Register for Upcoming Webinar on EPA’s Research and Regulation of Pesticidal Air Treatment Devices

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

 

Sept. 6, 1-2:30 p.m. ET

Register today for a free webinar about pesticidal air treatment devices featuring EPA’s Dr. Katherine Ratliff and Aline Heffernan.

Hosted by EPA’s Office of Air and Radiation, this webinar will provide an overview of EPA’s:

  • Role in regulating pesticidal air cleaning and treatment devices;
  • Research on the effectiveness of these technologies against infectious aerosols;
  • Work on developing standardized test methods.

Register Here for Webinar

Audio for this webinar is available through GoTo Webinar only. Upon joining the webinar, connect to audio using your computer’s microphone and speakers (VoIP) or via telephone (not toll-free) and PIN.

Featured Speakers

Katherine Ratliff, Ph.D., Office of Research and Development

Dr. Ratliff is a physical scientist and principal investigator in EPA’s Homeland Security Research Program. She uses models, lab, and field-scale studies to develop strategies for remediating environmental contaminants and leads EPA’s research to evaluate the efficacy of air treatment technologies against airborne pathogens. Dr. Ratliff received her B.A. in Earth and Environmental Sciences from Vanderbilt University and a Ph.D. in Earth and Ocean Sciences from Duke University.

Aline Heffernan, MPH, Office of Chemical Safety and Pollution Prevention

Aline Heffernan is the regulatory advisor in EPA’s Antimicrobials Division, where she is the chair of the Device and Federal Insecticide, Fungicide and Rodenticide Act Jurisdiction workgroup. She previously was the division’s SARS-CoV-2 review coordinator to help determine which antimicrobials were effective in killing the virus that causes COVID-19. Heffernan received her undergraduate degree from the State University of New York at Geneseo and her master’s in public health from the State University of New York at Albany.

Register for Upcoming Webinar on EPA’s Research and Regulation of Pesticidal Air Treatment Devices

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

 

Register today for a free webinar about pesticidal air treatment devices featuring EPA’s Dr. Katherine Ratliff and Aline Heffernan.

Hosted by EPA’s Office of Air and Radiation, this webinar will provide an overview of EPA’s:

  • Role in regulating pesticidal air cleaning and treatment devices;
  • Research on the effectiveness of these technologies against infectious aerosols;
  • Work on developing standardized test methods.

Register Here for Webinar

Audio for this webinar is available through GoTo Webinar only. Upon joining the webinar, connect to audio using your computer’s microphone and speakers (VoIP) or via telephone (not toll-free) and PIN.

Featured Speakers

Katherine Ratliff, Ph.D., Office of Research and Development

Dr. Ratliff is a physical scientist and principal investigator in EPA’s Homeland Security Research Program. She uses models, lab, and field-scale studies to develop strategies for remediating environmental contaminants and leads EPA’s research to evaluate the efficacy of air treatment technologies against airborne pathogens. Dr. Ratliff received her B.A. in Earth and Environmental Sciences from Vanderbilt University and a Ph.D. in Earth and Ocean Sciences from Duke University.

Aline Heffernan, MPH, Office of Chemical Safety and Pollution Prevention

Aline Heffernan is the regulatory advisor in EPA’s Antimicrobials Division, where she is the chair of the Device and Federal Insecticide, Fungicide and Rodenticide Act Jurisdiction workgroup. She previously was the division’s SARS-CoV-2 review coordinator to help determine which antimicrobials were effective in killing the virus that causes COVID-19. Heffernan received her undergraduate degree from the State University of New York at Geneseo and her master’s in public health from the State University of New York at Albany.

Register for Webinar

EPA Registers New Active Ingredient Pyraclonil

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

 

The U.S. Environmental Protection Agency (EPA) has registered two pesticide products containing the new active ingredient pyraclonil to control weeds in water-seeded rice in California. EPA’s registration decision includes measures to protect non-target organisms, including federally threatened and endangered (listed) species and their designated critical habitats.

In addition to the registration decision, EPA has finalized the biological evaluation for this pesticide under the Endangered Species Act (ESA). Today’s action furthers the goals outlined in EPA’s April 2022 ESA Workplan by identifying potential effects to listed species, implementing necessary mitigation, and initiating the consultation process with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) prior to registration.

Background on Pyraclonil

EPA has approved two products containing pyraclonil: a technical product that can be used to formulate other products and an end-use product that is formulated as a dust-free granule that can be applied aerially to flooded rice paddies. The end-use product is registered for pre- and early post-emergence control of grass, sedge, and broadleaf weeds in water-seeded rice in California only. Notably, it may help control barnyardgrass and watergrass, two problematic weed species for rice growers in the state. Generally, weeds are important to control because they compete with rice plants for valuable nutrients and sunlight, potentially reducing yield if left uncontrolled.

Pyraclonil is also expected to be a useful addition to Integrated Pest Management and Weed Resistance Management programs for water-seeded rice in California due to its efficacy and new mode of action. Rice producers in this area can use pyraclonil in rotation with other herbicides to reduce the potential spread of herbicide resistance.

EPA’s Human Health and Ecological Risk Assessments

Before issuing this registration decision, EPA assessed whether exposures to these products would cause unreasonable adverse effects to human health and the environment, as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Based on EPA’s human health risk assessment, there are no human health risk concerns from the registered uses of pyraclonil. However, EPA’s ecological risk assessment identified several risks of concern for the environment, including risks to aquatic plant species, listed and non-listed freshwater fish, listed and non-listed estuarine and marine invertebrates, and listed mammals.

EPA’s Final Biological Evaluation

The Agency also evaluated the effects of the proposed registration on listed species and critical habitats. EPA’s final effects determination found that pyraclonil is likely to adversely affect (LAA) 12 listed species and 10 critical habitats.

An LAA determination means that EPA reasonably expects that at least one individual animal or plant, among a variety of listed species, may be exposed to pyraclonil at a sufficient level to have an adverse effect. This is the case even if a listed species is almost recovered to a point where it may no longer need to be listed. The likely “take,” which includes unintentional harm or death, of even one individual of a listed species, is enough to trigger such a determination. As a result, there are often a high number of LAA determinations. An LAA determination, however, does not necessarily mean that a pesticide is putting a species in jeopardy.

EPA further refined its analysis for the species and critical habitats where it made LAA determinations to predict the likelihood that pyraclonil use could lead to a future jeopardy finding for certain listed species or adverse modification finding for critical habitats. These predictions examine effects of pyraclonil at the species scale (as opposed to one individual of a species). EPA’s draft biological evaluation predicted that, without additional mitigation, the proposed uses of pyraclonil would present a likelihood of jeopardy for two listed species (Sacramento River winter-run Chinook Salmon and Central Valley spring-run Chinook Salmon). EPA predicted no likelihood of adverse modification to critical habitats.

Mitigations

Based on these findings, the applicant has added the following mitigations to their labeling:

  • A water holding period in treated rice paddies after pyraclonil is applied to minimize pyraclonil off-site movement to non-target areas in which listed species live; and
  • Practices to 1) prevent water seepage from treated rice paddies through berms and levees, and 2) minimize overspray of pyraclonil granules onto berms and levees.

The applicant has also revised product labeling to include a requirement that users check the Bulletins Live Two! website to identify whether there are any areas where the pesticide cannot be used. Currently, there are no geographically-specific user restrictions, however, the Services may determine these mitigations are necessary during their review.

With these mitigations in place, EPA’s final biological evaluation predicts that the use of pyraclonil will not result in unreasonable adverse effects to non-target organisms or present a likelihood of jeopardy to these species.

Next Steps

Since EPA’s final biological evaluation found that pyraclonil is likely to adversely affect some listed species and critical habitats, EPA has initiated formal consultation and shared its findings with the Services.

During formal consultation, the Services use the information in EPA’s final biological evaluation (i.e., the final effects determination, predictions of the likelihood of jeopardy/adverse modification, and EPA’s mitigations to avoid jeopardy and minimize take) to inform their biological opinions. While EPA has made predictions about the likelihood of jeopardy and adverse modification as part of its biological evaluation, the Services are responsible for making the final jeopardy/adverse modification findings and have the sole authority to do so. If the Services determine in their final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination or to address any incidental take, then EPA will work with the registrant to ensure that any necessary registration or labeling changes are made.

The registration decision and final biological evaluation are available in docket EPA-HQ-OPP-2020-0004 at www.regulations.gov.

EPA Announces the Implementation of Mitigation Measures for Insecticide Malathion to Protect Endangered Species

This original announcement was published by the EPA on August 23, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is taking action to protect endangered and threatened species by implementing the U.S. Fish and Wildlife Service’s (FWS) nationwide final biological opinion (BiOp) for the insecticide malathion. The malathion BiOp is the first nationwide BiOp issued by FWS to cover all registered uses of a pesticide across the United States and its territories. Its implementation represents the final stage in the Endangered Species Act (ESA) consultation for malathion and is the culmination of a collaborative process over more than seven years involving EPA, FWS, the U.S. Department of Agriculture, pesticide registrants and other stakeholders.  Today, EPA is implementing this BiOp by issuing Endangered Species Protection Bulletins, available on the Bulletins Live! Two website, and approving malathion label amendments to incorporate measures to protect listed species. 

Malathion is an organophosphate insecticide commonly used to control foliage and soil insect pests. It is used in the agricultural production of a wide variety of food and feed crops to control many types of insects such as aphids, leafhoppers, and Japanese beetles, as well as by home gardeners for outdoor residential uses including vegetable gardens, fruit trees, and a variety of ornamentals. Malathion-containing pesticide products also have significant public health benefits when used in pest control programs for controlling mosquito-borne illnesses. Malathion was one of the initial pilots chosen by EPA to help develop ESA consultation processes for FIFRA actions and to incorporate recommendations from the National Academy of Sciences.  Malathion was the subject of litigation, and the timing associated with EPA’s consultation was dictated by that litigation.   

Under the ESA, EPA is responsible for ensuring that its actions—including many pesticide registration actions—do not jeopardize listed species or destroy or adversely modify their designated critical habitats. EPA completes a biological evaluation (BE) to assess the risk of a pesticide to listed species. In January 2017, EPA released the BE for malathion, which determined–given malathion’s large number of labeled uses—that the registered uses of malathion have the potential to adversely affect one or more individuals of most (>90%) federally threatened or endangered (listed) species. In its BE, EPA determines if an individual of a species may be affected or not. If EPA determines that a species may be affected, then EPA uses additional information to determine if pesticide is Not Likely to Adversely Affect (NLAA) or is Likely to Adversely Affect (LAA) an individual of a species or critical habitat. If EPA makes a LAA determination, as it did with malathion for many listed species, EPA must engage in formal consultation with the Services. Practically, the LAA threshold for a BE is very conservative as the likely “take” of even one individual of a species triggers LAA (even if that species is almost recovered).   

The Service(s) then may develop a BiOp that, among other things, determines whether the pesticide is expected to jeopardize listed species or destroy or adversely modify critical habitat, and if so, requires measures to protect these listed species and critical habitats. Such measures are identified through the consultation process, which involves EPA, the Services, USDA, the pesticide applicants, and other stakeholders. 

FWS’s draft BiOp for malathion identified 78 listed species that could be jeopardized by how malathion was used before the consultation process. The final BiOp specifies agreed-upon mitigation measures including no spray zones, reductions in application rates and number of applications, and other changes to the labels that, once implemented, avoid jeopardy and adverse modification of critical habitat. Registrants involved in the consultation agreed to implement these measures by modifying their product labels, which now contain directions on how to apply the pesticide in accordance with the FWS BiOp.  

Additionally, mitigation measures that are only applicable near a species’ habitat are available on EPA’s Bulletins Live! Two website, an online system that describes geographically specific pesticide use limitations to protect listed species and their designated critical habitats. 

FWS determined that the new mitigation measures, once implemented, will adequately reduce the potential effects of malathion products on listed species. These measures will not only protect listed species but also reduce exposure and ecological effects more broadly wherever malathion is used. 

After consultations between the EPA, NMFS, FWS, and the malathion registrants and with input from USDA, the FWS and NMFS issued “no jeopardy” BiOps that were finalized on February 28, 2022, and June 30, 2022, respectively. The Services came to a “no jeopardy” determination based on mitigation measures that were identified during the consultation process.  

EPA is also working to implement the National Marine Fisheries Service’s nationwide final BiOp for malathion, chlorpyrifos and diazinon by the BiOp implementation date of December 30, 2023. The newly approved amended malathion labels include changes necessary to comply with both BiOps, but only the FWS Bulletins are currently available in Bulletins Live! Two. Registrants have submitted requests to amend their product labeling to include the necessary mitigation measures to address spray drift and runoff, as well as guidance on how to report ecological incidents associated with pesticide applications, should users observe any. EPA reviewed these amendments and approved the amended labeling.  

For additional information on the FWS BiOp and the NMFS BiOp for malathion, visit EPA’s website. The registration review process for malathion is ongoing, with the Proposed Interim Decision, proposing any additional necessary mitigations for comment, expected to be completed by the end of this year. 

EPA Amended Request for Applications for Cooperative Agreement for the Pesticide Inspector Residential Training (PIRT) Program

This original announcement was published by the EPA on August 10, 2023. Click here for more information.

 

EPA has amended the request for applications to implement the Pesticide Inspector Residential Training (PIRT) Program for FY 2024 through FY 2028. The amendment includes updates to the list of eligible entities and an updated closing date of September 1, 2023. Eligible applicants include states, public nonprofit institutions/organizations (includes institutions of higher education and hospitals), other public institutions/organizations, federally recognized lndian Tribal governments, U.S. territories and possessions (includes institutions of higher education and hospitals), Native American organizations (includes lndian groups, cooperatives, corporations, partnerships, associations).  

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 states/tribes and U.S. territories working under FIFRA Cooperative Agreements with EPA throughout the United States. 

The Agency expects to provide an estimated $500,000 annually, depending on the Agency’s budget, for a total of up to $3,000,000 for five years (FY 2024 through 2028). EPA also expects to provide a onetime additional allocation of $500,000 at the start of the grant.   

EPA must receive proposals through Grants.gov no later than 11:59 p.m. Eastern Time on September 1, 2023. To apply, go to grant opportunity EPA-HQ-OECA-2023-001 at Grants.gov.  

EPA Posts Resources on Rule to Accelerate Use of Plant-Incorporated Biotechnologies to Protect Against Pests 

This original announcement was published by the EPA on August 4, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is providing resources to help biotechnology developers exercise the full benefits of the exemptions available under the Plant Incorporated Protectants (PIPs) exemption rule. These resources are available on EPA’s public website, https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0 and include the following:

  • Fact sheet and background information on PIPs rule
  • Examples of genetic modifications that are exempt under the rule
  • Description of how to submit a self-determination or a request for EPA confirmation of exemption under the rule
  • Sample documents for submitting a self-determination or request for confirmation

The PIPs Exemption Final Rule went into effect on July 31, 2023.

Background

In May 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting two categories of plant-incorporated protectants (PIPs) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). This rule ensures that human health and the environment are protected while reducing costs for the regulated community, consistent with the September 2022 Executive Order 14081 on Advancing Biotechnology. The rule may also result in increased research and development activities, commercialization of new pest control options for farmers, and reduced use of conventional pesticides.

The final rule reflects the biotechnological advances made since 2001, when the Agency first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements, but did not at that time exempt PIPs created through biotechnology. Specifically, the final rule exempts PIPs derived through genetic engineering from FIFRA registration and FFDCA tolerance requirements in cases where the PIPs are essentially equivalent to those exempted by the 2001 rule.

The rule contains conditions for exempting:

1) PIPs in which genetic engineering has been used to insert a gene from a sexually compatible plant or to modify a gene to match a gene found in a sexually compatible plant. This category of PIPs requires EPA confirmation of eligibility for the exemption; and

2) Loss-of-function (LoF) PIPs, in which a gene is modified through genetic engineering to reduce or eliminate the activity of that gene. The loss of the activity of that gene then results in the pesticidal effect. For this category of PIP, biotechnology developers can make a self-determination that their PIP meets the exemption criteria, which requires notification but no EPA review, or request EPA confirmation of eligibility for the exemption.

EPA also indicated in the preamble to the rule that EPA would consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements and expanding the categories of PIPs that are allowed the option to self-determine and do not require EPA confirmation of eligibility for the exemption.

The resources mentioned above, as well as the final rule and additional information, including EPA’s response to comments, are available on EPA’s website https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0.

EPA Seeks Public Comments to Ensure Information on Bilingual (Spanish) Pesticide Labels Reaches the Hands of America’s Farmworkers

This original announcement was published by the EPA on August 3, 2023. Click here for more information.

 

The U.S. Environmental Protection Agency (EPA) is seeking public comments on how to make bilingual pesticide labeling accessible to farmworkers. As part of the Pesticide Registration Improvement Act of 2022, safety and health portions of pesticide product labels are required to be translated into Spanish. EPA wants input from stakeholders including labor groups, agricultural retailers, individual farmers and farmworkers and more on how to successfully set up an implementation plan that will ensure pesticide label information reaches America’s farmworkers to help prevent pesticide exposure and assist in addressing long-standing environmental justice issues.

Spanish is the primary language of communication for most American farmworkers. EPA is seeking the public’s input to create a strategy to share bilingual (Spanish) pesticide labels with farmworkers and account for communication challenges (such as lack of internet or cell service) in the nation’s farm fields. Specifically, EPA is seeking information on outreach and communication approaches, engagement methods, cultural perspectives, technology considerations, partnerships, and potential environmental justice matters.

Help EPA make pesticide product labels accessible to farmworkers by providing your feedback in public docket EPA–HQ–OPP–2023–0270, Pesticide Registration Improvement Act Bilingual Labeling Requirements: Making Bilingual Pesticide Labeling Accessible to Farmworkers on or before Monday, August 21, 2023. By improving access to bilingual (Spanish) pesticide labels, EPA hopes the implementation plan will increase knowledge, information sharing, and the safety of our nation’s farmworkers.

For general inquiries, email: OPPbilinguallabels@epa.gov.