By Lisa R. Burchi and Barbara A. Christianson

On July 1, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2019 (2019 Report).  87 Fed. Reg. 39517.  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2019 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration.  The 2019 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA.  The report is available at EPA-HQ-OPP-2014-0125.  Comments can be submitted on or before August 30, 2022.

EPA’s completed product reregistration actions totaled 161, short of EPA’s goal of 400 actions.  The table below details the actions completed in FY 2019.

EPA also states that 4,081 products had product reregistration decisions pending at the end of FY 2019, compared to 4,193 products with product reregistration decisions pending at the end of FY 2018, and 4,370 products with product reregistration decisions pending at the end of FY 2017.  Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”

The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has dropped slightly in 2019, with 2,574, 2,303, and 1,739 in 2017, 2018, and 2019, respectively.

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By Lynn L. Bergeson and Carla N. Hutton

According to a May 9, 2022, news item published by the U.S. Environmental Protection Agency (EPA), “Advancing EPA’s Understanding of the Next Generation of Pesticides,” over the past decade, EPA “has received an increasing number of pesticide product applications that potentially contain nanomaterials.” The article notes that EPA’s current pesticide review method was not designed for nanomaterials, so each product is reviewed on a case-by-case basis. An EPA research team led by EPA scientist Dr. Chunming Su conducted an exhaustive search for patents and published literature related to nanopesticides to understand the state of the science. The item states that the team found and analyzed more than 36,000 patents and 500 peer-reviewed journal articles. The team established two general categories of nanopesticides to help inform EPA’s regulatory reviews: products with mostly metal-based nanomaterials as the active ingredient, like nanosilver and nanocopper oxide/hydroxide; and products that encapsulate and carry the active ingredient using nanomaterials (mostly carbon based) like graphene and carbon nanotubes. According to the item, the research team also developed a review framework “that includes a simple decision tree to determine what products should be classified and evaluated as a nanopesticide.” Products determined to contain nanomaterials are subject to additional assessment or data needs from the manufacturer. Dr. Andrew Byro of EPA’s Office of Pesticide Programs (OPP) states that the framework “represents a major steppingstone in the development of a method for identification of nanomaterials.” EPA will use this framework as a platform to help inform its data needs and future determinations regarding the evaluation of nanomaterials in antimicrobial pesticides.

EPA’s research team collected their findings related to the physical and chemical properties and efficacy of nanopesticides in a peer-reviewed journal article in Nature Nanotechnology, “Nano-enabled pesticides for sustainable agriculture and global food security.” According to EPA’s news item, the team “found that nano-enabled pesticides adhere better to plant surfaces and have a reduced impact on non-target organisms. Nanopesticides may also enhance plant resilience against stressors from heat or drought.” EPA states that these benefits “could lead to higher crop yield and provide more agricultural resilience to address climate change and weather extremes.” EPA notes that the research team’s findings “also highlight the data gaps and the need for additional research on potential adverse impacts of nanopesticides.”

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Bergeson & Campbell, P.C.’s (B&C^®) April 20, 2022, webinar “FIFRA Hot Topics” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/7426709986449689102. During this one-hour webinar, Lisa M. Campbell, Partner, B&C, moderated a lively and informative discussion between Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C, as they discussed key OPP developments and priorities.
 
With year one of the Biden Administration’s term in the history books, EPA OPP is focusing on long-standing challenges, especially EPA-wide efforts to implement Environmental Justice (EJ) work and determining how best to meet core pesticide registration review obligations in 2022. During this webinar, Messina spoke about the recently released Endangered Species Act (ESA) Workplan, chlorpyrifos and dicamba developments, pesticide product performance data requirements, and per- and polyfluoroalkyl substances (PFAS) issues, as Aidala followed up with questions informed by his many years of experience in senior positions at EPA.
 
We encourage you to view the webinar, subscribe to B&C’s informative FIFRAblog™ and pesticide newsletter, and access more pesticide development news directly from OPP on its website.

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By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On October 28, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report).  85 Fed. Reg. 68327.  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration.  The 2018 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA.  The report is available at EPA-HQ-OPP-2014-0125.  Comments can be submitted on or before December 28, 2020.

EPA’s completed product reregistration actions totaled 177, short of EPA’s goal of 400 actions.  The table below details the actions completed in FY 2018.

Table 1.  Product Reregistration Actions Completed in FY 2018 (as of September 30, 2018)

EPA also states that 4,193 products had product reregistration decisions pending at the end of FY 2018, compared to 4,370 products with product reregistration decisions pending at the end of FY 2017, and 4,621 products with product reregistration decisions pending at the end of FY 2016.  Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”

The number of applications for registration requiring expedited processing (i.e., “fast-track” applications) that EPA considered and approved has been more consistent in recent years, with 2,422, 2,574, and 2,303 in 2016, 2017, and 2018, respectively.

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By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

On April 6, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017 (2017 Report).  Section 4(l) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA’s annual achievements in this area.  The 2017 Report discusses the completion of tolerance reassessment and describe the status of various regulatory activities associated with reregistration.  The 2017 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA.  The report is available at EPA-HQ-OPP-2014-0125.  Comments can be submitted on or before June 5, 2020.

EPA’s completed product registration actions totaled 255, short of EPA’s goal of 600 actions.  The table below details the actions completed in FY 2017.

Table 1.—Product Reregistration Actions Completed in FY 2017 (as of September 30, 2017)

EPA also states that there were 4,370 products had product reregistration decisions pending at the end of FY 2017, compared to 4,621 products with product reregistration decisions pending at the end of FY 2016, and 5,133 products with product reregistration decisions pending at the end of FY 2015.  Regarding changes in the universe of products in product reregistration, EPA states: “an increase or decrease can be due to fluctuations in numbers of products associated with product-specific Data Call-Ins (PDCIs).”

The number of applications for registration requiring expedited processing (i.e., “fast track” applications) that EPA considered and approved has been more consistent in recent years, with 2,223, 2,422, and 2,574 in 2015, 2016, and 2017 respectively.

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By Jason E. Johnston

On September 4, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ Environmental Fate and Effects Division (EFED) announced that the next Environmental Modeling Public Meeting (EMPM) will be held on October 16, 2019.  The EMPM is a semi-annual public forum for EPA, pesticide registrants, and other stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for risk assessments in a regulatory context.

In a press release to the public, EPA indicates that the topics covered at the October meeting will include sources of usage data (relating to the actual application of pesticides, in terms of the quantity applied or units treated); spatial applications of usage data; model parameterization; extrapolation of usage data to fill in gaps; temporal variability of usage; and updates on ongoing topics.  Presentations concerning the incorporation of pesticide usage data into environmental exposure and ecological risk assessments will also be included.

Registration is required. Requests to participate in the meeting must be received on or before September 23, 2019, as noted in the Federal Register notice.

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By James V. Aidala, Lisa M. Campbell, and Sheryl Lindros Dolan

Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down.

Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown.  According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B) [7 USC § 136w-8(m)(2)(B)], the fee for any pesticide application that is subject to a service fee and submitted after December 21, 2018, will be reduced by 70 percent below the fee in effect on September 30, 2017, but no corresponding review period will be assigned.  Any applications submitted now thus will not have a required EPA review period and thus will likely be the lowest priority for EPA review when the shutdown ends.  For this reason, despite the lower fees, registrants should not submit applications until PRIA is enacted and defined review periods once again are established.

The enactment of some version of PRIA is expected soon, especially given the consequences of the current situation for EPA and government functions generally.  Most likely any kind of authorization for funding government operations, such as a CR for a limited time period or for Fiscal Year 2019, is expected to include at least a simple reauthorization of the PRIA 3 for the duration of the CR.  This would also mean the new Congress will have to act sometime in the next session to reauthorize PRIA either to continue PRIA 3 beyond a new CR time period or approve amendments such as those considered as PRIA 4 during the 115th Congress.  Given the difficulty of Congress in reaching agreement on appropriations legislation, it is possible that PRIA reauthorizations continue to be included as part of CRs for an indefinite time period.

This uncertainty about the status of PRIA may also impact generally the program’s ability to plan and schedule review of registration applications.

Regardless of when PRIA is enacted, however, the shutdown will prevent EPA action on newly submitted applications.  OPP states on its web site:

• Applications received on or prior to December 21, 2018, will be reviewed under the decision time frames specified in PRIA 3;
• Applications received after December 21, 2018, will be subject to the provisions of FIFRA Section 33(m)(2)(B); and
• Applications received after December 28, 2018, will not be considered as received or processed until the shutdown ends.

Registrants should monitor developments closely. 

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By Lisa M. Campbell and Heather F. Collins, M.S.

On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C.  The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada.  Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation. 

During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration.  The U.S. and Canadian agencies are working together to:

• Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
• Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
• Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
• Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
• Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.

Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.  

Specific times for this and other breakout sessions, as well as more detail, will be made available online.  The Stakeholder Forum is open to the public, with advance registration.  Space is limited and registrations will be accepted on a first-come-first-served basis.  Registration is available online.

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By Lynn L. Bergeson and Carla N. Hutton

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.”  According to the FWP, EPA has identified the following use patterns to date:  swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics.  The FWP states that people may be exposed to nanosilver through inhalation and dermal exposures while applying the products to swimming pools and from incidental oral exposures during swimming.  Further exposures may come from material preservative uses either while applying or from nanosilver that leaches out when textiles and plastics are washed.  Nontarget organisms can be exposed when swimming pool water is released or when nanosilver used as a material preservative leaches.  

According to the FWP, EPA “anticipates the need to require generation and submission of human health hazard and exposure data and to conduct a human health risk assessment for nanosilver during registration review.”  The FWP states that EPA plans to conduct an environmental risk assessment for the nanosilver uses, “particularly focusing on materials preservative uses, such as plastics and textiles if the particular nanosilver chemistries are shown to leach, and swimming pool uses.”  Any of the other use patterns may also be subject to ecological assessment if the fate and product chemistry profiles indicate the potential for environmental exposures.  According to the FWP, the risk assessment integrates the environmental fate and effects data to determine if any uses pose risks to nontarget organisms.  Potential risks to fish, aquatic invertebrates, aquatic plants, and birds and mammals will be assessed after the data gaps specified in the FWP are satisfied and the relevant data are available.

EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity.  EPA anticipates issuing in 2018 a DCI requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.”

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