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 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.”


 

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

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process.

EPA announced that it is considering 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 ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537.  Although the issuance of this proposed rulemaking has been 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, should it proceed, it will be important for stakeholders to review carefully.  Discussed below are the issues raised in the ANPRM for stakeholder consideration.

EPA states it is seeking public input on:

  • Whether programmatic changes are necessary to ease state regulation of federally exempt products; and
  • Whether EPA should consider adding any new classes of pesticidal substances for exemption.

Specific questions posed 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. Are these factors appropriate for EPA to consider in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
  3. Are there other factors that should be considered?  Please explain how these factors should be weighed in a minimum risk determination.
  4. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  5. Are there other pesticidal substances or systems (e.g., peat), that EPA should consider adding as a new class at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?
  6. 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.
  7. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier to identify specific chemicals used in minimum risk pesticide products?
  8. Are there state challenges to implementing the minimum risk program you would like to share with EPA?  Do you have suggestions for improvements to the program to address these issues?

Commentary

In the ANPRM, EPA states it is soliciting information that will help determine if any changes in the regulations should be made.  The ANPR does not contain specific possible changes to FIFRA exemptions.  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.”  Given the change in Administrations and the current “pause” on issuance of this proposed rulemaking, it is unclear whether EPA will issue this proposal, and if so whether EPA will take further steps regarding the exemption after reviewing the comments received.  Should EPA proceed to issue the ANPR, it will provide an opportunity for stakeholders to submit comments on these issues, and companies should consider identifying challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

It is noteworthy that EPA received a petition from the Consumer Specialty Products Association in 2006 requesting that EPA address issues related to efficacy claims for Section 25(b) products and that EPA promised to address this petition by rulemaking or other avenues.  The potential for changes to the Section 25(b) requirements thus is not a new concern for EPA, and it will be important to monitor this issue.


 

By Heather F. Collins, M.S.

The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 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, as the majority of EPA staff are still working remotely and may not be on site to receive mailed reports.

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. and Barbara A. Christianson

The January 15, 2021, 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 that 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.

This year, 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 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 emailed to .(JavaScript must be enabled to view this email address).  A paper copy should not be sent to EPA.

The fee for 2021 is $4,000 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 Friday, January 15, 2021.  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 do not exceed $10,000,000; 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, Lisa R. Burchi, and Barbara A. Christianson

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307.

The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption.  EPA on August 20, 2020, issued a Federal Register notice stating that a draft regulatory document on this issue had been forwarded to the U.S. Department of Agriculture (USDA).  EPA states that no comments were submitted on that notice by USDA or any other person.  EPA also forwarded the draft to the FIFRA Scientific Advisory Panel for review, but according to EPA, the Panel “waived review of this proposed rule, concluding that the proposed rule does not contain scientific issues that warrant scientific review by the Panel.”  On October 8, 2020, EPA again announced it was considering adding chitosan to the list of active ingredients allowed for use in minimum risk pesticides and provided a pre-publication version of the proposed rule.

EPA states in the November 2, 2020, Federal Register notice regarding the proposed rule: “Based on all the information available to the Agency, there are low risk concerns for human health or the environment if chitosan is intended for use as a minimum risk pesticide.”  According to EPA, adding chitosan to this list may save stakeholders time and money through waived FIFRA registration requirements for certain products containing chitosan.  Specifically, EPA estimates the cost savings of avoiding the application process (e.g., guideline studies, registration fees) to be up to $116,000 initially and approximately $3,400 per year thereafter for each new product.

Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701.   EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides.

Additional information on chitosan is available on our blog.


 

By Lisa M. Campbell and Lisa R. Burchi

On October 15, 2020, the U.S. Environmental Protection Agency (EPA) announced a settlement with Electrolux Home Products, Inc. (Electrolux) to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for importing air filter products that contain nanosilver.  Specifically, the settlement resolves EPA’s claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notices of Arrival in violation of FIFRA Section 12(a)(2)(N).  As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400.  The Consent Agreement and Final Order (CAFO) is available here.

According to EPA, Electrolux imported approximately 420,000 Frigidaire brand dehumidifiers and air conditioners that contained filters incorporating an unregistered nanosilver and that were labeled and marketed with pesticidal claims.  With regard to the incorporation of nanosilver, there currently are no nanosilver pesticide products registered with EPA for use in home appliances to disinfect the ambient air or protect the health of the user. The only nanosilver pesticides that are currently registered with EPA are approved solely for incorporation into textiles to protect those articles themselves from antimicrobial pests such as mold and bacteria that can cause deterioration, discoloration, or odors.  In those cases, the products (textiles) incorporated with nanosilver can be exempt from FIFRA registration under the “treated article” exemption.  With regard to the claims, EPA states that claims it considers pesticidal include “antibacterial filter,” and “helps eliminate bacteria in the air that can make breathing difficult.” 

Commentary

The penalty in this case is significant, and represents a potentially growing trend for penalty amounts substantially higher than past cases.  This trend is due at least in part to the inflation adjustments to statutory civil penalty amounts, as discussed further here

In addition to the civil penalty, the CAFO states that Electrolux has replaced the filters manufactured with nanosilver and removed the online and on-box pesticidal claims for the products it had imported, as well as some additional products already in the United States.  The CAFO states:

The SSURO also provided for the movement of subject products for the purpose of consolidating the products for a rework project whereby Respondent, among other things, would replace the filter manufactured with nanosilver contained in each unit with a filter that was not manufactured with a pesticidal substance, affix a sticker with modified language over any pesticidal claims on the product packaging, and remove all pesticidal claims made for the subject products in Respondent’s online marketing

The CAFO further states that “Respondent offered to rework all dehumidifiers and air conditioners that contained a filter manufactured with nanosilver within its possession regardless of the date those products were imported.”  To date, EPA states that Electrolux has brought over 500,000 air conditioners and dehumidifiers into compliance.


 
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