FIFRA Tutor online training courses include video lessons and detailed handout materials, including copies of all presentations and relevant course materials from the U.S. Environmental Protection Agency (EPA) and other sources. The full list of modules currently available includes:

• F101 -- An Overview of FIFRA
• F102 -- Import and Export of Pesticides
• F104 -- Reporting and Recordkeeping Requirements
• F105 -- Due Diligence and Transferring FIFRA Registrations and/or Data
• F109 -- Defining Tolerances and Their Regulation
• F110 -- Adverse Effects Reporting Requirements
• F206 -- Antimicrobial Pesticides
• F208 -- Data Citation, Data Compensation, and Data Sharing

FIFRA Tutor courses are developed and presented by members of B&C’s renowned FIFRA practice group, which includes former EPA officials, an extensive scientific staff, and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of FIFRA law, regulation, policy, compliance, and litigation.
 

Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.FIFRAtutor.com to view sample course segments and purchase modules.

Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.

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By Heather F. Collins, M.S. and Barbara A. Christianson

On May 17, 2023, the U.S. Environmental Protection Agency (EPA) announced it released, and is seeking public comment on, draft guidance that claims to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. When the guidance is issued in final, EPA states that it will fulfill the requirements outlined in the Pesticide Registration Improvement Act of 2022 (PRIA 5) and extends the goals outlined in EPA’s 2022 ESA Workplan to protect listed species from exposure to pesticides.

EPA will accept public comments on the draft guidance document for 30 days in docket EPA-HQ-OPP-2023-0281. Comments are due on or before June 16, 2023.

One of the requirements under PRIA 5 is that EPA develop, receive comments with respect to, and finalize guidance to registrants regarding analyses necessary to support the evaluation of potential adverse effects from outdoor uses of conventional pesticides and biopesticide products on listed species and designated critical habitat. EPA states that “The information in this guidance reflects lessons EPA has learned over the past several years as it continues to make progress towards meeting its ESA obligations.” PRIA 5 specifies that the draft guidance must be available for public comment and must be issued in final within nine months of PRIA 5 issuance.

The draft guidance applies to:

• New conventional pesticide and biopesticide active ingredients that are intended for outdoor use; and
• Existing conventional pesticide and biopesticide active ingredients that are intended for outdoor use that are being reevaluated under registration review.

According to EPA, the guidance document does not create new requirements for applicants, but will help applicants, through recommendations outlined in the document, address potential effects to listed species for new active ingredients and registration review actions. In particular, the recommendations focus on actions that applicants can pursue voluntarily to inform their proposed mitigation measures for listed species. These actions include identifying where a pesticide will be used, how species may be exposed to the pesticide, and how to select mitigation to reduce the exposure. If followed, these recommendations should expedite the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) action and improve the efficiency of the overall ESA-FIFRA process.

EPA states that the guidance document for new uses of existing active ingredients will be made available at a later date.

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By Barbara A. Christianson

On January 13, 2023, the U.S. Environmental Protection Agency (EPA) announced it is notifying pesticide registrants that EPA will send supplemental invoices to reflect the new annual pesticide registration maintenance fee for fiscal year (FY) 2023. To meet new statutory requirements in the Pesticide Registration Improvement Act of 2022 (PRIA 5), which was signed into law on December 29, 2022, the revised fee for FY 2023 for each registered pesticide product will be $4,875, increased from the $3,400 level specified in the EPA invoices provided in early December 2022.

According to EPA, PRIA 5 directs EPA to collect, to the extent practicable, an average amount of $42 million in pesticide registration maintenance fees annually for FYs 2023-2027. The previous collection target for FY 2023 under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) was $31 million. Additionally, EPA notes that maximum payment caps and small business caps are increased in PRIA 5 and will be reflected in the forthcoming reinvoicing.

EPA states that all registrants with FIFRA Section 3 and Section 24(c) pesticide product registrations will receive an e-mail to notify them of this change. Registrants will need to access their product filing forms, pay any outstanding portion of the revised maintenance fees, and return completed documents to EPA. EPA instructs that if a company has already made payment to EPA in response to the earlier invoicing, the company will need to pay the difference between that initial payment and the amount owed under the supplemental invoicing. As PRIA 5 was enacted following EPA’s initial invoicing and shortly before the statutory payment deadline of January 17, 2023, EPA states it understands that registrants may encounter difficulties with timely payment of appropriate FY 2023 maintenance fees but encourages registrants to submit the required fee and form to EPA as soon as possible after the supplemental invoicing. EPA also encourages registrants to reach out to it with any .(JavaScript must be enabled to view this email address).

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By Heather F. Collins, M.S.

The January 17, 2023, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental distributor registrations, which are identified by a three-element registration number.

EPA states that entire process remains electronic in 2023. EPA will not send maintenance fee information by mail again this year. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website. When completed, the filing submission should be e-mailed to .(JavaScript must be enabled to view this email address). A paper copy should not be sent to EPA.

The fee for 2023 is $3,400 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 17, 2023. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.

For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:

1. The applicant has 500 or fewer employees globally;
2. During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that does not exceed $10 million; and
3. The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.

More information on the annual maintenance fees is available on EPA’s website.

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By James V. Aidala, Heather F. Collins, M.S., and Barbara A. Christianson

On January 20, 2022, the U.S. Environmental Protection Agency (EPA) announced it is extending supply-chain flexibilities for registrants of certain conventional and biopesticide products to alleviate a supply-chain issue facing the pesticide industry.

This is an extension of EPA’s July 2, 2021, action when EPA implemented supply-chain flexibilities that allowed registrants to substitute a combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide (PO) feedstocks. This was intended to address the limited supply of PO feedstocks due to weather events that occurred in the U.S. Gulf Coast in February 2021. This action was originally set to expire on December 31, 2021, but EPA has extended these supply-chain flexibilities until December 31, 2022, due to continued disruptions to production.

EPA emphasized in its initial July 2021 action that this relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.

The pre-approved alternates for propylene glycol, a derivative of PO feedstocks, include:

• glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5);
• diethylene glycol (CAS RN 111-46-6);
• ethylene glycol (CAS RN 107-21-1); and/or
• 1,3-propanediol (CAS RN 504-63-2).

These substitutions can be added to a product formulation or a brand name mixture.

Registrants must self-certify that the substitute inert ingredients will:

• Serve the same function in the product as propylene glycol;
• Maintain the validity of product-specific data submitted in support of the registration;
• Maintain the product’s acute toxicity category and physical/chemical characteristics such that no label modifications are required; and
• Maintain the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, and any other factor.

EPA states that any registrants that wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.

Commentary

Supply-chain issues have become a national concern whether one is shopping for furniture or manufacturing pesticides. The Biden Administration across government agencies and programs has sought ways to ease difficulties as part of a national response to economic disruptions caused by the COVID-19 pandemic. Pesticide ingredients may not be subject to as much media coverage as consumer products, but in the end, could have impacts affecting availability of disinfectants and other pesticide products. In the broader economy, supply-chain issues have been identified as a factor affecting the availability of pesticides used to help meet the food and fiber production needs of the nation, along with concerns about freight capacity limiting the normal distribution of crop inputs and ultimately affecting the movement of finished crops.

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By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.

Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.

EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.

If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.

EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.

Commentary

This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.

This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.

Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.

In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.

For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.

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By Heather F. Collins, M.S.

The January 18, 2022, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental registrations of distributors, which are identified by a three-element registration number.

Due to the COVID-19 pandemic, EPA states that most EPA staff continue to telework and are not in the EPA offices; therefore, EPA will not send maintenance fee information by mail again this year. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website. When completed, the filing submission should be e-mailed to .(JavaScript must be enabled to view this email address). A paper copy should not be sent to EPA.

The fee for 2022 is $3,660 for each registration up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Tuesday, January 18, 2022. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.

For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent, if the applicant meets the following criteria:

1. The applicant has 500 or fewer employees globally;
2. During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that does not exceed $10 million; and
3. The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.

More information on the annual maintenance fees is available on EPA’s website.

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By James V. Aidala and Lisa R. Burchi

On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with the U.S. Environmental Protection Agency (EPA) to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides (Petition). The Petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition.

The Petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.

The Petition also states that EPA must take the following actions:

• Update EPA’s human health risk assessments (HHRA) for OP pesticides to use a regulatory endpoint that the Petition claims will protect children from learning disabilities and other neurodevelopmental harm.
• Complete Endangered Species Act (ESA) consultations and ensure its registrations comply with the ESA;
• Conduct endocrine disruptor screening of all pesticides.
• Complete a cumulative risk assessment for all the OPs to address their cumulative acute poisoning and neurodevelopmental effects.

The Petition focuses on 15 OPs that are currently going through registration review:

• Acephate (EPA-HQ-OPP-2008-0915);
• Bensulide (EPA-HQ-OPP-2008-0022);
• Chlorethoxyfos (EPA-HQ-OPP-2008-0843);
• Chlorpyrifos-methyl (EPA-HQ-OPP-2010-0119);
• Diazinon (EPA-HQ-OPP-2008-0351);
• Dichlorvos (EPA-HQ-OPP-2009-0209);
• Dicrotophos (EPA-HQ-OPP-2008-0440);
• Dimethoate (EPA-HQ-OPP-2009-0059);
• Ethoprop (EPA-HQ-OPP-2008-0560);
• Malathion (EPA-HQ-OPP-2009-0317);
• Naled (EPA-HQ-OPP-2009-0053);
• Phorate (EPA-HQ-OPP-2007-0674);
• Phosmet (EPA-HQ-OPP-2009-0316);
• Terbufos (EPA-HQ-OPP-2008-0119); and
• Tribufos (EPA-HQ-OPP-2008-0883).

Commentary

Now that EPA is in receipt of the Petition, it must determine that it has received a “complete” petition to revoke a tolerance based on criteria set forth in EPA’s regulations (40. C.F.R. § 180.7). If EPA determines the Petition is complete, it will publish in the Federal Register within 30 days a notice of filing for the Petition, which must include the informative summary of the Petition submitted by the petitioner. FFDCA Section 408(d)(3). A public comment period follows.

Generally, the Petition is an important signaling document that the petitioners use to outline how EPA should approach the 2022 registration review deadline for these OP products. It signals that unless EPA completes all elements of a registration review, including a complete ESA assessment and an endocrine disruptor review -- which may be impossible for EPA to complete -- then EPA should act now to revoke OP tolerances in light of arguments contained in the Petition. It stresses the environmental justice commitments announced by the Biden Administration, arguing that evidence is clear, in their view, of the need to take immediate action to end OP use across virtually all of the members of the class. It seems to anticipate that even if EPA rolls out registration reviews of the individual OP pesticides before the deadline, there will likely be comment and debate about the specific analyses and evaluation of each member of the category. This would additionally delay the completion of any revised cumulative risk assessment for the OPs.

From the view of the petitioners, not only will EPA miss the 2022 deadline, but they also argue the evidence is sufficient now for EPA to take action to revoke tolerances for these compounds based on evidence already before EPA. Other stakeholders and EPA’s eventual analyses will dispute such conclusions, but completing registration review (as defined in the Petition) will likely be impossible to complete before next October. As a result, the Petition here suggests the template these advocacy groups will use to challenge continued registration of OP products past the 2022 deadline.

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By Barbara A. Christianson

On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses.

EPA activated its EVP guidance for antimicrobial pesticides for the first time in January 2020 in response to the emergence of SARS-CoV-2. EPA has allowed for expedited review and approval of surface disinfectant products for use against SARS-CoV-2 for more than 12 months, including accelerated review for products seeking to add EVP claims to product labels. To date, EPA has added 591 products with emerging viral pathogens claims to its list of Disinfectants for Coronavirus (List N).

EPA states that registrants must remove EVP claims from consumer messaging no later than 24 months after the original notification of the outbreak, unless directed otherwise by EPA. With this extension, EPA will now provide a notification at least six months before inactivating the EVP guidance for SARS-CoV-2 to allow registrants time to adjust product marketing materials as required.

Additional information on the EVP guidance is available here.

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By Carla N. Hutton

On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3, 2021, press release, on October 15, 2021, all five agencies met as part of the Interagency Working Group (IWG) created under the 2018 Farm Bill to discuss improvements to the consultation process for pesticide registration and registration review under Section 7 of the Endangered Species Act (ESA). EPA states that the group’s first meeting resulted in specific commitments to improve the pesticide consultation process for endangered species and engaging stakeholders, including by capitalizing on the strong interest among stakeholders for a workable process.

According to the press release, the IWG is optimistic about its ability to collaborate on improvements that the Biden Administration can implement. The IWG’s actions focused on improving processes that will contribute to tangible benefits for species conservation and for stakeholders. EPA states that the IWG “is intent to adopt improvements expeditiously and that endure across administrations.” To guide its future work, the IWG has identified the following initial priorities and approaches:

• Focus on improvements that deliver real world benefits for species conservation, public health, and food production. Examples include:
  • Use pilot projects to begin implementing mitigation measures as part of upcoming pesticide consultations and to demonstrate process improvements;
  • Adopt measures early in the pesticide consultation process to avoid, minimize, and offset the effects of pesticide use on ESA-listed species; and
  • Ensure that mitigation measures are effective and practical to implement;
• Consider opportunities to engage with stakeholders as an interagency body to complement the stakeholder activities of each agency; and
• Communicate the IWG’s work to stakeholders in a transparent manner.

EPA states that “[e]ffective endangered species protection cannot be accomplished solely by federal agencies,” but also requires “open and continuous engagement with stakeholders on practical solutions to harmonizing species conservation with pesticide use.” To that end, the IWG plans to hold its first stakeholder listening session in early 2022 and will provide details on the proposed session before the end of 2021.

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