Tag Archive for: EPA

EPA Marks Endangered Species Day by Publishing Maps to Help Pesticide Users Better Understand Risks to Endangered Species

This original announcement was published by the EPA on May 19, 2023. Click here for more information.

 

Today, in recognition of Endangered Species Day, the U.S. Environmental Protection Agency (EPA) is publishing a group of StoryMaps to raise public awareness about protecting endangered species from pesticides. These StoryMaps use an interactive format to describe 11 endangered and threatened (listed) species, their habitats, and why they are at risk from pesticide exposure.

Through its Vulnerable Species Pilot, EPA has been identifying endangered species that are vulnerable to pesticides, developing mitigations to protect them from pesticide exposure, and will apply the mitigations to many types of pesticides.

The species included in this pilot are:

  • listed as endangered or threatened species by the U.S. Fish and Wildlife Service;
  • located in areas where pesticides are likely to be applied; and
  • have relatively small ranges (where they live, are suspected to live, and areas that impact the species’ survival in some way).

As described in EPA’s Endangered Species Workplan, the pilot focuses on implementing protections for 27 vulnerable federally listed endangered and threatened (listed) species.

The StoryMaps released today include descriptions of 11 of the pilot species and their habitats and explains why they are vulnerable to pesticides. These StoryMaps offer the unique ability to convey geospatial information about the location of these species and the protections they need from pesticides. For example, users can zoom in on the maps to view specific locations that may be of interest to them (e.g., where pesticide restrictions may apply to protect each species). Engaging the public and stakeholders through maps, other visuals, and narratives can help convey complex information in an easy-to-understand manner, offering a greater sense of place-based mitigations to protect species from pesticides.

EPA plans to propose mitigations and its implementation plan for all 27 species included in the Vulnerable Species Pilot in June 2023. At that time, the Agency will update the StoryMaps released today to include mitigations and will release StoryMaps for the 16 remaining species.

EPA and its federal partners are committed to developing tools for pesticide users to better understand pesticide risks to listed species and designated critical habitats, not just on Endangered Species Day, but every day.

View the StoryMaps page here.

Register for EPA’s Webinar on Bilingual Pesticide Labels

This original announcement was published by the EPA on May 18, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is hosting a public webinar on Thursday, June 15, 2023, from 5:00pm to 7:00pm EST to obtain input from the public on ways to make bilingual pesticide labeling accessible to farmworkers as required by the Pesticide Registration Improvement Act of 2022 (PRIA 5).  

The majority of our nation’s two million farmworkers speak Spanish. This effort will advance environmental justice by ensuring those farmworkers have access to important health and safety information on pesticide labels in their native language. During the webinar, EPA will provide a brief overview of the PRIA 5 requirements on bilingual pesticide labeling and milestones. PRIA 5 amended the Federal Insecticide, Fungicide, and Rodenticide Act, requiring Spanish language translation for key health and safety sections of the end-use pesticide product labels where the translation is available in the EPA Spanish Translation Guide for Pesticide Labeling. The Spanish language translation must appear on the pesticide product container or on a link to the translation via scannable technology or other electronic methods readily accessible on the product label. These translations are required on a rolling schedule from December 2025 to December 2030 depending on the type of product and the toxicity category. PRIA 5 also requires EPA to begin to seek stakeholder input on ways to make bilingual pesticide labeling accessible to farmworkers by June 30, 2023, and to implement a plan to ensure that farmworkers have access to the bilingual pesticide labeling by December 2025. 

As EPA determines the next steps in developing a plan to make bilingual pesticide labels accessible to farmworkers, the Agency is interested in feedback on the following items.  

  • What communication approaches, processes or strategies should the Agency consider to ensure bilingual pesticide labels are accessible to farmworkers?  What specific approaches should the Agency avoid or adopt when implementing efforts to best ensure access by farmworkers to bilingual pesticide labels? 
  • What technologies, mobile applications, and internet access should the Agency consider? Would web-based labels be accessible to farmworkers? How should the Agency overcome internet connectivity issues that some farmworkers may face?
  • How can the Agency effectively share health and safety information on pesticide labels with farmworkers? What should on-the-ground logistics look like? Which entities (e.g., community-based organizations) should the Agency work with to provide label information to farmworkers? 
  • As the Agency implements actions to meet this requirement, how can EPA effectively increase farmworker access to bilingual pesticide labels (e.g., communication plans, outreach strategies)? 

Attendees have two options for webinar participation – listen only or listen and speak during the webinar to provide recommendations to EPA. Speakers will have up to three minutes to provide recommendations to the Agency depending on the number of participants interested in providing remarks. Speakers must register for the event by Friday, June 9th. Attendees can register any time until the start of the webinar as a listen only participant. Further logistics and information will be provided to participants through the Eventbrite system. 

Following the webinar, EPA will open a comment period for 60 days through a Federal Register Notice to obtain written input on ways to make bilingual pesticide labeling accessible to farmworkers. Further information about the public docket will be provided during the event and in future EPA announcements.  

Stakeholders are encouraged to share this announcement with their networks. This webinar will be held in English with Spanish and American Sign Language interpretation services. For general inquiries about this webinar, email: OPPbilinguallabels@epa.gov. 

EPA Opens Public Comment on Draft Guidance for Pesticide Application Submissions that Require Endangered Species Act Reviews

This original announcement was published by the EPA on May 17, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is seeking public comment on draft guidance to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. This guidance, when finalized, fulfills requirements outlined in the Pesticide Registration Improvement Act of 2022 (PRIA 5) and furthers goals outlined in EPA’s 2022 ESA Workplan to protect listed species from exposure to pesticides.  

Among other requirements, PRIA 5 mandates that EPA develop and issue guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from outdoor uses of pesticide products on listed species and designated critical habitat. PRIA 5 specifies that the draft guidance be available for public comment and be finalized within nine months of PRIA 5 issuance. 

The draft guidance applies to:

  • New conventional pesticides and biopesticides that are intended for outdoor use; and 
  • Existing conventional pesticides and biopesticides that are intended for outdoor use that are being reevaluated under registration review. 

Although this document does not create new requirements for applicants, the recommendations in the guidance will help applicants address potential effects to listed species for new active ingredients and registration review actions. In particular, the recommendations focus on actions that applicants can voluntarily pursue to inform their proposed mitigation measures for listed species. These actions include identifying where a pesticide will be used, how species may be exposed to the pesticide, and how to select mitigation to reduce the exposure. If followed, these recommendations should expedite the FIFRA action and improve the efficiency of the overall ESA-FIFRA process.

Guidance for new uses of existing active ingredients will be made available at a later date. 

The draft guidance, which incorporates lessons EPA has learned over the past several years as it has worked to implement EPA’s ESA workplan, is available for public comment in docket EPA-HQ-OPP-2023-0281 at www.regulations.gov for 30 days.   

Upcoming Virtual Public Meeting on Formaldehyde Studies

This original announcement was published by the EPA on May 9, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) will hold a virtual public meeting on May 16-18, 2023, from 1:00 – 5:00 pm Eastern Time to consult the Human Studies Review Board (HSRB), an independent advisory committee, about the scientific and ethical conduct of two human health studies on formaldehyde, as well as a draft weight of evidence document on the use of human studies for evaluating formaldehyde’s acute respiratory effects.  

Under EPA’s Human Studies Rule, this consultation is required for all studies that involve intentional exposure of human subjects to a substance or pesticide. This consultation process ensures that EPA relies on research that meets the appropriate standards for protection of human subjects.  

EPA is currently developing a draft Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) risk assessment for formaldehyde’s use as a pesticide and a draft risk evaluation of formaldehyde under the Toxic Substances Control Act (TSCA). The Agency will consider the studies being reviewed by the HSRB along with other studies as part of the FIFRA and TSCA assessments.  

Visit EPA’s website for the materials that will be discussed at the HSRB meeting, including the relevant studies, EPA’s science and ethics reviews of these studies, and the weight of evidence document that will be considered by HSRB.  

Register for the meeting here.  

Background on EPA’s Draft IRIS Assessment of Formaldehyde  

EPA’s IRIS Program released a draft health assessment on formaldehyde for review and comment in April 2022, that provided scientific support for evaluating health risks from chronic exposure to formaldehyde through inhalation. The two controlled human exposure studies that will be presented to the HSRB at the upcoming meeting in May were used in the IRIS assessment to inform conclusions on how inhaled formaldehyde can irritate the eyes, nose and throat. EPA received public comments on the IRIS document and is now in the process of independent scientific peer review managed by the National Academies of Sciences, Engineering, and Medicine (NASEM). On Oct. 12 and Dec. 22, 2022, and on Jan. 20, 2023, NASEM held public meetings on the Review of EPA’s 2022 Draft Formaldehyde Assessment. The NASEM review is assessing whether EPA’s draft IRIS assessment was adequate and transparent in evaluating the scientific literature and used appropriate methods to synthesize the science. NASEM is also reviewing conclusions that were informed by the two controlled human exposure studies the HSRB will be reviewing at the May meeting. 

To learn more about EPA’s assessment of formaldehyde, visit EPA’s website.  

EPA Takes Next Step in the Endangered Species Act Review of Three Neonicotinoids

This original announcement was published by the EPA on May 6, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is releasing new analyses identifying federally endangered or threatened (listed) species that it predicts face the greatest risks from clothianidin, imidacloprid, and thiamethoxam, part of a group of insecticides known as neonicotinoids used on a variety of crops, turf, and ornamentals, and for other residential and commercial indoor and outdoor uses. While these types of analyses—which predict which species could be at jeopardy and which critical habitats could face adverse modification from the use of these pesticides—have not historically been part of EPA’s Endangered Species Act (ESA) assessments, EPA has recently conducted some of these analyses in order to expedite ESA consultations with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services). The analyses will also help EPA and the Services prioritize mitigation measures for the highest risk species. These analyses were completed as part of EPA’s efforts to meet its obligations under the ESA and furthers the goals outlined in EPA’s April 2022 ESA Workplan to provide practical protections for listed species from pesticides.

EPA finalized biological evaluations (BEs) for clothianidin, imidacloprid, and thiamethoxam in June 2022. The BE is EPA’s determination of whether the continued registration of these insecticides will have an effect on each listed species or its designated critical habitat. When EPA makes a “may affect” determination, the Agency also determines if continued registration will likely adversely affect (LAA) or not likely adversely affect (NLAA) a listed species or critical habitat.

In the final BEs, the Agency made numerous LAA determinations. An LAA determination means that EPA reasonably expects that at least one individual of any listed species may be exposed to a chemical at a sufficient level to have an adverse effect. This is the case even if a listed species is almost recovered to a point where it may no longer need to be listed. The likely “take,” which includes unintentional harm or death, of even one individual of a species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

Whenever EPA makes an LAA determination, the Agency consults with the Services, which will analyze whether those impacts rise to the level of jeopardizing the existence of the entire species or adversely modifying its critical habitat. The Services’ analysis is typically complex and time consuming. To help expedite this analysis, EPA in its BE has predicted whether each of the three pesticides could lead to a future jeopardy or adverse modification finding for each species or critical habitat with an LAA finding. Although EPA has made these predictions, the Services are responsible for making the actual jeopardy/adverse modification findings and have the sole authority to do so.

Below are the findings from the BEs and the new analyses on jeopardy and adverse modification (last two bullets). The BEs evaluated the effects of the three neonicotinoids on over 1,700 listed species and over 800 critical habitats in the United States.

Clothianidin

  • Will have no effect on 16% of species and 17% of critical habitats;
  • May affect but is not likely to adversely affect 20% of species and 27% of critical habitats;
  • Is likely to adversely affect but EPA predicts that use will not likely cause jeopardy to 55% of listed species or adversely modify 52% of critical habitats;
  • Is likely to adversely affect and EPA predicts that use may cause jeopardy to 9% of listed species and adversely modify 4% of critical habitats.

For more information on clothianidin, see https://www.epa.gov/endangered-species/final-national-level-listed-species-biological-evaluation-clothianidin.

Imidacloprid

  • Will have no effect on 15% of species and 13% of critical habitats;
  • May affect but is not likely to adversely affect 13% of species and 11% of critical habitats;
  • Is likely to adversely affect but EPA predicts that use will not likely cause jeopardy to 61% of listed species or adversely modify 73% of critical habitats;
  • Is likely to adversely affect and EPA predicts that use may cause jeopardy to 11% of listed species and adversely modify 3% of critical habitats.

For more information on imidacloprid, see https://www.epa.gov/endangered-species/final-national-level-listed-species-biological-evaluation-imidacloprid.

Thiamethoxam

  • Will have no effect on 15% of species and 13% of critical habitats;
  • May affect but is not likely to adversely affect 14% of species and 10% of critical habitats;
  • Is likely to adversely affect, but EPA predicts that use will not likely cause jeopardy to 60% of listed species or adversely modify 73% of critical habitats;
  • Is likely to adversely affect and EPA predicts that use may cause jeopardy to 11% of listed species and adversely modify 4% of critical habitats.

For more information on thiamethoxam, see https://www.epa.gov/endangered-species/final-national-level-listed-species-biological-evaluation-thiamethoxam.

Next Steps

These neonicotinoids are also currently undergoing registration review. Proposed Interim Decisions (PIDs) for these neonicotinoids were released in January 2020.

EPA anticipates releasing amended proposed interim decisions later this year that will include additional ecological mitigation measures to reduce neonicotinoid exposures for non-target organisms, including some listed species for which EPA has predicted that jeopardy is likely.

EPA expects to finalize these additional mitigation measures in interim decisions, which the Agency foresees releasing in 2024. EPA will inform the Services of any additional mitigations identified during registration review, which may be considered during formal consultation.

During formal consultation, the Services use EPA’s effects determinations and jeopardy/adverse modification predictions to inform their biological opinions, which will include their final determinations of jeopardy/adverse modification. Prior to issuing the final biological opinions, the Services will provide a draft opinion to EPA, which the Agency will share for public comment. EPA will summarize and provide all comments to the Services for consideration as they complete the final opinion.

Learn about the updated review schedule for neonicotinoid pesticides by visiting EPA’s website: Schedule for Review of Neonicotinoid Pesticides

EPA Proposes Registration of New Pesticide for Use on Rice

This original announcement was published by the EPA on April 17, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) has released for public comment its proposed registration decision for granular pesticide products containing the new active ingredient pyraclonil to control weeds in water-seeded rice in California. EPA’s proposed registration decision includes measures to protect non-target organisms, including federally endangered and threatened (listed) species and their designated critical habitats. In addition to its proposed registration decision, EPA has also released its draft biological evaluation (BE) for this pesticide under the Endangered Species Act (ESA). Today’s action furthers the goals outlined in EPA’s April 2022 ESA Workplan by identifying potential effects to listed species and proposing protective measures prior to pesticide registration.

Background on Pyraclonil

Pyraclonil is formulated as a dust free granule that would be applied aerially to flooded rice paddies. Currently, it is intended for pre- and early post-emergence control of grass, sedge and broadleaf weeds in water-seeded rice in California only. Notably, pyraclonil would help control barnyard grass and watergrass, two problematic weed species for rice growers in the state.

Additionally, pyraclonil would be a useful addition to Integrated Pest Management and Weed Resistance Management programs for water-seeded rice in California. Rice producers in this area would be able to use pyraclonil in rotation with herbicides that have other modes of action, reducing the potential for herbicide resistance.

Results of EPA’s Risk Assessments and Draft Biological Evaluation

Before issuing this proposed registration decision, EPA assessed whether exposures to these products (one end-use product and one technical product) would cause unreasonable adverse effects to human health and the environment, as required by the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA). Based on EPA’s human health risk assessment, there are no human health risk concerns from the proposed uses of pyraclonil. However, EPA’s ecological risk assessment identified several risks of concern to the environment, including risks to aquatic plant species, listed and non-listed freshwater fish, listed and non-listed estuarine and marine invertebrates, and listed mammals.

Consistent with the ESA workplan, the Agency also evaluated the effects of the proposed registration (taking into account any mitigations proposed on the draft label by the registrant) on listed species and critical habitats. EPA’s draft BE finds that pyraclonil:

  • Will have no effect on 212 listed species and 39 critical habitats;
  • May affect but is not likely to adversely affect 6 listed species; and
  • Is likely to adversely affect (LAA) 12 listed species and 10 critical habitats.

An LAA determination means that EPA reasonably expects that at least one individual animal or plant, among a variety of listed species, may be exposed to pyraclonil at a sufficient level to have an adverse effect. This is the case even if a listed species is almost recovered to a point where it may no longer need to be listed. The likely “take,” which includes unintentional harm or death, of even one individual of a species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations in a BE. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

EPA further refined its analysis for the species for which it made LAA determinations to predict the likelihood that pyraclonil use could lead to a future jeopardy finding for  listed species or adverse modification finding for critical habitats. These predictions examine effects of pyraclonil at the species scale (as opposed to an individual of a species). EPA predicts the originally proposed uses of pyraclonil would present a likelihood of jeopardy for two listed species (Sacramento River winter-run Chinook Salmon and Central Valley spring-run Chinook Salmon) but no adverse modification to critical habitats. EPA has therefore determined that additional mitigations are necessary to address effects to these listed species.

Proposed Protections

EPA is proposing to require:

  • A water holding period in treated rice paddies after pyraclonil is applied to minimize pyraclonil off-site movement to non-target areas in which listed species live; and
  • Practices to 1) prevent water seepage from treated rice paddies through berms and levees, and 2) minimize overspray of pyraclonil granules onto berms and levees.

In accordance with the ESA Workplan, EPA is also proposing a requirement that users must check the Bulletins Live Two! website to identify whether there are any areas where the pesticide cannot be used. Currently there are no area restrictions; however, the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) may determine these mitigations are necessary during their review.

With these proposed mitigations in place, EPA predicts that approving the use of pyraclonil would not result in unreasonable adverse effects to non-target organisms or present a likelihood of jeopardy to these species.

Next Steps

After considering public comments on the proposed registration and the draft BE, EPA will determine whether the registration action meets the FIFRA standard and ESA obligations. If EPA determines that the registration action can be granted, EPA will finalize the BE. If a final BE continues to find that pyraclonil is likely to adversely affect listed species and/or their critical habitats, then EPA will initiate formal consultation and share its findings with the Services, as appropriate.

During formal consultation, the Services use the information in EPA’s final BE to inform their biological opinions. While EPA has made predictions about the likelihood of jeopardy and adverse modification as part of its effects determinations, the Services are responsible for making the actual jeopardy/adverse modification findings and have the sole authority to do so. If the Services determine in their final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination or to address any incidental take, then EPA will work to ensure that any necessary registration or labeling changes are made.

EPA is accepting public comments on this proposal and its supporting documents via docket EPA-HQ-OPP-2020-0004 at www.regulations.gov for the next 30 days.

EPA Proposes New Standards to Protect Public Health, Reduce Exposure to Ethylene Oxide Pollution

This original announcement was published by the EPA on April 11, 2023. Click here for more information! 

WASHINGTON (April 11, 2023) – 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 proposal advances President Biden’s commitment to ending cancer as we know it as part of the Cancer Moonshot and the Administration’s commitment to securing environmental justice and protecting public health, including for communities that are most exposed to toxic chemicals.

“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” said EPA Administrator Michael S. Regan. “These proposals build on EPA’s extensive outreach to communities across the nation and reflects close coordination among key federal partners. Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide. EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections.”

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.

“OSHA’s mission is to ensure safe and healthful working conditions for workers,” said Doug Parker, Assistant Secretary of Labor for Occupational Safety and Health, “We will continue our partnership with EPA and other federal agencies to reduce risks for people who work every day to maintain our nation’s vital medical device supply chain.”

Reducing Air Emissions to Protect Communities

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.

New Safeguards to Protect Workers, Communities, and Reduce Exposure

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.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides like EtO. EPA is now proposing to increase control measures on the use of EtO in the Proposed Interim Decision, such as:

  • Prohibiting certain uses of EtO where alternatives exist including use in museums, archival settings, beekeeping, some cosmetics, and musical instruments;
  • Reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance;
  • Requiring engineering controls that reduce worker exposures to EtO, such as automation or emissions capture technology; and
  • Mandating Personal Protective Equipment (PPE) in sterilization facilities when EtO is detected using state-of-the-art monitoring technology.

Some commercial sterilization facilities have already successfully implemented some of these measures, including reducing the amount of EtO used for sterilization and installing engineering controls that reduce worker  and community exposures. EPA’s proposal would now require these measures nationwide to further protect workers at EtO commercial sterilization facilities and healthcare facilities and people in communities near these facilities. The proposal includes different timelines for controls depending on their complexity and feasibility. For example, workers can use respirators far more quickly than it takes to reengineer control systems.

EPA is proposing unprecedented real-time monitoring of EtO using technology that can accurately measure EtO within sterilization facilities down to 10 parts per billion (ppb). If levels surpass 10 ppb, workers would be required to wear PPE.  EPA is also instructing industry to develop technologies and methods to identify lower concentrations of EtO, below 10 parts per billion (ppb), inside contract 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 Proposal Driven by Latest Science

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.

For more information about EPA’s risk findings, visit EPA’s webpage and/or read EPA’s Draft Risk Assessment Addendum.

Next Steps

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.

In addition to the proposed measures announced today, EPA continues to take significant action to address EtO and advance critical EtO research. These actions include:

Additionally, EPA announced a separate action last week to reduce risk from EtO to people who live near facilities that make and use EtO in manufacturing.

For more information on EtO, please visit EPA’s website

EPA Proposes New Standards to Protect Public Health, Reduce Exposure to Ethylene Oxide Pollution

This announcement was published by the EPA on April 11, 2023. Click here for more information.

 

Proposals would slash Ethylene Oxide emissions by 80% per year, require stronger worker protections

Contact: EPA Press Office (press@epa.gov)

WASHINGTON (April 11, 2023) – 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 proposal advances President Biden’s commitment to ending cancer as we know it as part of the Cancer Moonshot and the Administration’s commitment to securing environmental justice and protecting public health, including for communities that are most exposed to toxic chemicals.

“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” said EPA Administrator Michael S. Regan. “These proposals build on EPA’s extensive outreach to communities across the nation and reflects close coordination among key federal partners. Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide. EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections.”

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.

“OSHA’s mission is to ensure safe and healthful working conditions for workers,” said Doug Parker, Assistant Secretary of Labor for Occupational Safety and Health, “We will continue our partnership with EPA and other federal agencies to reduce risks for people who work every day to maintain our nation’s vital medical device supply chain.”

Reducing Air Emissions to Protect Communities

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.

New Safeguards to Protect Workers, Communities, and Reduce Exposure

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.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides like EtO. EPA is now proposing to increase control measures on the use of EtO in the Proposed Interim Decision, such as:

  • Prohibiting certain uses of EtO where alternatives exist including use in museums, archival settings, beekeeping, some cosmetics, and musical instruments;
  • Reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance;
  • Requiring engineering controls that reduce worker exposures to EtO, such as automation or emissions capture technology; and
  • Mandating Personal Protective Equipment (PPE) in sterilization facilities when EtO is detected using state-of-the-art monitoring technology.

Some commercial sterilization facilities have already successfully implemented some of these measures, including reducing the amount of EtO used for sterilization and installing engineering controls that reduce worker  and community exposures. EPA’s proposal would now require these measures nationwide to further protect workers at EtO commercial sterilization facilities and healthcare facilities and people in communities near these facilities. The proposal includes different timelines for controls depending on their complexity and feasibility. For example, workers can use respirators far more quickly than it takes to reengineer control systems.

EPA is proposing unprecedented real-time monitoring of EtO using technology that can accurately measure EtO within sterilization facilities down to 10 parts per billion (ppb). If levels surpass 10 ppb, workers would be required to wear PPE.  EPA is also instructing industry to develop technologies and methods to identify lower concentrations of EtO, below 10 parts per billion (ppb), inside contract 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 Proposal Driven by Latest Science

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.

For more information about EPA’s risk findings, visit EPA’s webpage and/or read EPA’s Draft Risk Assessment Addendum.

Next Steps

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.

In addition to the proposed measures announced today, EPA continues to take significant action to address EtO and advance critical EtO research. These actions include:

Additionally, EPA announced a separate action last week to reduce risk from EtO to people who live near facilities that make and use EtO in manufacturing.

For more information on EtO, please visit EPA’s website

EPA Publishes Updated Registration Review Schedule

This original announcement was published by the EPA on April 10, 2023. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) is releasing an updated registration review schedule for the next three years to provide a roadmap and advance notice of actions for stakeholders. This update reflects the four-year extension for the registration review deadline provided for in the FY 2023 budget. The deadline for the completion of registration review final decisions is now October 1, 2026, for the pesticides registered before October 1, 2007.  

This schedule update also reflects some of the broader policies that EPA is pursuing. For example, the registration review schedules for the rodenticides and many of the herbicides, insecticides, and fungicides are in-line with the Agency’s Endangered Species Act strategies for these pesticide types over the next four years. The schedule is designed to allow EPA to adopt consistent mitigation measures across the chemicals and to improve the efficiency of its registration review work. EPA affirms its plan to continue the review of remaining pesticide cases and issue decisions to protect people, endangered species, and the environment, while providing pesticide users with predictability about the legal status of pesticides in registration review.    

In 2007, an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) formalized a requirement that EPA review each registered pesticide at least once every fifteen years to ensure that it can still be used without unreasonable adverse effect on human health or the environment. During the registration review process, EPA completes draft risk assessments, proposed interim decisions/proposed final decisions, and interim decisions/final decisions. Registration review decisions also require compliance with the Endangered Species Act. Throughout the registration review process, EPA makes its information, assessments and supporting material for each case available to the public through the case’s docket at www.regulations.gov.   

When EPA identifies risks of concern to human health or the environment, it imposes pesticide label amendments designed to reduce risk. Mitigation measures can include the cancellation of uses or pesticide registrations, reduced application rates, spray drift restrictions, use of personal protective equipment, and advisory language. If EPA determines there are urgent human or environmental risks from pesticide exposures that require prompt attention, the Agency can take appropriate regulatory action, regardless of the registration review status of the pesticide.   

By following the science and making evidence-based decisions that rely on the input of career scientists, EPA will continue to ensure that risk assessments and regulatory decisions reflect the best available public health and ecological science. 

The original registration review deadline for the 726 pesticides registered before October 1, 2007, was October 1, 2022. While EPA has completed final or interim decisions for all but 144 of the 726 total pesticide cases, the Agency has been delayed in its ability to issue many final decisions. This delay is due to the demands of focusing resources to respond swiftly to COVID-19 antimicrobial actions, delays in receiving data from registrants, a lack of resources to respond to ongoing and increasing litigation, and the scientific complexity associated with many of the pesticides yet to go through the registration review process. EPA also must comply with the Endangered Species Act obligations and complete cumulative risk assessments before its registration review work can be finalized.  

In addition to the 726 cases registered before October 1, 2007, there are 63 cases registered after October 1, 2007, with a registration review deadline prior to October 1, 2026. To date, for these 789 cases, EPA has:  

  • Completed draft risk assessments for 90% of total number of cases. 
  • Completed proposed interim decisions or proposed final decisions for 85% of total number of cases. 
  • Issued interim decisions for 57% of total number of cases. 
  • Issued final decisions for 20% of total number of cases. 
  • Of the interim or final decisions, more than 15% of the total number of cases resulted in cancellations of some or all uses. 

Registration Review Process

As the Agency works through the remaining priority registration review actions, it will continue to maintain an open and transparent process by accepting public comments at most stages of the registration review process. In addition, EPA will update the schedule generally on a quarterly basis going forward. 

EPA Releases Final Biological Evaluation for Effects of Sulfoxaflor on Federally Listed Endangered and Threatened Species and Designated Critical Habitats

This original announcement was published by the EPA on March 30, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) has released its final biological evaluation (BE) and its response to comments received on the draft BE. Sulfoxaflor is an insecticide used on a variety of crops to target difficult pests such as aphids and tarnished plant bugs (lygus). As an alternative to older insecticides including carbamates, neonicotinoids, organophosphates, and pyrethroids, sulfoxaflor typically requires fewer applications resulting in less exposure to non-target pests and plants.

In the BE, EPA evaluated sulfoxaflor to determine the potential effects on federally listed endangered and threatened (listed) species and their designated critical habitats, along with predictions of whether sulfoxaflor is likely to jeopardize endangered and threatened (listed) species or adversely modify designated critical habitats. The BE is part of EPA’s efforts to meet its obligations under the Endangered Species Act (ESA). This work furthers the goals outlined in EPA’s April 2022 ESA Workplan to provide practical protections from pesticides for listed species.

EPA carefully considered the comments on the draft BE received during the public comment period in 2022. Additionally, since the draft BE was issued, the registrant provided comments and submitted revised proposed labels that EPA incorporated in the analysis for the final BE. The revised proposed labels, once approved, would decrease exposure (e.g., reducing aerial application rates for certain use patterns, prohibiting aerial application for certain uses) which resulted in a reduction of the “likely to adversely affect” determinations and jeopardy/adverse modification predictions in the final BE.

In the final BE, and taking into account the new mitigations in the revised proposed labels, EPA evaluated the effects of sulfoxaflor on more than 1,700 listed species and more than 800 designated critical habitats in the United States, determining that sulfoxaflor:

  • Will cause no effect to 47 percent of listed species and 54 percent of critical habitats (as compared to 36 percent and 52 percent, respectively from the draft BE, which did not include the mitigations in the revised proposed labels);
  • May affect but is not likely to adversely affect 22 percent of listed species and 37 percent of critical habitats (as compared to 30 percent and 35 percent, respectively, from the draft BE, which did not include the mitigations in the revised proposed labels);
  • Is likely to adversely affect but EPA predicts the likelihood that use will not cause jeopardy to 27 percent of listed species or adversely modify 6 percent of critical habitats (as compared to 27 percent and 9 percent, respectively from the draft BE which did not include the mitigations in the revised proposed labels); and
  • Is likely to adversely affect and EPA predicts the likelihood that use may cause jeopardy to 4 percent of listed species and adversely modify 3 percent of critical habitats (as compared to 7 percent and 4 percent, respectively from the draft BE which did not include the mitigations in the revised proposed labels).

This LAA determination means EPA reasonably expects at least one individual animal or plant, among a variety of listed species, may be exposed to sulfoxaflor at a sufficient level to have an adverse effect. This is the case even if a listed species is almost recovered to a point where it may no longer need to be listed. The likely “take,” which includes unintentional harm or death, of even one individual of a species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations in a BE. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

Since EPA determined that sulfoxaflor is likely to adversely affect certain listed species and/or critical habitats, the Agency has initiated formal consultation with the U.S. Fish and Wildlife Service and National Marine Fisheries Service (collectively “the Services”). EPA will also continue discussions with the registrant to determine what additional mitigation measures could be implemented to further protect listed species and critical habitats while the consultation is ongoing.

During formal consultation, the Services use EPA’s effects determinations to inform their biological opinions, which will include their final determinations of whether a pesticide jeopardizes each relevant listed species and/or adversely modifies designated critical habitats. The Agency intends to work with the sulfoxaflor registrant, as well as the Services and other stakeholders, during the formal consultation process to identify additional mitigation measures to protect listed species and/or designated critical habitats.

The final BE and the response to comments are available in docket EPA-HQ-OPP-2010-0889 on regulations.gov.