EPA Releases Risk Assessment Showing Significant Risks to Human Health from the Herbicide DCPA

This original announcement was published by the EPA on May 31, 2023. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) is taking an important step to determine whether the herbicide dimethyl tetrachloroterephthalate (DCPA) can continue to be used safely in light of significant health risks identified. The Agency is releasing and requesting public comment on an Occupational and Residential Exposure (ORE) assessment on pesticide products containing DCPA, showing risks to workers and others exposed to the pesticide, with the most serious of risks to the fetuses of pregnant individuals. Additionally, EPA is releasing a companion document summarizing EPA’s ongoing review of DCPA, the health risks the Agency has identified, and potential next steps for the Agency. Given the potential for serious, permanent, and irreversible health risks, EPA is considering whether feasible mitigation measures exist that would address these potential risks or whether canceling the registration of all products containing DCPA is necessary. Given the potential that cancellation of this pesticide could take several years to complete, EPA is releasing this assessment in order to provide the public with timely information about its risks. 

Background on DCPA  

DCPA is an herbicide registered to control weeds in both agricultural and non-agricultural settings. Agricultural crops include cole crops (e.g., broccoli, Brussels sprouts, cabbage), onions, and other vegetables. Non-agricultural uses include non-residential turf and ornamentals. 

DCPA is currently undergoing registration review, a process that requires re-evaluation of registered pesticides every 15 years to ensure that as the ability to assess risk evolves and as policies and practices change, pesticides continue to meet the statutory standard of causing no unreasonable adverse effects on human health or the environment.  

The data EPA examined showed that the dose that caused adverse effects in the fetuses of pregnant rats exposed to DCPA was very low, and these effects were observed at a dose lower than the dose that affected the pregnant rats themselves. Significant thyroid hormone changes were observed in the fetuses in a 2022 study that EPA had ordered the registrant for DCPA to conduct in 2013. In general, changes in fetal thyroid hormones are linked to low birth weight, impaired brain development, decreased IQ, and impaired motor skills observed later in life. These thyroid hormone effects are harmful to the fetuses of individuals of child-bearing age that could be exposed to DCPA. The differences in the doses affecting the pregnant rats and their fetuses, extrapolated to humans, mean that a pregnant individual could be exposed to DCPA without experiencing adverse health effects to their own body, while the fetus being carried could experience permanent and significant lifelong adverse effects. 

In 2013, the Agency issued a Data Call-In to the pesticide registrant, AMVAC, requiring it to submit more than 20 studies to support the existing registrations of DCPA. Between 2013 and 2021, numerous studies submitted by AMVAC were deemed insufficient by the Agency, and some studies, including the thyroid toxicity test, had not been submitted. In April 2022, EPA issued a Notice of Intent to Suspend (NOITS) for the DCPA technical-grade (high-concentration) product based on the registrant’s failure to submit the complete set of required data, leaving large uncertainties in risk estimates, including data on DCPA’s thyroid toxicity. In August 2022, after the issuance of the NOITS, the Agency received the thyroid toxicity data that showed the significant changes in the fetal thyroid effects discussed above. 

Occupational and Residential Exposure Assessment and Companion Document  

The Agency found that based on the currently allowed uses of DCPA, there is potential for some people to be exposed to DCPA at levels approaching those that, based on the rat thyroid toxicity test, are expected to result in adverse effects in humans. For the most common uses of DCPA, there are risks of concern for workers applying and supporting applications of DCPA, using typical equipment at the maximum application rate, even when personal protective equipment and engineering controls are used. There are specific concerns for the fetuses of pregnant individuals who apply DCPA. Based on current labels, some pregnant individuals could be subjected to exposures from 10 to 1,500 times greater than what is considered safe.  

Furthermore, risks to fetuses of individuals entering areas where DCPA has already been applied (post-application workers involved in tasks such as transplanting, weeding, and harvesting) are of concern. In addition, living near areas treated with DCPA could also put the fetuses of pregnant individuals at risk. While DCPA does not appear to be widely used on turf, based on the current label directions that allow such use, there are also potential risks of concern for individuals using turf golf courses and athletic fields long after DCPA is applied. The labels currently specify that entry into treated fields must be restricted for 12 hours after application. However, for many crops and tasks, levels of DCPA in the previously treated fields remain of concern for 30 days or more.    

In addition to the ORE assessment, EPA is releasing a companion document that summarizes the Agency’s findings from the thyroid toxicity data received in response to a DCPA Generic Data Call-in and explains the regulatory approach the Agency is considering to address the risks identified in the ORE assessment, in line with the Agency’s commitment to sound science and protecting human health. EPA is also publishing relevant supporting documents, including an analysis of the benefits associated with the use of DCPA. Given the breadth and severity of the potential risks identified by the Agency, the Agency’s current efforts are to determine whether effective and feasible mitigation strategies exist to fully address these risks, and barring any new information provided by public comments, the Agency is considering whether cancelation of all uses and registrations for products containing DCPA is necessary. 

Upon publication of the Federal Register notice, EPA will accept public comments on the ORE assessment and its anticipated regulatory approach for DCPA for 30 days—with no extension—in docket EPA-HQ-OPP-2011-0374 at www.regulations.gov. EPA will carefully consider public input when addressing these risks. The Agency is committed to transparency as it moves forward with regulatory action on DCPA and will keep the public advised of prospective actions in the registration review process for DCPA. 

EPA Completes Scientific Testing of Pesticide Products for PFAS

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

 

Today, the U.S. Environmental Protection Agency (EPA) is taking another step in addressing concerns that per- and polyfluoroalkyl substances (PFAS) have been found in pesticide products by releasing a summary of the laboratory analysis of 10 pesticide products reported to contain PFAS residues. EPA did not find any PFAS in the tested pesticide products, differing from the results of a published study in the Journal of Hazardous Materials. EPA is also releasing its newly developed and validated analytical methodology used in the testing process alongside the summary of its findings. EPA is confident in the results of this newly released method, which is specifically targeted to detect the presence of PFAS in pesticide products formulated with surfactants.   

Since learning about potential PFAS contamination in a small number of mosquitocide products in September 2020, EPA has taken a number of steps to address this issue. This includes releasing data in March 2021 that preliminarily determined that PFAS in those specific products was most likely formed from a chemical reaction during the container fluorination process which then leached into the pesticide product, releasing another study in September 2022 testing the leaching potential of PFAS over a specific time into test solutions packaged in different brands of HDPE fluorinated containers, and notifying manufacturers (including importers), processors, distributors, users, and those that dispose of fluorinated HDPE containers and similar plastics that the presence of PFAS formed as a byproduct in these containers may be a violation of the Toxic Substances Control Act. Following that notification, the Department of Justice, on behalf of EPA, filed a complaint against Inhance, the company that manufactured the plastic mosquitocide containers in which PFAS was found, for its failure to comply with TSCA’s notice, review, and determination requirements prior to manufacture.  

As a continuation of these ongoing efforts, EPA has completed its verification analysis of a study published in September 2022 in the Journal of Hazardous Materials entitled “Targeted analysis and Total Oxidizable Precursor assay of several insecticides for PFAS.” This study reported the presence of PFOS in six of 10 pesticide products tested. 

EPA evaluated the 10 pesticide products included in this study using two different test methods to detect PFAS. The first method was developed by the Agency to specifically measure PFAS in pesticide samples containing surfactants and non-volatile oils, and the second method was used in the study published in the Journal of Hazardous Materials. 

EPA obtained samples of the specific pesticide products from the study author and purchased additional products with the same EPA registration numbers on the open market to conduct analyses. EPA tested all samples using both methods and   did not detect the presence of PFOS, nor any of 28 additional PFAS it screened for, above the lowest level that our lab instruments can detect (0.2 parts per billion) in any of the pesticide products using either method of detection. The equipment and methodology used by EPA would have shown PFAS detections if present in those pesticide products given that our level of detection (LOD) is 2,500 times more sensitive than the LOD reported by the equipment used by the study author. EPA requested additional information, including raw data from the study author, but did not receive any beyond the published results. EPA’s study report contains additional scientific details regarding how the two methods differ and the significance of using the Agency’s new method when testing these specific formulations. 

One of the most important differences between the two methods is that EPA’s method ensures accurate measuring of PFAS by eliminating interference from the oils and surfactants present in these formulations which can result in false positive detections.  

EPA’s PFAS Strategic Roadmap renewed the Agency’s commitment to using sound science and investing in research to proactively stop PFAS chemicals from entering the environment. This latest action is an important step in EPA’s ongoing efforts to better understand and manage, when necessary, pesticide formulations that contain PFAS to ensure enduring and protective solutions. As part of our continuing efforts, EPA will continue to invest in scientific research to fill gaps in understanding of PFAS, to identify which PFAS may pose human health and ecological risks at which exposure levels and develop methods to better test and measure them.  

EPA Seeking Public Comment on Candidates to be ad hoc Reviewers for Analysis of Atrazine Ecological Risks

This original announcement was published by the EPA on May 24, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is accepting public comments on candidates who are being considered as ad hoc reviewers to assist the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) with the review of the Agency’s analysis and assessment of ecological risk from atrazine use. This 15-day comment period follows a March 2023 call for nominations.  

Approximately 8-12 ad hoc reviewers will be selected to assist with the review. The review will take place during the August 22-24, 2023, public meeting from 10:00 a.m. to approximately 5:00 p.m. EDT. Registration information for the meeting will be announced on the FIFRA SAP website in July. 

Public comments on the nominees should be submitted to docket EPA-HQ-OPP-2023-0154 on www.regulations.gov. The public comment period will begin on May 24, 2023, and end on June 8, 2023. These comments will be used to assist the Agency in selecting the ad hoc reviewers. Biographies for each of the nominees are available in the docket.  

When submitting comments, follow the online instructions. Do not electronically submit any information you consider to be confidential business information or other information where disclosure is restricted by statute. Copyrighted material will not be posted without explicit permission of the copyright holder. Members of the public should also be aware that personal contact information, if included in any written comments, may be posted on the internet at www.regulations.gov.   

The FIFRA SAP serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice and recommendations to EPA on health and safety issues related to pesticides. 

For additional information, please contact the Designated Federal Official, Tamue Gibson, at gibson.tamue@epa.gov or 202-564-7642. 

EPA Extends Comment Periods for Ethylene Oxide (EtO) Proposals

This original announcement was published by the EPA on May 25, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is announcing a 15-day extension of the comment period for the ethylene oxide (EtO) proposed interim decision and draft risk assessment addendum under the Federal Insecticide, Fungicide, and Rodenticide Act, as well as the proposed air toxics rule for EtO commercial sterilizers. These two proposals, issued on April 11, 2023, will provide a comprehensive approach to addressing EtO pollution concerns that will increase safety in communities and for workers. Several State, local and industry groups requested more time to review the proposals. Consequently, EPA is extending the comment deadline from June 12, 2023, to June 27, 2023. 

Learn about the proposed EtO actions.

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.