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1) Apr 27 -- National Emission Standards for Hazardous Air Pollutants: Ethylene Production, Miscellaneous Organic Chemical Mfg, Organic Liquids Distribution (Non-Gasoline), and Petroleum Refineries Reconsideration

On July 6, 2020, EPA finalized the residual risk and technology review (RTR) conducted for the Ethylene Production source category, which is part of the Generic Maximum Achievable Control Technology (GMACT) Standards National Emission Standards for Hazardous Air Pollutants (NESHAP); on July 7, 2020, the EPA finalized the RTR conducted for the Organic Liquids Distribution (Non-Gasoline) NESHAP; and on August 12, 2020, the EPA finalized the RTR conducted for the Miscellaneous Organic Chemical Manufacturing NESHAP. Amendments to the Petroleum Refineries NESHAP were most recently finalized on February 4, 2020. Subsequently, the EPA received and granted various petitions for reconsideration on these NESHAP for, among other things, the provisions related to the work practice standards for pressure relief devices (PRDs), emergency flaring, and degassing of floating roof storage vessels. In response to the petitions, the EPA is proposing amendments to the work practice standards for PRDs, emergency flaring, and degassing of floating roof storage vessels. In addition, the EPA is proposing other technical corrections and clarifications for each of the rules. Comments must be received on or before June 12, 2023.

FRN: https://www.federalregister.gov/d/2023-07627

2) Apr 13 -- National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review

The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category. The EPA is proposing decisions concerning the risk and technology review (RTR), including proposing amendments pursuant to the technology review for certain point source emissions and proposing amendments pursuant to the risk review to specifically address ethylene oxide (EtO) emissions from point source and room air emissions from all commercial sterilization facilities. The EPA is also proposing amendments to correct and clarify regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing general exemptions for periods of SSM and adding work practice standards for periods of SSM where appropriate. Lastly, the EPA is proposing to revise monitoring and performance testing requirements and to add provisions for electronic reporting of performance test results and reports, performance evaluation reports, and compliance reports. We estimate that, if finalized, these proposed amendments would reduce EtO emissions from this source category by 19 tons per year (tpy) and reduce risks to public health to acceptable levels. Comments must be received on or before June 12, 2023.
 
FRN: https://www.federalregister.gov/d/2023-06676 [68 pages]
 
3) Pesticide Registration Review; Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide; Notice of Availability
 
This notice announces the availability of and solicits public comment on EPA's proposed interim registration review decision and draft risk assessment addendum for ethylene oxide. Comments must be received on or before June 12, 2023.

This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental and human health advocates; distributors and users of medical devices; owners and operators of commercial sterilization facilities; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides.

FRN: https://www.federalregister.gov/d/2023-07727

4) Apr 11 [press release] -- Today, the U.S. Environmental Protection Agency (EPA) is proposing new health protections to reduce exposure to Ethylene Oxide (EtO), including more stringent air emissions standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and certain spices. If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. Together, these proposals will provide a comprehensive approach to addressing EtO pollution concerns, including cancer risk, that will increase safety in communities and for workers while providing a path to maintain a robust supply chain for sterilized medical equipment. . . .

The two new proposals announced today mark significant progress as EPA continues to leverage the full range  of its regulatory authority under the law to protect public health by reducing the risk posed by EtO. Long-term exposure to EtO over the course of a 35-year career or 70-year lifetime in or near a commercial sterilizer can increase the risk of certain types of cancer. People who go to school near places where EtO is used are also potentially at an elevated risk of cancer due to EtO levels in the air. Actual risks will vary based upon a facility’s control measures for workers and community members and the distance and amount of time people live, work, or go to school near a facility.

These proposals were informed by collaboration across the federal government to deliver risk reductions while maintaining critical sterilization capabilities, including consultation between EPA, the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry, and the Occupational Safety and Health Administration. The proposals include controls that many facilities are already using, and that EPA would apply nationwide. The Agency has also undertaken robust public engagement on this topic and will continue to provide the public, especially in impacted communities and workplaces, with access to the information they need to make informed, independent judgements about risk and to encourage public involvement in the regulatory process. . . .

Under EPA’s Clean Air Act authority, the Agency is issuing a proposed rule outlining new requirements for 86 commercial sterilizers across the country.  If finalized, the proposal would reduce EtO emissions from these facilities by 80%, bringing emission levels down so that risk falls below the EPA’s Clean Air Act benchmark for elevated cancer risk.

While many of these facilities have already taken steps to reduce emissions, the proposal will require all 86 facilities and any new facilities to comply with these stricter pollution controls, which have already proven to be effective and achievable. All commercial sterilizers will also be required to use advanced source monitoring methods to confirm that these pollution controls are operating effectively. Facilities would be required to report results to EPA twice per year. Under the proposal, facilities would be required to comply with these new requirements within 18 months. This represents an expedited timeline under EPA authority.

EPA’s proposal is informed by the latest data, science, and extensive outreach and takes full account of the important function of medical sterilization to provide a safe supply of medical devices for patients and hospitals. EPA required all commercial sterilizers to submit detailed information about EtO emissions and control technologies as part of a 2021 Information Collection Request. EPA used this data to estimate risk to people who live near these facilities.  EPA also conducted extensive pre-proposal outreach in 2022, including community meetings and webinars, which supported state and local efforts to protect communities and generated information that informed and strengthened this proposal.

In addition to new emissions standards, EPA is proposing a comprehensive set of new mitigation measures that will decrease risk for workers who use EtO to sterilize products and for other people in communities near sterilization facilities. . . .

EPA’s proposal also includes new data collection and reporting requirements that would help identify and improve protective monitoring technologies and assess the effectiveness of the proposed mitigation measures. Based on this data, EPA intends to initiate the next round of registration review for EtO earlier than the mandated timeframe, including assessing these measures and incorporating additional protections based on advances in technology that occur.

EPA is moving urgently to advance these new protections based on the Agency’s latest assessment of cancer risks from EtO exposure in occupational settings, which are more significant than previously understood. Of note, EPA has not found that routine exposure to EtO from these facilities causes short-term or acute health risks. EPA’s new analysis estimates the additional lifetime cancer risk associated with continuous workplace exposure to EtO for 8 hours a day, for 240 days per year, over a period of 35 years in an occupational setting is between 1 in 36 and 1 in 10 for workers who apply EtO in sterilization facilities, and between 1 in 25 and 1 in 12 for workers who apply EtO in healthcare facilities. These risks can be reduced through measures that have already been taken or can be taken immediately by increasing access to personal protective equipment, adequate ventilation, and safety protocols to avoid direct contact with EtO.  As stated above, many facilities have already successfully implemented these measures, reducing risks.

In commercial sterilization facilities, EPA also found that continuous, long-term exposure to EtO could lead to elevated cancer risk for workers who do not directly handle EtO but work in other areas of these facilities. EPA’s proposed mitigations will reduce risk for people who may be exposed to EtO in or near these settings and many facilities are already taking these measures or can take additional measures immediately.

Last year, EPA released the latest available information on air emissions of EtO from these facilities and undertook extensive engagement with communities where EPA identified the potential for elevated lifetime cancer risks due to long-term exposure to EtO. The Clean Air Act standards EPA is proposing today would, if finalized, reduce lifetime cancer risks for people who live near all commercial sterilizers.

EPA is encouraging stakeholders, including community, industry and public health leaders to participate in the public comment process for each action released today as the Agency strives to reduce risk from EtO while also ensuring continued availability of sterile medical devices that the American public relies upon. EPA’s Proposed Interim Decision and EPA’s Draft Risk Assessment Addendum, can be found on EPA’s website and will soon be in docket EPA-HQ-OPP-2013-0244 at www.regulations.gov. EPA’s proposed revisions to the air emission standards for commercial sterilization facilities, can be found by visiting docket EPA-HQ-OAR-2019-0178 at www.regulations.gov. Both dockets will be open for public comment for 60 days after publication in the Federal Register.

EPA will also host a public webinar on May 1, 2023, at 8:00 pm ET to discuss proposals and risk assessment. Information for the public to register for the webinar will be available on EPA’s Hazardous Air Pollutants: Ethylene Oxide (EtO) webpage. For those who are unable to attend, EPA will post a recording of the webinar on the Agency’s website. . . .
 
Hazardous Air Pollutants: Ethylene Oxide (EtO): https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide
Press release: https://www.epa.gov/newsreleases/epa-proposes-new-standards-protect-public-health-reduce-exposure-ethylene-oxide

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