EPA Proposes Early Mitigation to Help Protect Endangered Species from Methomyl

This original announcement was published by the EPA on October 1, 2022. Click here for more information.

 

In line with the Agency’s commitment to improve outcomes for all federally threatened and endangered (listed) species, the U.S. Environmental Protection Agency (EPA) is proposing revisions to the 2020 Proposed Interim Decision (PID) for methomyl, a type of insecticide. The revised methomyl PID is a pilot case for identifying and proposing early mitigation for vulnerable endangered species through the registration review process while formal endangered species consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) is ongoing. This effort initiates one of four strategies EPA identified in its comprehensive 2022 Endangered Species Act (ESA) workplan that aims to improve protection for listed species meet the Agency’s ESA obligations.

Proposed Mitigations to Protect Specific Beetle, Tadpole Shrimp and Salamander Listed Species

EPA used its Biological Evaluation (BE) to identify three “pilot” species that are likely to be adversely affected (LAA) by methomyl use: the Valley Elderberry Longhorn Beetle, the Vernal Pool Tadpole Shrimp and the California Tiger Salamander. These pilot species have a high overlap with methomyl use, generally occurring in Northern California, specifically the Sacramento and San Joaquin River valleys. They are also representative of terrestrial invertebrates, aquatic invertebrates and amphibians that are at high risk of adverse effects.

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 the pesticide at a sufficient level to have an adverse effect. The likely “take,” which is the unintentional harm or death of even one individual of a listed species, is enough to trigger an LAA determination. This is the case even if a species is almost recovered to a point where it may no longer need to be listed. 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.

To mitigate potential risks to these species, the Agency developed mitigation measures that are expected to reduce their exposure to methomyl and their likelihood of being adversely affected. Proposed mitigation measures include prohibition of methomyl use in some areas, and measures that minimize methomyl spray drift and runoff in areas that extend over the pilot species’ range and critical habitat. EPA expects that undertaking these mitigations may prevent jeopardy to these species and adverse modification of the species’ critical habitat. Although these pilot species represent a small subset of the 1098 species and 281 critical habitats that received LAA determinations for methomyl, the proposed mitigations are intended to inform options for other listed species, as appropriate, that rise to the level of preliminary jeopardy or adverse modification due to methomyl use.

To learn more about this effort, including the methods used to identify these species and how EPA’s mitigation measures are expected to be protective, read pages 4-16 of EPA’s revised PID.

Proposed Mitigations to Protect Listed Salmon Species

Additionally, EPA is proposing mitigation measures to protect listed salmon species. In 2009, the National Marine Fisheries Service published a Biological Opinion that addresses effects of methomyl on Pacific salmonids. Now, in addition to the mitigations proposed in the 2020 methomyl PID, EPA is proposing mitigation measures to implement the 2009 Biological Opinion. These mitigations will help to reduce runoff, and they will establish a maximum annual application rate of methomyl that applicators cannot exceed.

Next Steps

The revised PID represents the next step in the registration review process for methomyl. EPA anticipates publishing the revised PID in the Federal Register the week of Oct. 3, 2022. Upon publication in the Federal Register, the public can comment on the revised PID for 60 days in the methomyl registration review docket EPA-HQ-OPP-2010-0751 at www.regulations.gov. After reviewing and considering comments, EPA will determine its next steps in the registration review process.

Background on Methomyl

Methomyl is a carbamate insecticide used to control foliage and soil-borne insect pests on a variety of food and feed crops, including field vegetables and orchard crops. The only non-agriculture use of methomyl is a fly bait product.

EPA has been evaluating methomyl as part of the registration review process. This review process requires the Agency to re-evaluate pesticides every 15 years to ensure that risk assessments and pesticide decisions reflect the best available science. Under ESA, the Agency must—in consultation with the Services—ensure that its registration review decisions do not jeopardize listed species or adversely modify their designated critical habitats.

In 2020, EPA released a PID for methomyl that proposed mitigation measures to ensure that use of methomyl products will not result in unreasonable adverse effects on the environment, consistent with EPA’s obligations under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Following the release of the PID, the Agency released the BE for methomyl. The BE contains EPA’s effects determinations and analysis of the potential exposure of methomyl to listed species and their designated critical habitats.

Since EPA made a number of LAA determinations, EPA initiated consultation with the Services after the completion of the final BE in March 2021. During consultation, which is still ongoing, the Services may determine that additional measures are needed to avoid jeopardy to listed species and adverse modification of critical habitats from the use of methomyl. The Services may also identify measures to reduce the potential for take.

EPA Responds to Treated Seed Petition

This original announcement was published by the EPA on September 28, 2022. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) is issuing a response to a petition filed by the Center for Food Safety (CFS) with and on behalf of beekeeper, farmer, and public interest groups. The petitioners asked the Agency to interpret or amend the treated article exemption at 40 C.F.R. §152.25(a) so that it does not cover seeds treated with systemic pesticidesand to aggressively enforce registration and labeling requirements for such treated seed.

The petition filed in April 2017 by CFS claims that EPA did not adequately assess the risks from use of seed treatment pesticides that have systemic properties and use of the seed treated by such pesticides. The petition also claims that the treated article exemption may not cover treated seed without an adequate assessment of the risks.  

Pesticides, such as fungicides, insecticides and nematicides, are applied to seeds prior to planting to protect them from diseases, insects, or other pests. EPA explains in its response that it does fully assess, as part of its review of the pesticide registered for treating seed, both the use of the treating pesticide and the treated seed and impacts to human health and the environment. These assessments take into account the fate and effect of the pesticide, including the uptake and distribution into the developing seedling and plant and the availability of the pesticide on the treated seed to all taxa. In addition, EPA explains that the treated article exemption regulatory text appropriately covers any seed treated if it meets the two regulatory conditions. The first condition is that the treating pesticide be a FIFRA section 3 pesticide product that is registered for use as a seed treatment for the specific seed crop and the treating pesticide and treated seed are distributed, sold, and used consistent with the registered product labeling. The second condition requires that any claims made are for the protection of the seed and what the seed becomes.  

As a result, EPA does not agree with the petition claims as to the treated article exemption and thus is not granting the petition requests to either interpret or amend the regulatory text for the exemption to categorically exclude seed treated with systemic pesticides from the exemption. However, EPA agrees with the petitioners’ concerns on clearly communicating the labeling instructions to the users of the treating pesticide and the treated seed. The Agency has been reviewing labeling instructions for pesticides registered for seed treatment use(s) in registration and registration review to ensure there are complete and appropriate instructions for the distribution, sale, and use of both the treating pesticide and the treated seed.  

In addition, EPA intends to issue an advanced notice of proposed rulemaking (ANPRM) to seek additional information on whether or to what extent pesticide-treated seed is being distributed, sold, or used in a manner inconsistent with treating pesticide labeling. EPA will consider actions appropriate to the circumstances, which might include enforcement where there is a FIFRA violation or administrative action on the treating pesticide registration, e.g., to clarify labeling or reduce use of the treating pesticide. Finally, as part of the ANPRM, EPA will also explore the option of issuing a rule pursuant to FIFRA section 3(a) to regulate pesticide-treated seed to ensure distribution, sale and use of the treated seed is consistent with treating pesticide and treated seed labeling. 

To read EPA’s full response to the petition visit EPA-HQ-OPP-2018-0805 at www.regulations.gov. 

Pesticide Registration Review Deadline: Status Update and Plans for Remaining Work

This original announcement was published by the EPA on September 26, 2022. Click here for more information!

The U.S. Environmental Protection Agency (EPA) is sharing an update on its progress in meeting the Oct. 1, 2022, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration review deadline for the 726 pesticide cases registered before October 2007. Pesticides without finalized review as of this deadline can remain on the market and be used according to the product label. EPA affirms its aggressive plan to review all remaining pesticide cases and issue decisions to protect humans, endangered species, and the environment, while providing pesticide users with predictability about the legal status of pesticides in registration review.  

In the past 15 years, EPA has: 

  • Completed 685 draft risk assessments (94% of total number of cases), evaluating the potential for human health and ecological effects of a pesticide. 
  • Completed 633 proposed interim decisions or proposed final decisions (87% of total number of cases), which present EPA’s responses to public comment on draft risk assessments and which propose label mitigations and/or restrictions so that a pesticide product can continue to be used safely.   
  • Issued 431 interim decisions (60% of total number of cases), which explain any changes to what had been proposed, respond to significant public comments, and require registrants to submit any product label amendments needed to protect human health and the environment. EPA’s issuance of interim decisions is an important way in which EPA has secured crucial human health and environmental protections and provided pesticide registrants and growers some regulatory certainty. 
  • Issued 151 final decisions (21% of total number of cases), which document any changes to what had been proposed, respond to significant public comments, and require registrants to submit any product label amendments needed to protect human health and the environment. 
  • Of the 582 interim or final decisions, 140 cases resulted in cancellations of some or all uses (19% of total number of cases).

Reg Review Process

Of the 726 total cases, 461 are conventional agricultural pesticides. Conventional pesticides are generally produced synthetically and are used to prevent, mitigate, kill or repel any pest. They may also act as a plant growth regulator, desiccant, defoliant or nitrogen stabilizer. For conventional pesticide cases, EPA has: 

  • Completed 99% of the draft risk assessments, completed more than 90% of the proposed interim decisions and issued more than 80% of the final or interim decisions. 
  • Cancelled some or all uses in 25% of cases with final or interim decisions. 
  • Required human health and/or ecological risk mitigation for nearly 70% of cases for which EPA completed interim or final decisions. 
  • Required new or additional personal protective equipment requirements and/or engineering controls for 98% of cases where EPA required mitigations to protect human health. 
  • Required application rate reductions in 60% of cases, changes to restricted entry intervals in 30% of cases and use cancellations in 20% of cases where EPA required mitigations to protect human health.  
  • Instituted requirements to reduce pesticide drift for 80% of cases where EPA required mitigations to protect from ecological risks. 
  • Set requirements to reduce pesticide runoff, such as no-spray buffer zones, vegetative filter strips and/or application rate reductions for more than 20% of cases where EPA required mitigations to protect from ecological risks. 

Of the 726 total cases, 265 are nonconventional pesticides (140 antimicrobial pesticides and 125 biopesticides). Antimicrobial pesticides are intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms, or prevent contamination caused by bacteria, viruses, fungi, protozoa, algae or slime. Biopesticides are pesticides derived from natural materials like animals, plants, bacteria and certain minerals. For these cases, EPA has: 

  • Completed final or interim decisions for 71% of antimicrobial cases. 
  • Cancelled some or all uses in more than 30% of antimicrobial cases with interim or final decisions. 
  • Finalized human health and/or ecological risk mitigation for nearly 30% of antimicrobial cases with interim or final decisions. 
  • Increased personal protective equipment requirements and/or engineering controls for more than 65% of antimicrobial cases where EPA required mitigations to protect human health. 
  • Completed final or interim decisions for 98% of biopesticide cases. 

While EPA has completed final or interim decisions for all but 144 of the 726 total pesticide cases, EPA 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. As further described below, EPA also must comply with the Endangered Species Act (ESA) and Endocrine Disruptor Screening Program (EDSP) obligations and complete cumulative risk assessments before its registration review work can be finalized. 

Background 

In 2007, an amendment to FIFRA formalized a requirement that EPA review each registered pesticide every 15 years to determine whether pesticides continue to meet the standard for registration – that they do not present unreasonable adverse effects on human health or the environment. This amendment set the first registration review deadline as Oct. 1, 2022. During the registration review process, EPA has completed work plans, draft risk assessments, proposed interim decisions/proposed decisions and interim decisions/final decisions. Throughout this process, EPA makes its information, assessments and supporting material for each case available to the public through each case’s docket at www.regulations.gov. There are 726 conventional, biopesticide and antimicrobial pesticide cases that were registered before Oct. 1, 2007. In December 2021, EPA announced an updated registration review schedule through fiscal year 2025 and has been updating the schedule quarterly. 

In order to complete registration review for a pesticide and issue a final decision, EPA must complete an ESA listed-species assessment and any necessary ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services). For each pesticide ingredient, the entire FIFRA and ESA process typically takes no less than four years, and sometimes over 12 years. To minimize the time needed to complete this process, EPA has taken significant steps to fundamentally improve how it fulfills ESA obligations in its pesticides work. EPA’s workplan, Balancing Wildlife Protection and Responsible Pesticide Use, describes new approaches to come into compliance with ESA. 

As part of implementing the workplan, EPA expects to release a workplan update in November 2022 explaining how it will adopt early mitigation for ESA species as part of registration review decisions. Even though early mitigation does not mean that EPA has fully met its ESA obligations for a pesticide, it should contribute meaningfully to meeting those obligations and facilitate future ESA review. EPA will also host a public webinar to explain the update and other ongoing ESA efforts, including ESA pilot projects described in the workplan. More information on this event is forthcoming. 

EPA’s registration review final decisions have also taken into account EDSP screening, consistent with the Federal Food, Drug, and Cosmetic Act § 408(p). EPA is required to screen and test certain substances to determine whether they may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. EPA plans to issue a draft Endocrine Disruptor Screening Program White Paper for public comment. This white paper will address EPA’s use of new approach methodologies (NAMs) that may serve as alternatives to a vertebrate animal test and other in vitro assays. The availability of NAMs in EDSP, along with recent updates to internal EDSP standard operating procedures, represents an important next step in EPA’s efforts to rebuild this program. The current Tier 1 methods used for screening chemicals for endocrine disruption are expensive, require extensive staff time and use laboratory animals. These new approach methods will allow the Agency to screen chemicals more efficiently and ultimately provide better data.    

Finally, EPA must complete cumulative pesticide risk assessments as part of the registration review process where necessary. A cumulative risk assessment evaluates the potential for people to be exposed to more than one pesticide at a time from a group that shares an identified common mechanism of toxicity. A common mechanism of toxicity is identified when two or more chemicals or other substances cause common toxic effects by the same process. EPA’s cumulative risk assessments approximate people’s actual exposures and potential risks resulting from current uses of pesticides in different parts of the country. To develop these assessments, EPA considers potential exposures from food, drinking water and residential sources.  

In 2016, EPA published its final Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, a document that provides guidance on how to screen groups of pesticides for cumulative evaluation. The approach outlined in this document allows EPA to address the requirement under the Federal Food, Drug, and Cosmetic Act to consider available information concerning cumulative effects of pesticides having a common mechanism of toxicity while efficiently using resources. For this round of registration review, EPA has completed cumulative risk assessments for several groups of pesticides. 

Since October 2007, EPA has also approved many new pesticide active ingredients. EPA has approved 135 new biopesticides, 94 new conventional pesticides and 24 antimicrobials. These approvals have provided farmers and other pesticide users with new pest control tools alongside the cancellations and other restrictions resulting from registration review.  

As EPA works through priority registration review actions, it will keep close communication with stakeholders and continue to maintain an open and transparent process by accepting public comments at most stages of the registration review process.  

EPA Withdraws Glyphosate Interim Decision

This announcement was originally published by the EPA on September 24, 2022. Click here for more information.

 

Today, the U.S Environmental Protection Agency (EPA) is announcing its withdrawal of all remaining portions of the interim registration review decision for glyphosate. Pesticide products containing glyphosate continue to remain on the market and be used according to the product label and are unaffected by this action. 

Glyphosate is undergoing registration review, a periodic reevaluation of pesticide registrations to ensure that existing pesticide products continue to perform their intended function without unreasonable adverse effects on human health or the environment. Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), each pesticide must be reviewed every 15 years. 

On Feb. 3, 2020, EPA published the Glyphosate Interim Registration Review Decision (ID)The ID did not identify any human health risks of concern from exposure to glyphosate but did identify potential ecological risks. The ID included interim risk mitigation measures in the form of label changes, including labeling to manage spray drift and herbicide resistance. It concluded that the benefits of glyphosate outweigh the potential ecological risks when glyphosate is used in accordance with the labels. 

On March 20, 2020, the glyphosate ID was challenged in the U.S. Court of Appeals for the Ninth Circuit. Petitioners challenged EPA’s analysis of human health and ecological risk, the weighing of such risks against the benefits of glyphosate and the interim risk mitigation measures and alleged that EPA violated the Endangered Species Act (ESA). On May 18, 2021, EPA sought partial voluntary remand without vacatur of the ecological portion of the ID so the Agency could revisit aspects of its analysis in light of EPA’s November 2020 draft biological evaluation for glyphosate and recent court decisions for other herbicides, among other reasons.  

On June 17, 2022, the U.S. Court of Appeals for the Ninth Circuit vacated the human health portion of the glyphosate ID and held that EPA’s registration review decision under FIFRA was an ‘action’ that triggered ESA obligations. The court also granted EPA’s request for voluntary remand, without vacatur, of the ecological portion of the ID but imposed an Oct. 1, 2022, deadline for EPA to issue a new ecological portion. EPA sought relief from this deadline, which the court denied on Aug. 5, 2022. 

EPA has determined that withdrawal of the glyphosate ID is appropriate in consideration of the Ninth Circuit’s June 17, 2022, decision. The Agency is unable to finalize a new ecological portion in a registration review decision for glyphosate by the court-imposed Oct. 1, 2022, deadline because of the time needed to address the issues for which EPA sought remand of the ecological portion and satisfy ESA requirements. EPA initiated formal ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) for glyphosate in November 2021, and consultation is ongoing. Moreover, before issuing any decision, EPA must first prepare a proposed decision, publish for a 60-day public comment period, and consider any comments received. EPA cannot complete these processes by the court-imposed deadline.  

EPA’s underlying scientific findings regarding glyphosate, including its finding that glyphosate is not likely to be carcinogenic to humans, remain the same. In accordance with the court’s decision, the Agency intends to revisit and better explain its evaluation of the carcinogenic potential of glyphosate and to consider whether to do so for other aspects of its human health analysis. For the ecological portion, EPA intends to address the issues for which it sought remand, including: to consider whether additional or different risk mitigation may be necessary based on the outcome of ESA consultation for glyphosate, prepare an analysis of in-field effects of glyphosate on monarch butterfly habitat, consider whether there are other aspects of its analysis of ecological risks and costs to revisit, and consider what risk mitigation measures may be necessary to reduce potential risk following completion of analyses left outstanding in the ID. EPA also intends to complete ESA consultation with the Services, make a determination under the Endocrine Disruptor Screening Program, and respond to an administrative petition regarding glyphosate before issuing a final registration review decision.

A copy of the Withdrawal of the Glyphosate Interim Registration Review Decision is posted to the glyphosate registration review docket EPA-HQ-OPP-2009-0361 at https://www.regulations.gov.For more information about glyphosate, visit EPA’s website 

EPA Awards Grants to Advance Smart, Sensible, and Sustainable Pest Control in Agriculture

This original announcement was published by the EPA on September 15, 2022. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) is announcing the selection of six recipients that will receive a total of $780,000 from the Pesticide Environmental Stewardship Program (PESP) grant competition. The selected grantees will explore the use of Integrated Pest Management (IPM) in agriculture over the course of two years to reduce the risk of pests and pesticides.

While traditional pest control involves the routine application of pesticides, IPM focuses on pest prevention and only using pesticides as needed. IPM provides a more effective, environmentally sensitive approach to pest management—especially for historically underserved communities that are disproportionately impacted by unnecessary exposure to pests and pesticides. Furthermore, IPM has the potential to reduce greenhouse gas emissions that contribute to climate change. IPM strategies often use fewer pesticides resulting in less fuel consumption for pesticide application.

“As EPA works to protect human health and the environment, we’re eager to promote IPM, demonstrate its value, and provide tools to those interested in establishing IPM programs,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “The work done under this grant has the potential to minimize economic, health and environmental risks and we’re excited to see how the grantees will advance our understanding of what sustainable pest management can look like.”

The grantees are:

  • Oregon State University: Through outreach and educational efforts, this project seeks to slow the spread of herbicide-resistant weeds, preserve the useful life of current herbicides, and increase the adoption of IPM practices. The project will deliver herbicide resistance training through web-based and in-person workshops to Pacific Northwest agricultural professionals.
  • Purdue University: This project aims to increase grower adoption of integrated pest and pollinator management tactics on watermelon farms to protect pollinators. Through a statewide scouting program, project directors will partner with Illinois and Indiana growers to implement integrated pest and pollinator practices on their farms. This project aims to support 200 watermelon growers.
  • University of Florida: This project will create a process for ornamental plant growers to produce and market their products as wildlife friendly based on compatibility with pollinators and other beneficial wildlife. The project will also develop and deliver educational resources, Integrated Pest and Pollinator Management certification programs, and training opportunities for ornamental plant producers in the southeastern U.S.
  • University of Tennessee: This project seeks to improve pollinator protection and health by developing a national framework to assess the effectiveness of pollinator protection trainings. Through targeted surveys, trainings (in English and Spanish) and evaluations of trained pesticide applicators across at least 12 states, this project will assess how knowledge transfer can be successful in affecting the behavioral practices of pesticide applicators.
  • University of Vermont: This project aims to help reduce neonicotinoid seed treatments applied to row crops in Vermont by providing education in English and Spanish to more than 1,000 growers on IPM practices. The project will also provide hands-on training to 250 farmers, including tribal members and women, to assist them in making informed decisions about whether seed treatment is needed to avoid crop losses.
  • West Virginia University: This project will further educate English- and Spanish-speaking growers and pesticide applicators about pesticides and IPM tactics utilizing several outreach programs already established at West Virginia University. This includes providing pesticide workshops and sharing educational videos for hundreds of growers and applicators.

To learn more about the grantees’ projects and the work they are doing to advance sustainable agriculture, visit EPA’s webpage.

EPA Releases Data on Leaching of PFAS in Fluorinated Packaging

This original announcement was published by the EPA on September 8, 2022. Click here for more information. 

 

The U.S. Environmental Protection Agency (EPA) is taking the next step to address per- and polyfluoroalkyl substances (PFAS) related to packaging potentially used to house pesticides and other substances. EPA is releasing the results from its evaluation of several fluorinated containers to determine the potential for PFAS to leach into the contents of these containers.

Previously, EPA learned of potential PFAS contamination in a small number of mosquitocide products. Prompted by this concern, from December 2020 through January 2021, EPA studied several samples of used and unused fluorinated high-density polyethylene (HDPE) containers. In March 2021, EPA released the data that preliminarily determined PFAS was most likely formed from a chemical reaction during the container fluorination process, which then leached into the pesticide product.

To build upon the initial findings, EPA completed another study to test the leaching potential of PFAS over a specific time into test solutions packaged in different brands of HDPE fluorinated containers. The results from this study indicate:

  • Water or methanol used as surrogates for pesticide formulations (or other solutions similar to water or methanol) stored in fluorinated containers had quantifiable PFAS levels, which indicated that PFAS from container walls leached into the contents of the container.
  • The total amount of leached PFAS at each point in time varied for different brands of fluorinated containers, which is likely a reflection of different fluorination levels and techniques used to fluorinate these containers.
  • The total PFAS leached into the solutions increased gradually over the 20-week test period.
  • Higher amounts of total PFAS were found in methanol solution than in water for the same containers, an observation consistent with the chemistry of methanol as a stronger solvent in dissolving organic compounds.

Based on these results, EPA has determined that liquid products packaged in HDPE containers treated with fluorination technology could leach certain PFAS into products from the container walls, even with water-based products. In addition, the total amount of PFAS leached into the products could increase over storage time and cause undisclosed levels of PFAS in a pesticide (or other) product. It is unclear at this time if PFAS would be present in all fluorinated containers treated by different fluorination technologies (since this study did not test all containers made using such technologies).

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. Studies like this one advance EPA’s understanding of PFAS and shape further studies that can help determine the risk to human health and the environment from PFAS contamination.

EPA remains committed to using all available regulatory and non-regulatory tools to continue tackling PFAS. Most recently, EPA announced the removal of certain PFAS-related compounds from being authorized for use as inert ingredients in pesticides. This action adds to EPA’s commitment to better manage potential PFAS-related exposures to pesticides.

EPA continues to ask companies using fluorinated containers and entities providing container fluorination services to examine their distribution chains to identify potential sources of contamination. Under the Federal Insecticide, Fungicide and Rodenticide Act section 6(a)(2), pesticide registrants should report to EPA additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS).

EPA considers any level of PFAS to be potentially toxicologically significant. 6(a)(2) information about impurities must be received by EPA no later than the 30th calendar day after the registrant first possesses or knows of the information.

Furthermore, EPA considers the manufacturing of certain PFAS from the fluorination of polyolefins to be subject to EPA’s 2020 long-chain perfluoroalkyl carboxylate (LCPFAC) significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA). Specifically, the SNUR requires industry to notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use, so that EPA could review any associated risks and impose any needed protections. The failure to submit such a notification would be a violation of TSCA.

If companies find PFAS in their products, they should notify EPA and take action to remove contaminated products. If product packaging is suspected as a source and replacing the packaging is being considered, please consult with EPA on data to be submitted for review prior to distribution of the pesticide product with the alternative packaging.

As more information becomes available, EPA will continue to work with other federal entities to provide guidance to states and localities that may be affected by PFAS in pesticide containers.

To review the leaching testing results and to learn more, please visit https://www.epa.gov/pesticides/pfas-packaging.

EPA Proposes to Stop Authorized Use of Certain PFAS in Pesticide Products

This original announcement was published by the EPA on September 2, 2022. Click here for more!

 

The U.S. Environmental Protection Agency (EPA) is proposing to remove 12 chemicals identified as per- and polyfluoroalkyl substances (PFAS) from the current list of inert ingredients approved for use in pesticide products to better protect human health and the environment.

“Exposure to PFAS is an urgent public health and environmental issue in our country and we’re continuing to work aggressively to reduce the use of these dangerous chemicals,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “Ensuring that these 12 chemicals can no longer be used in pesticides is an important step to protect workers, the public, and our planet from unnecessary PFAS exposure.”

Under the PFAS Strategic Roadmap, EPA committed to taking a renewed look at previous PFAS decisions, and, as part of this review, undertook a thorough review of its list of chemical substances that have been approved for use as inert ingredients in pesticide products. EPA then used its authority to take quick action on PFAS inert ingredients not currently used in registered pesticide products.

Pesticide products contain at least one active ingredient and other intentionally added inert ingredients. Inert ingredients play key roles in pesticide effectiveness and product performance including extending the product’s shelf life or improving the ease of application by preventing caking or foaming. EPA reviews safety information for inert ingredients before they can be included in a pesticide.

While these PFAS are no longer used in any registered pesticide products, EPA determined it is important to remove these 12 chemicals from the list of approved inert ingredients to allow for an updated review of available information for these chemicals to be required, if their future use in pesticide products is requested:

  • 2-Chloro-1,1,1,2-tetrafluoroethane (CAS Reg. No. 2837-89-0);
  • α-(Cyclohexylmethyl)-ω-hydropoly(difluoromethylene) (CAS Reg. No. 65530-85-0);
  • Dichlorotetrafluoroethane (CAS Reg. No. 1320-37-2);
  • Ethane, 1,1,1,2,2-pentafluoro- (CAS Reg. No. 354-33-6);
  • Hexafluoropropene, polymer with tetrafluoroethylene (CAS Reg. No. 25067-11-2);
  • Montmorillonite-type clay treated with polytetrafluoroethylene (No CAS Reg. No.);
  • Poly(difluoromethylene), α-chloro-ω-(1-chloro-1-fluoroethyl) (CAS Reg. No. 131324-06-6);
  • Poly(difluoromethylene), α-chloro-ω-(2,2-dichloro-1,1,2-trifluoroethyl)- (CAS Reg. No. 79070-11-4);
  • Poly(difluoromethylene), α-(2,2-dichloro-2-fluoroethyl)-, ω-hydro- (CAS No. 163440-89-9);
  • Poly(difluoromethylene), α-fluoro-ω-[2-[(2-methyl-1-oxo-2- propenyl)oxy]ethyl]- (CAS Reg. No. 65530-66-7);
  • Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, ether with α-fluoro-ω-(2-hydroxyethyl)poly(difluoromethylene) (1:1) (CAS Reg. No. 65545-80-4); and
  • Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS Reg. No. 431-89-0).

Upon publication of the Federal Register notice, EPA will accept public comments on this proposal for 30 days in docket EPA-HQ-OPP-0542 at www.regulations.gov. If removed from the list, any proposed future use of these chemicals as inert ingredients will need to be supported by data which may include studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as data on environmental effects.

Pesticide registration decisions are based on extensive data requirements as outlined in 40 CFR 158 which applies to both active ingredients and the inert materials contained in end use products. EPA continues to evaluate all pesticide active ingredients to determine if any meet the current  structural definition of PFAS or are part of other related chemistries that have been identified by stakeholders as being of concern. EPA will continue to provide updates as more information becomes available.

To read a prepublication version of this proposal and for more information on inert ingredients approved for use in pesticide products visit the Inert Ingredients Overview and Guidance page.

EPA Accepting Public Comments on Nominees for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel

This original announcement was published by the EPA on July 28, 2022. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is accepting public comments on nominations for membership on the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). 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. The FIFRA SAP is a permanent panel consisting of seven members who are appointed by the EPA Administrator after being nominated by the National Institutes of Health (NIH) and the National Science Foundation (NSF). This action follows EPA’s request for nominations for the FIFRA SAP from NIH and NSF on March 24, 2022.

The Agency anticipates selecting new members to serve on the panel to replace members whose terms will soon expire. Current members of the FIFRA SAP are also eligible for reappointment during this period. Therefore, the appointments completed over the next year may include a mix of newly appointed and reappointed members.

Public comments on the nominees should be submitted to docket EPA-HQ-OPP-2022-0602 at www.regulations.gov on or before August 29, 2022. These comments will be used to assist the Agency in selecting the new members for the chartered panel. Biographies for each of the nominees are available in the docket. For additional information, please see the Federal Register notice or contact Steven Knott (knott.steven@epa.gov), M.S., DFO, Office of Program Support, Environmental Protection Agency (202-564-0103).

EPA Extends Application Period for Cooperative Agreement for the Pesticide Inspector Residential Training (PIRT) Program

This original announcement was published by the EPA on July 27, 2022. Click here for more information.

 

EPA has extended the application deadline for applications to implement the Pesticide Residential Inspector Training (PIRT) Program for CY 2023 through 2027. EPA must receive proposals through Grants.gov no later than 11:59 p.m. Eastern Time on September 8, 2022. To apply, go to grant opportunity EPA-HQ-OECA-2022-001 at Grants.gov.

Eligible applicants include states, federally recognized Indian tribes, Alaska Native Villages, inter-tribal consortia, and state and tribal institutions. Under this program EPA will provide financial assistance on an annual basis to carry out a pesticide inspector residential training program. This pesticide-related training is intended for inspectors, scientists, supervisors, and managers of pesticide regulatory programs from state/tribes and U.S. territories working under FIFRA Cooperative Agreements with EPA throughout the United States.

The Agency expects to provide an estimated $220,000-250,000 annually, depending on the Agency’s budget, for a total of up to $1,780,000 for five years (CY 2023 through 2027) depending on the Agency’s budget. EPA. EPA also expects to provide a onetime additional allocation of $530,000 at the start of the grant.

EPA Releases Draft Assessment of Effects of Sulfoxaflor on Endangered Species for Public Comment

This original announcement was published by the EPA on July 20, 2022. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is releasing its draft biological evaluation (BE) that contains EPA’s analysis of the potential effects of the insecticide sulfoxaflor on federally listed endangered and threatened (listed) species and designated critical habitats. The draft BE will be available for comment for 60 days.

Sulfoxaflor was first registered in 2013 and is 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. The draft assessment finds that, overall, when compared to insecticides like the neonicotinoids imidacloprid, clothianidin and thiamethoxam, and the organophosphate insecticides malathion, chlorpyrifos and diazinon, sulfoxaflor is less persistent and less toxic to most species, which generally leads to lower risks to human health and the environment.

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.

Background on sulfoxaflor

In 2015, the Ninth Circuit Court of Appeals vacated EPA’s 2013 sulfoxaflor registration, citing inadequate data on the effects of sulfoxaflor on bees. Following the court’s decision, EPA issued a cancellation order on Nov. 12, 2015, prohibiting the distribution or sale of sulfoxaflor.

In 2016, EPA issued a new, limited registration for sulfoxaflor, allowing its use only on crops that are not attractive to pollinators or in situations that minimize or eliminate potential exposure to bees. These new restrictions practically eliminated exposure to bees in the field, and EPA was able to register certain uses of sulfoxaflor while protecting pollinators.

In 2019, after completing a comprehensive risk assessment of the effects of sulfoxaflor that utilized a large suite of data on potential honey bee effects, EPA expanded the sulfoxaflor registration to include uses on alfalfa, corn, cacao, grains, pineapple, sorghum, teff, teosinte, tree plantations, citrus, cotton, cucurbits, soybeans, and strawberries. EPA also amended instructions for uses that were registered in 2016.

Draft biological evaluation

EPA’s draft BE finds that sulfoxaflor is likely to adversely affect certain listed species and designated critical habitats. The “likely to adversely affect” (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 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.

In this BE, EPA further refined its analysis to predict the likelihood that sulfoxaflor use could lead to jeopardy for certain listed species or adverse modification of designated critical habitats. In contrast to its LAA determinations, EPA’s draft likelihood of jeopardy and adverse modification predictions examine effects of sulfoxaflor at the species scale (population as opposed to an individual of a species). The U.S. Fish and Wildlife Service and National Marine Fisheries Service (collectively “the Services”) will make the final determination as to whether sulfoxaflor use could lead to jeopardy or adverse modification.

As part of its assessment, EPA evaluated the effects of sulfoxaflor on over 1,700 listed species and over 800 designated critical habitats in the United States, determining that sulfoxaflor, without further mitigation:

  • Will cause no effect to 36 percent of listed species and 52 percent of critical habitats;
  • May affect but is not likely to adversely affect 30 percent of listed species and 35 percent of critical habitats;
  • 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 9 percent of critical habitats; and
  • Is likely to adversely affect and EPA predicts the likelihood that use may:
    • Cause jeopardy to 7 percent of listed species; and
    • Adversely modify 4 percent of critical habitats.

EPA has begun discussions with the registrant to determine what additional mitigation measures could be implemented in the near term to protect listed species and critical habitats. In response, the registrant recently proposed additional amendments to sulfoxaflor product labels that include certain mitigation measures. EPA may consider mitigations in addition to those proposed by the registrant, such as adding or increasing buffers, imposing geographical use limits, or incorporating additional methods to reduce pesticide drift. EPA encourages public comments on the proposed label amendments and other mitigation measures that may be appropriate.

In this draft BE, EPA used historical insecticide usage data for certain use patterns and use areas to better understand where and how farmers use insecticides that target a similar group of pests as sulfoxaflor. This allowed EPA to better understand where listed species could be exposed to sulfoxaflor. The Agency is also interested in stakeholder comments regarding the usage data that EPA incorporated in the BE.

After considering public comments on the draft BE and any additional mitigations that are agreed upon with the sulfoxaflor registrant, EPA will make any appropriate changes and issue a final BE. If EPA determines in its final BE that sulfoxaflor is not likely to adversely affect listed species and/or critical habitats given the agreed-upon mitigation measures, EPA will enter informal consultation with the Service(s) for their concurrence. If EPA determines that sulfoxaflor is likely to adversely affect listed species and/or critical habitats, EPA will initiate formal consultation and share its findings with the Services. During formal consultation, the Services use EPA’s effects determinations to inform their biological opinions (BiOps), which will include the final determinations of whether a pesticide jeopardizes each relevant listed species and/or adversely modifies designated critical habitats. Through the formal consultation process, the Service(s), EPA, the sulfoxaflor registrant, and other stakeholders may develop additional mitigation measures to protect listed species and/or designated critical habitats.

The draft BE will be available for public comment for 60 days in docket EPA-HQ-OPP-2010-0889.