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.