Search Results for: ethylene oxide

Computer Monitor screen, concept of email
Emissions / EPA
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EPA Introduces New Email Account for Regulated Community to Request Presidential Exemption

The Environmental Protection Agency announced March 12 it set up an e-mail account allowing the regulated community to request a presidential exemption under Section 112(i)(4) of the Clean Air Act (“CAA”). 

The CAA permits the president to grant exemptions to stationary sources from compliance with any standard or limitation set forth under Section 112 for up to two years if the technology required to meet the standard is not available and if it’s in the United States’ national security interests.

In particular, the EPA requested …

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Ecological catastrophe
Emissions / EPA
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EPA Finalizes New Rule Requiring More Than 200 Chemical Plants to Reduce Toxic Emissions

The U.S. Environmental Protection Agency announced April 9 a set of final rules under sections 111 and 112 of the Clean Air Act (CAA) to significantly reduce toxic air pollution from more than 200 chemical plants in the United States.

The plants affected make products such as synthetic organic chemicals, plastics, paints, synthetic fabrics, pesticides, petrochemical products, and various polymers and resins, including neoprene. The new rules strengthen protections for communities living near these industrial facilities, especially along the Gulf Coast, and it is anticipated …

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Close-up of exhaust fan on factory roof
EPA
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EPA’s Final EtO Rule Finally Finalized

The Environmental Protection Agency on March 14 announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) applicable to 90 large commercial sterilization facilities that use ethylene oxide (EtO), a chemical to which long-term exposure can cause cancer or other serious injury.

The EtO rulemaking process has engendered some criticism – most dramatically in lawsuits filed against the EPA by advocates representing neighbors of EtO facilities who claim the rulemaking process was too little too late (covered by ELM here). But …

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Sterile storage of medical and surgical instruments in the dentist's office. View from above. Closeup shoot.
Emerging Issues / EPA
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FDA Finally Recognizes EtO Sterilizing Alternative as the World Becomes a Force Majeure Pile-Up

Perhaps nothing has proven the indispensable value of commercial sterilizers more than the devastating worldwide COVID-19 pandemic. Without the highly effective and efficient commercial sterilizer ethylene oxide (EtO), we would not have been able to rely on lifesaving sterilized medical equipment and supplies – such as cotton swabs for nasal-swab testing, masks, ventilators, and thermometers – to get us through the past four years. Moreover, maintaining basic hospital functionality and everyday healthcare needs outside of the pandemic requires sterile equipment and supplies simply for civilization …

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EPA Offices, Washington DC
Emissions / EPA
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Lawsuits Claim EPA’s EtO Rules are Too Little, Too Late

Following the U.S. Environmental Protection Agency’s 2016 finding that ethylene oxide (EtO), a highly effective chemical routinely used to sterilize medical devices and equipment, was significantly more hazardous than previously understood, individuals and shareholders began filing lawsuits against various EtO-using entities throughout the United States with no end in sight. At the end of last month, however, it was the EPA that became the legal target of furious environmental justice and health advocates acting on behalf of the communities the EPA is tasked to …

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EPA Offices, Washington DC
Emerging Issues / EPA
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FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused medical providers to spend billions on alternative sterile medical products and even implementing rations in some cases. Complicating the issue is the fact that, typically, only a handful of manufacturers and suppliers distribute these life-saving products, so alternatives can be difficult to procure. Shortages appear to be endangering other …

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Gavel and stethoscope. medical jurisprudence. legal definition of medical malpractice. attorney. common errors doctors, nurses and hospitals make
Emerging Issues / EPA
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American Public Is Thrown Into the EtO Mix with Government and Industry

After a COVID-related dip, ethylene oxide (EtO) cannot seem to stay out of the news these days. Every week there is some EtO-related legal or technological development in the United States. And now the public is being encouraged to shape the oversight of EtO use and manufacture. 

Following a long pause in years-long and intense regulatory focus — a direct result of the pandemic, an emergency requiring exponential use of EtO, a highly efficient sterilizing chemical used on billions of medical devices and hospital supplies …

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United States Environmental Protection Agency
Clean Air Act / EPA
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Highly Anticipated Proposed EtO Rules the EPA Just Announced: Were They Worth The Wait?

After years of delays – largely due to the COVID-19 pandemic – on April 11, 2023, the U.S. Environmental Protection Agency finally issued two proposals that would reduce ethylene oxide (EtO) emissions affecting fence-line communities neighboring EtO sterilization facilities and establish direct protections for facility employees likely to be regularly exposed to this sterilizing chemical. The proposals, which fall under the Clean Air Act (CAA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), are expected to dramatically reduce EtO emissions by a whopping 80% …

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Emerging Issues / Emissions
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New Sprawling EtO Litigations Mount as Our Pandemic-Shaken World Increasingly Relies on Commercial Sterilizers

Right on the heels of the eye-popping $408 million settlement between a major commercial sterilizer and plaintiffs claiming injuries resulting from exposure to ethylene oxide (EtO) emitted from the company’s Illinois facility (covered by ELM here), the company now faces two different legal actions initiated by two new groups of plaintiffs but similarly stemming from fugitive EtO emissions from the company’s U.S. facilities. These legal battles come at a time when there are not yet viable alternatives to EtO, a highly efficient medical-equipment sterilizing …

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Emerging Issues / EPA
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EPA Renews Push for New ‘EtO’ Regulations and Outreach   

Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene oxide (EtO) emissions from 23 of specific sterilizer facilities.  

The agency further announced that, using data from the same study as well as ongoing critical EtO research, EPA will propose new regulations intended to protect public health from EtO emissions and protect workers at the facilities themselves, by the end of 2022 …

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