Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

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

 On May 6, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and requesting comments on, data related to aquatic toxicity of chitosan salts. 87 Fed. Reg. 27059. Specifically, EPA is seeking comments on the following two aquatic toxicity reports submitted by Tidal Vision Products, LLC (Tidal Vision), the company that submitted a petition to EPA on October 10, 2018, requesting that EPA add chitosan to the list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b):

  1. Tidal Vision USA. (2019). Aquatic Toxicology Report by Eurofins Environmental Testing Test America. Lab I.D. No. B4345. Report Date: June 17, 2019. EPA Master Record Identification (MRID) 51861901.
  2. Tidal Vision USA. (2019). Aquatic Toxicology Report by Eurofins Environmental Testing Test America. Lab I.D. No. B4421. Report Date: August 28, 2019. EPA Master Record Identification (MRID) 51861902.

EPA is seeking input on how these reports may be used by EPA in its assessment of aquatic toxicity of chitosan and its salts. EPA states “chitosan may form as a salt (e.g., acetate, lactate, hydrochloride, and salicylate) when it is solubilized in acids for end use product formulation and subsequently applied in the environment” and the new information submitted by Tidal Vision pertains to these salts.  Comments on the aquatic toxicity reports are due on or before June 6, 2022, in Docket EPA-HQ-OPP-2019-0701.

As background, EPA on August 20, 2020, announced that it was seeking to add chitosan to the list of active ingredients allowed in minimum risk pesticides that are exempt from pesticide registration requirements and was providing to the United States Department of Agriculture (USDA) for review a draft regulatory document titled ‘‘Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.”  A minimum risk product must meet six specific conditions to be exempt from pesticide registration. One of those conditions is that the active ingredient in the minimum risk pesticide be one that is listed specifically by EPA. If EPA adds chitosan to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions also are satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims).

On November 2, 2020, EPA requested comments on the proposed rule to add chitosan to the list of active ingredients eligible for the exemption. In the May 6, 2022, Notice, EPA states that  comments received on the proposed rule expressed concerns regarding derivatives of chitosan that are likely to be produced when chitosan is mixed with certain acids and on the potential hazard for aquatic organisms exposed to chitosan salts. Because of the concerns raised, EPA now is requesting comments on the two aquatic toxicity reports that pertain to these salts.

Commentary

EPA continues to remain focused on listing this specific substance rather than address other issues related to minimum risk pesticides that have been raised by industry to EPA over many years. There is, for example, a petition filed in 2006 by the Consumer Specialty Products Association (CSPA) requesting that EPA modify the minimum risk pesticide regulations to exclude products claiming to control public health pests from the Section 25(b) exemption. Comments submitted in response to the November 2, 2020, proposed rule raise additional concerns, including but not limited to the fact that the vast majority of states now require registration of minimum risk pesticides, thus shifting the burden away from EPA with costly and potential inconsistent results.

Though this EPA list is called “minimum risk,” it more accurately could be described as -- “so safe no one could, or at least should, have any concern about toxicity.”  There is long-standing reluctance for EPA to call any pesticide whatsoever as “safe” for various reasons, even to the point of an outright prohibition on using the word “safe” on registered labels.  (This is the clever distinction that “minimum risk” pesticides do meet the FIFRA definition of a pesticide, but the Section 25(b) designation allows that the label not be subject to EPA review and registration of the label.) 

This issue of possible risks from adding chitosan to the Section 25(b) list in light of the studies EPA seeks comment on appears to allow EPA to back away from its intended designation as minimum risk or to have the public comment reaffirm EPA’s assessment that chitosan’s safety profile is sufficiently beyond reproach to align with the other members of this category.  There are many other pesticides considered of very low risk but not so low as to have made the Section 25(b) list until now.  That there is a hint of debate about possible toxicity could signal that future additions to the list are being contemplated to encourage more “minimum risk” product development.  Or more simply, it may signal EPA’s reaction to the comments received has triggered some reconsideration of how “minimum” any minimum risk needs to be to qualify for the Section 25(b) list.


 

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.”


 

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.


 

By Heather F. Collins, M.S.

The March 1, 2022, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2021 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”

Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.

EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics. EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report.

Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.

Further information is available on EPA’s website.


 

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.


 

By Lisa M. Campbell and Lisa R. Burchi

On September 29, 2021, the U.S. Environmental Protection Agency (EPA) announced developments in its efforts to address per- and polyfluoroalkyl substances (PFAS) in the environment. In particular, EPA provided an update on its progress in testing pesticide products and containers for PFAS.

EPA states that as part of its ongoing efforts, it is releasing an internally validated method for the detection of 28 PFAS compounds in oily matrices, such as pesticide products formulated in oil, petroleum distillates, or mineral oils. According to EPA, the oily matrix method is modified from EPA Method 537.1, a method that is mainly used for drinking water and was previously used in analyzing PFAS in fluorinated high-density polyethylene (HDPE) containers.

The new method is intended to assist pesticide manufacturers, state regulators, and other interested stakeholders in testing oily matrix products for PFAS and joining efforts to detect any possible contamination. In the announcement, EPA states: “In a shared interest to remove PFAS from the environment, if companies find PFAS in their product, EPA is requesting that they engage in good product stewardship and notify the Agency.”

In developing this method, EPA collaborated with the Maryland Department of Agriculture. As part of this collaboration, the method was used to analyze three stored samples of mosquito control pesticide products as well as samples obtained directly from the product line from the pesticide manufacturer. EPA determined that none of the tested samples contained PFAS at or above EPA’s method limit of detection.

EPA states that its investigation continues to determine the scope of this issue and its potential impact on human health and the environment. EPA acknowledges that “[t]o date, the only PFAS contamination in mosquito control pesticide products that the Agency has identified originated from fluorinated HDPE containers used to store and transport a different mosquito control pesticide product.” EPA will continue to test additional fluorinated containers to determine whether they contain and/or leach PFAS and will present those results when the studies are complete. EPA further states it is working with other federal agencies and trade organizations to raise awareness of this issue and discuss expectations of product stewardship. EPA also is encouraging the pesticide industry to explore alternative packaging options, such as steel drums or non-fluorinated HDPE.

Additional information on EPA’s oily matrix method report and information on PFAS in pesticide packaging is available here.


 

By Kelly N. Garson and Barbara A. Christianson

On August 25, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The violations, which EPA states that Seychelle has since corrected, involved the sale of unregistered antimicrobial products and the manufacture of products in an unregistered establishment.

According to EPA, in 2017 and 2018, Seychelle sold a collection of related water filtration products known as the “Seychelle Standard Filter” and the “Seychelle Advanced Filter.” EPA states that these Seychelle filter products made “numerous” antimicrobial claims, and thus under FIFRA, EPA considered these products to be pesticides that must be registered with EPA. Additionally, under FIFRA, pesticide manufacturers must register their facilities with EPA as establishments and annually report their pesticide production. Since Seychelle’s water filter products were not produced in an EPA-registered establishment, EPA determined there was another FIFRA violation. Based on the sale or distribution of an unregistered pesticide and the unregistered establishment, EPA assessed a penalty to Seychelle in the amount of $150,000 (USD).


 

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

On August 17, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is now accepting official Foreign Purchaser Acknowledgement Statements (FPAS) and FPAS annual summaries through the Central Data Exchange Pesticide Submission Portal (CDX PSP). EPA states this improved process allows for pesticide exporters to submit an FPAS electronically rather than physically mailing them, providing a key flexibility during the COVID-19 public health emergency. According to the Federal Register notice, an FPAS may be submitted using CDX PSP as of August 18, 2021.  86 Fed. Reg. 46246.

Pesticides intended solely for export from the U.S. to a foreign country are not required to be registered in the U.S., but exporters must submit an FPAS to EPA to comply with requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 17(a)(2). An FPAS includes critical information about the pesticide intended for export, which EPA uses to notify the Designated National Authority of the importing country.

Exporters have two options for complying with FIFRA Section 17(a) and 40 C.F.R. Section 168.75 through submission of an FPAS to EPA: per-shipment reporting and annual reporting.

Per-Shipment Reporting: To comply with requirements for per-shipment reporting, the exporter must provide EPA with the signed purchaser acknowledgement statement and the accompanying certification for each export within seven working days of the exporter’s receipt of the signed statement or by the date of export (whichever occurs first). The exporter must continue to submit this documentation prior to each shipment.

Annual Reporting: The exporter must submit a signed per-shipment purchaser acknowledgement statement for the first shipment each calendar year of an unregistered pesticide product to a particular purchaser and an annual summary of shipments to that purchaser. This FPAS should indicate that the exporter is choosing to provide an annual summary and certifying that the shipment in the FPAS was the first of the calendar year.  When using the annual reporting option, the exporter is required to submit an annual report for each unregistered pesticide exported within the preceding calendar year. The exporter must submit the annual summary no later than March 1 of the following calendar year.

The annual summary report must be in writing, signed by the exporter, and include the following information:

  • The dates of each shipment of the pesticide exported to the foreign purchaser during that calendar year; and
  • If known, or reasonably ascertainable, the country or countries of final destination of the export shipments.

Information on the required contents of FPAS about submitting statements electronically is available here.


 

By Barbara A. Christianson

On June 4, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will host a webinar for pesticide registrants to provide registrants an overview on how to request Certificates of Registration, commonly known as Gold Seal letters, using the Pesticide Submission Portal. Gold Seal letters serve as proof for pesticide exporters that the product is registered with EPA and meets all necessary registration requirements.

According to EPA, since launching the digital platform in 2020 in response to the COVID-19 public health emergency, the electronic process has resulted in quicker processing of Gold Seal letters and thorough and complete internal tracking. Due to continuing safety precautions within EPA, it is still unable to produce traditional, paper-based Gold Seal letters. Accordingly, registrants must continue to submit requests through the Pesticide Submission Portal.

Stakeholders interested in attending the presentation can click here to join the online meeting (registration is not required). The webinar will be held on June 14, 2021, at 1:00 p.m. (EDT).

Information on how to request a Gold Seal certificate letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here.


 

By Lisa M. Campbell and Lisa R. Burchi

On April 8, 2021, the U.S. Environmental Protection Agency (EPA) issued an Advance Notice of Proposed Rulemaking (ANPR) to solicit information on the current pesticide exemption provision process.  86 Fed. Reg. 18232.  EPA announced its intent to issue this ANPR on January 19, 2021, as discussed here.  The issuance of the ANPR was paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies.

EPA states that it is soliciting comments and suggestions to determine whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPR are due before July 7, 2021.  Discussed below are the issues raised in the ANPR for stakeholder consideration and changes made since the ANPR was first announced in January 2021.

The ANPR is generally the same as what was first announced in January 2021, in which EPA states it is seeking public input for two main categories:

  • Whether EPA should be streamlining the petition process and revisions to how EPA evaluates the potential minimum risk active and inert substances, factors used in classes of exemptions, state implementation of the minimum risk program, and the need for any future exemptions or modifications to current exemptions; and
  • Whether EPA should consider amending existing exemptions or adding any new classes of pesticidal substances for exemption.

One important difference is that the April 2021 ANPR now includes a discussion of environmental justice.  EPA states that Executive Order 12989 directed agencies, “to the greatest extent practicable and permitted by law, to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of its actions on minority and low-income populations.”  EPA states in the ANPR that it has not identified any such disproportionate effects, since this ANPR is soliciting comments and is not proposing any specific actions or regulatory changes.

Specific questions posed that relate to environmental justice include the following:

  1. Given the identified minimum risk characteristics of these products and anticipated low impacts on communities, are current approaches effective for seeking input from the public and stakeholders, including state, local, tribal, and territorial officials, scientists, labor unions, environmental advocates, and environmental justice organizations?  Are there particular approaches that are more or less effective?
  2. Are there other policies that EPA should consider in determining whether a substance should be exempt from FIFRA regulation via the Minimum Risk Pesticide Listing Program?  For example, should EPA consider additional environmental justice and pollution prevention policies?
  3. When considering products that are a “minimum risk” to public health and the environment, should the product also be considered to be of low impact to all communities, including low-income and minority populations?  Please explain why or why not.
  4. When considering whether a category or class of products are a “minimum risk” to public health and the environment, should the category or class of products also be considered as being of low impact to all communities, including low-income and minority populations?  Are there other factors that EPA should consider?

Other questions posed that have not changed substantively since the 2021 ANPR include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  3. Are there other pesticidal substances or systems (e.g., peat) that EPA should consider adding as new classes at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?  How do these other pesticidal substances or systems meet the existing factors?
  4. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  5. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and labeling changes, made it easier for manufacturers, the public, and federal, state, and tribal inspectors to identify specific chemicals used in minimum risk pesticide products?
  6. Are there state challenges to implementing the minimum risk program?  Can EPA address those challenges with changes to its program?  Do states have suggestions for improvements to the program?

Commentary

Given the change in Administrations and the “pause” that was imposed and further review that was required before this proposed rulemaking could be issued, it was unclear whether EPA would issue this proposal.

Now that EPA has issued the ANPR, it is important for stakeholders to review these issues carefully and consider submitting comments to identify challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  EPA also notes that with regard to environmental justice, it is seeking public input on the consideration of environmental justice concerns in the context of the issues raised in the ANPR, and that “if and when the Agency proposes regulatory options regarding exemptions under FIFRA or the related procedures, EPA will seek additional input from the public, as appropriate.”


 
 1 2 3 >  Last ›