EPA Adds Chitosan to the List of Active Ingredients Eligible for Minimum Risk Pesticide Exemption

This original announcement was published by the EPA on November 9, 2022. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) finalized a rule adding chitosan (Poly-D-Glucosamine), a naturally occurring substance found in the cell walls of all crustaceans, most fungi, and the exoskeletons of most insects, to its minimum risk pesticide exemption list. In doing so, EPA is specifying that the listing also includes those chitosan salts that can be formed when chitosan is mixed with the acids that are listed as active or inert ingredients eligible for use in minimum risk pesticide products.  

The purpose of the exemption list is to eliminate the need for the Agency to expend significant resources to regulate products deemed to be of minimum risk to human health and the environment. Products that contain only those active and inert ingredients allowed by the exemption and meet certain Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requirements are exempt from the normal FIFRA registration requirements. Approximately a decade has passed since a substance was added to the list of ingredients eligible for the minimum risk pesticide exemption. 

Chitosan is currently registered with EPA under FIFRA as a fungicide, antimicrobial agent, and plant growth regulator that boosts the ability of plants to defend against fungal infections. Chitosan is currently widely available to the public for non-pesticidal uses, and has established applications in various industries including textiles, cosmetics, beverage processing, and water treatment.  

On October 10, 2018, EPA received a petition from Tidal Vision Products, LLC requesting that chitosan be added to the list of active ingredients allowed in exempted minimum risk pesticide products. In November 2020, EPA requested comments from the public on a proposed rule to add chitosan to the list of active ingredients eligible for the exemption. In November 2021, EPA requested additional information from the petitioner on chitosan salts and their potential effect on the environment. In response, received two aquatic toxicity reports which were made available for public comment via a Notice of Data Availability in May 2022. 

After reviewing the latest available science, reviewing comments on the proposed rule and on the Notice of Data Availability, EPA is now adding chitosan to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption. The Agency’s analysis of the available data suggests that chitosan and chitosan salts are of low toxicity to humans and no environmental risks of concern have been identified. As a result of this final rule, chitosan products will no longer need to be registered under FIFRA. EPA estimates this action will result in cost savings of up to $116,000 initially and about $3,400 per year thereafter for registrants and manufacturers of chitosan-containing pesticide products. 

The final rule is available in docket EPA-HQ-OPP-2019-0701 at www.regulations.gov. 

EPA Provides Annual Notification of Updates to the Environmental Chemistry Methods Index for Monitoring Pesticide Residues

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

 

The U.S. Environmental Protection Agency (EPA) is providing an annual summary of additions to the Environmental Chemistry Methods (ECM) Index made during FY 2022. The ECM Index is a list which currently includes 889 analytical methods for monitoring pesticide residues, primarily in soil or water. In the past year, 24 new analytical methods have been added to the ECM Index, including three methods for a newly registered pesticide. The ECM reports listed in the ECM Index were submitted to EPA by pesticide registrants to support submitted field and monitoring studies, and potential monitoring by states, tribes and other entities.  

ECMs may be used in conjunction with Aquatic Life Benchmarks, which are estimated concentrations below which pesticides are not expected to present a risk of concern for freshwater organisms. Comparing concentrations of a pesticide in water using ECMs to Aquatic Life Benchmarks can be helpful in interpreting monitoring data and in identifying and prioritizing monitoring sites for further investigation. State, tribal and local governments as well as international regulatory authorities and researchers may use these ECMs in their work. 

EPA updates the ECM Index quarterly and as new chemicals are registered. 

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

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

The U.S. Environmental Protection Agency (EPA) is releasing its draft biological evaluation (BE) that contains the Agency’s analysis of the potential effects of the fungicide inpyrfluxam on federally listed endangered and threatened (listed) species and their designated critical habitats. While EPA finds that inpyrfluxam is likely to adversely affect certain listed species and critical habitats, EPA does not predict that inpyrfluxam will lead to a future jeopardy or adverse modification finding for these species and habitats. The draft BE will be available for public comment for 60 days. 

The draft BE is part of EPA’s efforts to meet its obligations under the Endangered Species Act (ESA), which are discussed in EPA’s workplan: Balancing Wildlife Protection and Responsible Pesticide Use.  

Background on inpyrfluxam 

Inpyrfluxam is a fungicide that was first registered in 2020. It is used to protect a variety of crops against fungal pests, such as Rhizoctonia species, that cause seed decay, seedling damping‐off, and root rot. The proposed and currently approved product labels include some mitigation measures to reduce risks to plants and animals. These risks were identified in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) ecological risk assessments that EPA conducted before registering products containing inpyrfluxam.

After EPA registered several products containing the new active ingredient inpyrfluxam, several organizations challenged those registrations because EPA had not met its ESA obligations before issuing the registrations. Under the ESA, EPA must assess the effects of inpyrfluxam on listed species and designated critical habitats and, if necessary, initiate consultation with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service (the Services). In July 2022, the Ninth Circuit Court of Appeals ruled in Center for Biological Diversity v. EPA (No. 20-73146) that EPA was required to complete a final effects determination, which EPA will include in its final inpyrfluxam BE, by June 22, 2023. 

Draft biological evaluation 

For this draft BE, EPA evaluated the effects of inpyrfluxam on over 1,700 listed species and over 800 designated critical habitats in the United States. The BE encompasses all currently proposed and registered uses and product labels for pesticide products containing inpyrfluxam. EPA’s draft BE finds that inpyrfluxam: 

  • Will have no effect on 35 percent of species and 33 percent of designated critical habitats. 
  • May affect but is not likely to adversely affect 56 percent of species and 58 percent of designated critical habitats.  
  • Is likely to adversely affect 9 percent of listed species and 8 percent of designated critical habitats.  

A “may affect but is not likely to adversely affect” determination is made when effects on a listed species or designated critical habitat are expected to be discountable (for example, effects that are extremely unlikely to occur), insignificant, or beneficial. A “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 inpyrfluxam 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 inpyrfluxam use could lead to a future jeopardy finding for certain listed species or adverse modification finding for designated critical habitats. In contrast to its LAA determinations, EPA’s draft likelihood of jeopardy and adverse modification predictions examine effects of inpyrfluxam at the species scale (population as opposed to an individual of a species). EPA does not predict that the approved and proposed uses of inpyrfluxam would lead to future jeopardy for any listed species or adversely modify their critical habitats. While EPA has made predictions about the likelihood of jeopardy and adverse modification as part of its effects determinations consistent with 50 CFR 402.40(b)(1), the Services are responsible for making the actual jeopardy/adverse modification findings and have the sole authority to do so. 

After reviewing public comments on the draft BE, EPA will make any appropriate changes and issue a final BE. If EPA’s final BE continues to find that inpyrfluxam is likely to adversely affect listed species and/or their designated critical habitats, then EPA will initiate formal consultation and share its findings with the appropriate Service(s). During formal consultation, the Services use the information in EPA’s BE to inform their biological opinions. 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.

The draft BE is available for public comment for 60 days in docket EPA-HQ-OPP-2018-0038-0051. 

EPA Hosting Webinar on Protecting Species through Pesticide Registration Review

This original announcement was published by the EPA on October 21, 2022. Click here for more information. 

The U.S. Environmental Protection Agency (EPA) is holding a public webinar on Nov. 17, 2022, to share an update on efforts to better protect non-target species, including federally listed endangered and threatened (listed) species, from registered conventional pesticides.  

This webinar is a follow-up to EPA’s April 2022 Workplan outlining actions that will help EPA meet its obligations under the Endangered Species Act (ESA). The webinar will include information on practical protections for non-target organisms, including listed species that EPA expects to adopt as part of many future registration review decisions.  

During the webinar, EPA staff will discuss: 

  • Efforts to develop mitigation measures to protect species during the registration review process for conventional pesticides. 
  • The continued use of Bulletins Live! Two as a tool to set forth geographically specific pesticide use limitations to protect certain listed species. 
  • Additional approaches for advancing the second and third strategies in the April 2022 Workplan: improving approaches to ESA mitigation and improving the interagency consultation process. 
  • Opportunities for public participation. 

EPA invites all interested stakeholders to attend. The Nov. 17 meeting will be held via webinar from 1–2:30 p.m. EST. A meeting link and agenda will be sent to everyone who registers for the event. 

Register now

Background 

When EPA registers a pesticide or reevaluates it in registration review, the Agency has a responsibility under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to determine whether the pesticide presents unreasonable adverse effects on human health or the environment. EPA conducts human health and ecological risk assessments to determine what risks are posed by a pesticide and whether changes to the use or proposed use are necessary to protect the environment.  

EPA also has a responsibility under the ESA to ensure that certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats.  In the past couple of decades, EPA has seen an increase in litigation due to the Agency’s failures to meet its ESA obligations when taking FIFRA actions. In April 2022, EPA released a workplan to address the complexity of meeting its ESA obligations under FIFRA. Because EPA does not have the capacity or scientific processes in place to meet all of its obligations immediately, the workplan identifies the FIFRA actions that are the highest priority for fulfilling its ESA obligations. These include actions with court-enforceable deadlines and new registrations of conventional pesticides.  

The ESA workplan also outlines extensive actions that EPA will pursue over time, in collaboration with other federal agencies, to improve protection for listed species and meet its ESA obligations while minimizing regulatory impacts to pesticide users.  

As part of implementing the workplan, EPA continues to consider strategies and processes to address its ESA obligations for registration review decisions. As part of the webinar, EPA will discuss FIFRA mitigation measures that EPA is considering proposing to address risks to non-target species, including listed species, and other key steps the Agency plans to pursue under its workplan.     

EPA Releases Updated Lists of Disinfectants for Emerging Viral Pathogens Including Ebola

This original announcement was published by the EPA on October 19, 2022. Click here for more information.

 

On October 12, 2022, EPA triggered its emerging viral pathogen (EVP) guidance in support of the Centers for Disease Control and Prevention’s (CDC) response to the Ebola virus cases in western Uganda. With EPA’s EVP guidance, additional disinfectants, for which emerging viral pathogen claims have been approved, can be used against the Ebola virus. 

EPA developed its EVP guidance to facilitate the availability of EPA-registered disinfectants for use against emerging viral pathogens. EPA divides viruses into three tiers based on how difficult they are to kill. The Ebola virus falls into Tier 1, the category of viruses that are easiest to kill. Thus, EPA expects disinfectants qualified for use against any emerging viral pathogens in Tiers 1, 2, and 3 to be effective against the Ebola virus when used according to the label use directions.  

The use of products with EVP claims supplements but does not replace other infection control practices. Individuals should follow CDC, state, and local public health guidelines.  

EPA’s website provides the list of products registered for use against Ebola and list of disinfectants for emerging viral pathogens.

EPA Responds to Petition and Releases Revised Human Health Risk Assessment for Tetrachlorvinphos

This original announcement was published by the EPA on October 13, 2022. Click here for more information.

 

Today, the U.S. Environmental Protection Agency (EPA) released a revised human health risk assessment for the pesticide tetrachlorvinphos (TCVP) and its registered pet uses to control various insects including public health pests such as fleas, ticks, flies, lice, and pest larvae. 

Based on this assessment, the Agency is issuing a partial grant / partial denial of the Natural Resources Defense Council’s (NRDC) 2009 petition to cancel all pet uses of TCVP and is moving to draft a proposed Notice of Intent to Cancel (NOIC) the TCVP pet collars registrations. Having conducted an extensive evaluation of available data on TCVP’s potential human health impacts, EPA finds that there are unacceptable risks from pet collars for children exposed when contacting pets wearing collars and is granting the petition as to pet collars containing TCVP. However, it is EPA’s understanding that the registrant is currently working on two studies related to the risks of TCVP from pet collars and plans to submit that data to EPA by the end of the year. Should the Agency receive data that impacts the current conclusions for TCVP pet collars, the Agency will review that data, make its review publicly available, update the TCVP risk assessment as appropriate, and make this information available for public comment. Additionally, EPA is denying the petition as to the remainder of currently registered TCVP pet uses based on the Agency not finding risks of concern to residents from use of liquid pumps/trigger sprays containing TCVP. 

Petition response 

EPA initially issued a denial of NRDC’s petition in November 2014 based on the available data at the time. In January 2015, NRDC filed a petition for review of EPA’s denial. In September 2015, EPA sought a voluntary remand of its 2014 denial, which the Court granted in June 2016. In December 2016, EPA issued a new risk assessment for TCVP, and EPA informed NRDC in March 2017 that the Agency intended to address any risk mitigation issues in the course of registration review. On a Petition for Writ of Mandamus, the Ninth Circuit ordered EPA to respond to NRDC’s petition by July 21, 2020, which EPA did by denying the petition. On a Petition for Review of that 2020 denial, the Court vacated EPA’s decision and remanded to the Agency for a new decision by October 11, 2022.  

Upon reevaluation of the data in the October 2022 revised human health risk assessment, the Agency found that risk estimates for all pet collars exceeded the level of concern for residential uses. Risk estimates for currently registered liquid sprays containing TCVP do not exceed EPA’s level of concern. Based on currently available data and taking into consideration the benefits of currently registered residential uses for TCVP, EPA cannot determine that there are no unreasonable adverse effects from residential exposure to TCVP in pet collars. EPA is granting the petition to cancel TCVP use in pet collars in order to reduce risks to vulnerable populations, especially children, by reducing TCVP exposure from pet collars. 

EPA is moving to draft a proposed NOIC for TCVP pet collars but is awaiting more data from the registrant that the registrant has informed EPA it is preparing. EPA intends to incorporate into the drafting of the NOIC any data received by the end of the year. Should the new data change the Agency’s conclusions, those conclusions will be captured in an updated risk assessment, as well as the Proposed Interim Decision (PID) for TCVP, which will be open for public comment. The Agency would not further pursue a NOIC if the data demonstrate that there is no longer a risk of concern for any TCVP pet collars. 

Revised human health risk assessment 

The October 2022 revised human health risk assessment updates a 2020 risk assessment and uses a more refined assessment of exposure data. EPA reevaluated the methodology used in a pet collar dust torsion study submitted and originally reviewed in 2019 and determined that the study did not adequately assess the physical form (liquid or dust) of TCVP released from the pet collars.  

The October 2022 revised human health risk assessment is the basis for EPA’s response to NRDC’s petition on remand and will also be incorporated into the ongoing registration review of TCVP under section 3(g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (a separate process from the NRDC response). FIFRA section 3(g) requires EPA to review pesticides every 15 years to ensure that risk assessments reflect the best available science, and to ensure that registered products in the marketplace do not present unreasonable adverse effects to human health and the environment.  

The action EPA is announcing today also responds to the Ninth Circuit U.S. Court of Appeals’ vacatur of EPA’s 2020 denial of NRDC’s petition to cancel all pet uses of TCVP and remand to the Agency to issue a new response to NRDC’s petition by October 11, 2022. 

EPA will take public comment on the revised human health risk assessment during the same 60-day public comment period that the Agency plans to open when it issues its PID in 2023. The PID, which is the next step in the FIFRA registration review process, will outline potential risk management options for this insecticide to address any potential risks of concern identified in the draft risk assessments. EPA will update the TCVP risk assessment and make this updated information available for public comment. Should data be submitted to EPA by the end of the year that demonstrates that there is no longer a risk of concern for any TCVP pet collars, the Agency would no longer pursue a NOIC. Based on the currently available data, EPA is moving to initiate a NOIC for TCVP pet collars. Learn more about the registration review process. 

EPA always encourages consumers to read and follow all pesticide product labels. Product labels are the law, and they are a vital part of EPA’s efforts to ensure that consumers have the information they need to safely, legally, and effectively use EPA-approved pesticide products.    

Consumers should continue to read the label and take certain precautions when handling TCVP products in residential areas. These precautions are listed on TCVP product labels, including not allowing children to play with TCVP pet collar products, keeping TCVP spray out of reach of children, and washing hands thoroughly with soap and water after handling. 

EPA Releases Test Methods and Guidance for Long-Lasting Antimicrobial Efficacy Claims

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

Today, the U.S. Environmental Protection Agency (EPA) is issuing finalized guidance and test methods for registering antimicrobial products with residual efficacy against viruses and bacteria. While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks or years after the product is applied.  

Public interest in products with residual efficacy has increased during the COVID-19 public health emergency. In October 2020, EPA issued interim guidance and test methods for public comment as a pathway for companies to add claims of residual efficacy to their products’ labels.  

In finalizing the guidance, EPA made minor modifications to better represent the real-world conditions under which products with residual efficacy will be used. These revisions were based on data from EPA laboratory studies and information submitted through public comments.  

The finalized test methods and guidance are available at docket EPA-HQ-OPP-2020-0529 at regulations.gov.  

EPA maintains both a list of traditional disinfectants that kill the virus that causes COVID-19 (List N) and a list of products with residual efficacy that can be used to supplement routine cleaning and disinfection against the virus (List N Appendix). In addition, EPA also recently released a list of products effective against emerging viral pathogens, including monkeypox (List Q). 

Read the Guidance for Products Adding Residual Efficacy Claims.

 

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 pesticides, and 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.