U.S. EPA - Pesticide registration review deadline: Status update and plans for remaining work

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).
  

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.