Proposed Rule 20 Aug 2025 compliance, regulatory, safety, osha, business, ethylene oxide

⚠️OSHA Extends Comment Period for Ethylene Oxide Proposed Rule

OSHA is extending the period for submitting comments by 60 days to allow stakeholders interested in the Notice of Proposed Rulemaking (NPRM) on Ethylene Oxide additional time to review the NPRM and collect information and data necessary for comment.

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Presidential Document 23 Jul 2025 compliance, healthcare, regulations, national security, ethylene oxide, sterilization

🏥Regulatory Relief for Medical Sterilization Facilities Announced

Proclamation 10959 by the President grants a two-year exemption from compliance with the EtO Rule for specified commercial sterilization facilities. This exemption arises from concerns regarding the critical role of ethylene oxide in sterilizing medical equipment, emphasizing national security and the need to ensure availability of essential medical devices for patient care.

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Proposed Rule 1 Jul 2025 compliance, business costs, health, safety regulations, osha, labor, occupational safety and health, ethylene oxide, respirators

🦺OSHA Proposes Amendments to Ethylene Oxide Respirator Standards

This proposed rule revises some substance-specific respirator requirements to allow different types of respirators to be used under OSHA's Ethylene Oxide standard and better aligns this standard with OSHA's Respiratory Protection standard.

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Compliance, Regulatory Changes 22 Jan 2025 environmental regulation, environmental protection, epa, reporting and recordkeeping requirements, incorporation by reference, air pollution control, chemical manufacturing, hazardous substances, emissions standards, ethylene oxide

🌎Proposed EPA Regulations on Ethylene Oxide Emissions Standards

The Environmental Protection Agency (EPA) is proposing to establish a new area source category to address chemical manufacturing process units (CMPUs) using ethylene oxide (EtO). The EPA is proposing to list EtO in table 1 to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chemical Manufacturing Area Sources (referred to as the CMAS NESHAP in this document) and to add EtO- specific requirements to the CMAS NESHAP. The EPA is also proposing to add a fenceline monitoring program for EtO. In addition, the EPA is proposing new requirements for pressure vessels and pressure relief devices (PRDs). This proposal also presents the results of the EPA's technology review of the CMAS NESHAP as required under the Clean Air Act (CAA). As part of this technology review, the EPA is proposing to add new leak detection and repair (LDAR) requirements to the CMAS NESHAP for equipment leaks in organic HAP service and heat exchange systems. The EPA is also proposing performance testing once every 5 years and to add provisions for electronic reporting. We estimate that the proposed amendments to the CMAS NESHAP, excluding the proposed EtO emission standards, would reduce hazardous air pollutant (HAP) emissions from emission sources by approximately 158 tons per year (tpy). Additionally, the proposed EtO emission standards are expected to reduce EtO emissions by approximately 4.6 tpy.

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Compliance Regulations, Environmental Impact, Healthcare Standards 17 Jan 2025 compliance, healthcare, environmental regulations, emissions standards, ethylene oxide, sterilization
Compliance, Regulatory 14 Jan 2025 ethylene oxide, epa, pesticide, business compliance, environmental regulation

⚖️EPA Interim Decision on Ethylene Oxide

This notice announces the availability of EPA's interim registration review decision for ethylene oxide (EtO).

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