water treatment plants in Oxford and the Town of Millbury and provide a report identifying any corrective measures needed with a schedule for completion subject to MassDEP's review and approval. In addition, they must hire a third-party company to review and update Aquarion's Standard Operating Procedures (SOP) for its existing critical chemical feed systems to ensure its pH analyzers are properly managed and calibrated to measure a minimum pH of 10, and maintain a log documenting all testing of alarms and equipment maintenance. The revisions to the SOP and schedule for implementation are subject to MassDEP's review and approval. 

 

"Proper operations and maintenance of components to critical chemical feed systems such as a pH analyzer at water treatment facilities are essential to ensure the delivery of safe drinking water to its users," said Mary Jude Pigsley, director of MassDEP's Central Regional Office in Worcester. "It is important to test the components routinely and document those test results to ensure the safety system works as intended."

 

 

The Minnesota Pollution Control Agency (MPCA) closed 148 enforcement cases for air quality, waste, stormwater, and wastewater violations in the first half of 2022. Environmental enforcement investigations often take several months, in some cases more than a year, to complete the investigation and issue final enforcement documents to regulated parties. Penalties are calculated using several factors, including harm done to the environment, the economic benefit the company gained by failing to comply with environmental laws, or how responsive and cooperative a regulated party was in correcting problems.

 

Imposing monetary penalties is only part of the MPCA’s enforcement process. Agency staff continue to provide assistance, support, and information on the steps and tools necessary to bring any company, individual, or local government back into compliance. 

 

Click here for a list of violations.

 

A Jacksonville wood crate and pallet manufacturer's history of workplace safety violations continues after federal inspectors found the company exposed workers to amputation hazards in its February 2022 inspection.

 

OSHA opened an inspection on Feb. 8, 2022, at M&H Crates, Inc. after receiving a complaint. OSHA determined the company failed to develop, document or use lockout/tagout procedures to prevent sudden machine start-ups. They also discovered the company failed to ensure required machine guarding, which exposed workers to hazards, including amputation. In the manufacturing industry, machine guarding violations are OSHA’s most frequently cited infraction.

 

OSHA cited M&H Crates for serious and repeat violations for machine guarding hazards, housekeeping issues and failing to provide hearing protection as required. The company faces $248,866 in proposed penalties.

 

"M&H Crates Inc. continues to expose its employees to dangerous workplace hazards by ignoring required federal safety standards," explained OSHA Area Director Basil Singh in Dallas. "These safeguards can be the difference between ending a shift safely and suffering a serious and life-altering injury. M&H Crates must develop and implement a company culture where worker safety and health is a priority."

 

Prior to its recent inspection, OSHA cited M&H Crates following inspections in 2012, 2014 and 2020. In June 2020, inspectors examined safety failures after an employee cutting pallet boards suffered a finger amputation while using an unguarded band saw.

 

 

Annual training is required by 40 CFR 262.17(a)(7).  Learn how to complete EPA’s new electronic hazardous waste manifest, and the more than 60 changes in EPA’s Hazardous Waste Generator Improvements Rule.  Environmental Resource Center’s Hazardous Waste Training is available at nationwide locations, and via live webcasts.  If you plan to also attend DOT Hazardous Materials Training, call 800-537-2372 to find out how can get your course materials on an Amazon Fire HD 10 tablet at no extra charge.